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Forms: Alkeran (Melphalan HCl) 2 mg tablets
Quantity: 25, 50, 100 pills
Type: Melphalan brand, Alphalan brand, Alkeran generic
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Indications and usage:
Alkeran (Melphalan Hydrochloride) tablets are indicated for the palliative treatment of multiple myeloma and for the palliation of non-resectable epithelial carcinoma of the ovary.
Melphalan (Alkeran) should not be used in patients whose disease has demonstrated a prior resistance to this agent. Patients who have demonstrated hypersensitivity to melphalan should not be given the drug.
Overdoses of Alkeran (Melphalan HCl) tablets, including doses up to 50 mg/day for 16 days, have been reported. Immediate effects are likely to be vomiting, ulceration of the mouth, diarrhea, and hemorrhage of the gastrointestinal tract. The principal toxic effect is bone marrow suppression. Hematologic parameters should be closely followed for 3 to 6 weeks. An uncontrolled study suggests that administration of autologous bone marrow or hematopoietic growth factors (i.e., sargramostim, filgrastim) may shorten the period of pancytopenia. General supportive measures, together with appropriate blood transfusions and antibiotics, should be instituted as deemed necessary by the physician. This drug is not removed from plasma to any significant degree by hemodialysis.
Warnings and precautions:
In all instances where the use of Alkeran is considered for chemotherapy, the physician must evaluate the need and usefulness of the drug against the risk of adverse events. Melphalan should be used with extreme caution in patients whose bone marrow reserve may have been compromised by prior irradiation or chemotherapy, or whose marrow function is recovering from previous cytotoxic therapy. If the leukocyte count falls below 3,000 cells/mcL, or the platelet count below 100,000 cells/mcL, Alkeran should be discontinued until the peripheral blood cell counts have recovered.
A recommendation as to whether or not dosage reduction should be made routinely in patients with renal insufficiency cannot be made because:
Patients with azotemia should be closely observed, however, in order to make dosage reductions, if required, at the earliest possible time.
There are no known drug/drug interactions with oral Alkeran tablets.
Information for patients:
Patients should be informed that the major toxicities of Alkeran are related to bone marrow suppression, hypersensitivity reactions, gastrointestinal toxicity, and pulmonary toxicity. The major long-term toxicities are related to infertility and secondary malignancies. Patients should never be allowed to take the drug without close medical supervision and should be advised to consult their physician if they experience skin rash, vasculitis, bleeding, fever, persistent cough, nausea, vomiting, amenorrhea, weight loss, or unusual lumps/masses. Women of childbearing potential should be advised to avoid becoming pregnant.
Adverse reactions, side effects:
Hematologic: The most common side effect of Melphalan (Alkeran) is bone marrow suppression leading to leukopenia, thrombocytopenia, and anemia. Although bone marrow suppression frequently occurs, it is usually reversible if melphalan is withdrawn early enough. However, irreversible bone marrow failure has been reported.
Gastrointestinal: Nausea, vomiting, diarrhea, and oral ulceration occur. Hepatic disorders ranging from abnormal liver function tests to clinical manifestations such as hepatitis and jaundice have been reported.
Miscellaneous: Other reported adverse reactions include: pulmonary fibrosis (including fatal outcomes) and interstitial pneumonitis, skin hypersensitivity, maculopapular rashes, vasculitis, alopecia, and hemolytic anemia. Allergic reactions, including urticaria, edema, skin rashes, and rare anaphylaxis, have occurred after multiple courses of treatment. Cardiac arrest has also been reported rarely in association with such reports.
Alkeran is supplied as white, film-coated, round, biconvex tablets containing 2 mg Melphalan Hydrochloride in amber glass bottles with child-resistant closures. One side is engraved with 'GX EH3" and the other side is engraved with an "A". Bottle of 50 pills.
Store in a refrigerator, 2° to 8°C (36° to 46°F). Protect from light.
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