Melphalan — uses, dosing, side effects & the brands that sell it · pharmaranks
Melphalan: uses, dosing, side effects & brands
Melphalan is an alkylating drug sold in the U.S. under 5 brand and generic names, for breast neoplasms, multiple myeloma and neuroblastoma. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
By the pharmaranks editorial team·Reviewed against the FDA (openFDA label, NDC Directory & Enforcement) sources·How we research
Key facts
Drug class
Alkylating Drug
Treats
Breast Neoplasms, Multiple Myeloma and Neuroblastoma
Available as
Tablet · Injectable · Kit
Sold as
5 products — Alkeran, Ivra and Evomela, and others
From the FDA label for Ivra (application NDA217110). Other melphalan products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Recommended dosage is 16 mg/m 2 administered intravenously over 15 to 20 minutes at 2-week intervals for 4 doses, then, after adequate recovery from toxicity, at 4-week intervals. ( 2.2 ) See full prescribing information for preparation and administration instructions. ( 2.3 ) 2.1 Recommended Dosage The recommended dosage is 16 mg/m 2 intravenously over 15 to 20 minutes at 2-week intervals for 4 doses, then at 4-week intervals until unacceptable toxicity. Administer prophylactic antiemetics [see Warnings and Precautions ( 5.2 )]. 2.2 Dosage Modifications for Adverse Reactions See Table 1 for dosage modifications for adverse reactions related to bone marrow suppression [see Warnings and Precautions ( 5.1 )]. Table 1. Dosage Modifications for Adverse Reaction: Bone Marrow Suppression Parameter Dosing Recommendations White Blood Cell Count (WBC/mm 3 ) Platelet Count (Per mcL) Greater than or equal to 4,000 Greater than or equal to 100,000 Continue full IVRA dose Greater than or equal to 3,000 Greater than or equal to 75,000 Reduce IVRA to 75% of full dose Greater than or equal to 2,000 Greater than or equal to 50,000 Reduce IVRA to 50% of full dose Less than 2,000 Less than 50,000 Withold IVRA 2.3 Dosage Modifications for Renal Impairment Consider a dosage reduction of up to 50% in patients with renal insufficiency (BUN ≥30 mg/dL) [see Use in Specific Populations ( 8.6 )] . 2.4…
Melphalan side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: Bone Marrow Suppression [see Warnings and Precautions ( 5.1 )] Gastrointestinal Toxicity [see Warnings and Precautions ( 5.2 )] Hepatotoxicity [see Warnings and Precautions ( 5.3 )] Hypersensitivity [see Warnings and Precautions ( 5.4 )] Secondary Malignancies [see Warnings and Precautions ( 5.5 )] Most common adverse reactions (≥50%) are neutrophil count decreased, white blood cell count decreased, lymphocyte count decreased, platelet count decreased, diarrhea, nausea, fatigue, hypokalemia, anemia, and vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp. at 1-800-706-5575 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of melphalan may not reflect the rates observed in practice. The most common adverse reactions observed in at least 50% of patients with multiple myeloma treated with melphalan were neutrophil count decreased, white blood cell count decreased, lymphocyte count decreased, platelet count decreased, diarrhea, nausea, fatigue, hypokalemia, anemia, and vomiting. Palliative Treatment of Patients with Multiple Myeloma The safety of melphalan was evaluated in 295 patients with multiple…
Every melphalan product we track (5)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
IVRA contains melphalan which is an alkylating drug. The chemical name of melphalan hydrochloride is 4-[bis(2-chloroethyl)amino]-L-phenylalanine hydrochloride. The molecular formula is C 13 H 18 Cl 2 N 2 O 2 • HCl and the molecular weight is 341.67. The structural formula is: Melphalan hydrochloride is a white to off-white powder, with a melting range of 199°C to 201°C. It is practically insoluble in water, but freely soluble in 1N HCl and methanol. IVRA is supplied as a sterile, clear colorless to yellow solution in a multiple-dose vial for intravenous use. Each mL contains 90 mg melphalan free base equivalent to 100.75 mg melphalan hydrochloride, 170 mg propylene glycol, 5 mg monothioglycerol, 0.5 mg (1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid dihydrate), and 0.025 mL water for injection in polyethylene glycol 400. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. The pH of the drug product solution after dilution with 0.9% sodium chloride ranges from 2.4 - 3.5. Each mL contains 90 mg melphalan free base equivalent to 100.75 mg melphalan hydrochloride.
What kind of drug is melphalan?
The FDA classifies melphalan as an alkylating drug. Alkylating chemotherapy drugs attach chemical groups to a cell's DNA, forming cross-links that lock the two DNA strands together. This damage stops the cell from copying its DNA and dividing, which triggers it to die; because they are not limited to one phase of the cell cycle, they can act on cells whether or not they are actively dividing. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take melphalan with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run melphalan against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is melphalan sold under?
We track 5 melphalan-containing products in the U.S.: Alkeran, Ivra, Evomela, Hepzato and Melphalan Hydrochloride. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Who shouldn’t take melphalan
IVRA is contraindicated in patients with a history of severe hypersensitivity to melphalan. Reactions have included anaphylaxis [see Warnings and Precautions ( 5.4 )]. History of severe hypersensitivity to melphalan. ( 4 )
Melphalan drug interactions
Effect of Other Drugs on IVRA Cisplatin Concomitant use with cisplatin may alter melphalan clearance by inducing renal dysfunction. Consider intravenous IVRA dosage reduction in patients with renal insufficiency following concomitant use with cisplatin [see Dosage and Administration ( 2.2 )] . 7.2 Effect of IVRA on Other Drugs BCNU Concomitant use with BCNU may reduce the threshold for lung toxicity. Monitor for increased lung toxicity. 7.3 Cyclosporine Concomitant use with cyclosporine may increase the risk of developing severe renal failure [see Clinical Pharmacology ( 12.3 ) ]. Consider intravenous IVRA dosage reduction in patients with renal insufficiency following concomitant use with cyclosporine [see Dosage and Administration ( 2.2 )] .
Across the brands we track, melphalan is currently marketed as tablet, injectable and kit, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic melphalan?
Yes. Our catalog lists 1 generic melphalan product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.