NYVEPRIA: Package Insert and Label Information (Page 2 of 3)

8.2 Lactation

Risk Summary

There are no data on the presence of pegfilgrastim products in human milk, the effects on the breastfed child, or the effects on milk production. Other filgrastim products are secreted poorly into breast milk, and filgrastim products are not absorbed orally by neonates. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for NYVEPRIA and any potential adverse effects on the breastfed child from NYVEPRIA or from the underlying maternal condition.

8.4 Pediatric Use

The safety and effectiveness of pegfilgrastim have been established in pediatric patients. No overall differences in safety were identified between adult and pediatric patients based on postmarketing surveillance and review of the scientific literature.

Use of pegfilgrastim in pediatric patients for chemotherapy-induced neutropenia is based on adequate and well-controlled studies in adults with additional pharmacokinetic and safety data in pediatric patients with sarcoma [see Clinical Pharmacology (12.3) and Clinical Studies (14)].

8.5 Geriatric Use

Of the 932 patients with cancer who received pegfilgrastim in clinical studies, 139 (15%) were aged 65 and over, and 18 (2%) were aged 75 and over. No overall differences in safety or effectiveness were observed between patients aged 65 and older and younger patients.

10 OVERDOSAGE

Overdosage of pegfilgrastim products may result in leukocytosis and bone pain. Events of edema, dyspnea, and pleural effusion have been reported in a single patient who administered pegfilgrastim on 8 consecutive days in error. In the event of overdose, the patient should be monitored for adverse reactions [see Adverse Reactions (6)].

11 DESCRIPTION

Pegfilgrastim-apgf is a covalent conjugate of recombinant methionyl human G-CSF and monomethoxypolyethylene glycol. Recombinant methionyl human G-CSF is a water-soluble 175 amino acid protein with a molecular weight of approximately 19 kilodaltons (kD). Recombinant methionyl human G-CSF is obtained from the bacterial fermentation of a strain of E. coli transformed with a genetically engineered plasmid containing the human G-CSF gene. To produce pegfilgrastim-apgf, a 20 kD monomethoxypolyethylene glycol molecule is covalently bound to the N-terminal methionyl residue of recombinant methionyl human G-CSF. The average molecular weight of pegfilgrastim-apgf is approximately 39 kD.

NYVEPRIA for manual subcutaneous injection is supplied in 0.6 mL prefilled syringes. The prefilled syringe does not bear graduation marks and is designed to deliver the entire contents of the syringe (6 mg/0.6 mL).

The delivered 0.6 mL dose from the prefilled syringe for manual subcutaneous injection contains 6 mg pegfilgrastim-apgf (based on protein weight) in a sterile, clear, colorless, preservative-free solution (pH 4.0) containing acetate (0.35 mg), polysorbate 20 (0.02 mg), sodium (0.01 mg), and sorbitol (30 mg) in Water for Injection, USP.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Pegfilgrastim products are colony-stimulating factors that act on hematopoietic cells by binding to specific cell surface receptors, thereby stimulating proliferation, differentiation, commitment, and end cell functional activation.

12.2 Pharmacodynamics

Animal data and clinical data in humans suggest a correlation between pegfilgrastim products’ exposure and the duration of severe neutropenia as a predictor of efficacy. Selection of the dosing regimen of NYVEPRIA is based on reducing the duration of severe neutropenia.

12.3 Pharmacokinetics

The pharmacokinetics of pegfilgrastim was studied in 379 patients with cancer. The pharmacokinetics of pegfilgrastim was nonlinear, and clearance decreased with increases in dose. Neutrophil receptor binding is an important component of the clearance of pegfilgrastim, and serum clearance is directly related to the number of neutrophils. In addition to numbers of neutrophils, body weight appeared to be a factor. Patients with higher body weights experienced higher systemic exposure to pegfilgrastim after receiving a dose normalized for body weight. A large variability in the pharmacokinetics of pegfilgrastim was observed. The half-life of pegfilgrastim ranged from 15 to 80 hours after subcutaneous injection.

Specific Populations

No gender-related differences were observed in the pharmacokinetics of pegfilgrastim, and no differences were observed in the pharmacokinetics of geriatric patients (≥65 years of age) compared with younger patients (<65 years of age) [see Use in Specific Populations (8.5)].

