Usual Adult Dose for Malignant Melanoma

2 to 4.5 mg/kg IV once a day for 10 days; repeat every 4 weeks
OR
250 mg/m2 IV once a day for 5 days; repeat every 3 weeks

Use: For metastatic malignant melanoma

Usual Adult Dose for Hodgkin's Disease

150 mg/m2 IV once a day for 5 days in combination therapy; repeat every 4 weeks
OR
375 mg/m2 IV on Day 1 in combination therapy; repeat every 15 days

Use: For Hodgkin's disease as a second-line therapy when used in combination with other agents

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

US BOXED WARNINGS:

• This drug should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents.
• Hemopoietic depression is the most common toxicity with this drug.
• Hepatic necrosis has been reported.
• Studies have demonstrated this drug to have a carcinogenic and teratogenic effect when used in animals.
• In treatment of each patient, the physician should weigh therapeutic benefit against the risk of toxicity.

• Hypersensitivity to the active component or any of the ingredients

Dialysis

Data not available

Other Comments

• Restriction of oral intake for 4 to 6 hours prior to therapy help prevent GI adverse reactions.
• Use this drug cautiously in patients with renal and/or liver dysfunction.

• Store unopened product in a refrigerator 2C to 8C (36F to 46F).
• After reconstitution and prior to use, the vial may be stored at 4C for up to 72 hours or at normal room conditions (temperature and light) for up to 8 hours. If the reconstituted solution is further diluted in 5% dextrose injection or sodium chloride injection, the resulting solution may be stored at 4C for up to 24 hours or at normal room conditions for up to 8 hours.

• Compatible with sterile water, 5% dextrose injection, and sodium chloride injection.

• Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published; however, there is no general agreement that all the procedures recommended in the guidelines are necessary or appropriate.

• The hematologic profile should be monitored. Hematopoietic toxicity may warrant suspension or cessation of therapy.

• Patients should be advised to use sunscreens and to avoid sun exposure following administration of this drug.