(pegfilgrastim-apgf)

Prescribing Information
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8 USE IN SPECIFIC POPULATIONS

8 USE IN SPECIFIC POPULATIONS

     

8.1 Pregnancy

Risk Summary

Although available data with pegfilgrastim product use in pregnant women are insufficient to establish whether there is a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes, there are available data from published studies in pregnant women exposed to filgrastim products. These studies have not established an association of filgrastim product use during pregnancy with major birth defects, miscarriage, or adverse maternal or fetal outcomes.

In animal studies, no evidence of reproductive/developmental toxicity occurred in the offspring of pregnant rats that received cumulative doses of pegfilgrastim approximately 10 times the recommended human dose (based on body surface area). In pregnant rabbits, increased embryolethality and spontaneous abortions occurred at 4 times the maximum recommended human dose simultaneously with signs of maternal toxicity (see Data).

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Data

Animal Data

Pregnant rabbits were dosed with pegfilgrastim subcutaneously every other day during the period of organogenesis. At cumulative doses ranging from the approximate human dose to approximately 4 times the recommended human dose (based on body surface area), the treated rabbits exhibited decreased maternal food consumption, maternal weight loss, as well as reduced fetal body weights and delayed ossification of the fetal skull; however, no structural anomalies were observed in the offspring from either study. Increased incidences of post-implantation losses and spontaneous abortions (more than half the pregnancies) were observed at cumulative doses approximately 4 times the recommended human dose, which were not seen when pregnant rabbits were exposed to the recommended human dose.

Three studies were conducted in pregnant rats dosed with pegfilgrastim at cumulative doses up to approximately 10 times the recommended human dose at the following stages of gestation: during the period of organogenesis, from mating through the first half of pregnancy, and from the first trimester through delivery and lactation. No evidence of fetal loss or structural malformations was observed in any study. Cumulative doses equivalent to approximately 3 and 10 times the recommended human dose resulted in transient evidence of wavy ribs in fetuses of treated mothers (detected at the end of gestation but no longer present in pups evaluated at the end of lactation).

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 NYVEPRIA for chemotherapy-induced neutropenia have been established in pediatric patients aged newborn and older.

Use of NYVEPRIA in pediatric patients weighing at least 45 kg for chemotherapy-induced neutropenia is supported by evidence from adequate and well-controlled studies of pegfilgrastim in adults with additional pharmacokinetic and safety data of pegfilgrastim in pediatric patients aged 8 months and older 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.

Medication Guide

MEDICATION GUIDE

This Patient Information has been approved by the U.S. Food and Drug Administration.                        Revised: May 2026

Patient Information
NYVEPRIA™ (nigh-VEP ree-ah)
(pegfilgrastim-apgf)
injection
Single-Dose Prefilled Syringe

What is NYVEPRIA?
NYVEPRIA is a prescription medicine that is used in adults and children aged newborn and older to help reduce the chance of infection due to a low white blood cell count, in people with certain types of cancer (non-myeloid), who receive anti-cancer medicines (chemotherapy) that can cause fever and low blood cell count.

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:

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have a sickle cell disorder.
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have kidney problems.
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are pregnant or plan to become pregnant. It is not known if NYVEPRIA will harm your unborn baby.
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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?

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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 using the single-dose prefilled syringe.
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You and your caregiver will be shown how to prepare and inject NYVEPRIA using the single-dose prefilled syringe before you use it.
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You should not inject a dose of NYVEPRIA to children weighing less than 99 pounds (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.
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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.
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If you miss a dose of NYVEPRIA, talk to your healthcare provider about when you should give your next dose.
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If you inject too much NYVEPRIA, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.

What are possible side effects of NYVEPRIA?
NYVEPRIA may cause serious side effects, including:

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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.
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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.
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Serious allergic reactions. Allergic 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.
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Sickle cell crises in people with sickle cell disorder. You may have a severe sickle cell crisis, which could lead to death. Call your healthcare provider right away if you have symptoms of sickle cell crisis such as pain or difficulty breathing.
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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
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Increased white blood cell count (leukocytosis). Your healthcare provider will check your blood count during treatment with NYVEPRIA.
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Decreased platelet count (thrombocytopenia). Your healthcare provider will check your blood count during treatment with NYVEPRIA. Tell your healthcare provider if you have unusual bleeding or bruising during treatment with NYVEPRIA.
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Capillary Leak Syndrome (CLS). NYVEPRIA can cause fluid to leak from blood vessels into your body's tissues. 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
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Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML). 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 MDS or a blood cancer called AML. Call your healthcare provider if you develop any symptoms of MDS and AML, including tiredness, fever, or easy bruising or bleeding.
•
Inflammation of the aorta (aortitis). Inflammation of the aorta (the large blood vessel that carries blood from the heart to the body) has happened in people who receive pegfilgrastim products. Tell your healthcare provider if you develop fever, stomach (abdominal) pain, feeling tired, or back pain.
 
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 single-dose prefilled syringe?

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Store NYVEPRIA in the refrigerator between 36°F to 46°F (2°C to 8°C).
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Do not freeze. If NYVEPRIA is accidentally frozen, allow the prefilled syringe to thaw in the refrigerator before injecting.
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Do not use a NYVEPRIA prefilled syringe that has been frozen more than 1 time. Throw it away and use a new NYVEPRIA prefilled syringe.
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Keep NYVEPRIA in the original carton to protect from light or physical damage.
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Do not shake NYVEPRIA.
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Take NYVEPRIA out of the refrigerator 30 minutes before use and allow it to reach room temperature, 68°F to 77°F (20°C to 25°C), before preparing an injection.
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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 NYVEPRIA and all medicines 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 USA
US License No. 1974
Distributed by Pfizer Labs, division of Pfizer Inc., New York, NY 10001 USA

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LAB-1187-5.0
For more information go to www.pfizer.com or call 1-800-438-1985.

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