Hympavzi

Description for Hympavzi

Marstacimab-hncq is a tissue factor pathway inhibitor (TFPI) antagonist, human monoclonal immunoglobulin G Type 1 (IgG1) antibody. Marstacimab-hncq is produced by Chinese hamster ovary (CHO) cells by recombinant DNA technology and has a molecular mass of approximately 146 kDa.

HYMPAVZI (marstacimab-hncq) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose 150 mg/mL prefilled syringe or as a single-dose 150 mg/mL prefilled pen. The solution of marstacimab-hncq is clear and colorless to light yellow with a pH of 5.8.

Each 150 mg/mL prefilled syringe or prefilled pen delivers 1 mL of HYMPAVZI. Each 1 mL of HYMPAVZI contains 150 mg of marstacimab-hncq, and the inactive ingredients edetate disodium (0.05 mg), histidine (1.12 mg), L-histidine monohydrochloride (2.67 mg), polysorbate 80 (0.2 mg), and sucrose (85 mg), in Water for Injection, USP.

ADVERSE REACTIONS

The following clinically significant adverse reactions are described elsewhere in the labeling:

• Thromboembolic Events [see Warnings and Precautions (5.1)]
• Hypersensitivity [see Warnings and Precautions (5.2)]

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.

The safety of HYMPAVZI was evaluated in adolescent and adult patients with severe hemophilia A or B without inhibitors (coagulation factor activity <1%) enrolled in the BASIS study [see Clinical Studies (14.1)]. Patients (N = 116) received HYMPAVZI prophylaxis 300 mg loading dose followed by 150 mg every week starting at Day 8 administered subcutaneously. Among patients receiving HYMPAVZI, 97% were exposed for 6 months or longer and 75% were exposed for at least 1 year.

A serious adverse reaction of peripheral swelling occurred in one patient.

Table 1 summarizes the adverse reactions reported in ≥3% of patients who received HYMPAVZI prophylaxis.

Table 1: Adverse Reactions Reported in =3% of Patients Treated with HYMPAVZI*

Adverse Reaction	Number of Patients n (%) (N = 116)
Injection site reaction	11 (9)
Headache	8 (7)
Pruritus	4 (3)
*During BASIS trial 12-month active treatment phase

A serious adverse reaction of venous thrombosis occurred in 0.9% of patients (1/116) treated with HYMPAVZI in the open-label extension study [see Clinical Studies (14.1)].

Drug Interactions for Hympavzi

Partial Thromboplastin Time (aPTT) and Prothrombin Time (PT)

No clinically significant differences in standard measures of coagulation including activated partial thromboplastin time (aPTT) and prothrombin time (PT) were observed following marstacimab-hncq therapy.

Warnings for Hympavzi

Included as part of the PRECAUTIONS section.

Precautions for Hympavzi

Thromboembolic Events

HYMPAVZI is a tissue factor pathway inhibitor (TFPI) antagonist, and may increase the risk of thromboembolic complications. Venous thrombotic events were reported in clinical studies with HYMPAVZI [see Adverse Reactions (6.1)].

Patients with independent risk factors for thromboembolic events may be at increased risk of thromboembolic events with use of HYMPAVZI.

HYMPAVZI has not been studied in patients with a history of previous thromboembolic events [see Clinical Studies (14.1)]. Consider the benefit and risk of using HYMPAVZI in patients with known risk factors for thromboembolism.

Interrupt HYMPAVZI prophylaxis if diagnostic findings consistent with thromboembolism occur and manage as clinically indicated.

If factor VIII or factor IX products are indicated in a patient receiving HYMPAVZI prophylaxis, the minimum effective dose of factor VIII or factor IX according to the product label is recommended [see Dosage and Administration (2.4)].

Hypersensitivity

HYMPAVZI may cause hypersensitivity reactions (including, but not limited to urticaria and pruritus). If HYMPAVZI-treated patients develop a severe hypersensitivity reaction, advise patients to discontinue HYMPAVZI and seek immediate emergency treatment.

