(pegfilgrastim-apgf)

Prescribing Information
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6 ADVERSE REACTIONS

6 ADVERSE REACTIONS

The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling:

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Splenic Rupture [see Warnings and Precautions (5.1)]
•
Acute Respiratory Distress Syndrome [see Warnings and Precautions (5.2)]
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Serious Hypersensitivity Reactions [see Warnings and Precautions (5.3)]
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Use in Patients with Sickle Cell Disorders [see Warnings and Precautions (5.4)]
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Glomerulonephritis [see Warnings and Precautions (5.5)]
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Leukocytosis [see Warnings and Precautions (5.6)]
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Thrombocytopenia [see Warnings and Precautions (5.7)]
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Capillary Leak Syndrome [see Warnings and Precautions (5.8)]
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Potential for Tumor Growth Stimulatory Effects on Malignant Cells [see Warnings and Precautions (5.9)]
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Myelodysplastic Syndrome [see Warnings and Precautions (5.10)]
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Acute Myeloid Leukemia [see Warnings and Precautions (5.10)]
•
Aortitis [see Warnings and Precautions (5.11)]

6.1 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 with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Pegfilgrastim clinical trials safety data are based upon 932 patients receiving pegfilgrastim in seven randomized clinical trials. The population was 21 to 88 years of age and 92% female. The ethnicity was 75% Caucasian, 18% Hispanic, 5% Black, and 1% Asian. Patients with breast (n = 823), lung and thoracic tumors (n = 53) and lymphoma (n = 56) received pegfilgrastim after nonmyeloablative cytotoxic chemotherapy. Most patients received a single 100 mcg/kg (n = 259) or a single 6 mg (n = 546) dose per chemotherapy cycle over 4 cycles.

The following adverse reaction data in Table 1 are from a randomized, double-blind, placebo-controlled study in patients with metastatic or non-metastatic breast cancer receiving docetaxel 100 mg/m2 every 21 days (Study 3). A total of 928 patients were randomized to receive either 6 mg pegfilgrastim (n = 467) or placebo (n = 461). The patients were 21 to 88 years of age and 99% female. The ethnicity was 66% Caucasian, 31% Hispanic, 2% Black, and <1% Asian, Native American, or other.

The most common adverse reactions occurring in ≥5% of patients and with a between-group difference of ≥5% higher in the pegfilgrastim arm in placebo-controlled clinical trials are bone pain and pain in extremity.

Table 1. Adverse Reactions with ≥5% Higher Incidence in Pegfilgrastim Patients Compared to Placebo in Study 3
Body System
  Adverse Reaction		Placebo
(N = 461)		Pegfilgrastim 6 mg SC on Day 2
(N = 467)

Musculoskeletal and connective tissue disorders

  Bone pain

26%

31%

  Pain in extremity

4%

9%

Leukocytosis

In clinical studies, leukocytosis (WBC counts >100 × 109/L) was observed in less than 1% of 932 patients with non-myeloid malignancies receiving pegfilgrastim. No complications attributable to leukocytosis were reported in clinical studies.

6.3 Postmarketing Experience

The following adverse reactions have been identified during post-approval use of pegfilgrastim products. 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 drug exposure.

•
Splenic rupture and splenomegaly (enlarged spleen) [see Warnings and Precautions (5.1)]
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Acute respiratory distress syndrome (ARDS) [see Warnings and Precautions (5.2)]
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Allergic reactions/hypersensitivity, including anaphylaxis, skin rash, urticaria, generalized erythema, and flushing [see Warnings and Precautions (5.3)]
•
Sickle cell crisis [see Warnings and Precautions (5.4)]
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Glomerulonephritis [see Warnings and Precautions (5.5)]
•
Leukocytosis [see Warnings and Precautions (5.6)]
•
Thrombocytopenia [see Warnings and Precautions (5.7)]
•
Capillary Leak Syndrome [see Warnings and Precautions (5.8)]
•
Injection site reactions
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Sweet's syndrome (acute febrile neutrophilic dermatosis), cutaneous vasculitis
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Myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) in patients with breast and lung cancer receiving chemotherapy and/or radiotherapy [see Warnings and Precautions (5.10)]
•
Aortitis [see Warnings and Precautions (5.11)]
•
Alveolar hemorrhage
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:

•
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.
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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?

•
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.
•
You and your caregiver will be shown how to prepare and inject NYVEPRIA using the single-dose prefilled syringe before you use it.
•
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.
•
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:

•
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. 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.
•
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.
•
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 count during treatment with NYVEPRIA.
•
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?

•
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. 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.
•
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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