Applies to the following strengths: 2 mg; 50 mg
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Usual Adult Dose for:
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Usual Adult Dose for Multiple Myeloma
Usual Intravenous Dose: 16 mg/m2
The drug is administered as a single infusion over 15 to 20 minutes. Melphalan is administered at two week intervals for four doses, then, after adequate recovery from toxicity, at four week intervals.
Usual Oral Dose: 6 mg once a day. After 2 to 3 weeks of treatment, the drug should be discontinued for up to 4 weeks during which time the blood count should be followed carefully. When the white blood cell and platelet counts are rising, a maintenance dose of 2 mg daily may be instituted. Because of the patient to patient variation in melphalan plasma levels following oral administration of the drug, several investigators have recommended that the dosage of melphalan be cautiously escalated until some myelosuppression is observed in order to assure that potentially therapeutic levels of the drug have been reached.
Experience with oral melphalan suggests that repeated courses should be given since improvement may continue slowly over many months, and the maximum benefit may be missed if treatment is abandoned prematurely.
Other dosage regimens have been used by various investigators. Osserman and Takatsuki have used an initial course of 10 mg/day for 7 to 10 days. They report that maximal suppression of the leukocyte and platelet counts occurs within 3 to 5 weeks and recovery within 4 to 8 weeks. Continuous maintenance therapy with 2 mg/day is instituted when the white blood cell count is greater than 4000 cells/mcL and the platelet count is greater than 100,000 cells/mcL. Dosage is adjusted to between 1 and 3 mg/day depending upon the hematological response. It is desirable to try to maintain a significant degree of bone marrow depression so as to keep the leukocyte count in the range of 3000 to 3500 cells/mcL.
Hoogstraten et al have started treatment with 0.15 mg/kg per day for 7 days. This is followed by a rest period of at least 14 days, but it may be as long as 5 to 6 weeks. Maintenance therapy is started when the white blood cell and platelet counts are rising. The maintenance dose is 0.05 mg/kg per day or less and is adjusted according to the blood count.
One study by Alexanian et al has shown that the use of melphalan in combination with prednisone significantly improves the percentage of patients with multiple myeloma who achieve palliation. One regimen has been to administer courses of melphalan at 0.25 mg/kg per day for 4 consecutive days (or, 0.20 mg/kg per day for five consecutive days) for a total dose of 1 mg/kg per course. These four to five day courses are then repeated every 4 to 6 weeks if the granulocyte count and the platelet count have returned to normal levels.
Response may be very gradual over many months; it is important that repeated courses or continuous therapy be given since improvement may continue slowly over many months, and the maximum benefit may be missed if treatment is abandoned too soon.
Available evidence suggests about one third to one half of the patients with multiple myeloma show a favorable response to the drug.
Usual Adult Dose for Ovarian Cancer
For use in the treatment of epithelial ovarian cancer:
Common regimen: 0.2 mg/kg orally daily for 5 days as a single course.
Courses are repeated every four to five weeks depending upon hematologic tolerance.
Renal Dose Adjustments
In orally dosed patients with moderate to severe renal impairment, currently available pharmacokinetic data do not justify an absolute recommendation on dosage reduction. However, a reduced initial dose may be appropriate. In intravenously dosed patients, a reduction of up to 50% should be considered in patients with renal insufficiency (BUN greater than or equal to 30 mg/dL).
The following guidelines have been used for adult patients by some clinicians:
CrCl 10 to 50 mL/minute: 75% of dose
CrCl Less than 10 mL/minute: 50% of dose
Liver Dose Adjustments
Data not available
Dose adjustment on the basis of blood cell counts at the nadir and day of treatment should be considered. If the patient is dosed orally, blood counts should be performed at approximately weekly intervals. If the white blood cell count is less than 3000/mm3 or if platelets are less than 100,000/mm3, therapy should be withheld until recovery occurs.
Data not available
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