Stelara

Description for Stelara Injection

Ustekinumab is a human IgG1κ monoclonal antibody against the p40 subunit of the IL-12 and IL-23 cytokines. Using DNA recombinant technology, ustekinumab is produced in a well characterized recombinant cell line and is purified using standard bio-processing technology. The manufacturing process contains steps for the clearance of viruses. Ustekinumab is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons.

STELARA^® (ustekinumab) Injection is a sterile, preservative-free, colorless to light yellow solution and may contain a few small translucent or white particles with pH of 5.7- 6.3.

STELARA^® For Subcutaneous Use

Available as 45 mg of ustekinumab in 0.5 mL and 90 mg of ustekinumab in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 27 gauge fixed ½ inch needle and as 45 mg of ustekinumab in 0.5 mL in a single-dose 2 mL Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cover that contains dry natural rubber (a derivative of latex).

Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab, L-histidine and L-histidine monohydrochloride monohydrate (0.5 mg), Polysorbate 80 (0.02 mg), and sucrose (38 mg).

Each 1 mL prefilled syringe delivers 90 mg ustekinumab, L-histidine and L-histidine monohydrochloride monohydrate (1 mg), Polysorbate 80 (0.04 mg), and sucrose (76 mg).

STELARA^® For Intravenous Infusion

Available as 130 mg of ustekinumab in 26 mL, supplied as a single-dose 30 mL Type I glass vial with a coated stopper.

Each 26 mL vial delivers 130 mg ustekinumab, EDTA disodium salt dihydrate (0.52 mg), L-histidine (20 mg), L-histidine hydrochloride monohydrate (27 mg), L-methionine (10.4 mg), Polysorbate 80 (10.4 mg) and sucrose (2210 mg).

INDICATIONS AND USAGE

Plaque Psoriasis (PsO)

STELARA is indicated for the treatment of adults and pediatric patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

Psoriatic Arthritis (PsA)

STELARA is indicated for the treatment of adults and pediatric patients 6 years of age and older with active psoriatic arthritis.

Crohn’s Disease (CD)

STELARA is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease.

Ulcerative Colitis

STELARA is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.

Dosage for Stelara Injection

Recommended Dosage in Plaque Psoriasis

Subcutaneous Adult Dosage Regimen

• For patients weighing 100 kg or less, the recommended dosage is 45 mg initially and 4 weeks later, followed by 45 mg every 12 weeks.
• For patients weighing more than 100 kg, the recommended dosage is 90 mg initially and 4 weeks later, followed by 90 mg every 12 weeks.

In subjects weighing more than 100 kg, 45 mg was also shown to be efficacious. However, 90 mg resulted in greater efficacy in these subjects [see Clinical Studies (14)].

Subcutaneous Pediatric Dosage Regimen

Administer STELARA subcutaneously at Weeks 0 and 4, then every 12 weeks thereafter.

The recommended dose of STELARA for pediatric patients 6 years of age and older with plaque psoriasis based on body weight is shown below (Table 1).

Table 1: Recommended Dose of STELARA for Subcutaneous Injection in Pediatric Patients 6 Years of Age and Older With Plaque Psoriasis

Body Weight of Patient at the Time of Dosing	Recommended Dose
less than 60 kg	0.75 mg/kg
60 kg to 100 kg	45 mg
more than 100 kg	90 mg

For pediatric patients weighing less than 60 kg, the administration volume for the recommended dose (0.75 mg/kg) is shown in Table 2; withdraw the appropriate volume from the vial.

Table 2: Injection volumes of STELARA 45 mg/0.5 mL Vials for Pediatric Patients 6 Years of Age and Older With Plaque Psoriasis and Pediatric Patients 6 Years of Age and Older With Psoriatic Arthritis* Weighing Less Than 60 kg

Body Weight (kg) at the time of dosing	Dose (mg)	Volume of injection (mL)
15	11.3	0.12
16	12	0.13
17	12.8	0.14
18	13.5	0.15
19	14.3	0.16
20	15	0.17
21	15.8	0.18
22	16.5	0.18
23	17.3	0.19
24	18	0.20
25	18.8	0.21
26	19.5	0.22
27	20.3	0.22
28	21	0.23
29	21.8	0.24
30	22.5	0.25
31	23.3	0.26
32	24	0.27
33	24.8	0.28
34	25.5	0.28
35	26.3	0.29
36	27	0.30
37	27.8	0.31
38	28.5	0.32
39	29.3	0.32
40	30	0.33
41	30.8	0.34
42	31.5	0.35
43	32.3	0.36
44	33	0.37
45	33.8	0.38
46	34.5	0.38
47	35.3	0.39
48	36	0.40
49	36.8	0.41
50	37.5	0.42
51	38.3	0.43
52	39	0.43
53	39.8	0.44
54	40.5	0.45
55	41.3	0.46
56	42	0.46
57	42.8	0.47
58	43.5	0.48
59	44.3	0.49
* Refer to 2.2 Psoriatic Arthritis; Subcutaneous Pediatric Dosage Regimen.

Recommended Dosage in Psoriatic Arthritis

Subcutaneous Adult Dosage Regimen

• The recommended dosage is 45 mg initially and 4 weeks later, followed by 45 mg every 12 weeks.
• For patients with co-existent moderate-to-severe plaque psoriasis weighing more than 100 kg, the recommended dosage is 90 mg initially and 4 weeks later, followed by 90 mg every 12 weeks.

Subcutaneous Pediatric Dosage Regimen

Administer STELARA subcutaneously at Weeks 0 and 4, then every 12 weeks thereafter.

The recommended dose of STELARA for pediatric patients 6 years of age and older with psoriatic arthritis, based on body weight, is shown below (Table 3).

Table 3: Recommended Dose of STELARA for Subcutaneous Injection in Pediatric Patients 6 Years of Age and Older With Psoriatic Arthritis

Body Weight of Patient at the Time of Dosing	Recommended Dose
less than 60 kg*	0.75 mg/kg
60 kg or more	45 mg
greater than 100 kg with co-existent moderate-to-severe plaque psoriasis	90 mg
* For pediatric patients weighing less than 60 kg, the administration volume for the recommended dose (0.75 mg/kg) is shown in Table 2; withdraw the appropriate volume from the vial.

Recommended Dosage in Crohn’s Disease and Ulcerative Colitis

Intravenous Induction Adult Dosage Regimen

A single intravenous infusion dose of STELARA using the weight-based dosage regimen specified in Table 4 [see Instructions for dilution of STELARA 130 mg vial for intravenous infusion (2.5)].

Table 4: Initial Intravenous Dosage of STELARA

Body Weight of Patient at the time of dosing	Dose	Number of 130 mg/26 mL (5 mg/mL) STELARA vials
55 kg or less	260 mg	2
more than 55 kg to 85 kg	390 mg	3
more than 85 kg	520 mg	4

Subcutaneous Maintenance Adult Dosage Regimen

The recommended maintenance dosage is a subcutaneous 90 mg dose administered 8 weeks after the initial intravenous dose, then every 8 weeks thereafter.

General Considerations for Administration

• STELARA is intended for use under the guidance and supervision of a healthcare STELARA should only be administered to patients who will be closely monitored and have regular follow-up visits with a healthcare provider. The appropriate dose should be determined by a healthcare provider using the patient’s current weight at the time of dosing. In pediatric patients, it is recommended that STELARA be administered by a healthcare provider. If a healthcare provider determines that it is appropriate, a patient may self-inject or a caregiver may inject STELARA after proper training in subcutaneous injection technique. Instruct patients to follow the directions provided in the Instructions for Use [see Instructions for Use].
• The needle cover on the prefilled syringe contains dry natural rubber (a derivative of latex). The needle cover should not be handled by persons sensitive to latex.
• It is recommended that each injection be administered at a different anatomic location (such as upper arms, gluteal regions, thighs, or any quadrant of abdomen) than the previous injection, and not into areas where the skin is tender, bruised, erythematous, or indurated. When using the vial, a 1 mL syringe with a 27 gauge, ½ inch needle is recommended.
• Prior to administration, visually inspect STELARA for particulate matter and discoloration. STELARA is a colorless to light yellow solution and may contain a few small translucent or white Do not use STELARA if it is discolored or cloudy, or if other particulate matter is present. STELARA does not contain preservatives; therefore, discard any unused product remaining in the vial and/or syringe.

