What are the precautions for melphalan/melphalan tablets?

In clinical studies of related diseases treated with Melphalan/Melphalan tablets, precautions mainly include carcinogenesis, mutation occurrence, impaired fertility, pregnancy, etc. Melphalan tablets should be administered in carefully adjusted doses by experienced doctors who are familiar with the effects of the drug and the possible complications of its use, or under their supervision.

1. Like other nitrogen mustard drugs, overdose will produce significant bone marrow suppression. Myelosuppression is the most significant toxicity associated with AKRON in most patients. Therefore, the following tests should be performed at the beginning of treatment and before each subsequent course of melphalan tablets: platelet count, hemoglobin, white blood cell count and differential. Thrombocytopenia and/or leukopenia are indications for withholding further treatment until adequate recovery of blood counts. Frequent blood cell counts are essential to determine optimal dosage and avoid toxicity (see Precautions: Laboratory Tests). Dose adjustments should be considered based on nadir and blood cell counts on the day of treatment.

2. Hypersensitivity reactions, including allergic reactions, rarely occur (see adverse reactions). These reactions occur after multiple courses of treatment and recur in patients with hypersensitivity reactions to IV melphalan tablets. If a hypersensitivity reaction occurs, oral administration or melphalan tablets should not be repeated.

3. Carcinogenesis: Secondary malignancies, including acute non-lymphocytic leukemia, myeloproliferative syndromes and cancer, have been reported in cancer patients treated with alkylating agents (including melphalan). Some patients also received other chemotherapy drugs or radiation therapy. The risk of acute leukemia, myeloproliferative syndrome, or cancer cannot be precisely quantified. Published reports of leukemia in patients receiving melphalan (and other alkylating agents) indicate that the risk of leukemia increases with chronicity of treatment and with increasing cumulative dose. .

4. Mutation: Melphalan tablets have been proven to cause chromatid or chromosome damage in humans. Intramuscular injection of 6 and 60 mg/m2 melphalan tablets can cause structural aberrations of chromatids and chromosomes in animal bone marrow cells.

5. Impaired fertility: Melphalan tablets can inhibit the ovarian function of premenopausal women, leading to amenorrhea in a large number of patients. Reversible and irreversible testicular suppression have also been reported.

6. Pregnancy: Melphalan tablets taken by pregnant women may cause harm to the fetus, and may lead to embryonic lethality and teratogenesis. There are no adequate and well-controlled studies in pregnant women. If this medication is used during pregnancy, or if the patient becomes pregnant while taking this medication, the patient should be informed of the potential harm to the fetus. Women of childbearing potential should be advised to avoid pregnancy.