NYVEPRIA™ (pegfilgrastim-apgf) 5 WARNINGS AND PRECAUTIONS

(pegfilgrastim-apgf)

Prescribing Information

5 WARNINGS AND PRECAUTIONS

5.1 Splenic Rupture

Splenic rupture, including fatal cases, can occur following the administration of pegfilgrastim products. Evaluate for an enlarged spleen or splenic rupture in patients who report left upper abdominal or shoulder pain after receiving NYVEPRIA.

5.2 Acute Respiratory Distress Syndrome

Acute respiratory distress syndrome (ARDS) can occur in patients receiving pegfilgrastim products. Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving NYVEPRIA, for ARDS. Discontinue NYVEPRIA in patients with ARDS.

5.3 Serious Hypersensitivity Reactions

Serious hypersensitivity reactions, including anaphylaxis, can occur in patients receiving pegfilgrastim products. The majority of reported events occurred upon initial exposure. Hypersensitivity reactions, including anaphylaxis, can recur within days after the discontinuation of initial therapies to manage the reaction. Permanently discontinue NYVEPRIA in patients with serious hypersensitivity reactions. NYVEPRIA is contraindicated in patients with a history of a serious hypersensitivity reaction to pegfilgrastim products or filgrastim products.

5.4 Use in Patients with Sickle Cell Disorders

Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving pegfilgrastim products. Discontinue NYVEPRIA if sickle cell crisis occurs.

5.5 Glomerulonephritis

Glomerulonephritis has occurred in patients receiving pegfilgrastim products. The diagnoses were based upon azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events of glomerulonephritis resolved after dose-reduction or discontinuation of pegfilgrastim products. If glomerulonephritis is suspected, evaluate for cause. If causality is likely, consider dose-reduction or interruption of NYVEPRIA.

5.6 Leukocytosis

White blood cell (WBC) counts of 100 × 109/L or greater have been observed in patients receiving pegfilgrastim products. Monitoring of complete blood count (CBC) during NYVEPRIA therapy is recommended.

5.7 Thrombocytopenia

Pegfilgrastim products can cause thrombocytopenia. Monitor platelet counts during NYVEPRIA therapy.

5.8 Capillary Leak Syndrome

Capillary leak syndrome has been reported after G-CSF administration, including pegfilgrastim products, and is characterized by hypotension, hypoalbuminemia, edema and hemoconcentration. Episodes vary in frequency, severity and may be life-threatening if treatment is delayed. Patients who develop symptoms of capillary leak syndrome should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care.

5.9 Potential for Tumor Growth Stimulatory Effects on Malignant Cells

The granulocyte-colony stimulating factor (G-CSF) receptor through which pegfilgrastim products and filgrastim products act has been found on tumor cell lines. The possibility that pegfilgrastim products act as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which pegfilgrastim products are not approved, cannot be excluded.

5.10 Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) in Patients with Breast and Lung Cancer

MDS and AML have been associated with the use of pegfilgrastim products in conjunction with chemotherapy and/or radiotherapy in patients with breast and lung cancer. Monitor patients for signs and symptoms of MDS/AML in these settings.

5.11 Aortitis

Aortitis has been reported in patients receiving pegfilgrastim products. It may occur as early as the first week after start of therapy. Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g., c-reactive protein and white blood cell count). Consider aortitis in patients who develop these signs and symptoms without known etiology. Discontinue NYVEPRIA if aortitis is suspected.

5.12 Nuclear Imaging

Increased hematopoietic activity of the bone marrow in response to growth factor therapy, including pegfilgrastim products, has been associated with transient positive bone imaging changes. This should be considered when interpreting bone imaging results.

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. • 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. • 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. • 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. • 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 • 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. • Keep NYVEPRIA in the original carton to protect from light or physical damage. • Do not shake NYVEPRIA. • 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 LAB-1187-5.0 For more information go to www.pfizer.com or call 1-800-438-1985.

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