NYVEPRIA (pegfilgrastim-apgf) for Neutropenia

NYVEPRIA is a man-made form of G-CSF or granulocyte colony-stimulating factor. G-CSF stimulates the growth of neutrophils, a type of white blood cell important in the body’s fight against infection.

NYVEPRIA is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

• Do not take NYVEPRIA if you have had a serious allergic reaction to pegfilgrastim products or filgrastim products.

• NYVEPRIA should not be used for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

Before you receive NYVEPRIA, tell your doctor about all of your medical conditions, including if you:

• have a sickle cell disorder.

• have kidney problems.

• are pregnant or planning to become pregnant. It is not known if NYVEPRIA can harm your unborn baby.

• are breastfeeding or planning to breastfeed. It is not known if NYVEPRIA can pass into your breast milk.

Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

• NYVEPRIA is given as an injection under your skin by a doctor.

• 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 into children weighing less than 45 kg from an 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 doctor about when you should give your next dose.

The recommended dosage of NYVEPRIA is a single subcutaneous injection of 6 mg administered once per chemotherapy cycle. Do not administer NYVEPRIA between 14 days before and 24 hours after administration of cytotoxic chemotherapy.

The NYVEPRIA prefilled syringe does not allow direct administration of doses less than 0.6 mL (6 mg). The syringe does not bear graduation marks, which are necessary to accurately measure doses of NYVEPRIA less than 0.6 mL (6 mg) for direct administration to patients. Thus, the direct administration to patients requiring dosing of less than 0.6 mL (6 mg) is not recommended due to the potential for dosing errors.

• 10 – 20 kg
  • NYVEPRIA Dose: 1.5 mg
  • Volume to Administer: 0.15 mL

• 21 – 30 kg
  • NYVEPRIA Dose: 2.5 mg
  • Volume to Administer: 0.25 mL

• 31 – 44 kg
  • NYVEPRIA Dose: 4 mg
  • Volume to Administer: 0.4 mL

For pediatric patients weighing less than 10 kg, administer 0.1 mg/kg (0.01 mL/kg) of NYVEPRIA

The most common side effects of NYVEPRIA are a pain in the bones, arms, and legs

• Spleen rupture: Your spleen may become enlarged and can rupture. A ruptured spleen can cause death. Call your doctor 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 doctor 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 may 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 doctor right away.

• Sickle cell crises: You may get a serious sickle cell crisis, which could lead to death if you have a sickle cell disorder and receive NYVEPRIA. Call your doctor right away if you have symptoms of sickle cell crisis such as difficulty breathing or pain.

• Kidney injury (glomerulonephritis): NYVEPRIA can cause kidney injury. Call your doctor 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 doctor will check your blood during treatment with NYVEPRIA.

• Decreased platelet count (thrombocytopenia): Your doctor will check your blood during treatment with NYVEPRIA. Tell your doctor if you have unusual bleeding or bruising during treatment with NYVEPRIA.

• Nuclear Imaging: Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes.

• Potential for Tumor Growth Stimulatory Effects on Malignant Cells: The G-CSF receptor through which pegfilgrastim 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.

• Capillary Leak Syndrome (CLS): NYVEPRIA can cause fluid to leak from blood vessels into your body’s tissues. This condition is called CLS or Capillary Leak Syndrome. CLS can cause 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 and acute myeloid leukemia: If you have lung cancer or breast 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 myelodysplastic syndrome or a blood cancer called AML or acute myeloid leukemia. Symptoms of MDS and AML may include fever, tiredness, and easy bruising or bleeding. Call your doctor if you develop these symptoms during treatment with NYVEPRIA.

• Inflammation of the aorta (aortitis): Inflammation of the aorta has been reported in patients who received pegfilgrastim products. Symptoms may include fever, feeling tired, abdominal pain, and back pain. Call your doctor if you experience these symptoms.

• Store NYVEPRIA in the refrigerator between 2°C to 8°C.

• Do not freeze.

• Do not use an 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 it 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 any NYVEPRIA that has been left at room temperature, 68°F to 77°F, for more than 15 days.

• Keep the NYVEPRIA prefilled syringe out of the reach of children

Active ingredient: pegfilgrastim-apgf.
Inactive ingredients: sodium, acetate, polysorbate 20, and sorbitol in water for injection.