Embryofetal Toxicity

Based on its mechanism of action, HYMPAVZI may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)]. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with HYMPAVZI and for 2 months after the last dose [see Use in Specific Populations (8.1, 8.3)].

NONCLINICAL TOXICOLOGY

Carcinogenesis, Mutagenesis, Impairment of Fertility

No studies have been conducted to assess marstacimab-hncq for the potential for carcinogenicity or mutagenicity. Marstacimab-hncq did not affect fertility when administered as a repeat dose to male rats at doses up to 1000 mg/kg/dose and an exposure margin of 212-times the exposure at a clinical dose of 300 mg subcutaneous weekly. No effects were observed in male or female reproductive organs in the repeat-dose toxicity studies of up to 6 months in duration in rats and 3 months in duration in cynomolgus monkeys at doses of 1000 mg/kg/dose and 500 mg/kg/dose and exposure margins at least 201- and 219-times, respectively, the AUC exposure at a clinical dose of 300 mg subcutaneous weekly.

Patient Information for Hympavzi

• Advise the patient and/or caregivers to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
• Ensure that patients and caregivers who will administer HYMPAVZI receive appropriate training and instruction on the proper storage, use and handling of HYMPAVZI from a healthcare professional.

Thromboembolic Events

Inform patients and/or caregivers that HYMPAVZI increases coagulation potential. Discuss the appropriate dosing of concomitant agents such as FVIII or FIX with the patient prior to starting on HYMPAVZI prophylaxis [see Warnings and Precautions (5.1)]. Advise the patient to discontinue HYMPAVZI and seek immediate medical attention if any signs or symptoms of thromboembolism occur.

Hypersensitivity

Inform patients and/or caregivers that hypersensitivity reactions such as rash and pruritus are possible. Advise patients to discontinue HYMPAVZI and seek immediate emergency treatment if a severe hypersensitivity reaction occurs [see Warnings and Precautions (5.2)].

Pregnancy

Advise female patients of reproductive potential to use effective contraception during treatment with HYMPAVZI and for 2 months after the last dose. Advise patients to report known pregnancies [see Warnings and Precautions (5.3), Use in Specific Populations (8.1, 8.3)].

This product’s labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.

For medical information about HYMPAVZI, please visit www.pfizermedinfo.com or call 1-800-438-1985.

 

US License No. 2001

Distributed by:
Pfizer Labs
Division of Pfizer Inc.
New York, NY 10001

OVERDOSES

No information provided.

Contraindications for Hympavzi

No information provided.

Clinical Pharmacology for Hympavzi

Mechanism Of Action

Marstacimab-hncq is a human monoclonal IgG1 antibody directed against the Kunitz domain 2 (K2) of TFPI to neutralize TFPI activity and enhance coagulation. TFPI is the primary inhibitor of the extrinsic coagulation cascade and negatively regulates thrombin generation within the extrinsic pathway of coagulation by inactivating the protease functions of FXa/FVIIa/TF complex. TFPI binds to and inhibits the factor Xa active site via its second Kunitz inhibitor domain (K2).

Pharmacodynamics

Marstacimab-hncq causes an increase in total TFPI (comprised of free TFPI and TFPI bound to marstacimab) and downstream biomarkers of thrombin generation such as prothrombin fragments 1+2, peak thrombin, and D-Dimer in patients with hemophilia. These changes were observed and persisted over a 7-day period following a single subcutaneous dose and were reversible after treatment discontinuation.

Pharmacokinetics

Estimated mean marstacimab-hncq Cmin,ss, Cmax,ss, and Cavg,ss for adults and adolescents weighing at least 35 kg following marstacimab-hncq 150 mg subcutaneous once-weekly administration are shown in Table 2.