Preparation and Administration of STELARA 130 mg/26 mL (5 mg/mL) Vial for Intravenous Infusion (Crohn’s Disease and Ulcerative Colitis)

STELARA solution for intravenous infusion must be diluted, prepared, and infused by a healthcare professional using aseptic technique.

1. Calculate the dose and the number of STELARA vials needed based on patient weight (Table 4). Each 26 mL vial of STELARA contains 130 mg of ustekinumab.
2. Withdraw, and then discard a volume of the 0.9% Sodium Chloride Injection, USP from the 250 mL infusion bag equal to the volume of STELARA to be added (discard 26 mL sodium chloride for each vial of STELARA needed, for 2 vials- discard 52 mL, for 3 vials- discard 78 mL, 4 vials- discard 104 mL). Alternatively, a 250 mL infusion bag containing 0.45% Sodium Chloride Injection, USP may be used.
3. Withdraw 26 mL of STELARA from each vial needed and add it to the 250 mL infusion bag. The final volume in the infusion bag should be 250 mL. Gently mix.
4. Visually inspect the diluted solution before Do not use if visibly opaque particles, discoloration or foreign particles are observed.
5. Infuse the diluted solution over a period of at least one hour. Once diluted, the infusion should be completely administered within eight hours of the dilution in the infusion bag.
6. Use only an infusion set with an in-line, sterile, non-pyrogenic, low protein-binding filter (pore size 0.2 micrometer).
7. Do not infuse STELARA concomitantly in the same intravenous line with other
8. STELARA does not contain preservatives. Each vial is for a one-time use in only one patient. Discard any remaining solution. Dispose any unused medicinal product in accordance with local requirements.

Storage

If necessary, the diluted infusion solution may be kept at room temperature up to 25 °C (77 °F) for up to 7 hours. Storage time at room temperature begins once the diluted solution has been prepared. The infusion should be completed within 8 hours after the dilution in the infusion bag (cumulative time after preparation including the storage and the infusion period). Do not freeze. Discard any unused portion of the infusion solution.

HOW SUPPLIED

Dosage Forms And Strengths

STELARA (ustekinumab) is a colorless to light yellow solution and may contain a few small translucent or white particles.

Subcutaneous Injection

• Injection: 45 mg/0.5 mL or 90 mg/mL solution in a single-dose prefilled syringe
• Injection: 45 mg/0.5 mL solution in a single-dose vial

Intravenous Infusion

• Injection: 130 mg/26 mL (5 mg/mL) solution in a single-dose vial

How supplied/Storage And Handling

STELARA^® (ustekinumab) injection is a sterile, preservative-free, colorless to light yellow solution and may contain a few small translucent or white particles. It is supplied as individually packaged, single-dose prefilled syringes or single-dose vials.

For Subcutaneous Use

Prefilled Syringes

• 45 mg/0.5 mL (NDC 57894-060-03)
• 90 mg/mL (NDC 57894-061-03)

Each prefilled syringe is equipped with a 27-gauge fixed ½ inch needle, a needle safety guard, and a needle cover that contains dry natural rubber.

Single-dose Vial

• 45 mg/0.5 mL (NDC 57894-060-02)

For Intravenous Infusion

Single-dose Vial

• 130 mg/26 mL (5 mg/mL) (NDC 57894-054-27)

Storage and Stability

Store STELARA vials and prefilled syringes refrigerated between 2 ºC to 8 ºC (36 ºF to 46 ºF). Store STELARA vials upright. Keep the product in the original carton to protect from light until the time of use. Do not freeze. Do not shake.

If needed, individual prefilled syringes may be stored at room temperature up to 30 °C (86 °F) for a maximum single period of up to 30 days in the original carton to protect from light. Record the date when the prefilled syringe is first removed from the refrigerator on the carton in the space provided. Once a syringe has been stored at room temperature, do not return to the refrigerator. Discard the syringe if not used within 30 days at room temperature storage. Do not use STELARA after the expiration date on the carton or on the prefilled syringe.

Side Effects for Stelara Injection

The following serious adverse reactions are discussed elsewhere in the label:

• Infections [see Warnings and Precautions (5.1)]
• Malignancies [see Warnings and Precautions (5.4)]
• Hypersensitivity Reactions [see Warnings and Precautions (5.5)]
• Posterior Reversible Encephalopathy Syndrome (PRES) [see Warnings and Precautions (5.6)]
• Noninfectious Pneumonia [see Warnings and Precautions (5.8)]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adult Subjects with Plaque Psoriasis

The safety data reflect exposure to STELARA in 3117 adult subjects with plaque psoriasis, including 2414 exposed for at least 6 months, 1855 exposed for at least one year, 1653 exposed for at least two years, 1569 exposed for at least three years, 1482 exposed for at least four years and 838 exposed for at least five years.

Table 5 summarizes the adverse reactions that occurred at a rate of at least 1% with higher rates in the STELARA groups during the placebo-controlled period of Ps STUDY 1 and Ps STUDY 2 [see Clinical Studies (14)].

Table 5: Adverse Reactions, Reported by ≥1% of Subjects with Plaque Psoriasis and at Higher Rates in the STELARA groups through Week 12 in Ps STUDY 1 and Ps STUDY 2

Subjects treated	Placebo (665)	STELARA 45 mg (664)	STELARA 90 mg (666)
Nasopharyngitis	51 (8%)	56 (8%)	49 (7%)
Upper respiratory tract infection	30 (5%)	36 (5%)	28 (4%)
Headache	23 (3%)	33 (5%)	32 (5%)
Fatigue	14 (2%)	18 (3%)	17 (3%)
Back pain	8 (1%)	16 (2%)	19 (3%)
Dizziness	8 (1%)	8 (1%)	14 (2%)
Pharyngolaryngeal pain	7 (1%)	9 (1%)	9 (1%)
Pruritus	9 (1%)	10 (2%)	9 (1%)
Injection site erythema	3 (<1%)	6 (1%)	6 (1%)
Myalgia	4 (1%)	7 (1%)	8 (1%)
Depression	3 (<1%)	8 (1%)	4 (1%)

Adverse reactions that occurred at rates less than 1% in the controlled period of Ps STUDIES 1 and 2 through week 12 included: cellulitis, herpes zoster, diverticulitis, and certain injection site reactions (pain, swelling, pruritus, induration, hemorrhage, bruising, and irritation).

One case of PRES occurred during clinical trials in adult subjects with plaque psoriasis [see Warnings and Precautions (5.6)].

Infections

In the placebo-controlled period of clinical trials of subjects with plaque psoriasis (average follow- up of 12.6 weeks for subjects receiving placebo and 13.4 weeks for STELARA-treated subjects), 27% of STELARA-treated subjects reported infections (1.39 per patient-years of follow-up) compared with 24% of subjects receiving placebo (1.21 per patient-years of follow-up). Serious infections occurred in 0.3% of STELARA-treated subjects (0.01 per patient-years of follow-up) and in 0.4% of subjects receiving placebo (0.02 per patient-year of follow-up) [see Warnings and Precautions (5.1)].

In the controlled and non-controlled portions of clinical trials in subjects with plaque psoriasis (median follow-up of 3.2 years), representing 8998 patient-years of exposure, 72.3% of STELARA-treated subjects reported infections (0.87 per patient-years of follow-up). Serious infections were reported in 2.8% of subjects (0.01 per patient-years of follow-up).

