Nursing Mothers It is not known whether this drug is excreted in human milk. IV melphalan should not be given to nursing mothers. Pediatric Use The safety and effectiveness in pediatric patients have not been established. Geriatric Use Clinical studies of ALKERAN for Injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
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Severe bone marrow suppression with resulting infection or bleeding may occur. Controlled trials comparing intravenous IV melphalan to oral melphalan have shown more myelosuppression with the IV formulation. Monitor hematologic laboratory parameters. Melphalan produces chromosomal aberrations in vitro and in vivo. Phase IIa cross-over study of propylene glycol-free melphalan LGD and Alkeran in multiple myeloma autologous transplantation. Bone Marrow Transplant. Melphalan Hydrochloride for Injection [prescribing information].
A phase IIb, multicenter, open-label, safety, and efficacy study of high-dose, propylene glycol-free melphalan hydrochloride for injection EVOMELA for myeloablative conditioning in multiple myeloma patients undergoing autologous transplantation.
Biol Blood Marrow Transplant. Contraindications History of serious allergic reaction to melphalan. Do not begin the conditioning regimen if a stem cell product is not available for rescue.
Monitor complete blood counts, provide supportive care for infections, anemia and thrombocytopenia until there is adequate hematopoietic recovery. Provide supportive care for infections, bleeding, and symptomatic anemia. Use prophylactic antiemetic medication. Provide supportive care for nausea, vomiting, diarrhea, and mucositis. Provide nutritional support and analgesics for patients with severe mucositis. Use prophylactic antiemetics.
Provide supportive care for nausea, vomiting, diarrhea and mucositis. Hepatotoxicity: Hepatic disorders ranging from abnormal liver function tests to clinical manifestations such as hepatitis and jaundice have been reported after treatment with melphalan.
Hepatic veno-occlusive disease has also been reported. Monitor liver chemistries. Symptoms may include urticaria, pruritus, edema, and skin rashes and, in some patients, tachycardia, bronchospasm, dyspnea, and hypotension.
Secondary Malignancies: Secondary malignancies such as myeloproliferative syndrome or acute leukemia have been reported in multiple myeloma patients treated with melphalan-containing chemotherapy regimens. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, advise the patient of potential risk to the fetus.
Reversible or irreversible testicular suppression has also been reported. Drug Interactions No formal drug interaction studies have been conducted.
When nalidixic acid and IV melphalan are given simultaneously, the incidence of severe hemorrhagic necrotic enterocolitis has been reported to increase in pediatric patients. Use in Specific Populations Lactation: It is not known whether melphalan is present in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from melphalan, breastfeeding is not recommended during treatment with EVOMELA.
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EVOMELA Important Safety Information
Yozshujas Do not have Melphalan if you are planning to have a baby. Find out more here. This is repeated every 4 to 8 weeks. If any of the side effects gets serious, or if you insrrt any side effects not listed in this leaflet, please tell your doctor or pharmacist. This is to check the number of cells in your blood. The diluent contains water, sodium citrate, propylene glycol and ethanol. Talk to your doctor if you packags any of the following side effects which may also happen with this medicine: To email a medicine you must sign up and log in.
More Warning This medicine may lower the ability of the bone marrow to make blood cells that the body needs. If blood cell counts get very low, this can lead to bleeding problems, infections, or anemia. If you have questions, talk with the doctor. Have blood work checked as you have been told by the doctor. Talk with the doctor. Other types of cancer may rarely happen later in life. Allergic reactions may rarely occur.