Alkeran ALPHALAN Alphalan Melphalan Tablets 2mg

[Drug Name] Alkeran (Melphalan Tablets)

[Generic Name] Melphalan Tablets

[Brand Name] Alkeran

[Composition] The active ingredient of this product is melphalan.

[Indications] Melphalan tablets are indicated for the treatment of multiple myeloma and advanced ovarian adenocarcinoma. When used alone or in combination with other drugs, melphalan tablets demonstrate significant efficacy in certain patients with advanced breast cancer. Melphalan is effective in some patients with polycythemia vera; it has also been used as an adjuvant therapy following surgery for breast cancer.

[Packaging Specifications] 2 mg

[Dosage and Administration] Melphalan exerts a myelosuppressive effect; therefore, during the course of treatment, frequent monitoring of blood counts (blood cell counts) is mandatory. If necessary, administration should be temporarily suspended or the dosage adjusted. Alternatively, follow the physician's instructions. Adult Oral Administration: The absorption of oral melphalan is variable; to ensure that therapeutic levels are achieved, the dosage should be increased cautiously until signs of myelosuppression appear. Multiple Myeloma: Various treatment regimens exist; relevant literature should be consulted in detail. The combination of melphalan and prednisone may be more effective than melphalan monotherapy; combination therapy is typically administered intermittently. Although the superiority of prolonged continuous administration has not been established, a typical dosage is 0.15 mg/kg of body weight daily, administered in divided doses over four days, with the course repeated every six weeks. For patients who respond to treatment, extending the course beyond one year does not improve efficacy. Ovarian Adenocarcinoma: A typical treatment regimen involves 0.2 mg/kg of body weight daily for five days, with the course repeated every 4 to 8 weeks or once peripheral blood counts have recovered; the dosage should be reduced if myelotoxicity occurs. Advanced Breast Cancer: Oral melphalan is administered at a dosage of 0.15 mg/kg of body weight daily, or 6 mg/m² of body surface area daily, for five days, with the course repeated every six weeks; intravenous melphalan may also be used for treatment. Polycythemia Vera: During the induction of remission phase, administer 6–10 mg daily for 5–7 days; thereafter, the dosage may be reduced to 2–4 mg daily until symptoms are satisfactorily controlled. The maintenance dose may be administered once weekly at 2–6 mg. Throughout this period, patients must undergo careful and rigorous hematological monitoring, and the dosage should be adjusted appropriately based on blood cell count results. Patients with Renal Impairment: Based on currently established pharmacokinetic data, a dose reduction is not strictly recommended for patients with moderate to severe renal impairment receiving oral melphalan; however, the initial dosage should be reduced with caution.

[Adverse Reactions] The most common adverse reaction associated with melphalan is bone marrow suppression, which may lead to leukopenia and thrombocytopenia. Up to 30% of patients experience gastrointestinal discomfort—including nausea and vomiting—following the administration of standard oral doses of melphalan. Gastritis is rarely observed with standard doses; however, patients receiving high-dose intravenous melphalan may be at increased risk of developing diarrhea, vomiting, and gastritis. Reports suggest that pretreatment with cyclophosphamide may reduce melphalan-induced gastrointestinal toxicity. Occasionally, patients undergoing treatment for several months or longer have experienced hypersensitivity reactions to melphalan, such as urticaria, edema, skin rashes, and anaphylactic shock. Two cases of cardiac arrest have also been reported; however, a definitive causal link between this adverse event and melphalan has not been established. Maculopapular rashes and pruritus have also been reported occasionally. Isolated cases of pulmonary fibrosis and hemolytic anemia occurring after melphalan administration have been documented. Alopecia has been reported, though it is not a common occurrence.

[Contraindications] Melphalan is contraindicated in patients with a history of hypersensitivity reactions to the drug.