Marstacimab-hncq area under the plasma concentration-time curve (AUC) and maximum plasma concentration (C_max) increase in a greater than dose-proportional manner over the dose range of 100 mg to 450 mg (0.67 to 3 times the approved recommended dosage).

Mean steady-state accumulation ratio for marstacimab-hncq is approximately 4 to 5. Marstacimab-hncq steady-state concentrations are achieved by approximately 60 days (8^th or 9^th subcutaneous dose) when administered once weekly.

Table 2: Steady-State Marstacimab-hncq Plasma Concentrations Following Once-Weekly Subcutaneous Administration of 150 mg (with a Loading Dose of 300 mg Subcutaneous)

Parameter	Adults	Adolescents
Cmin,ss (mcg/mL)	13.7 (90.4%)	27.3 (53.2%)
Cmax,ss (mcg/mL)	17.9 (77.5%)	34.7 (48.5%)
Cavg,ss (mcg/mL)	16.5 (81.2%)	32.1 (49.5%)
Data are presented as arithmetic mean (%CV). Cmin,ss = minimum plasma concentration at steady state; Cmax,ss = maximum plasma concentration at steady state; Cavg,ss = average plasma concentration at steady state.

Absorption

Bioavailability of marstacimab-hncq following subcutaneous administration is approximately 71%. Median Tmax ranges from 23 to 59 hours following multiple subcutaneous administrations of marstacimab-hncq to patients with hemophilia. No clinically significant differences were seen in marstacimab-hncq bioavailability when administered subcutaneously in the arm, thigh or abdomen.

Distribution

Marstacimab-hncq steady-state apparent volume of distribution is 8.6 L in patients with hemophilia.

Elimination

Marstacimab-hncq is cleared via linear and non-linear mechanisms. Marstacimab-hncq exhibited non-linear pharmacokinetics due to target-mediated drug disposition (TMDD) which occurs when it forms marstacimab-hncq/TFPI complex. Once the target becomes saturated, linear pathway (i.e., catabolism) dominates.

Based on population pharmacokinetic analysis, 90% of marstacimab is expected to be eliminated by the end of approximately 1 month after the last dose (median time for 50% of drug to be eliminated is approximately 7 to 10 days).

Metabolism

Marstacimab-hncq is expected to be metabolized into small peptides and amino acids by catabolic pathways in the same manner as endogenous IgG.

Specific Populations

No clinically significant differences in pharmacokinetics of marstacimab-hncq were observed based on race, hemophilia type (A and B), mild renal impairment (eGFR of 60 to 89 mL/min/1.73 m²), and mild hepatic impairment (total bilirubin >1× to ≤1.5× ULN). The effects of geriatric age (>65 years), moderate to severe renal (eGFR <59 mL/min/1.73 m²) and moderate to severe hepatic (Child Pugh class B and C) impairment on marstacimab-hncq pharmacokinetics are unknown.

Body Weight

Body weight was a significant covariate impacting the pharmacokinetics of marstacimab-hncq.

Marstacimab-hncq exposures over the body weight range of 35 to 120 kg show a trend for increase in exposure with decrease in body weight. However, dose adjustment based on body weight is not required.

Pediatric Patients

Marstacimab-hncq clearance (CL) was 29% lower in adolescents (12 to <18 years of age) compared to adults (18 years and older). No clinically significant difference in adolescent marstacimab-hncq CL (L/hr/kg) compared to adults was observed after adjusting for body weight.

Immunogenicity

The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and the specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies (ADA) in the studies described below with the incidence of ADA in other studies, including those of marstacimab-hncq or of other marstacimab products.

During the 12-month active treatment phase in the BASIS study, 23 of the 116 (19.8%) ADA-evaluable marstacimab-hncq-treated patients developed ADAs. Among the 23 patients who tested positive for ADA, 6 patients (26%) developed neutralizing antibodies (NAbs) against marstacimab-hncq. Subjects who received marstacimab-hncq and developed anti-marstacimab-hncq antibodies had reduced marstacimab-hncq steady-state concentrations, geometric mean decrease in the range of 24% to 50%, compared to those who did not develop anti-marstacimab-hncq antibodies through the course of the treatment period.

