FYLNETRA (pegfilgrastim-pbbk) for Neutropenia

FYLNETRA is a prescription medicine used to prevent Chemotherapy-induced Neutropenia and treat the symptoms of Hematopoietic Subsyndrome of Acute Radiation Syndrome. FYLNETRA may be used alone or with other medications.

FYLNETRA 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 that is important in the body’s fight against infection.

FYLNETRA 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.

• FYLNETRA is contraindicated in patients who have had a serious allergic reaction to pegfilgrastim products or filgrastim products.

• FYLNETRA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

Before you receive FYLNETRA, 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 FYLNETRA can harm your unborn baby.

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

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

• FYLNETRA is given as an injection under your skin by a doctor. If your doctor decides that the subcutaneous injections can be given at home by you or your caregiver.

• You should not inject a dose of FYLNETRA into children weighing less than 45 kg from an FYLNETRA prefilled syringe. A dose less than 0.6 mL (6 mg) cannot be accurately measured using the FYLNETRA prefilled syringe.

• You and your caregiver will be shown how to prepare and inject FYLNETRA before you use it.

• If you are receiving FYLNETRA because you are also receiving chemotherapy, the last dose of FYLNETRA should be injected at least 14 days before and 24 hours after your dose of chemotherapy.

• If you miss a dose of FYLNETRA, talk to your doctor about when you should give your next dose.

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

The FYLNETRA 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 FYLNETRA 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
  • FYLNETRA Dose: 1.5 mg
  • Volume to Administer: 0.15 mL

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

• 31 – 44 kg
  • FYLNETRA 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 FYLNETRA.

The most common side effects of FYLNETRA are:

• pain in the bones, arms, and legs

FYLNETRA may cause serious side effects, including:

• 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: FYLNETRA 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 FYLNETRA 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 FYLNETRA. Call your doctor right away if you have symptoms of sickle cell crisis such as pain or difficulty breathing.

• Kidney injury (glomerulonephritis): FYLNETRA can cause 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

• 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.

• Increased white blood cell count (leukocytosis): Your doctor will check your blood during treatment with FYLNETRA.

• Decreased platelet count (thrombocytopenia): Your doctor will check your blood during treatment with FYLNETRA. Tell your doctor if you have unusual bleeding or bruising during treatment with FYLNETRA. This could be a sign of decreased platelet counts, which may reduce the ability of your blood to clot.

• Capillary Leak Syndrome (CLS): FYLNETRA 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 FYLNETRA 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 FYLNETRA.

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

• 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 FYLNETRA in the refrigerator between 20 C to 80 C (360 F to 460 F).

• Do not freeze.

• Keep the prefilled syringe in the original carton to protect it from light or physical damage.

• Do not shake the prefilled syringe.

• Take FYLNETRA out of the refrigerator 30 minutes before use and allow it to reach room temperature before preparing an injection.

• Throw away any FYLNETRA that has been left at room temperature, 680 F to 770 F, for more than 72 hours.

• Keep the FYLNETRA prefilled string

Active ingredient: pegfilgrastim-pbbk
Inactive ingredients: polysorbate 20, sodium hydroxide, acetic acid, and sorbitol in water for injection