Malignancies

In the controlled and non-controlled portions of clinical trials in subjects with plaque psoriasis (median follow-up of 3.2 years, representing 8998 patient-years of exposure), 1.7% of STELARA-treated subjects reported malignancies excluding non-melanoma skin cancers (0.60 per hundred patient-years of follow-up). Non-melanoma skin cancer was reported in 1.5% of STELARA-treated subjects (0.52 per hundred patient-years of follow-up) [see Warnings and Precautions (5.4)]. The most frequently observed malignancies other than non-melanoma skin cancer during the clinical trials were: prostate, melanoma, colorectal and breast. Malignancies other than non- melanoma skin cancer in STELARA-treated subjects during the controlled and uncontrolled portions of trials were similar in type and number to what would be expected in the general U.S. population according to the SEER database (adjusted for age, gender and race).¹

Pediatric Subjects with Plaque Psoriasis

The safety of STELARA was assessed in two trials of pediatric subjects with moderate to severe plaque psoriasis. Ps STUDY 3 evaluated safety for up to 60 weeks in 110 pediatric subjects 12 to 17 years old. Ps STUDY 4 evaluated safety for up to 56 weeks in 44 pediatric subjects 6 to 11 years old. The safety profile in pediatric subjects was similar to the safety profile from trials in adults with plaque psoriasis.

Psoriatic Arthritis

The safety of STELARA was assessed in 927 subjects in two randomized, double-blind, placebo- controlled trials in adults with active psoriatic arthritis (PsA). The overall safety profile of STELARA in subjects with PsA was consistent with the safety profile seen in clinical trials in adult subjects with plaque psoriasis. A higher incidence of arthralgia, nausea, and dental infections was observed in STELARA-treated subjects when compared with placebo-treated subjects (3% vs. 1% for arthralgia and 3% vs. 1% for nausea; 1% vs. 0.6% for dental infections) in the placebo- controlled portions of the PsA clinical trials.

Crohn’s Disease

The safety of STELARA was assessed in 1407 subjects with moderately to severely active Crohn’s disease (Crohn’s Disease Activity Index [CDAI] greater than or equal to 220 and less than or equal to 450) in three randomized, double-blind, placebo-controlled, parallel-group, multicenter trials. These 1407 subjects included 40 subjects who received a prior investigational intravenous ustekinumab formulation but were not included in the efficacy analyses. In trials CD-1 and CD-2 there were 470 subjects who received STELARA 6 mg/kg as a weight-based single intravenous induction dose and 466 who received placebo [see Dosage and Administration (2.3)]. Subjects who were responders in either trial CD-1 or CD-2 were randomized to receive a subcutaneous maintenance regimen of either 90 mg STELARA every 8 weeks, or placebo for 44 weeks in trial CD-3. Subjects in these 3 trials may have received other concomitant therapies including aminosalicylates, immunomodulatory agents [azathioprine (AZA), 6-mercaptopurine (6-MP), methotrexate (MTX)], oral corticosteroids (prednisone or budesonide), and/or antibiotics for their Crohn’s disease [see Clinical Studies (14.4)].

The overall safety profile of STELARA was consistent with the safety profile seen in the clinical trials in adult subjects with plaque psoriasis and psoriatic arthritis. Common adverse reactions in trials CD-1 and CD-2 and in trial CD-3 are listed in Tables 6 and 7, respectively.

Table 6: Common Adverse Reactions Through Week 8 in Trials CD-1 and CD-2 occurring in ≥3% of STELARA-Treated Subjects and Higher Than Subjects Receiving Placebo

	Placebo N=466	STELARA 6 mg/kg single intravenous induction dose N=470
Vomiting	3%	4%

Other less common adverse reactions reported in subjects in trials CD-1 and CD-2 included asthenia (1% vs 0.4%), acne (1% vs 0.4%), and pruritus (2% vs 0.4%).

Table 7: Common Adverse Reactions Through Week 44 in Trial CD-3 occurring in ≥3% of STELARA-Treated Subjects and Higher Than Subjects Receiving Placebo

	Placebo N=133	STELARA 90 mg subcutaneous maintenance dose every 8 weeks N=131
Nasopharyngitis	8%	11%
Injection site erythema	0%	5%
Vulvovaginal candidiasis/mycotic infection	1%	5%
Bronchitis	3%	4%
Pruritus	2%	4%
Urinary tract infection	2%	3%
Sinusitis	2%	3%

Infections

In subjects with Crohn’s disease, serious or other clinically significant infections included anal abscess, gastroenteritis, and pneumonia. In addition, listeria meningitis and ophthalmic herpes zoster were reported in one subject each [see Warnings and Precautions (5.1)].

Malignancies

With up to one year of treatment in the Crohn’s disease clinical trials, 0.2% of STELARA-treated subjects (0.36 events per hundred patient-years) and 0.2% of placebo-treated subjects (0.58 events per hundred patient-years) developed non-melanoma skin cancer. Malignancies other than non- melanoma skin cancers occurred in 0.2% of STELARA-treated subjects (0.27 events per hundred patient-years) and in none of the placebo-treated subjects.

Hypersensitivity Reactions Including Anaphylaxis

In CD trials, two subjects reported hypersensitivity reactions following STELARA administration. One subject experienced signs and symptoms consistent with anaphylaxis (tightness of the throat, shortness of breath, and flushing) after a single subcutaneous administration (0.1% of subjects receiving subcutaneous STELARA). In addition, one subject experienced signs and symptoms consistent with or related to a hypersensitivity reaction (chest discomfort, flushing, urticaria, and increased body temperature) after the initial intravenous STELARA dose (0.08% of subjects receiving intravenous STELARA). These subjects were treated with oral antihistamines or corticosteroids and in both cases symptoms resolved within an hour.

Ulcerative Colitis

The safety of STELARA was evaluated in two randomized, double-blind, placebo-controlled clinical trials (UC-1 [IV induction] and UC-2 [SC maintenance]) in 960 adult subjects with moderately to severely active ulcerative colitis [see Clinical Studies (14.5)]. The overall safety profile of STELARA in subjects with ulcerative colitis was consistent with the safety profile seen across all approved indications. Adverse reactions reported in at least 3% of STELARA-treated subjects and at a higher rate than placebo were:

• Induction (UC-1): nasopharyngitis (7% vs 4%).
• Maintenance (UC-2): nasopharyngitis (24% vs 20%), headache (10% vs 4%), abdominal pain (7% vs 3%), influenza (6% vs 5%), fever (5% vs. 4%), diarrhea (4% vs 1%), sinusitis (4% vs 1%), fatigue (4% vs 2%), and nausea (3% vs 2%).

Infections

In subjects with ulcerative colitis, serious or other clinically significant infections included gastroenteritis and pneumonia. In addition, listeriosis and ophthalmic herpes zoster were reported in one subject each [see Warnings and Precautions (5.1)].

Malignancies

With up to one year of treatment in the ulcerative colitis clinical trials, 0.4% of STELARA-treated subjects (0.48 events per hundred patient-years) and 0.0% of subjects receiving placebo (0.00 events per hundred patient-years) developed non-melanoma skin cancer. Malignancies other than non-melanoma skin cancers occurred in 0.5% of STELARA-treated subjects (0.64 events per hundred patient-years) and 0.2% of subjects receiving placebo (0.40 events per hundred patient- years).

Immunogenicity

The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies in the studies described below with the incidence of anti-drug antibodies in studies of other ustekinumab products. Approximately 6 to 12.4% of subjects treated with STELARA in clinical trials in subjects with plaque psoriasis and psoriatic arthritis developed antibodies to ustekinumab, which were generally low-titer. In clinical trials in subjects with plaque psoriasis, antibodies to ustekinumab were associated with reduced or undetectable serum ustekinumab concentrations and reduced efficacy. In trials in subjects with plaque psoriasis, the majority of subjects who were positive for antibodies to ustekinumab had neutralizing antibodies.

In clinical trials in subjects with Crohn’s disease and ulcerative colitis, 2.9% and 4.6% of subjects, respectively, developed antibodies to ustekinumab when treated with STELARA for approximately one year. No apparent association between the development of antibodies to ustekinumab and the development of injection site reactions was seen.

Postmarketing Experience

The following adverse reactions have been reported during post-approval use of STELARA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to STELARA exposure.