Renal Impairment

In a study of 30 subjects with varying degrees of renal dysfunction, including end stage renal disease, renal dysfunction had no effect on the pharmacokinetics of pegfilgrastim.

Pediatric Patients with Cancer Receiving Myelosuppressive Chemotherapy

The pharmacokinetics and safety of pegfilgrastim were studied in 37 pediatric patients with sarcoma in Study 4 [see Clinical Studies (14)]. The mean (± standard deviation [SD]) systemic exposure (AUC_0–inf ) of pegfilgrastim after subcutaneous administration at 100 mcg/kg was 47.9 (± 22.5) mcg∙hr/mL in the youngest age group (0 to 5 years, n = 11), 22.0 (± 13.1) mcg∙hr/mL in the 6 to 11 years age group (n = 10), and 29.3 (± 23.2) mcg∙hr/mL in the 12 to 21 years age group (n = 13). The terminal elimination half-lives of the corresponding age groups were 30.1 (± 38.2) hours, 20.2 (± 11.3) hours, and 21.2 (± 16.0) hours, respectively.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

No carcinogenicity or mutagenesis studies have been performed with pegfilgrastim products.

Pegfilgrastim did not affect reproductive performance or fertility in male or female rats at cumulative weekly doses approximately 6 to 9 times higher than the recommended human dose (based on body surface area).

14 CLINICAL STUDIES

Pegfilgrastim was evaluated in three randomized, double-blind, controlled studies. Studies 1 and 2 were active-controlled studies that employed doxorubicin 60 mg/m² and docetaxel 75 mg/m² administered every 21 days for up to 4 cycles for the treatment of metastatic breast cancer. Study 1 investigated the utility of a fixed dose of pegfilgrastim. Study 2 employed a weight-adjusted dose. In the absence of growth factor support, similar chemotherapy regimens have been reported to result in a 100% incidence of severe neutropenia (ANC <0.5 × 10⁹ /L) with a mean duration of 5 to 7 days and a 30% to 40% incidence of febrile neutropenia. Based on the correlation between the duration of severe neutropenia and the incidence of febrile neutropenia found in studies with filgrastim, duration of severe neutropenia was chosen as the primary endpoint in both studies, and the efficacy of pegfilgrastim was demonstrated by establishing comparability to filgrastim-treated patients in the mean days of severe neutropenia.

In Study 1, 157 patients were randomized to receive a single subcutaneous injection of pegfilgrastim (6 mg) on day 2 of each chemotherapy cycle or daily subcutaneous filgrastim (5 mcg/kg/day) beginning on day 2 of each chemotherapy cycle. In Study 2, 310 patients were randomized to receive a single subcutaneous injection of pegfilgrastim (100 mcg/kg) on day 2 or daily subcutaneous filgrastim (5 mcg/kg/day) beginning on day 2 of each chemotherapy cycle.

Both studies met the major efficacy outcome measure of demonstrating that the mean days of severe neutropenia of pegfilgrastim-treated patients did not exceed that of filgrastim-treated patients by more than 1 day in cycle 1 of chemotherapy. The mean days of cycle 1 severe neutropenia in Study 1 were 1.8 days in the pegfilgrastim arm compared to 1.6 days in the filgrastim arm [difference in means 0.2 (95% CI -0.2, 0.6)] and in Study 2 were 1.7 days in the pegfilgrastim arm compared to 1.6 days in the filgrastim arm [difference in means 0.1 (95% CI -0.2, 0.4)].

A secondary endpoint in both studies was days of severe neutropenia in cycles 2 through 4 with results similar to those for cycle 1.

Study 3 was a randomized, double-blind, placebo-controlled study that employed docetaxel 100 mg/m² administered every 21 days for up to 4 cycles for the treatment of metastatic or non-metastatic breast cancer. In this study, 928 patients were randomized to receive a single subcutaneous injection of pegfilgrastim (6 mg) or placebo on day 2 of each chemotherapy cycle. Study 3 met the major trial outcome measure of demonstrating that the incidence of febrile neutropenia (defined as temperature ≥38.2°C and ANC ≤0.5 × 10⁹ /L) was lower for pegfilgrastim-treated patients as compared to placebo-treated patients (1% versus 17%, respectively, p < 0.001). The incidence of hospitalizations (1% versus 14%) and IV anti-infective use (2% versus 10%) for the treatment of febrile neutropenia was also lower in the pegfilgrastim-treated patients compared to the placebo-treated patients.