There was no identified clinically significant effect of ADAs, including NAbs, on safety or efficacy of marstacimab-hncq over the treatment duration of 12 months.

INSTRUCTIONS FOR USE

This Instructions for Use contains information on how to inject HYMPAVZI.

Read this Instructions for Use carefully before using HYMPAVZI Prefilled Syringe and each time you get a refill prescription as there may be new information.

Your healthcare provider should show you or your caregiver how to prepare and inject a dose of HYMPAVZI the right way before you use it for the first time. Do not inject yourself or someone else until you have been shown how to inject HYMPAVZI.

Important Information You Need to Know Before Injecting HYMPAVZI

• Each HYMPAVZI Prefilled Syringe is a Single-Dose Prefilled Syringe (called “Syringe” in this Instructions for Use). The HYMPAVZI Prefilled Syringe contains 150 mg of HYMPAVZI for injection under the skin (subcutaneously).
• Do not inject HYMPAVZI into a vein.
• To help you remember when to inject HYMPAVZI, you can mark your calendar ahead of Call your healthcare provider if you or your caregiver have any questions about the right way to inject HYMPAVZI, or call the helpline at 1-888-496-7289 (1-888 HYMPAV-Z).
• Use HYMPAVZI exactly as prescribed by your healthcare provider.
• HYMPAVZI is not made with natural rubber latex.

Storing HYMPAVZI

• Store HYMPAVZI in a refrigerator at 36°F to 46°F (2°C to 8°C).
• Store HYMPAVZI in the original carton to protect from light.
• If needed, HYMPAVZI may be stored one time at room temperature, up to 86°F (30°C) in the original carton for up to 7 days. Do not return HYMPAVZI to the refrigerator after storing at room temperature.
• Throw away (dispose of) HYMPAVZI that has been left out of the refrigerator for more than 7 days.
• Do not freeze HYMPAVZI.
• Do not shake HYMPAVZI.
• Do not use past the expiration date (Exp) printed on the HYMPAVZI Prefilled Syringe.
• Keep HYMPAVZI and all medicines out of the reach of children.

Supplies Needed For HYMPAVZI Injection

Gather the following supplies on a clean flat surface:

Included in the carton:

• 1 HYMPAVZI Prefilled Syringe

Not included in the carton:

• 1 alcohol swab
• 1 cotton ball or gauze pad
• 1 FDA-cleared sharps disposal container for Syringe disposal (see “Step 11 – Disposal of Syringe” and “Safe Syringe Disposal” information section)

HYMPAVZI Prefilled Syringe

Always hold HYMPAVZI Prefilled Syringe by the barrel to prevent damage.

