GRANIX Dosage & Rx Info | Uses, Side Effects

Granix Generic Name & Formulations

Legal Class

General Description

Tbo-filgrastim 300mcg, 480mcg; soln for SC inj; preservative- and latex-free.

Pharmacological Class

Granulocyte colony stimulating factor.

How Supplied

Single-dose prefilled syringe (0.5mL, 0.8mL)—1, 10 (w. safety needle guard) or 1, 5 (w.o safety needle guard); Single-dose vial (1mL, 1.6mL)—10

Manufacturer

Teva Pharmaceuticals

Generic Availability

Mechanism of Action

Tbo-filgrastim is a human granulocyte colony-stimulating factor (G-CSF) produced by recombinant DNA technology. Tbo-filgrastim binds to G-CSF receptors and stimulates proliferation of neutrophils. G-CSF is known to stimulate differentiation commitment and some end-cell functional activation, which increases neutrophil counts and activity.

Granix Indications

Indications

To reduce the duration of severe neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.

Granix Dosage and Administration

Adults and Children

<1 month: not established. Administer the 1^st dose no earlier than 24hrs following myelosuppressive chemotherapy. Do not administer within 24hrs prior to chemotherapy. Give by SC inj into abdomen (except for the 2-inch area around navel), front of middle thighs, upper outer area of buttocks, or upper back portion of upper arms; rotate inj sites. Avoid injecting into tender, red, bruised or hard areas, or that has scars or stretch marks. ≥1 month: 5mcg/kg once daily until expected neutrophil nadir is passed and neutrophil count has recovered to normal range.

Administration

Administer the 1^st dose no earlier than 24hrs following myelosuppressive chemotherapy. Do not administer within 24hrs prior to chemotherapy. Avoid injecting into tender, red, bruised or hard areas, or that has scars or stretch marks.

Granix Contraindications

Contraindications

Serious allergy to filgrastim or pegfilgrastim products.

Granix Boxed Warnings

Not Applicable

Granix Warnings/Precautions

Warnings/Precautions

Monitor CBC prior to chemotherapy and twice per week until recovery; discontinue if ANC >10,000/mm³ after chemotherapy-induced ANC nadir has occurred. Risk of splenic rupture; discontinue and evaluate if symptoms of enlarged spleen or rupture occur. Evaluate for acute respiratory distress syndrome (ARDS) if fever and lung infiltrates or respiratory distress develop after treatment; discontinue if ARDS is confirmed. Permanently discontinue if serious allergic reactions occur. Sickle cell disease: consider potential risks and benefits prior to treatment and discontinue if sickle cell crisis develops. Consider reducing or interrupting dose if glomerulonephritis occurs. Monitor for MDS/AML in those with severe chronic neutropenia, breast or lung cancer. Hepatic or moderate-to-severe renal impairment: not studied. Pregnancy. Nursing mothers: not recommended (during and for 2 weeks after the last dose).

Granix Pharmacokinetics

Absorption

Median time to maximal serum concentrations: 4–6 hours. Mean maximum serum concentration: 20–31 ng/mL. Absolute bioavailability: 33%.

Elimination

Half-life: 3–3.5 hours.

Granix Interactions

Interactions

Concomitant chemotherapy, radiation: not recommended. May cause transient positive changes in bone-imaging test results.

Granix Adverse Reactions

Adverse Reactions

Bone pain; splenic rupture (may be fatal), ARDS, serious allergic reactions, sickle cell crisis, potential for tumor growth stimulatory effects on malignant cells, glomerulonephritis, capillary leak syndrome (monitor), leukocytosis, aortitis (discontinue if suspected).

Granix Clinical Trials

See Literature

Granix Note