PegaGen (Pegylated Filgrastim) for Neutropenia

Pegfilgrastim is a covalent conjugate of monomethoxypolyethylene glycol and recombinant methionyl human G-CSF (filgrastim).

PegaGen is used to prevent neutropenia (lack of certain white blood cells) that is caused by receiving chemotherapy. It is also used to increase survival in patients acutely exposed to myelosuppressive doses of radiation.

Do not take PegaGen if you have had an allergic reaction to Pegfilgrastim or filgrastim or any component present in this medicine

• You should only receive a dose of PegaGen on the day your doctor tells you. You should not receive your dose of PegaGen any sooner than 24 hours after you finish receiving your chemotherapy.

• You should not inject a dose of 6 mg PegaGen into children weighing less than 45 kg. Dosing is based on the weight of the patient in this group. So you should not use the medicine for children weighing less than 45 kg.

Important safety information

• Capillary leak syndrome (CLS): characterized by hypoalbuminemia, edema, hypotension, and hemoconcentration, may occur in patients receiving human granulocyte colony-stimulating factors, including pegfilgrastim products. If CLS develops, your doctor will monitor you closely and manage it symptomatically. CLS may be life-threatening if the treatment is delayed.

• Hypersensitivity, including anaphylaxis or serious allergic reactions, may occur: usually with the initial dose; may recur within days after discontinuation of initial anti-allergic treatment. Patients with a history of serious allergic reactions to pegfilgrastim or filgrastim products shouldn’t use PegaGen. Urticaria, generalized erythema, skin rash, and flushing have been reported. ­

• Glomerulonephritis: may occur, and is generally resolved after pegfilgrastim dose reduction or discontinuation. The diagnosis was made by the presence of microscopic and macroscopic hematuria, azotemia, proteinuria, and renal biopsy. If glomerulonephritis is suspected; if felt due to pegfilgrastim products, your doctor may consider dose reduction or stopping therapy.

• Leukocytosis: has been reported in patients receiving pegfilgrastim products. Monitor complete blood counts during therapy.

• Acute respiratory distress syndrome (ARDS): has been reported with use; to evaluate patients with pulmonary symptoms such as pulmonary infiltrates, fever, or respiratory distress for ARDS. Discontinue treatment with PegaGen if ARDS occurs.

• Rare cases of splenic rupture have been reported: your doctor will evaluate you for an enlarged spleen or splenic rupture in patients who report left upper abdominal pain or shoulder pain

Other drugs may affect PegaGen, including prescriptions, over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all the medicines you use.

Use PegaGen exactly as your doctor has told you.

The usual dose for Adolescents >45 kg is one 6 mg subcutaneous injection and it should be given 24-72 hours after your last dose of chemotherapy at the end of each chemotherapy cycle.

Dosing for children and Adolescents <45 kg is 100 μg/kg and is injected under your skin.

• Store PegaGen in the refrigerator between 2- 8 °C and do not freeze.

• Discard PegaGen if frozen more than once.

• Store PegaGen in its original package in the refrigerator, protected from light, and do not shake.

• Discard PegaGen stored at room temperature for more than 48 hours.

• Keep PegaGen out of the reach of children.