Immune system disorders: Serious hypersensitivity reactions (including anaphylaxis and angioedema), other hypersensitivity reactions (including rash and urticaria).

Infections and infestations: Lower respiratory tract infection (including opportunistic fungal infections and tuberculosis).

Neurological disorders: Posterior Reversible Encephalopathy Syndrome (PRES).

Respiratory, thoracic, and mediastinal disorders: Interstitial pneumonia, eosinophilic pneumonia, and cryptogenic organizing pneumonia.

Skin reactions: Pustular psoriasis, erythrodermic psoriasis, hypersensitivity vasculitis.

Drug Interactions for Stelara Injection

Concomitant Therapies

In trials in subjects with plaque psoriasis the safety of STELARA in combination with immunosuppressive agents or phototherapy has not been evaluated. In trials in subjects with psoriatic arthritis, concomitant MTX use did not appear to influence the safety or efficacy of STELARA. In trials in subjects with Crohn’s disease (CD-1 and CD-2) and ulcerative colitis (UC-1), immunomodulators (6-MP, AZA, MTX) were used concomitantly in approximately 30% of subjects and corticosteroids were used concomitantly in approximately 40% and 50% of Crohn’s disease and ulcerative colitis subjects, respectively. Use of these concomitant therapies did not appear to influence the overall safety or efficacy of STELARA.

CYP450 Substrates

The formation of CYP450 enzymes can be suppressed by increased levels of certain cytokines (e.g., IL-1, IL-6, TNFα, IFN) during chronic inflammation. Thus, use of STELARA, an antagonist of IL-12 and IL-23, could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of STELARA in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect or drug concentration and adjust the individual dosage of the CYP substrate as needed. See the prescribing information of specific CYP substrates.

A CYP-mediated drug interaction effect was not observed in subjects with Crohn’s disease [see Clinical Pharmacology (12.3)].

Allergen Immunotherapy

STELARA has not been evaluated in patients who have undergone allergy immunotherapy. STELARA may decrease the protective effect of allergen immunotherapy (decrease tolerance) which may increase the risk of an allergic reaction to a dose of allergen immunotherapy. Therefore, caution should be exercised in patients receiving or who have received allergen immunotherapy, particularly for anaphylaxis.

Warnings for Stelara Injection

Included as part of the PRECAUTIONS section.

Precautions for Stelara Injection

Infections

STELARA may increase the risk of infections and reactivation of latent infections. Serious bacterial, mycobacterial, fungal, and viral infections were observed in patients receiving STELARA [see Adverse Reactions (6.1, 6.3)].

Serious infections requiring hospitalization, or otherwise clinically significant infections, reported in clinical trials included the following:

• Plaque Psoriasis: diverticulitis, cellulitis, pneumonia, appendicitis, cholecystitis, sepsis, osteomyelitis, viral infections, gastroenteritis, and urinary tract infections.
• Psoriatic arthritis:
• Crohn’s disease: anal abscess, gastroenteritis, ophthalmic herpes zoster, pneumonia, and listeria meningitis.
• Ulcerative colitis: gastroenteritis, ophthalmic herpes zoster, pneumonia, and

Avoid initiating treatment with STELARA in patients with any clinically important active infection until the infection resolves or is adequately treated. Consider the risks and benefits of treatment prior to initiating use of STELARA in patients with a chronic infection or a history of recurrent infection.

Instruct patients to seek medical advice if signs or symptoms suggestive of an infection occur while on treatment with STELARA and discontinue STELARA for serious or clinically significant infections until the infection resolves or is adequately treated.

Theoretical Risk for Vulnerability to Particular Infections

Individuals genetically deficient in IL-12/IL-23 are particularly vulnerable to disseminated infections from mycobacteria (including nontuberculous, environmental mycobacteria), salmonella (including nontyphi strains), and Bacillus Calmette-Guerin (BCG) vaccinations. Serious infections and fatal outcomes have been reported in such patients.

It is not known whether patients with pharmacologic blockade of IL-12/IL-23 from treatment with STELARA may be susceptible to these types of infections. Consider appropriate diagnostic testing, (e.g., tissue culture, stool culture, as dictated by clinical circumstances).

Pre-treatment Evaluation for Tuberculosis

Evaluate patients for tuberculosis infection prior to initiating treatment with STELARA.

Avoid administering STELARA to patients with active tuberculosis infection. Initiate treatment of latent tuberculosis prior to administering STELARA. Consider anti-tuberculosis therapy prior to initiation of STELARA in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed. Closely monitor patients receiving STELARA for signs and symptoms of active tuberculosis during and after treatment.

Malignancies

STELARA is an immunosuppressant and may increase the risk of malignancy. Malignancies were reported among subjects who received STELARA in clinical trials [see Adverse Reactions (6.1)]. In rodent models, inhibition of IL-12/IL-23p40 increased the risk of malignancy [see Nonclinical Toxicology (13)].

The safety of STELARA has not been evaluated in patients who have a history of malignancy or who have a known malignancy.

There have been post-marketing reports of the rapid appearance of multiple cutaneous squamous cell carcinomas in patients receiving STELARA who had pre-existing risk factors for developing non-melanoma skin cancer. Monitor all patients receiving STELARA for the appearance of non- melanoma skin cancer. Closely follow patients greater than 60 years of age, those with a medical history of prolonged immunosuppressant therapy and those with a history of PUVA treatment [see Adverse Reactions (6.1)].

Hypersensitivity Reactions

Hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with STELARA [see Adverse Reactions (6.1, 6.3)]. If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue STELARA.

Posterior Reversible Encephalopathy Syndrome (PRES)

Two cases of posterior reversible encephalopathy syndrome (PRES), also known as Reversible Posterior Leukoencephalopathy Syndrome (RPLS), were reported in clinical trials. Cases have also been reported in postmarketing experience in patients with psoriasis, psoriatic arthritis, and Crohn’s disease. Clinical presentation included headaches, seizures, confusion, visual disturbances, and imaging changes consistent with PRES a few days to several months after ustekinumab initiation. A few cases reported latency of a year or longer. Patients recovered with supportive care following withdrawal of ustekinumab.

Monitor all patients treated with STELARA for signs and symptoms of PRES. If PRES is suspected, promptly administer appropriate treatment and discontinue STELARA.

Immunizations

Prior to initiating therapy with STELARA, patients should receive all age-appropriate immunizations as recommended by current immunization guidelines. Patients being treated with STELARA should avoid receiving live vaccines. Avoid administering BCG vaccines during treatment with STELARA or for one year prior to initiating treatment or one year following discontinuation of treatment. Caution is advised when administering live vaccines to household contacts of patients receiving STELARA because of the potential risk for shedding from the household contact and transmission to patient.

Non-live vaccinations received during a course of STELARA may not elicit an immune response sufficient to prevent disease.

Noninfectious Pneumonia

Cases of interstitial pneumonia, eosinophilic pneumonia, and cryptogenic organizing pneumonia have been reported during post-approval use of STELARA. Clinical presentations included cough, dyspnea, and interstitial infiltrates following one to three doses. Serious outcomes have included respiratory failure and prolonged hospitalization. Patients improved with discontinuation of therapy and in certain cases administration of corticosteroids. If diagnosis is confirmed, discontinue STELARA and institute appropriate treatment [see Postmarketing Experience (6.3)].

NONCLINICAL TOXICOLOGY

Carcinogenesis, Mutagenesis, Impairment of Fertility

Animal studies have not been conducted to evaluate the carcinogenic or mutagenic potential of STELARA. Published literature showed that administration of murine IL-12 caused an anti-tumor effect in mice that contained transplanted tumors and IL-12/IL-23p40 knockout mice or mice treated with anti-IL-12/IL-23p40 antibody had decreased host defense to tumors. Mice genetically manipulated to be deficient in both IL-12 and IL-23 or IL-12 alone developed UV-induced skin cancers earlier and more frequently compared to wild-type mice. The relevance of these experimental findings in mouse models for malignancy risk in humans is unknown.

