NEUPOGEN Dosage & Rx Info | Uses, Side Effects

Neupogen Generic Name & Formulations

Legal Class

General Description

Filgrastim 600mcg/mL; for SC inj or IV infusion; preservative-free.

Pharmacological Class

Granulocyte colony stimulating factor.

How Supplied

Prefilled syringes (0.5mL, 0.8mL)—1, 10; Vials (1mL, 1.6mL)—10

Manufacturer

Amgen, Inc.

Mechanism of Action

Colony-stimulating factors are glycoproteins which act on hematopoietic cells by binding to specific cell surface receptors and stimulating proliferation‚ differentiation commitment‚ and some end-cell functional activation.

Neupogen Indications

Indications

See full labeling. To decrease incidence of infection in patients with nonmyeloid malignancies receiving certain myelosuppressive anti-cancer drugs. To reduce time to neutrophil recovery and fever duration after induction or consolidation chemotherapy treatment of adults with AML. To reduce duration of neutropenia and related sequelae in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone-marrow transplantation (BMT). To mobilize hematopoietic progenitor cells (PBPC) into peripheral blood for collection by leukapheresis. To reduce the incidence and duration of neutropenia sequelae in severe chronic neutropenia (SCN).

Neupogen Dosage and Administration

Adult

See full labeling. Do not give for at least 24hrs before or after cytotoxic chemotherapy dose. BMT: Give 1^stdose at least 24hrs after bone marrow infusion. SCN: Give on a daily basis.

Children

See full labeling.

Neupogen Contraindications

Contraindications

Hypersensitivity to E. coli-derived products.

Neupogen Boxed Warnings

Not Applicable

Neupogen Warnings/Precautions

Warnings/Precautions

Monitor blood, including CBCs, differentials, and platelets, before and during therapy (myelosuppressive chemotherapy: monitor twice weekly; BMT: at least 3 times weekly; SCN: twice per week during initial 4 weeks of therapy and during 2 weeks after dose adjustment). Discontinue if post nadir absolute neutrophil count (ANC) reaches 10,000/mm³ for patients receiving myelosuppressive chemotherapy; other indications: see full labeling. Monitor for splenomegaly/splenic rupture and for acute respiratory distress syndrome (ARDS); discontinue if ARDS occurs. Confirm diagnosis and do appropriate pretreatment hematological workup in SCN. Preexisting cardiac or hyperplastic skin conditions. Sickle cell disease: may cause severe sickle cell crisis (discontinue if occurs). Monitor for MDS/AML in those with severe chronic neutropenia, breast or lung cancer. Monitor for aortitis; discontinue if suspected. Possible transient (+) bone imaging changes in nuclear imaging. Pregnancy. Nursing mothers.

Neupogen Pharmacokinetics

Absorption

Absolute bioavailability after SC administration: 60–70%.

Distribution

Volume of distribution: 150 mL/kg (IV).

Elimination

Renal.
Half-life: ~3.5 hours (IV); ~210 minutes (SC).
Clearance rate: 0.5 to 0.7 mL/minute/kg.

Neupogen Interactions

Interactions

Avoid simultaneous use with chemo- and radiation therapy. Caution with mitomycin C, and with concomitant (same day) drugs that decrease platelets, or increase release of neutrophils (eg, lithium), or cause delayed myelosuppression, or with myelosuppressive doses of antimetabolites (eg, nitrosoureas, 5-FU).

Neupogen Adverse Reactions

Adverse Reactions

Bone pain, pyrexia, rash, cough, dyspnea, epistaxis, headache, anemia, diarrhea, hypoesthesia, alopecia; splenomegaly, capillary leak syndrome, cutaneous vasculitis, thrombocytopenia, leukocytosis, others (see full labeling).

Neupogen Clinical Trials

See Literature

Neupogen Note