Nyvepria

Nyvepria is used to help reduce the chance of infection due to low white blood cell counts in adults and children aged newborn and older with certain types of cancer (non-myeloid), who receive anti-cancer medicines (chemotherapy) that can cause fever and low blood cell count. Nyvepria is administered as a subcutaneous injection.

Nyvepria (pegfilgrastim-apgf) works by attaching to certain white blood cells in your body and signaling them to grow, multiply, and mature into fully working infection-fighting cells. Boosting these cells helps your body defend against infection when chemotherapy has lowered your white blood cell count. Nyvepria belongs to the drug class called colony-stimulating factors.

Nyvepria (pegfilgrastim-apgf) was FDA-approved as a biosimilar to Neulasta (pegfilgrastim) on June 11, 2020.

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 allergic to latex. The needle cap on some prefilled syringes contains dry natural rubber (derived from latex).
• 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.

Common side effects

The most common side effects of Nyvepria are pain in the bones, arms, and legs.

Serious side effects

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: swelling of your face or ankles blood in your urine or dark colored urine 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: swelling or puffiness and are urinating less than usual trouble breathing swelling of your stomach area (abdomen) and feeling of fullness dizziness or feeling faint 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 arteries (arteritis). Serious inflammation of the large and medium blood vessels that carry blood from your heart to the body, including the aorta (the largest artery), can happen in people receiving pegfilgrastim products. Tell your healthcare provider right away if you develop fever, stomach (abdominal) pain, back pain, headache, neck pain, or generally feel unwell.

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 the FDA at 1-800-FDA-1088.

• 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.

• Store Nyvepria in the refrigerator between 36°F and 46°F (2°C and 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 it 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.

Active ingredient: pegfilgrastim-apgf.

Inactive ingredients: acetate, polysorbate 20, sodium, and sorbitol in water for injection.

Nyvepria (pegfilgrastim-apgf) is manufactured by Hospira, Inc., a Pfizer Company, Lake Forest, IL 60045 USA. US License No. 1974.

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There are 2 for Nyvepria.

Neulasta (pegfilgrastim) - Amgen Inc.

View Neulasta information in detail.

Neulasta Onpro (pegfilgrastim) - Amgen Inc.

View Neulasta Onpro information in detail.

Neulasta, Neulasta Onpro biosimilar products

Biosimilar products can only be dispensed in place of the reference product if the healthcare provider specifically prescribes the biosimilar product by name.

Pharmacy laws for biosimilar prescribing may vary by state

Armlupeg (pegfilgrastim-unne) - Lupin Limited (Biotech Division)

View Armlupeg information in detail.

Ennumo (pegfilgrastim-pccg) - Accord BioPharma Inc.

Ennumo

Fulphila (pegfilgrastim-jmdb) - Biocon Biologics Inc.

View Fulphila information in detail.

Fylnetra (pegfilgrastim-pbbk) - Kashiv BioSciences, LLC

View Fylnetra information in detail.

Nyvepria (pegfilgrastim-apgf) - Hospira Inc., a Pfizer Company

Stimufend (pegfilgrastim-fpgk) - Fresenius Kabi USA, LLC

View Stimufend information in detail.

Udenyca (pegfilgrastim-cbqv) - Accord BioPharma Inc.

View Udenyca information in detail.

Udenyca Onbody (pegfilgrastim-cbqv) - Accord BioPharma Inc.

View Udenyca Onbody information in detail.

Ziextenzo (pegfilgrastim-bmez) - Sandoz Inc.

View Ziextenzo information in detail.