No effects on fertility were observed in male cynomolgus monkeys that were administered ustekinumab at subcutaneous doses up to 45 mg/kg twice weekly (45 times the MRHD on a mg/kg basis) prior to and during the mating period. However, fertility and pregnancy outcomes were not evaluated in mated females.

No effects on fertility were observed in female mice that were administered an analogous IL-12/IL- 23p40 antibody by subcutaneous administration at doses up to 50 mg/kg, twice weekly, prior to and during early pregnancy.

Patient Information for Stelara Injection

Advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).

Infections

Inform patients that STELARA may lower the ability of their immune system to fight infections and to contact their healthcare provider immediately if they develop any signs or symptoms of infection [see Warnings and Precautions (5.1)].

Malignancies

Inform patients of the risk of developing malignancies while receiving STELARA [see Warnings and Precautions (5.4)].

Hypersensitivity Reactions

• Advise patients to seek immediate medical attention if they experience any signs or symptoms of serious hypersensitivity reactions and discontinue STELARA [see Warnings and Precautions (5.5)].
• Inform patients the needle cover on the prefilled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions in individuals sensitive to latex [see Dosage and Administration (2.4)]

Posterior Reversible Encephalopathy Syndrome (PRES)

Inform patients to immediately contact their healthcare provider if they experience signs and symptoms of PRES (which may include headache, seizures, confusion, or visual disturbances) [see Warnings and Precautions (5.6)].

Immunizations

Inform patients that STELARA can interfere with the usual response to immunizations and that they should avoid live vaccines [see Warnings and Precautions (5.7)].

Administration

Instruct patients to follow sharps disposal recommendations, as described in the Instructions for Use.

Prefilled Syringe Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044, USA License No. 1864 at Baxter Pharmaceutical Solutions, Bloomington, IN 47403 and at Cilag AG, Schaffhausen, Switzerland

Vial Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044, USA License No. 1864 at Cilag AG, Schaffhausen, Switzerland

© Johnson & Johnson and its affiliates 2025

Overdose Information for Stelara Injection

Single doses up to 6 mg/kg intravenously have been administered in clinical trials without dose-limiting toxicity. In case of overdosage, monitor the patient for any signs or symptoms of adverse reactions or effects and institute appropriate symptomatic treatment immediately. Consider contacting the Poison Help line 1-800-222-1222 or a medical toxicologist for additional overdose management recommendations.

Contraindications for Stelara Injection

STELARA is contraindicated in patients with clinically significant hypersensitivity to ustekinumab or to any of the excipients in STELARA [see Warnings and Precautions (5.5)].

Clinical Pharmacology for Stelara Injection

Mechanism Of Action

Ustekinumab is a human IgG1Ò› monoclonal antibody that binds with specificity to the p40 protein subunit used by both the IL-12 and IL-23 cytokines. IL-12 and IL-23 are naturally occurring cytokines that are involved in inflammatory and immune responses, such as natural killer cell activation and CD4+ T-cell differentiation and activation. In in vitro models, ustekinumab was shown to disrupt IL-12 and IL-23 mediated signaling and cytokine cascades by disrupting the interaction of these cytokines with a shared cell-surface receptor chain, IL-12Rβ1. The cytokines IL-12 and IL-23 have been implicated as important contributors to the chronic inflammation that is a hallmark of Crohn’s disease and ulcerative colitis. In animal models of colitis, genetic absence or antibody blockade of the p40 subunit of IL-12 and IL-23, the target of ustekinumab, was shown to be protective.

Pharmacodynamics

Plaque Psoriasis

In a small exploratory trial, a decrease was observed in the expression of mRNA of its molecular targets IL-12 and IL-23 in lesional skin biopsies measured at baseline and up to two weeks post-treatment in subjects with plaque psoriasis.

Ulcerative Colitis

In both trial UC-1 (induction) and trial UC-2 (maintenance), a positive relationship was observed between exposure and rates of clinical remission, clinical response, and endoscopic improvement. The response rate approached a plateau at the ustekinumab exposures associated with the recommended dosing regimen for maintenance treatment [see Clinical Studies (14.5)].

Pharmacokinetics

Absorption

In adult subjects with plaque psoriasis, the median time to reach the maximum serum concentration (T_max) was 13.5 days and 7 days, respectively, after a single subcutaneous administration of 45 mg (N=22) and 90 mg (N=24) of ustekinumab. In healthy subjects (N=30), the median Tmax value (8.5 days) following a single subcutaneous administration of 90 mg of ustekinumab was comparable to that observed in subjects with plaque psoriasis.

Following multiple subcutaneous doses of STELARA in adult subjects with plaque psoriasis, steady-state serum concentrations of ustekinumab were achieved by Week 28. The mean (±SD) steady-state trough serum ustekinumab concentrations were 0.69 ± 0.69 mcg/mL for subjects less than or equal to 100 kg receiving a 45 mg dose and 0.74 ± 0.78 mcg/mL for subjects greater than 100 kg receiving a 90 mg dose. There was no apparent accumulation in serum ustekinumab concentration over time when given subcutaneously every 12 weeks.

Following the recommended intravenous induction dose, mean ±SD peak serum ustekinumab concentration was 125.2 ± 33.6 mcg/mL in subjects with Crohn’s disease, and 129.1 ±

27.6 mcg/mL in subjects with ulcerative colitis. Starting at Week 8, the recommended subcutaneous maintenance dosing of 90 mg ustekinumab was administered every 8 weeks. Steady state ustekinumab concentration was achieved by the start of the second maintenance dose. There was no apparent accumulation in ustekinumab concentration over time when given subcutaneously every 8 weeks. Mean ±SD steady-state trough concentration was 2.5 ± 2.1 mcg/mL in subjects with Crohn’s disease, and 3.3 ± 2.3 mcg/mL in subjects with ulcerative colitis for 90 mg ustekinumab administered every 8 weeks.

Distribution

Population pharmacokinetic analyses showed that the volume of distribution of ustekinumab in the central compartment was 2.7 L (95% CI: 2.69, 2.78) in subjects with Crohn’s disease and 3.0 L (95% CI: 2.96, 3.07) in subjects with ulcerative colitis. The total volume of distribution at steady- state was 4.6 L in subjects with Crohn’s disease and 4.4 L in subjects with ulcerative colitis.

Elimination

The mean (±SD) half-life ranged from 14.9 ± 4.6 to 45.6 ± 80.2 days across all trials in subjects with plaque psoriasis following subcutaneous administration. Population pharmacokinetic analyses showed that the clearance of ustekinumab was 0.19 L/day (95% CI: 0.185, 0.197) in subjects with Crohn’s disease and 0.19 L/day (95% CI: 0.179, 0.192) in subjects with ulcerative colitis with an estimated median terminal half-life of approximately 19 days for both IBD (Crohn’s disease and ulcerative colitis) populations.

These results indicate the pharmacokinetics of ustekinumab were similar between subjects with Crohn’s disease and ulcerative colitis.

Metabolism

The metabolic pathway of ustekinumab has not been characterized. As a human IgG1κ monoclonal antibody, ustekinumab is expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG.

Specific Populations

Weight

When given the same dose, subjects with plaque psoriasis or psoriatic arthritis weighing more than 100 kg had lower median serum ustekinumab concentrations compared with those subjects weighing 100 kg or less. The median trough serum concentrations of ustekinumab in subjects of higher weight (greater than 100 kg) in the 90 mg group were comparable to those in subjects of lower weight (100 kg or less) in the 45 mg group.

Age: Geriatric Population

A population pharmacokinetic analysis (N=106/1937 subjects with plaque psoriasis greater than or equal to 65 years old) was performed to evaluate the effect of age on the pharmacokinetics of ustekinumab. There were no apparent changes in pharmacokinetic parameters (clearance and volume of distribution) in subjects older than 65 years old.

