Guselkumab

Guselkumab is a prescription medicine used for the treatment of:

• Moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy
• Active psoriatic arthritis
• Moderately to severely active ulcerative colitis
• Moderately to severely active Crohn's disease

Guselkumab is available under the following different brand names: Tremfya

Adult dosage

Solution for SC injection

• 100 mg/mL (single-dose prefilled syringe; single-dose One-Press patient-controlled injector)
• 200 mg/2 mL (single-dose prefilled pen or syringe)

Solution for IV infusion

• 200 mg/20 mL (single-dose vial)

Plaque Psoriasis

Adult dosage

• 100 mg SC at Week 0, Week 4, and every 8 weeks thereafter

Psoriatic Arthritis

Adult dosage

• 100 mg SC at Week 0, Week 4, and every 8 weeks thereafter
• It may be administered alone or in combination with a conventional disease-modifying antirheumatic drug (cDMARD) (e.g., methotrexate)

Ulcerative colitis

Adult dosage

• Induction: 200 mg IV at Weeks 0, 4, and 8; infuse IV over at least 1 hr
• Maintenance
  • 100 mg SC at week 16 and  every 8 weeks thereafter, or
  • 200 mg SC at week 12 and every 4 weeks thereafter
  • Use the lowest effective recommended dose to maintain the therapeutic response

Crohn disease

Adult dosage

• Induction
  • 200 mg IV at Weeks 0, 4, and 8; infuse IV over at least 1 hr, or
  • 400 mg SC (give 2 consecutive injections of 200 mg each) at weeks 0, 4, and 8
• Maintenance
  • 100 mg SC at week 16 and  every 8 weeks thereafter, or
  • 200 mg SC at week 12 and every 4 weeks thereafter
  • Use the lowest effective recommended dose to maintain the therapeutic response

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Guselkumab include:

• upper respiratory infections
• headache
• injection site reactions
• joint pain
• diarrhea
• gastroenteritis (nausea, vomiting, diarrhea, cramps, and fever)
• tinea infections (athlete's foot, ringworm, jock itch)
• herpes simplex infections

Serious side effects of Guselkumab include:

• severe allergic reaction
• severe infection

Rare side effects of Guselkumab include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Guselkumab has severe interactions with the following drug:
  • upadacitinib
• Guselkumab has serious interactions with at least 20 other drugs.
• Guselkumab has moderate interactions with at least 34 other drugs.
• Guselkumab has minor interactions with no other drugs. 

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• History of serious hypersensitivity reaction to guselkumab or any of the excipients

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Guselkumab?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Guselkumab?”

Cautions

Hypersensitivity reactions

• Serious hypersensitivity reactions, including anaphylaxis, reported with postmarket use
• Some cases required hospitalization
• If a serious hypersensitivity reaction occurs, discontinue the drug and initiate appropriate therapy

Infections

• May increase infection risk; consider risks and benefits in patients with a chronic infection or history of recurrent infection
• Discontinue the drug if the patient develops a serious infection or is not responding to therapy
• Do not initiate treatment with any clinically important active infection until the infection resolves or is adequately treated

Pretreatment evaluation for TB

• Screen for tuberculosis (TB) before initiating treatment
• Initiate treatment for latent TB before administering
• Monitor for signs and symptoms of active TB during and after treatment
• Do not administer guselkumab to patients with active TB

Hepatotoxicity

• Serious adverse reaction of drug-induced liver injury was reported in a clinical trial participant with Crohn's disease following 3 doses of a higher than recommended induction regimen
• This toxicity resulted in ALT 18x ULN, AST 11x ULN, and total bilirubin 2.4x ULN
• Guselkumab was discontinued, and liver test abnormalities resolved following corticosteroid administration
• In patients with Crohn's disease or ulcerative colitis, evaluate liver enzymes and bilirubin at baseline, for at least 16 weeks of treatment, and periodically thereafter according to routine patient management
• Consider other treatment options in patients with evidence of acute liver disease or cirrhosis
• Promptly investigate the cause of liver enzyme elevations to identify potential cases of drug-induced liver injury
• Interrupt treatment if drug-induced liver injury suspected until this diagnosis is excluded
• Instruct patients to seek immediate medical attention if they experience symptoms suggestive of hepatic dysfunction

Drug interaction overview

• Immunizations
  • Avoid the use of live vaccines
  • Consider completion of all age-appropriate immunizations before initiating guselkumab; avoid live vaccines
• CYP450 substrates
  • The formation of CYP450 enzymes can be altered by increased levels of certain cytokines (eg, interleukin [IL]-1, IL-6, IL-10, tumor necrosis factor-alpha, interferon) during chronic inflammation
  • Guselkumab may modulate serum levels of some cytokines
  • Therefore, upon initiating or discontinuing guselkumab in patients who are receiving concomitant drugs that are CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for effect (eg, for warfarin) or drug concentration (eg, for cyclosporine) and consider dosage modification of the CYP450 substrate

Pregnancy and Lactation

• There is a pregnancy registry that monitors pregnancy outcomes in women exposed to the drug during pregnancy; encourage patients to enroll by calling 1-877-311- 8972
• No available data on use in pregnant women to inform a drug-associated risk of adverse developmental outcomes
• Human IgG antibodies are known to cross the placental barrier; therefore, guselkumab may be transmitted from the mother to the developing fetus

Clinical considerations

• Prescribing information states that published data suggest that the risk of adverse pregnancy outcomes in women with inflammatory bowel disease (IBD) is associated with increased disease activity
• Adverse pregnancy outcomes include preterm delivery (less than 37 weeks of gestation), low birth weight (less than 2,500 g) infants, and small for gestational age at birth

Lactation

• Unknown if distributed in human breast milk; maternal IgG is known to be present in human milk
• Guselkumab was not detected in the milk of lactating cynomolgus monkeys
• Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or the underlying maternal condition