Preparing to Inject HYMPAVZI
Step 1: Getting Ready Remove the Syringe from its carton and keep out of direct sunlight. Make sure the name HYMPAVZI appears on the carton and Syringe label. Check the Syringe for any visible damage such as cracks or leaks. Wash and dry your hands. Do not remove the needle cover until you are ready to inject. Throw away (dispose of) the Syringe if it is damaged, or if the Syringe or the carton containing the Syringe has been dropped. Do not use the Syringe if: it has been stored in direct Exposure to room light during dose preparation and injection is acceptable. it has been frozen or thawed or it has been out of the refrigerator for more than 7 days. Note: For a more comfortable injection, allow the Syringe to warm up to room temperature [up to 86°F (30°C)] in the carton away from direct sunlight for about 15 to 30 minutes. Do not use any other methods to warm up the Syringe, such as warming the Syringe in a microwave or hot water.
Step 2: Check Expiration Date Check the expiration date (Exp) printed on the Syringe label. Do not use if the expiration date (Exp) has passed.
Step 3: Check Medicine Gently tilt the Syringe back and forth. Look carefully at the medicine in the Syringe. The medicine should be clear and colorless to light yellow. Do not use the Syringe if the medicine is cloudy, dark yellow, or contains flakes or particles. Note: It is normal to see air bubbles in the Syringe. If you have any questions about the medicine, contact your healthcare provider.
Step 4: Choose and Clean Your Injection Site
Choose an injection site on your stomach area (abdomen) or front of thigh unless a different site has been suggested by your healthcare provider. HYMPAVZI may also be injected into the back of your upper arms by a healthcare provider or caregiver only. Keep at least 2 inches away from your belly button. Change (rotate) the injection site each time you give yourself an injection of HYMPAVZI and away from any other medicine given under your You may use the same area of your body but be sure to choose a different injection site in that area. Clean the injection site with soap and water, or an alcohol swab. Allow the site to air Do not touch, fan, or blow on the cleaned injection site. Do not inject HYMPAVZI into bony areas or areas on your skin that are bruised, red, sore (tender) or Avoid injecting into areas with scars or stretch marks. Do not inject HYMPAVZI into a vein. Do not inject HYMPAVZI through your clothes.
Step 5: Remove Cover Hold the Syringe by the barrel. Pull the needle cover straight off carefully. Put the needle cover into an FDA-cleared sharps disposal container right You will not need it again. Do not touch the needle or let it touch any surfaces. Note: It is normal to see a few drops of medicine at the needle tip. Caution: Handle the Syringe with care to avoid an accidental needle injury.
Injecting HYMPAVZI
Step 6: Insert Needle Pinch your cleaned skin between your thumb and fingers to create a firm surface. Fully insert the needle into your skin at a 45° angle, as Do not hold or push on the plunger while inserting the needle. Keep your skin pinched throughout the injection. Caution: If you change your mind where to inject after inserting the needle into your skin, you will need to throw away (dispose of) the Syringe and get a new HYMPAVZI Prefilled Syringe.
Step 7: Inject Medicine Slowly inject all of HYMPAVZI by gently pushing the plunger rod all the way down, until the barrel is empty.
Step 8: Remove Needle Pull the needle and Syringe out of your skin at the same angle as inserted. Note: If you see a small drop of medicine on your skin, wait a little longer before removing the needle when you give your next injection.
Step 9: Check Syringe Check the Syringe to make sure the gray plunger stopper is in the position shown. If the gray plunger stopper is not in the position shown, this means you have not received a full dose. Call your healthcare provider for help. Never re-insert the needle. Do not inject another dose.
Step 10: After Care Press lightly on the injection site for a few seconds with a clean cotton ball or gauze pad if you see a drop of blood. Do not rub the area. Note: If bleeding does not stop, contact your healthcare provider. Note: If your prescribed dose requires 2 injections of HYMPAVZI, repeat steps 1-10. Change (rotate) the injection site each time you give yourself an injection of HYMPAVZI. You may use the same area of your body but be sure to choose a different injection site in that area.
Step 11: Disposal of Syringe Put the used Syringe in an FDA-cleared sharps disposal container right away after use. Never re-cap the needle.  Do not throw away (dispose of) Syringes in the household trash. Note: If you do not have an FDA-cleared sharps disposal container, please see the “Safe Syringe Disposal” information section.

Safe Syringe Disposal 

• Always throw away (dispose of) Syringes in a sharps disposal Do not dispose of Syringes in the 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,
  • is upright and stable during use,
  • is leak-resistant, and
  • is 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 throw away (dispose of) your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about safe sharps disposal for the state you live in, go to the FDA’s website at: https://www.fda.gov/safesharpsdisposal.
• Do not recycle your used sharps disposal container.

 

US License No. 2001

Distributed by:
Pfizer Labs
Division of Pfizer Inc.
New York, NY 10001
LAB-1576-1.2 

For more information, go to www.pfizer.com or call 1-800-438-1985.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.