Age: Pediatric Population

Following multiple recommended doses of STELARA in pediatric subjects 6 years of age and older with plaque psoriasis, steady-state serum concentrations of ustekinumab were achieved by Week 28. At Week 28, the mean ±SD steady-state trough serum ustekinumab concentrations were 0.36 ± 0.26 mcg/mL and 0.54 ± 0.43 mcg/mL, respectively, in pediatric subjects 6 to 11 years of age and pediatric subjects 12 years of age and older.

Overall, the observed steady-state ustekinumab trough concentrations in pediatric subjects with plaque psoriasis were within the range of those observed for adult subjects with plaque psoriasis and adult subjects with PsA after administration of STELARA.

Drug Interaction Studies

The effects of IL-12 or IL-23 on the regulation of CYP450 enzymes were evaluated in an in vitro study using human hepatocytes, which showed that IL-12 and/or IL-23 at levels of 10 ng/mL did not alter human CYP450 enzyme activities (CYP1A2, 2B6, 2C9, 2C19, 2D6, or 3A4).

No clinically significant changes in exposure of caffeine (CYP1A2 substrate), warfarin (CYP2C9 substrate), omeprazole (CYP2C19 substrate), dextromethorphan (CYP2D6 substrate), or midazolam (CYP3A substrate) were observed when used concomitantly with ustekinumab at the approved recommended dosage in subjects with Crohn’s disease [see Drug Interactions (7.2)].

Population pharmacokinetic analyses indicated that the clearance of ustekinumab was not impacted by concomitant MTX, NSAIDs, and oral corticosteroids, or prior exposure to a TNF blocker in subjects with psoriatic arthritis.

In subjects with Crohn’s disease and ulcerative colitis, population pharmacokinetic analyses did not indicate changes in ustekinumab clearance with concomitant use of corticosteroids or immunomodulators (AZA, 6-MP, or MTX); and serum ustekinumab concentrations were not impacted by concomitant use of these medications.

Animal Toxicology and/or Pharmacology

In a 26-week toxicology study, one out of 10 monkeys subcutaneously administered 45 mg/kg ustekinumab twice weekly for 26 weeks had a bacterial infection.

MEDICATION GUIDE

What is the most important information I should know about STELARA?

STELARA is a medicine that affects your immune system. STELARA can increase your risk of having serious side effects, including:

• Serious infections. STELARA may lower the ability of your immune system to fight infections and may increase your risk of Some people have serious infections during treatment with STELARA, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses. Some people have to be hospitalized for treatment of their infection.
  • Your healthcare provider should check you for TB before starting
  • If your healthcare provider feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with STELARA and during treatment with STELARA.
  • Your healthcare provider should watch you closely for signs and symptoms of TB while you are being treated with STELARA.

You should not start STELARA if you have any kind of infection unless your healthcare provider says it is okay.

Before starting STELARA, tell your healthcare provider if you:

• think you have an infection or have symptoms of an infection such as:

  fever, sweat, or chills muscle aches cough shortness of breath blood in phlegm

  weight loss warm, red, or painful skin or sores on your body diarrhea or stomach pain burning when you urinate or urinate more often than normal feel very tired

• are being treated for an infection or have any open
• get a lot of infections or have infections that keep coming
• have TB or have been in close contact with someone with

After starting STELARA, call your healthcare provider right away if you have any symptoms of an infection (see above). These may be signs of infections such as chest infections, or skin infections or shingles that could have serious complications. STELARA can make you more likely to get infections or make an infection that you have worse.

• People who have a genetic problem where the body does not make any of the proteins interleukin 12 (IL-12) and interleukin 23 (IL-23) are at a higher risk for certain serious These infections can spread throughout the body and cause death. People who take STELARA may also be more likely to get these infections.
• Cancers. STELARA may decrease the activity of your immune system and increase your risk for certain types of cancers. Tell your healthcare provider if you have ever had any type of cancer. Some people who are receiving STELARA and have risk factors for skin cancer have developed certain types of skin cancers. During your treatment with STELARA, tell your healthcare provider if you develop any new skin growths.

What is STELARA?

STELARA is a prescription medicine used to treat:

• adults and children 6 years of age and older with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills).
• adults and children 6 years of age and older with active psoriatic
• adults with moderately to severely active Crohn’s
• adults with moderately to severely active ulcerative

It is not known if STELARA is safe and effective in children with Crohn’s disease or ulcerative colitis or in children less than 6 years of age with plaque psoriasis or psoriatic arthritis.

Who should not use STELARA?

Do not use STELARA if you are allergic to ustekinumab or any of the ingredients in STELARA. See the end of this Medication Guide for a complete list of ingredients in STELARA.

Before you use or receive STELARA, tell your healthcare provider about all of your medical conditions, including if you:

• have any of the conditions or symptoms listed in the section “What is the most important information I should know about STELARA?”
• ever had an allergic reaction to Ask your healthcare provider if you are not sure.
• are allergic to The needle cover on the prefilled syringe contains latex.
• have recently received or are scheduled to receive an immunization (vaccine). People who are being treated with STELARA should avoid receiving live vaccines. Tell your healthcare provider if anyone in your house needs a live vaccine. The viruses used in some types of live vaccines can spread to people with a weakened immune system and can cause serious problems. You should avoid receiving the BCG vaccine during the one year before receiving STELARA or one year after you stop receiving STELARA.
• have any new or changing lesions within psoriasis areas or on normal
• are receiving or have received allergy shots, especially for serious allergic Allergy shots may not work as well for you during treatment with STELARA. STELARA may also increase your risk of having an allergic reaction to an allergy shot.
• receive or have received phototherapy for your
• are pregnant or plan to become It is not known if STELARA can harm your unborn baby. You and your healthcare provider should decide if you will receive STELARA.
• are breastfeeding or plan to STELARA can pass into your breast milk.
• Talk to your healthcare provider about the best way to feed your baby if you receive

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I use STELARA?

• Use STELARA exactly as the healthcare provider tells you The healthcare provider will determine the right dose of STELARA, the amount for each injection, and how often it should be given. Be sure to keep all scheduled follow- up appointments.
• The needle cover on the STELARA prefilled syringe contains Do not handle the needle cover if you are sensitive to latex.
• Adults with Crohn’s disease and ulcerative colitis will receive the first dose of STELARA through a vein in the arm (intravenous infusion) in a healthcare facility by a healthcare provider. It takes at least 1 hour to receive the full dose of STELARA will then be received as an injection under the skin (subcutaneous injection) 8 weeks after the first dose of STELARA, as described below.
• Adults and children 6 years of age and older with plaque psoriasis or psoriatic arthritis will receive STELARA as an injection under the skin as described below.
• Injecting STELARA under the skin
  • STELARA is intended for use under the guidance and supervision of a healthcare
  • In children, it is recommended that STELARA be administered by a healthcare If a healthcare provider decides that you or a caregiver may give the injections of STELARA at home, you or a caregiver should receive training on the right way to prepare and inject STELARA.
  • Do not try to inject STELARA until you have been shown how to inject STELARA by a healthcare
  • STELARA can be injected under the skin in the upper arms, buttocks, upper legs (thighs) or stomach area (abdomen).
  • Do not give an injection in an area of the skin that is tender, bruised, red or
  • Use a different injection site each time you use
• If you inject too much STELARA, call the healthcare provider or Poison Help line at 1-800-222-1222, or go to the nearest emergency room right away.

Read the detailed Instructions for Use at the end of this Medication Guide for instructions about how to prepare and inject a dose of STELARA, and how to properly throw away (dispose of) used needles, syringes, and vials. The syringe, needle, and vial must never be re-used. After the rubber stopper is punctured, STELARA can become contaminated by harmful bacteria which could cause an infection if re-used. Therefore, throw away any unused portion of STELARA.

What should I avoid while using STELARA?

You should avoid receiving a live vaccine during treatment with STELARA. See “Before you use or receive STELARA, tell your healthcare provider about all of your medical conditions, including if you:”

What are the possible side effects of STELARA?

