Usual Adult Dose for Non-Small Cell Lung Cancer

800 mg IV over 60 minutes on Days 1 and 8 of each 3-week cycle prior to gemcitabine and cisplatin infusion

Duration of therapy: Continue until disease progression or unacceptable toxicity.

Comments:

• For patients who have experienced a previous Grade 1 or 2 infusion-related reaction (IRR), premedicate with diphenhydramine (or equivalent) prior to all infusions of this drug.
• For patients who have experienced a second Grade 1 or 2 occurrence of IRR, premedicate for all subsequent infusions, with diphenhydramine (or equivalent), acetaminophen (or equivalent), and dexamethasone (or equivalent) prior to each infusion of this drug.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

INFUSION-RELATED REACTIONS (IRR):

• Grade 1 IRR: Reduce the infusion rate by 50%.
• Grade 2 IRR: Stop the infusion until symptoms have resolved to Grade 0 or 1; resume therapy at 50% reduced infusion rate for all subsequent infusions.
• Grade 3 or 4 IRR: Permanently discontinue therapy.

• Withhold this drug for Grade 3 rash or acneiform rash until symptoms resolve to Grade 2 or less, then resume therapy at a reduced dose of 400 mg for at least 1 treatment cycle. If symptoms do not worsen, may increase dose to 600 mg and 800 mg in subsequent cycles.
• Permanently discontinue this drug if Grade 3 rash or acneiform rash do not resolve to Grade 2 or less within 6 weeks, OR reactions worsen or become intolerable at a dose of 400 mg, OR if the patient experiences Grade 3 skin induration/fibrosis, OR Grade 4 dermatologic toxicity.

Precautions

US BOXED WARNINGS:
CARDIOPULMONARY ARREST and HYPOMAGNESEMIA:

• Cardiopulmonary arrest and/or sudden death occurred in 3% of patients treated with this drug in combination with gemcitabine and cisplatin. Closely monitor serum electrolytes, including serum magnesium, potassium, and calcium, with aggressive replacement when warranted during and after administration of this drug.
• Hypomagnesemia occurred in 83% of patients receiving this drug in combination with gemcitabine and cisplatin, and was severe in 20% of patients. Monitor patients for hypomagnesemia, hypocalcemia, and hypokalemia prior to each dose of this drug during treatment and for at least 8 weeks following completion of or treatment. Withhold this drug for Grade 3 or 4 electrolyte abnormalities. Replete electrolytes as medically appropriate.

Dialysis

Data not available

Other Comments

General:

• This drug is not indicated for treatment of non-squamous non-small cell lung cancer.

• The manufacturer product information should be consulted.

• Store under refrigeration at 2C to 8C (36F to 46F).
• Protect from light by storing in the original package until time of use.
• Do not freeze or shake.