Study 4 was a multicenter, randomized, open-label study to evaluate the efficacy, safety, and pharmacokinetics [see Clinical Pharmacology (12.3)] of pegfilgrastim in pediatric and young adult patients with sarcoma. Patients with sarcoma receiving chemotherapy age 0 to 21 years were eligible. Patients were randomized to receive subcutaneous pegfilgrastim as a single dose of 100 mcg/kg (n = 37) or subcutaneous filgrastim at a dose 5 mcg/kg/day (n = 6) following myelosuppressive chemotherapy. Recovery of neutrophil counts was similar in the pegfilgrastim and filgrastim groups. The most common adverse reaction reported was bone pain.

16 HOW SUPPLIED/STORAGE AND HANDLING

NYVEPRIA (pegfilgrastim-apgf) injection is a clear, colorless solution supplied in a prefilled single-dose syringe for manual use containing 6 mg pegfilgrastim-apgf, supplied with a 27-gauge 1/2-inch needle and a BD UltraSafe Plus™ Passive Needle Guard.

The NYVEPRIA syringe plunger stopper and needle cover are not made with natural rubber latex.

NYVEPRIA is provided in a dispensing pack containing one sterile 6 mg/0.6 mL prefilled syringe (NDC 0069-0324-01).

NYVEPRIA prefilled syringe does not bear graduation marks and is intended only to deliver the entire contents of the syringe (6 mg/0.6 mL) for direct administration. Use of the prefilled syringe is not recommended for direct administration for pediatric patients weighing less than 45 kg who require doses that are less than the full contents of the syringe.

Store refrigerated between 36°F to 46°F (2°C to 8°C) in the carton to protect from light. Do not shake. Discard syringes stored at room temperature for more than 15 days. Avoid freezing; if frozen, thaw in the refrigerator before administration. Discard syringe if frozen more than once.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Advise patients of the following risks and potential risks with NYVEPRIA:

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Splenic rupture and splenomegaly

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Acute Respiratory Distress Syndrome

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Serious allergic reactions

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Sickle cell crisis

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Glomerulonephritis

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Increased risk of Myelodysplastic Syndrome and/or Acute Myeloid Leukemia in patients with breast and lung cancer who receive pegfilgrastim products in conjunction with chemotherapy and/or radiation therapy

•

Capillary Leak Syndrome

•

Aortitis

Instruct patients who self-administer NYVEPRIA using the single-dose prefilled syringe of the:

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Importance of following the Instructions for Use.

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Dangers of reusing syringes.

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Importance of following local requirements for proper disposal of used syringes.

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

Manufactured by
Hospira, Inc., a Pfizer Company,
Lake Forest, IL 60045 USAUS License No. 1974

Distributed by Pfizer Labs, division of Pfizer Inc., New York, NY 10001 USA

BD UltraSafe Plus is a trademark of Becton Dickinson and Company.