STELARA may cause serious side effects, including:

• See “What is the most important information I should know about STELARA?”
• Serious allergic Serious allergic reactions can occur with STELARA. Stop using STELARA and get medical help right away if you get any of the following symptoms of a serious allergic reaction:

  feeling faint swelling of your face, eyelids, tongue, or throat

  chest tightness skin rash

• Posterior Reversible Encephalopathy Syndrome (PRES). PRES is a rare condition that affects the brain and can cause death. Tell your healthcare provider right away if you get any symptoms of PRES during treatment with STELARA, including:

  headache seizures

  confusion vision problems

• Lung Cases of lung inflammation have happened in some people who receive STELARA and may be serious. These lung problems may need to be treated in a hospital. Tell your healthcare provider right away if you develop shortness of breath or a cough that doesn’t go away during treatment with STELARA.

The most common side effects of STELARA include:

nasal congestion, sore throat, and runny nose upper respiratory infections fever headache tiredness itching nausea and vomiting influenza

redness at the injection site vaginal yeast infections urinary tract infections sinus infection bronchitis diarrhea stomach pain joint pain

These are not all of the possible side effects of STELARA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may also report side effects to Janssen Biotech, Inc. at 1-800-526-7736.

How should I store STELARA?

• Store STELARA vials and prefilled syringes in a refrigerator between 36 °F to 46 °F (2 °C to 8 °C).
• Store STELARA vials standing up straight (upright).
• Store STELARA in the original carton to protect it from light until time to use
• Do not freeze
• Do not shake
• If needed, individual STELARA prefilled syringes may also be stored at room temperature up to 86 ºF (30 °C) for a maximum single period of up to 30 days in the original carton to protect from light.
• Record the date when the prefilled syringe is first removed from the refrigerator on the carton in the space
• After a prefilled syringe has been stored at room temperature, do not return it to the
• Throw away (discard) the prefilled syringe if it is not used within 30 days at room temperature
• Do not use STELARA after the expiration date on the carton or on the prefilled

Keep STELARA and all medicines out of the reach of children.

General information about the safe and effective use of STELARA.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use STELARA for a condition for which it was not prescribed. Do not give STELARA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about

STELARA that was written for health professionals.

What are the ingredients in STELARA?

Active ingredient: ustekinumab

Inactive ingredients: Single-dose prefilled syringe and single-dose vial for subcutaneous use contain L-histidine, L-histidine monohydrochloride monohydrate, Polysorbate 80, and sucrose. Single-dose vial for intravenous infusion contains EDTA disodium salt dihydrate, L-histidine, L-histidine hydrochloride monohydrate, L-methionine, Polysorbate 80, and sucrose.

Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044, USA License No. 1864

© Johnson & Johnson and its affiliates 2025 For more information, go to www.stelarainfo.com or call 1-800-526-7736.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revised:06/2025

INSTRUCTIONS FOR USE

This Instructions for Use contains information on how to inject STELARA using a prefilled syringe.

Read this Instructions for Use before you start using STELARA. A healthcare provider should show you how to prepare and give an injection of STELARA the right way.

If you cannot give the injection:

• ask a healthcare provider to help you, or
• ask someone who has been trained by a healthcare provider to give the injections.

Do not try to inject STELARA until you have been shown how to inject STELARA by a healthcare provider.

Important information You Need to Know Before Injecting STELARA:

• For subcutaneous use only (inject directly under the skin).
• Before you start, check the carton to make sure that it is the right You will have either 45 mg or 90 mg as prescribed by the healthcare provider.
  • If the dose is 45 mg, you will receive one 45 mg prefilled syringe.
  • If the dose is 90 mg, you will receive either one 90 mg prefilled syringe or two 45 mg prefilled If you receive two 45 mg prefilled syringes for a 90 mg dose, you will need to give two injections, one right after the other.
• Check the expiration date on the prefilled syringe and carton. If the expiration date has passed or if the prefilled syringe has been kept at room temperature up to 86ºF (30ºC) for longer than a maximum single period of 30 days or if the prefilled syringe has been stored above 86ºF (30ºC), do not use If the expiration date has passed or if the prefilled syringe has been stored above 86ºF (30ºC) or at room temperature for longer than 30 days, call the healthcare provider or pharmacist, or call 1-800-526-7736 for help.
• Make sure the syringe is not damaged.
• The needle cover on the prefilled syringe contains Do not handle the needle cover on the STELARA prefilled syringe if you are allergic to latex.
• Check the prefilled syringe for any particles or The liquid in the prefilled syringe should look clear and colorless to light yellow with a few small clear or white particles.
• Do not use if it is frozen, discolored, cloudy or has large Get a new prefilled syringe.
• Do not shake the prefilled syringe at any time. Shaking the prefilled syringe may damage the STELARA If the prefilled syringe has been shaken, do not use it. Get a new prefilled syringe.
• To reduce the risk of accidental needle sticks, each prefilled syringe has a needle guard that is automatically activated to cover the needle after you have given the Do not pull back on the plunger at any time.

Storing STELARA prefilled syringes

• Store STELARA prefilled syringes in the refrigerator between 36 °F to 46 °F (2 °C to 8 °C).
• Store STELARA prefilled syringes in the original carton to protect from light.
• Do not freeze STELARA prefilled syringes.
• If needed, STELARA prefilled syringe may be stored at room temperature up to 86 °F (30 °C) for a maximum single period of up to 30 days in the original carton to protect from light.
• Record the date when the prefilled syringe is removed from the refrigerator on the carton in the space provided.
• After a prefilled syringe has been stored at room temperature, do not return it to the refrigerator.
• Throw away (discard) the prefilled syringe if it is not used within 30 days at room temperature storage.

Keep STELARA and all medicines out of the reach of children.

Gather the supplies you will need to prepare and to give the injection. (See Figure A)

You will need:

• antiseptic wipes
• cotton balls or gauze pads
• adhesive bandage
• your prescribed dose of STELARA (See Figure B)

FDA-cleared sharps disposal container. See “Step 4: Disposing of the syringes”

Figure A

Figure B

To prevent early activation of the needle safety guard, do not touch the NEEDLE GUARD ACTIVATION CLIPS at any time during use.

Step 1: Preparing the injection

• Choose a well-lit, clean, flat work surface.
• Wash your hands well with soap and warm water.
• Hold the prefilled syringe with the covered needle pointing upward.

Step 2: Preparing the injection site

• Choose an injection site around the stomach area (abdomen), buttocks, upper legs (thighs). If a caregiver is giving the injection, the outer area of the upper arms may also be used. (See Figure C)
• Use a different injection site for each Do not give an injection in an area of the skin that is tender, bruised, red or hard.
• Clean the skin with an antiseptic wipe where you plan to give the injection.
• Do not touch this area again before giving the Let the skin dry before injecting.
• Do not fan or blow on the clean area.

Figure C

*Areas in gray are recommended injection sites.

Step 3: Injecting STELARA

• Remove the needle cover when you are ready to inject STELARA.
• Do not touch the plunger or plunger head while removing the needle cover.
• Hold the body of the prefilled syringe with one hand and pull the needle cover straight off. (see Figure D)
• Put the needle cover in the trash.
• You may also see a drop of liquid at the end of the This is normal.
• Do not touch the needle or let it touch anything.
• Do not use the prefilled syringe if it is dropped without the needle cover in place.

Figure D

• Hold the body of the prefilled syringe in one hand between the thumb and index fingers.(See Figure E)

Figure E

• Do not pull back on the plunger at any time.
• Use the other hand to gently pinch the cleaned area of Hold firmly.
• Use a quick, dart-like motion to insert the needle into the pinched skin at about a 45-degree angle. (See Figure F)

Figure F

• Inject all of the liquid by using your thumb to push in the plunger until the plunger head is completely between the needle guard wings. (See Figure G)

Figure G

• When the plunger is pushed as far as it will go, keep pressure on the plunger Take the needle out of the skin and then let go of the skin.
• Slowly take your thumb off the plunger This will let the empty syringe move up until the entire needle is covered by the needle guard. (See Figure H)

Figure H

• When the needle is pulled out of the skin, there may be a little bleeding at the injection site. This is You can press a cotton ball or gauze pad to the injection site if needed. Do not rub the injection site. You may cover the injection site with a small adhesive bandage, if necessary.

