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GRANIX
White blood cell disorders
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Drug Name:

GRANIX Rx

Generic Name and Formulations:
Tbo-filgrastim 300mcg/0.5mL, 480mcg/0.8mL; soln for SC inj; preservative-free.

Company:
Teva Pharmaceuticals

Therapeutic Use:

Indications for GRANIX:

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.

Adult:

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

Children:

<18yrs: not established.

Contraindications:

Serious allergy to filgrastim or pegfilgrastim products.

Warnings/Precautions:

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 acute respiratory distress syndrome is diagnosed. 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. Hepatic or moderate-to-severe renal impairment. Pregnancy. Nursing mothers.

Interactions:

Caution with drugs that may potentiate release of neutrophils (eg, lithium). May cause transient positive changes in bone-imaging test results.

Pharmacological Class:

Granulocyte colony stimulating factor.

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.

How Supplied:

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

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