Melphalan

Melphalan is a prescription medication used for treating multiple myeloma and ovarian cancer.

• Melphalan is available under various brand names: Alkeran (DSC), Evomela

Common side effects of Melphalan include:

• low blood cell counts,
• mouth sores,
• tiredness,
• low potassium levels, and
• hair loss

Serious side effects of Melphalan include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• itching,
• skin redness,
• blurred vision,
• lightheadedness,
• fast heartbeats,
• fever,
• chills,
• cough,
• pain or burning while urinating,
• pale skin,
• unusual tiredness,
• shortness of breath,
• cold hands and feet,
• easy bruising,
• unusual bleeding,
• purple or red spots under the skin,
• sores or white patches in or around the mouth,
• trouble swallowing or talking,
• dry mouth,
• bad breath,
• altered sense of taste,
• severe ongoing nausea,
• vomiting,
• diarrhea,
• new or worsening cough,
• fever,
• unusual lumps or masses,
• missed menstrual periods,
• warmth or tingling,
• skin rash,
• headache,
• body aches,
• night sweats,
• weight loss,
• weakness,
• tiredness,
• loss of appetite,
• stomach pain (upper right side),
• dark urine,
• clay-colored stools,
• yellowing of the skin or eyes (jaundice),
• leg cramps,
• constipation,
• irregular heartbeats,
• fluttering in the chest,
• increased thirst or urination,
• numbness or tingling,
• muscle weakness, and
• limp feeling

Rare side effects of Melphalan include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injection, lyophilized powder for reconstitution

• 50 mg (Evomela, generic)

Tablet

• 2 mg (generic)

Multiple Myeloma

Adult dosage

Palliative treatment

Tablets only

• 6 mg orally every day for 2-3 weeks, OR
• 10 mg orally every day for 7-10 days, OR
• 0.15 mg/kg/day orally for 7 days, THEN
• After adequate recovery from toxicity (monitor WBCs and platelets) give 1-3 mg or 0.05 mg/kg orally every day

Conditioning treatment

• 100 mg/m²/day IV administered over 30 min for 2 consecutive days (Day -3 and Day -2) prior to autologous stem cell transplantation (ASCT, Day 0)

Ovarian Cancer

Adult dosage

• 0.2 mg/kg/day orally for 5 days; repeat every 4-5 weeks, depending on hematologic tolerance 

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Melphalan has severe interactions with the following drugs:
  • adenovirus types 4 and 7 live, oral
  • BCG vaccine live
  • cholera vaccine
  • influenza virus vaccine quadrivalent, intranasal
  • measles (rubeola) vaccine
  • measles mumps and rubella vaccine, live
  • measles, mumps, rubella and varicella vaccine, live
  • rotavirus oral vaccine, live
  • rubella vaccine
  • smallpox (vaccinia) vaccine, live
  • typhoid polysaccharide vaccine
  • typhoid vaccine live
  • varicella virus vaccine live
  • yellow fever vaccine
  • zoster vaccine live
• Melphalan has serious interactions with the following drugs:
  • axicabtagene ciloleucel
  • brexucabtagene autoleucel
  • ciltacabtagene autoleucel
  • idecabtagene vicleucel
  • lisocabtagene maraleucel
  • natalizumab
  • nivolumab
  • ocrelizumab
  • palifermin
  • pimecrolimus
  • ropeginterferon alfa 2b
  • tacrolimus
  • tisagenlecleucel
  • tofacitinib
• Melphalan has moderate interactions with at least 55 other drugs.
• Melphalan has no noted minor interactions with the following drugs:
  • digoxin
  • ibuprofen/famotidine
  • vitamin A
  • vitamin E

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity to melphalan or chlorambucil
• Prior resistance to melphalan

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Melphalan?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Melphalan?”

Cautions

• Renal impairment, leukopenia, thrombocytopenia, anemia, CLL
• Possibility of delayed myelosuppression that can last 4-6 weeks
• Avoid pregnancy

Pregnancy & Lactation

Based on mechanism of action, therapy can cause fetal harm when administered to a pregnant woman, including teratogenicity and/or embryo-fetal lethality; product is a genotoxic drug and can cause chromatid or chromosome damage in humans

• Contraception
  • Females: Advise females of reproductive potential to use effective contraception during treatment and for 6 months after last dose
  • Males: Drug administration may damage spermatozoa and testicular tissue, resulting in possible genetic fetal abnormalities; advise males with female partners of reproductive potential to use effective contraception during treatment and for 3 months after last dose
• Infertility
  • Females: Therapy causes suppression of ovarian function in premenopausal women, resulting in amenorrhea in a significant number of patients
  • Males: Reversible and irreversible testicular suppression has been reported in male patients after administration of melphalan
• Lactation
  • It is not known whether drug is present in human milk; because many drugs are excreted in human milk and because of potential for serious adverse reactions in nursing children from melphalan, breastfeeding is not recommended during treatment and for one week after last dose
  • Females: Therapy causes suppression of ovarian function in premenopausal women, resulting in amenorrhea in a significant number of patients
  • Males: Reversible and irreversible testicular suppression has been reported in male patients after administration of melphalan