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.
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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.
The following information on adverse reactions is based on data from both oral and IV administration of melphalan as a single agent, using several different dose schedules for treatment of a wide variety of malignancies. Hematologic The most common side effect is bone marrow suppression leading to leukopenia, thrombocytopenia, and anemia.
Irreversible bone marrow failure has been reported. Gastrointestinal Gastrointestinal disturbances such as nausea and vomiting, diarrhea, and oral ulceration occur infrequently. Hepatic disorders ranging from abnormal liver function tests to clinical manifestations such as hepatitis and jaundice have been reported. Hepatic veno-occlusive disease has been reported.
Hypersensitivity Acute hypersensitivity reactions including anaphylaxis were reported in 2. These reactions were characterized by urticaria, pruritus, edema, skin rashes, and in some patients, tachycardia, bronchospasm, dyspnea, and hypotension. These patients appeared to respond to antihistamine and corticosteroid therapy. If a hypersensitivity reaction occurs, IV or oral melphalan should not be readministered since hypersensitivity reactions have also been reported with oral melphalan.
Cardiac arrest has also been reported rarely in association with such reports. Miscellaneous Other reported adverse reactions include skin hypersensitivity, skin ulceration at injection site, skin necrosis rarely requiring skin grafting, maculopapular rashes, vasculitis, alopecia, hemolytic anemia, allergic reaction, pulmonary fibrosis including fatal outcomes , and interstitial pneumonitis. Temporary significant elevation of the blood urea has been seen in the early stages of therapy in patients with renal damage.
Elevations in liver enzymes and veno-occlusive disease occur infrequently. Significant hyponatremia caused by an associated inappropriate secretion of ADH syndrome has been observed.
Nephrotoxicity and adult respiratory distress syndrome have been reported rarely. The principal toxic effect is bone marrow suppression. An uncontrolled study suggests that administration of autologous bone marrow or hematopoietic growth factors i. 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 or hemoperfusion.
Available evidence suggests about one third to one half of the patients with multiple myeloma show a favorable response to the drug. 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.
Dose adjustment on the basis of blood cell counts at the nadir and day of treatment should be considered. Skin reactions associated with accidental exposure may occur. The use of gloves is recommended.
Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published. Parenteral drug products should be visually inspected for particulate matter and discoloration prior to administration whenever solution and container permit.
If either occurs, do not use this product. Care should be taken to avoid possible extravasation of melphalan and in cases of poor peripheral venous access, consideration should be given to use of a central venous line see WARNINGS. Immediately shake vial vigorously until a clear solution is obtained. Rapid addition of the diluent followed by immediate vigorous shaking is important for proper dissolution. Immediately dilute the dose to be administered in 0.
Controlling Occupational Exposure to Hazardous Drugs. OSHA, American Society of Health-System Pharmacists. Am J Health-Syst Pharm. Chemotherapy and Biotherapy Guidelines and Recommendations for Practice. Distributed by.
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.
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].