[Precautions] Melphalan is a potent cytotoxic agent and should be administered only under the supervision of physicians experienced in the use of such drugs. Safe Handling of Melphalan Tablets: Melphalan tablets should be handled in accordance with local regulations or guidelines regarding the safe handling of cytotoxic agents (e.g., the *Handbook of Cytotoxic Drugs* published by the Royal Pharmaceutical Society of Great Britain). Contact with intact, film-coated melphalan tablets poses no hazard. Melphalan tablets must never be broken or crushed prior to administration. Disposal: Melphalan tablets must be disposed of in accordance with relevant local regulations regarding the disposal of cytotoxic drugs. Therapeutic Monitoring: Since melphalan is a myelosuppressive agent, blood counts (blood cell counts) must be monitored throughout the entire course of treatment to avoid excessive myelosuppression and to mitigate the risk of irreversible bone marrow aplasia. Blood cell counts may continue to decline even after treatment has been discontinued. Treatment should be temporarily interrupted at the first sign of an abnormal or significant decrease in leukocyte or platelet counts. Particular caution should be exercised in patients who have recently undergone radiotherapy or chemotherapy, given the potential for increased myelotoxicity. Renal Impairment: During the initial phase of melphalan therapy, myeloma patients with renal impairment have been observed to experience significant early-onset elevations in blood urea nitrogen (BUN); therefore, patients with renal impairment should be closely monitored for the potential development of uremic myelosuppression. Mutagenicity: Melphalan has demonstrated mutagenic effects in animals, and there have been reports of chromosomal aberrations occurring in patients treated with melphalan. Carcinogenicity: An increasing number of reports suggest that melphalan, like other alkylating agents, carries a potential risk of inducing leukemia in humans. Cases have been reported in which patients with amyloidosis, malignant melanoma, cold agglutinin syndrome, or ovarian cancer developed acute leukemia following melphalan therapy, particularly after prolonged courses of treatment. One clinical study demonstrated that the incidence of acute leukemia in ovarian cancer patients treated with alkylating agents—including melphalan—was significantly higher than in those who did not receive alkylating agents. Prior to initiating melphalan therapy, the potential therapeutic benefits must be carefully weighed against the risk of developing leukemia. Melphalan exerts an inhibitory effect on ovarian function and may induce amenorrhea in a significant proportion of premenopausal women. Effects on Driving and Operating Machinery: Unknown. Product Specifications

Product Name: Natco Alkeran (Melphalan Tablets) | Melphalan 2mg x 25 Tablets | Alkeran ALPHALAN Melphalan Tablets 2mg

Common Name: Alkeran

Composition: The primary active ingredient of this product is Melphalan.

Dosage Form: Tablets

Specification: 25 Tablets

Manufacturer: Natco Pharma Ltd

Indications: Melphalan tablets are indicated for the treatment of multiple myeloma and advanced ovarian adenocarcinoma. When used alone or in combination with other medications, Melphalan tablets demonstrate significant efficacy in certain patients with advanced breast cancer. Melphalan is also effective in some patients with polycythemia vera and has been utilized as an adjuvant therapy following surgical treatment for breast cancer.

Usage and Dosage: Melphalan exerts myelosuppressive effects; therefore, during the course of treatment, frequent monitoring of blood counts (blood cell counts) is mandatory. If necessary, administration should be temporarily suspended or the dosage adjusted. Alternatively, follow the instructions of a physician. Adult Oral Administration: The absorption of oral Melphalan is variable; to ensure that therapeutic levels are achieved, the dosage should be increased cautiously until signs of myelosuppression appear. Multiple Myeloma: Various treatment regimens exist; relevant literature should be consulted in detail. The combination of Melphalan and Prednisone may be more effective than Melphalan monotherapy; combination therapy is typically administered intermittently. Although the superiority of prolonged continuous administration has not been established, a typical dosage involves 0.15 mg per kg of body weight daily, administered in divided doses over four days, with the treatment course repeated every six weeks. For patients who respond to treatment, extending the course beyond one year does not result in improved efficacy. Ovarian Adenocarcinoma: A typical treatment regimen involves 0.2 mg per kg of body weight daily for five days, with the treatment course repeated every 4 to 8 weeks or once peripheral blood counts have recovered; the dosage should be reduced if signs of myelotoxicity appear. Advanced Breast Cancer: Oral Melphalan is administered at a dosage of 0.15 mg per kg of body weight daily (or 6 mg per square meter of body surface area) for five days, with the treatment course repeated every six weeks; intravenous administration of Melphalan may also be utilized for treatment. Polycythemia Vera: For induction of remission, administer 6–10 mg daily for 5–7 days; thereafter, administer 2–4 mg daily until symptoms are satisfactorily controlled. The maintenance dose may be administered once weekly at 2–6 mg. Throughout this period, patients must undergo careful and rigorous hematological monitoring, and the dosage should be adjusted appropriately based on blood cell count results. Patients with Renal Impairment: Based on currently established pharmacokinetic data, a dose reduction is not strictly recommended for patients with moderate to severe renal impairment receiving oral melphalan; however, the initial dose should be reduced with caution.