LAB-1186-4.0

This Patient Information has been approved by the U.S. Food and Drug Administration.	Revised: March 2023
Patient Information NYVEPRIA™ (Nigh-VEP ree-ah) (pegfilgrastim-apgf) injection Single-Dose Prefilled Syringe
What is NYVEPRIA? NYVEPRIA is a man-made form of granulocyte colony-stimulating factor (G-CSF). G-CSF is a substance produced by the body. It stimulates the growth of neutrophils, a type of white blood cell important in the body’s fight against infection.
Do not take NYVEPRIA if you have had a serious allergic reaction to pegfilgrastim products or filgrastim products.
Before you receive NYVEPRIA, tell your healthcare provider about all of your medical conditions, including if you: • have a sickle cell disorder. • have kidney problems. • are pregnant or plan to become pregnant. It is not known if NYVEPRIA will harm your unborn baby. • are breastfeeding or plan to breastfeed. It is not known if NYVEPRIA passes into your breast milk. Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How will I receive NYVEPRIA? • NYVEPRIA is given as an injection under your skin (subcutaneous injection) by a healthcare provider. If your healthcare provider decides that the subcutaneous injections can be given at home by you or your caregiver, follow the detailed “Instructions for Use” that comes with your NYVEPRIA for information on how to prepare and inject a dose of NYVEPRIA. • You and your caregiver will be shown how to prepare and inject NYVEPRIA before you use it. • You should not inject a dose of NYVEPRIA to children weighing less than 45 kg from a NYVEPRIA prefilled syringe. A dose less than 0.6 mL (6 mg) cannot be accurately measured using the NYVEPRIA prefilled syringe. • If you are receiving NYVEPRIA because you are also receiving chemotherapy, the last dose of NYVEPRIA should be injected at least 14 days before and 24 hours after your dose of chemotherapy. • If you miss a dose of NYVEPRIA, talk to your healthcare provider about when you should give your next dose.
What are possible side effects of NYVEPRIA? NYVEPRIA may cause serious side effects, including: • Spleen rupture. Your spleen may become enlarged and can rupture. A ruptured spleen can cause death. Call your healthcare provider right away if you have pain in the left upper stomach area or your left shoulder. • A serious lung problem called Acute Respiratory Distress Syndrome (ARDS). Call your healthcare provider or get emergency help right away if you have shortness of breath with or without a fever, trouble breathing, or a fast rate of breathing. • Serious allergic reactions. NYVEPRIA can cause serious allergic reactions. These reactions can cause a rash over your whole body, shortness of breath, wheezing, dizziness, swelling around your mouth or eyes, fast heart rate, and sweating. If you have any of these symptoms, stop using NYVEPRIA and call your healthcare provider or get emergency medical help right away. • Sickle cell crises. You may have a serious sickle cell crisis, which could lead to death, if you have a sickle cell disorder and receive NYVEPRIA. Call your healthcare provider right away if you have symptoms of sickle cell crisis such as pain or difficulty breathing. • Kidney injury (glomerulonephritis). NYVEPRIA can cause kidney injury. Call your healthcare provider right away if you develop any of the following symptoms: o swelling of your face or ankles o blood in your urine or dark colored urine o you urinate less than usual • Increased white blood cell count (leukocytosis). Your healthcare provider will check your blood during treatment with NYVEPRIA. • Decreased platelet count (thrombocytopenia). Your healthcare provider will check your blood during treatment with NYVEPRIA. Tell your healthcare provider if you have unusual bleeding or bruising during treatment with NYVEPRIA. This could be a sign of decreased platelet counts, which may reduce the ability of your blood to clot. • Capillary Leak Syndrome. NYVEPRIA can cause fluid to leak from blood vessels into your body’s tissues. This condition is called “Capillary Leak Syndrome” (CLS). CLS can quickly cause you to have symptoms that may become life-threatening. Get emergency medical help right away if you develop any of the following symptoms: o swelling or puffiness and are urinating less than usual o trouble breathing o swelling of your stomach area (abdomen) and feeling of fullness o dizziness or feeling faint o a general feeling of tiredness • Myelodysplastic syndrome and acute myeloid leukemia. If you have breast cancer or lung cancer, when NYVEPRIA is used with chemotherapy and radiation therapy, or with radiation therapy alone, you may have an increased risk of developing a precancerous blood condition called myelodysplastic syndrome (MDS) or a blood cancer called acute myeloid leukemia (AML). Symptoms of MDS and AML may include tiredness, fever, and easy bruising or bleeding. Call your healthcare provider if you develop these symptoms during treatment with NYVEPRIA. • Inflammation of the aorta (aortitis). Inflammation of the aorta (the large blood vessel which transports blood from the heart to the body) has been reported in patients who received pegfilgrastim products. Symptoms may include fever, abdominal pain, feeling tired, and back pain. Call your healthcare provider if you experience these symptoms. The most common side effects of NYVEPRIA are pain in the bones, arms, and legs. These are not all the possible side effects of NYVEPRIA. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store NYVEPRIA? • Store NYVEPRIA in the refrigerator between 36°F to 46°F (2°C to 8°C). • Do not freeze. If NYVEPRIA is accidentally frozen, allow the prefilled syringe to thaw in the refrigerator before injecting. • Do not use a NYVEPRIA prefilled syringe that has been frozen more than 1 time. Use a new NYVEPRIA prefilled syringe. • Keep the prefilled syringe in the original carton to protect from light or physical damage. • Do not shake the prefilled syringe. • Take NYVEPRIA out of the refrigerator 30 minutes before use and allow it to reach room temperature before preparing an injection. • Throw away (dispose of) any NYVEPRIA that has been left at room temperature, 68°F to 77°F (20°C to 25°C), for more than 15 days. Keep the NYVEPRIA prefilled syringe out of the reach of children.
General information about the safe and effective use of NYVEPRIA. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use NYVEPRIA for a condition for which it was not prescribed. Do not give NYVEPRIA 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 NYVEPRIA that is written for health professionals.
What are the ingredients in NYVEPRIA? Active ingredient: pegfilgrastim-apgf.Inactive ingredients: acetate, polysorbate 20, sodium, and sorbitol in water for injection.Manufactured by Hospira, Inc., a Pfizer Company, Lake Forest, IL 60045 USAUS License No. 1974Distributed by Pfizer Labs, division of Pfizer Inc., New York, NY 10001 USA LAB-1187-4.0For more information go to www.pfizer.com or call 1-800-438-1985.