INSTRUCTIONS FOR USE

This Instructions for Use contains information on how to inject HYMPAVZI.

Read this Instructions for Use carefully before using HYMPAVZI Prefilled Pen and each time you get a refill prescription as there may be new information.

Your healthcare provider should show you or your caregiver how to prepare and inject a dose of HYMPAVZI the right way before you use it for the first time. Do not inject yourself or someone else until you have been shown how to inject HYMPAVZI.

Important Information You Need to Know Before Injecting HYMPAVZI

• Each HYMPAVZI Prefilled Pen is a Single-Dose Prefilled Pen (called “Pen” in this Instructions for Use). The HYMPAVZI Prefilled Pen contains 150 mg of HYMPAVZI for injection under the skin (subcutaneously).
• Do not inject HYMPAVZI into a vein.
• To help you remember when to inject HYMPAVZI, you can mark your calendar ahead of Call your healthcare provider if you or your caregiver have any questions about the right way to inject HYMPAVZI, or call the helpline at 1-888-496-7289 (1-888 HYMPAV-Z).
• Use HYMPAVZI exactly as prescribed by your healthcare provider.
• HYMPAVZI is not made with natural rubber latex.

Storing HYMPAVZI

• Store HYMPAVZI in a refrigerator at 36°F to 46°F (2°C to 8°C).
• Store HYMPAVZI in the original carton to protect from light.
• If needed, HYMPAVZI may be stored one time at room temperature, up to 86°F (30°C) in the original carton for up to 7 days. Do not return HYMPAVZI to the refrigerator after storing at room temperature.
• Throw away (dispose of) HYMPAVZI that has been left out of the refrigerator for more than 7 days.
• Do not freeze HYMPAVZI.
• Do not shake HYMPAVZI.
• Do not use past the expiration date (EXP) printed on the HYMPAVZI Prefilled Pen.
• Keep HYMPAVZI and all medicines out of the reach of children.

Supplies Needed For HYMPAVZI Injection

Gather the following supplies on a clean flat surface:

Included in the carton:

• 1 HYMPAVZI Prefilled Pen

Not included in the carton:

• 1 alcohol swab
• 1 cotton ball or gauze pad
• 1 FDA-cleared sharps disposal container for Pen disposal (see “Step 10 – Disposal of Pen” and “Safe Pen Disposal” information section)