If the dose is 90 mg, you will receive either one 90 mg prefilled syringe or two 45 mg prefilled syringes. If you receive two 45 mg prefilled syringes for a 90 mg dose, you will need to give a second injection right after the first. Repeat Steps 1 to 3 for the second injection using a new syringe. Choose a different site for the second injection.

Step 4: Disposing of the syringes

• Put the syringe in an FDA-cleared sharps disposal container right away after Do not throw away (dispose of) syringes in your household trash.
• If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
  • made of heavy-duty plastic,
  • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
  • upright and stable during use,
  • leak-resistant,
  • and properly labeled to warn of hazardous waste inside the container.
• When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal There may be local or state laws about how to throw away syringes and needles. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: https://www.fda.gov/safesharpsdisposal.
• Do not dispose of your sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your sharps disposal container.
• If you have any questions, talk to your healthcare provider or pharmacist. 

Prefilled Syringe Manufactured by:

Janssen Biotech, Inc., Horsham, PA 19044, USA License No. 1864 at Baxter Pharmaceutical Solutions, Bloomington, IN 47403 and at Cilag AG, Schaffhausen, Switzerland

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Revised: 06/2025

© Johnson & Johnson and its affiliates 2025

INSTRUCTIONS FOR USE

This Instructions for Use contains information on how to inject STELARA using a vial.

Read this Instructions for Use before you start using STELARA. A healthcare provider should show you how to prepare, measure the dose, and give an injection of STELARA the right way.

If you cannot give the injection:

• ask a healthcare provider to help you, or
• ask someone who has been trained by a healthcare provider to give the injections.

Do not try to inject STELARA until you have been shown how to inject STELARA by a healthcare provider.

Important information You Need to Know Before Injecting STELARA:

• For subcutaneous use only (inject directly under the skin).
• Before you start, check the carton to make sure that it is the right You will have either 45 mg or 90 mg as prescribed by the healthcare provider.
  • If the dose is 45 mg or less, you will receive one 45 mg vial.
  • If the dose is 90 mg, you will receive two 45 mg vials and you will need to give two injections, one right after the other.
• Check the expiration date on the vial and carton. If the expiration date has passed, do not use If the expiration date has passed, call the healthcare provider or pharmacist, or call 1- 800-526-7736 for help.
• Check the vial for any particles or The liquid in the vial should look clear and colorless to light yellow with a few small clear or white particles.
• Do not use if it is frozen, discolored, cloudy or has large Get a new vial.
• Do not shake the vial at any Shaking the vial may damage the STELARA medicine. If the vial has been shaken, do not use it. Get a new vial.
• Do not use a STELARA vial more than one time, even if there is medicine left in the After the rubber stopper is punctured, STELARA can become contaminated by harmful bacteria which could cause an infection if re-used. Therefore, throw away any unused STELARA after you give the injection.
• Safely throw away (dispose of) STELARA vials, needles, and syringes after See “Step 6: Disposing of needles, syringes, and vials.”
• Do not re-use syringes or needles.
• To avoid needle-stick injuries, do not recap needles.

Storing STELARA vials

• Store STELARA vials in a refrigerator between 36 °F to 46 °F (2 °C to 8 °C).
• Store STELARA vials standing up straight (upright).
• Store STELARA vials in the original carton to protect from light until the time of use.
• Do not freeze STELARA vials.

Keep STELARA and all medicines out of the reach of children.

Gather the supplies you will need to prepare STELARA and to give the injection. (See Figure A)

You will need:

• a syringe with the needle attached, you will need a prescription from a healthcare provider to get syringes with the needles attached from a pharmacy.
• antiseptic wipes
• cotton balls or gauze pads
• adhesive bandage
• your prescribed dose of STELARA
• FDA-cleared sharps disposal See “Step 6: Disposing of needles, syringes, and vials.”

Figure A

Step 1: Preparing the injection

• Choose a well-lit, clean, flat work surface.
• Wash your hands well with soap and warm water.

Step 2: Preparing your injection site

• Choose an injection site around the stomach area (abdomen), buttocks, and upper legs (thighs).
• If a caregiver is giving the injection, the outer area of the upper arms may also be used.

(See Figure B)

• Use a different injection site for each injection. Do not give an injection in an area of the skin that is tender, bruised, red or hard.
• Clean the skin with an antiseptic wipe where you plan to give the injection.
• Do not touch this area again before giving the Let the skin dry before injecting.
• Do not fan or blow on the clean area.

Figure B

*Areas in gray are recommended injection sites.

Step 3: Preparing the vial

• Remove the cap from the top of the vial. Throw away the cap but do not remove the rubber stopper. (See Figure C)

Figure C

• Clean the rubber stopper with an antiseptic wipe. (See Figure D)

Figure D

• Do not touch the rubber stopper after you clean it.
• Put the vial on a flat surface.

Step 4: Preparing the syringe

• Pick up the syringe with the needle attached.
• Remove the cap that covers the needle. (See Figure E)
• Throw the needle cap Do not touch the needle or allow the needle to touch anything.

Figure E

• Carefully pull back on the plunger to the line that matches the dose prescribed by the healthcare provider.
• Hold the vial between your thumb and index (pointer) finger.
• Use your other hand to push the syringe needle through the center of the rubber stopper. (See Figure F)

Figure F

• Push down on the plunger until all of the air has gone from the syringe into the vial.
• Turn the vial and the syringe upside down. (See Figure G)
• Hold the STELARA vial with one hand.
• It is important that the needle is always in the liquid in order to prevent air bubbles forming in the syringe.
• Pull back on the syringe plunger with your other hand.
• Fill the syringe until the black tip of the plunger lines up with the mark that matches the prescribed dose.

Figure G

• Do not remove the needle from the Hold the syringe with the needle pointing up to see if it has any air bubbles inside.
• If there are air bubbles, gently tap the side of the syringe until the air bubbles rise to the top. (See Figure H)
• Slowly press the plunger up until all of the air bubbles are out of the syringe (but none of the liquid is out).
• Remove the syringe from the Do not lay the syringe down or allow the needle to touch anything.

Figure H

Step 5: Injecting STELARA

• Hold the barrel of the syringe in one hand, between the thumb and index fingers.
• Do not pull back on the plunger at any time.
• Use the other hand to gently pinch the cleaned area of Hold firmly.
• Use a quick, dart-like motion to insert the needle into the pinched skin at about a 45-degree angle. (See Figure I)

Figure I

• Push the plunger with your thumb as far as it will go to inject all of the Push it slowly and evenly, keeping the skin gently pinched.
• When the syringe is empty, pull the needle out of the skin and then let go of the skin. (See Figure J)

Figure J

• When the needle is pulled out of the skin, there may be a little bleeding at the injection site. This is You can press a cotton ball or gauze pad to the injection site if needed. Do not rub the injection site. You may cover the injection site with a small adhesive bandage, if necessary.

If the dose is 90 mg, you will receive two 45 mg vials and you will need to give a second injection right after the first. Repeat Steps 1 to 5 using a new syringe. Choose a different site for the second injection. 

Step 6: Disposing of needles, syringes, and vials

• Do not re-use a syringe or needle.
• To avoid needle-stick injuries, do not recap a needle.
• Put the needles and syringes in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) needles and syringes in your household
• If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
  • made of heavy-duty plastic,
  • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
  • upright and stable during use,
  • leak-resistant,
  • and properly labeled to warn of hazardous waste inside the container.
• When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal There may be local or state laws about how to throw away syringes and needles. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: https://www.fda.gov/safesharpsdisposal.
• Do not dispose of your sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your sharps disposal container.
• Throw away the vial into the container where you put the syringes and needles.
• If you have any questions, talk to your healthcare provider or pharmacist.

Vial Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044, USA License No. 1864 at Cilag AG, Schaffhausen, Switzerland

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Revised: 06/2025
© Johnson & Johnson and its affiliates 2025