Instructions for Use
NYVEPRIA (Nigh-VEP ree-ah) (pegfilgrastim-apgf) Injection, for subcutaneous use Single-Dose Prefilled Syringe
Guide to parts
Before use		After use
(click image for full-size original)		(click image for full-size original)
Important: The needle is covered by the needle cover before use.
Important Read the Patient Information for important information that you need to know about NYVEPRIA before using these Instructions for Use.Before you use a NYVEPRIA prefilled syringe, read this important information.
	Storing the prefilled syringe
• Store NYVEPRIA in the refrigerator between 36°F to 46°F (2°C to 8°C). • Do not freeze. If NYVEPRIA is accidentally frozen, allow the prefilled syringe to thaw in the refrigerator before injecting. • Do not use a NYVEPRIA prefilled syringe that has been frozen more than 1 time. Use a new NYVEPRIA prefilled syringe. • Keep the prefilled syringe in the original carton to protect from light or physical damage. o Take the prefilled syringe out of the refrigerator 30 minutes before use and allow it to reach room temperature before preparing an injection. o Throw away (dispose of) any NYVEPRIA that has been left at room temperature, 68°F to 77°F (20°C to 25°C), for more than 15 days. • Keep the NYVEPRIA prefilled syringe out of the reach of children.
	Using the prefilled syringe
• It is important that you do not try to give the injection unless you or your caregiver has received training from your healthcare provider. • Make sure the name NYVEPRIA appears on the carton and prefilled syringe label. • Check the carton and prefilled syringe label to make sure the dose strength is 6 mg/0.6 mL. • You should not inject a dose of NYVEPRIA to children weighing less than 45 kg from a NYVEPRIA prefilled syringe. A dose less than 0.6 mL (6 mg) cannot be accurately measured using the NYVEPRIA prefilled syringe. • Do not use a prefilled syringe after the expiration date on the label. • Do not shake the prefilled syringe. o Do not remove the needle cover from the prefilled syringe until you are ready to inject. • Do not use the prefilled syringe if the carton is open or damaged. • Do not use a prefilled syringe if it has been dropped on a hard surface. The prefilled syringe may be broken even if you cannot see the break. Use a new prefilled syringe. • The prefilled syringe has a needle guard that automatically activates to cover the needle after the injection is given. Do not use a prefilled syringe if the needle guard has been activated. Use another prefilled syringe that has not been activated and is ready to use. Call your healthcare provider if you have any questions.
	Step 1: Prepare
A. Remove the prefilled syringe carton from the refrigerator.Remove the inner carton containing the prefilled syringe from the outer carton by peeling away the cover. On a clean, well-lit surface, place the inner carton containing the prefilled syringe at room temperature for 30 minutes before you give an injection. • Do not use the prefilled syringe if the inner carton containing the prefilled syringe is damaged. • Do not try to warm the prefilled syringe by using a heat source such as hot water or microwave. • Do not leave the prefilled syringe in direct sunlight. • Do not shake the prefilled syringe. Open the inner carton containing the prefilled syringe by peeling away the cover. Grab the needle guard to remove the prefilled syringe from the inner carton containing the prefilled syringe. (click image for full-size original) • Do not grab the plunger rod. • Do not grab the needle cover. B. Inspect the medicine and prefilled syringe. (click image for full-size original) Make sure the medicine in the prefilled syringe is clear and colorless. • Do not use the prefilled syringe if: o The medicine is cloudy or discolored, or contains flakes or particles. o Any part appears cracked or broken. o The prefilled syringe has been dropped. o The needle cover is missing or not securely attached. o The expiration date printed on the label has passed. In all cases, use a new prefilled syringe and call your healthcare provider.C. Gather all materials needed for the injection.Wash your hands thoroughly with soap and water.On a clean, well-lit work surface, place the: • Prefilled syringe • Alcohol wipe • Cotton ball or gauze pad • Adhesive bandage • Sharps disposal container (click image for full-size original)
