Alkeran Side Effects

Generic Name: melphalan

Please note - some side effects for Alkeran may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Alkeran - for the Consumer

Alkeran

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Alkeran:

Diarrhea; hair loss; nausea; vomiting.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood in urine or stools; chest pain; dark urine; diarrhea; fainting; fatigue; fever or chills; irregular or absent menstrual periods; joint pain; lower back or side pain; numbness of an arm or leg; pain, swelling, or redness at the injection site; persistent cough; persistent nausea or vomiting; shortness of breath; sore throat; sores on the mouth or lips; stomach pain; sudden severe headache; swollen feet or lower legs; unusual bruising or bleeding; unusual lumps or growths; unusual tiredness; weight loss; yellowing eyes and skin.

Alkeran Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Alkeran Tablets:

Hair loss; loss of appetite; nausea; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood in urine or stools; chest pain; dark urine; diarrhea; fainting; fatigue; fever or chills; irregular or absent menstrual periods; joint pain; lower back or side pain; numbness of an arm or leg; persistent cough; persistent nausea or vomiting; shortness of breath; sore throat; sores on the mouth or lips; stomach pain; sudden severe dizziness, headache, or vomiting; swelling of hands, ankles, or feet; unusual bruising or bleeding; unusual lumps or growths; unusual tiredness or weakness; yellowing eyes and skin.

Alkeran Side Effects - for the Professional

Alkeran

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. White blood cell count and platelet count nadirs usually occur 2 to 3 weeks after treatment, with recovery in 4 to 5 weeks after treatment. 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 2.4% of 425 patients receiving Alkeran for Injection for myeloma. 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. Subjective and transient sensation of warmth and/or tingling.

Side Effects by Body System

Hematologic

Hematologic side effects including bone marrow suppression and anemia have been reported. Bone marrow suppression is the most common and the most significant toxicity associated with melphalan in most patients. Hemolytic anemia has also been reported.

Bone marrow suppression is usually reversible if melphalan is withdrawn early enough.

Oncologic

Oncologic side effects including secondary malignancies such as acute nonlymphocytic leukemia, myeloproliferative syndrome, and carcinoma have been reported. Melphalan has been reported to cause chromatid or chromosome damage in humans.

The risk of leukemogenesis increases with chronicity of treatment and with cumulative dose.

Genitourinary

The suppression of ovarian function in premenopausal women has been reported to result in amenorrhea in a significant number of patients.

Genitourinary side effects including the suppression of ovarian function in premenopausal women and both reversible and irreversible testicular suppression have been reported.

Respiratory

Fatal outcomes associated with pulmonary fibrosis have been reported.

Respiratory side effects including pulmonary fibrosis and interstitial pneumonitis have been reported.

Dermatologic

Dermatologic side effects including , maculopapular rashes, skin rashes, alopecia, and skin hypersensitivity have been reported.

Cardiovascular

Cardiovascular side effects including cardiac arrest and vasculitis have been reported.

Gastrointestinal

Gastrointestinal side effects including nausea and vomiting, diarrhea, and oral ulceration have been reported infrequently.

Hepatic

Hepatic side effects including toxicity have been reported rarely.

Hypersensitivity

Hypersensitivity reactions have been reported after multiple courses of treatment and have recurred in patients who previously experienced a hypersensitivity reaction.

Hypersensitivity side effects including anaphylaxis have been reported rarely.

Endocrine

Endocrine side effects including two cases of syndrome of inappropriate antidiuretic hormone secretion have been reported following high-dose intravenous melphalan.

Other

Other side effects including a sensation of warmth and/or tingling have been reported.

Renal

Renal side effects including temporary significant elevation of the blood urea have been seen in the early stages of therapy in patients with renal damage.

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