HYMPAVZI Prefilled Pen

Preparing to Inject HYMPAVZI
Step 1: Getting Ready Remove the Pen from its carton and keep out of direct sunlight. Make sure the name HYMPAVZI appears on the carton and Pen label. Check the Pen for any visible damage such as cracks or leaks. Wash and dry your hands. Do not remove the needle cover until you are ready to inject. Throw away (dispose of) the Pen if it is damaged, or if the Pen or the carton containing the Pen has been dropped. Do not use the Pen if: it has been stored in direct Exposure to room light during dose preparation and injection is acceptable. it has been frozen or thawed or it has been out of the refrigerator for more than 7 days. Note: For a more comfortable injection, allow the Pen to warm up to room temperature [up to 86°F (30°C)] in the carton away from direct sunlight for about 15 to 30 minutes. Do not use any other methods to warm up the Pen, such as warming the Pen in a microwave or hot water.
Step 2: Check Expiration Date Check the expiration date (Exp) printed on the Pen label. Do not use if the expiration date (Exp) has passed.
Step 3: Check Medicine Look carefully at the medicine through the window on the Pen. The medicine should be clear and colorless to light yellow. Do not use the Pen if the medicine is cloudy, dark yellow, or contains flakes or particles. Note: It is normal to see air bubbles in the Pen. If you have any questions about the medicine, contact your healthcare provider.
Step 4: Choose and Clean Your Injection Site
Choose an injection site on your stomach area (abdomen) or front of thigh unless a different site has been suggested by your healthcare provider. HYMPAVZI may also be injected into the back of your upper arms by a healthcare provider or caregiver only. Keep at least 2 inches away from your belly button. Change (rotate) the injection site each time you give yourself an injection of HYMPAVZI and away from any other medicine given under your You may use the same area of your body but be sure to choose a different injection site in that area. Clean the injection site with soap and water, or an alcohol swab. Allow the site to air Do not touch, fan, or blow on the cleaned injection site. Do not inject HYMPAVZI into bony areas or areas on your skin that are bruised, red, sore (tender) or Avoid injecting into areas with scars or stretch marks. Do not inject HYMPAVZI into a vein. Do not inject HYMPAVZI through your clothes.
Step 5: Twist Off Cap Twist and pull off the cap. Put the cap into an FDA-cleared sharps disposal container right You will not need it again. Note: It is normal to see a few drops of medicine at the needle tip. The needle cover will stay inside the cap after cap removal. Caution: Handle the Pen with care as it contains a needle. Do not put or press your hand over the needle guard. Doing so may cause a needle injury.
Injecting HYMPAVZI
Step 6: Inject Medicine
Hold the Pen straight (at 90° angle) against your cleaned skin so you can see the window. Push the Pen down firmly straight against your skin and keep pushing until the injection is You will hear the 1st click when the injection starts. Keep pushing the Pen firmly against your skin while the yellow bar moves across the You will hear a 2nd click when the injection is almost complete. Count slowly to 5 after you hear the 2nd click to make sure you get a full dose. Do not remove the Pen from your skin until you have counted slowly to 5 after you hear the 2nd click and until the yellow marker completely fills the window (see “Step 7 – Remove Pen”). Note: The needle goes into your skin as you push the Pen down. Your healthcare provider may suggest gently pinching your skin while you inject. Note: If you do not hear a click when pushing the Pen against your skin, try pushing down harder. If you still cannot start the injection, get a new HYMPAVZI Prefilled Pen. Caution: If you change your mind where to inject after inserting the needle into your skin, you will need to throw away (dispose of) the Pen and get a new HYMPAVZI Prefilled Pen.
Step 7: Remove Pen Remove the Pen from your skin. If you see a small drop of medicine on your skin, wait a little longer before removing the Pen when you give your next injection. Note: After you remove the Pen from your skin, the needle guard will automatically cover the needle and lock in place. The Pen cannot be reused.
Step 8: Check Window Check the window to make sure all the medicine has been injected. If the yellow bar is not in the position shown, this means you have not received a full dose. Call your healthcare provider for help. Do not inject another dose.
Step 9: After Care Press lightly on the injection site for a few seconds with a clean cotton ball or gauze pad if you see a drop of blood. Do not rub the area. Note: If bleeding does not stop, contact your healthcare provider. Note: If your prescribed dose requires 2 injections of HYMPAVZI, repeat steps 1-9. Change (rotate) the injection site each time you give yourself an injection of HYMPAVZI. You may use the same area of your body but be sure to choose a different injection site in that area.
Step 10: Disposal of Pen Put the used Pen in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) Pens in the household trash. Note: If you do not have an FDA-cleared sharps disposal container, please see the “Safe Pen Disposal” information section.

Safe Pen Disposal

• Always throw away (dispose of) Pens in a sharps disposal Do not dispose of Pens in the 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,
  • is upright and stable during use,
  • is leak-resistant, and
  • is 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 throw away (dispose of) your sharps disposal container. There may be state or local laws about how you should throw away used needles and Pens. For more information about safe sharps disposal, and for specific information about safe sharps disposal for the state you live in, go to the FDA’s website at: https://www.fda.gov/safesharpsdisposal.
• Do not recycle your used sharps disposal container.

 

US License No. 2001

Distributed by:
Pfizer Labs
Division of Pfizer Inc.
New York, NY 10001
LAB-1576-1.2 

For more information, go to www.pfizer.com or call 1-800-438-1985.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.