	Step 2: Get ready
D. Prepare and clean the injection site(s). (click image for full-size original) You can use: • Thigh • Stomach area (abdomen), except for a 2 -inch area right around the navel (belly button) • Upper outer area of the buttocks (only if someone else is giving you the injection) • Outer area of upper arm (only if someone else is giving you the injection) Clean the injection site with an alcohol wipe. Let the skin dry. (click image for full-size original) • Do not touch this area again before injecting. • If you want to use the same injection site, make sure it is not the same spot on the injection site you used for a previous injection. • Do not inject into areas where the skin is tender, bruised, red or hard. Avoid injecting into areas with scars or stretch marks. E. Hold the prefilled syringe by the needle guard. Carefully pull the needle cover straight off and away from the body. Throw away the needle cover into the sharps disposal container. Do not recap. (click image for full-size original) • Do not remove the needle cover from the prefilled syringe until you are ready to inject. • Do not twist or bend the needle cover. • Do not hold the prefilled syringe by the plunger rod. • Do not put the needle cover back onto the prefilled syringe. Important: Throw the needle cover into the sharps disposal container.
	Step 3: Subcutaneous (under the skin) injection
F. Pinch the injection site to create a firm surface. (click image for full-size original) Important: Keep skin pinched while injecting.G. Hold the pinch. Insert the needle into the skin at 45 to 90 degrees. (click image for full-size original) H. Using slow and constant pressure, push the plunger rod down until it reaches the bottom. (click image for full-size original)
	Step 4: Finish
I. When the syringe is empty, keep the plunger rod fully pressed down while you carefully pull the needle straight out from the injection site and off your skin. (click image for full-size original) J. Slowly release the plunger rod and allow the syringe needle guard to automatically cover the exposed needle. Do not recap the needle. (click image for full-size original) Important: When you remove the syringe, if it looks like the medicine is still in the syringe barrel, this means you have not received a full dose. Call your healthcare provider right away.K. Examine the injection site. If there is blood, press a cotton ball or gauze pad on the injection site. Do not rub the injection site. Apply an adhesive bandage if needed.L. Discard (throw away) the used prefilled syringe. (click image for full-size original) • Put the used prefilled syringe in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) the syringe in your household trash. • If you do not have a FDA-cleared sharps disposal container, you may use a household container that is: o made of a heavy-duty plastic, o can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, o upright and stable during use, o leak-resistant, and o 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 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 sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal. • Do not reuse the prefilled syringe. • Do not recycle the prefilled syringe or sharps disposal container or throw them in the household trash. Important: Always keep the sharps disposal container out of the reach of children.This Instructions for Use has been approved by the U.S. Food and Drug Administration. Manufactured byHospira, Inc., a Pfizer Company,Lake Forest, IL 60045 USAUS License No. 1974Distributed by Pfizer Labs, division of Pfizer Inc., New York, NY 10001 USA For more information go to www.pfizer.com or call 1-800-438-1985.LAB-1188-3.0Issued: March 2023