Melphalan hydrochloride

What is Melphalan hydrochloride?

• Melphalan hydrochloride (Evomela; Alkeran) is an alkylating drug used in people with a type of cancer called multiple myeloma before receiving a stem cell transplant (conditioning treatment).

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Melphalan

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What are the uses of this medicine?

• Melphalan hydrochloride (Evomela; Alkeran) used in people with a type of cancer called multiple myeloma before receiving a stem cell transplant (conditioning treatment).

How does this medicine work?

• A bifunctional alkylating agent and phenylalanine derivative of nitrogen mustard.
• Melphalan hydrochloride is converted into highly reactive ethylenimmonium intermediates that induce covalent guanine N7-N7 intra- and inter-crosslinks and alkylation of adenine N3 of DNA.
• This agent also alkylates RNA and protein structures.
• As a result RNA transcription and protein synthesis are inhibited, ultimately leading to cell growth arrest and/or death.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• serious allergic reaction to melphalan.

What drug interactions can this medicine cause?

• No formal drug interaction studies have been conducted.
• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Be sure to mention any of the following:

• carmustine (BICNU)
• cisplatin
• cyclosporine (Sandimmune, Gengraf, Neoral)

Is this medicine FDA approved?

• Melphalan was approved for medical use in the United States in 1964.

How should this medicine be used?

• Administer prophylactic antiemetics.

Recommended dosage:

• For Conditioning Treatment, the recommended dose of Evomela is 100 mg/m2 /day administered over 30 minutes by intravenous infusion for 2 consecutive days (Day -3 and Day -2) prior to autologous stem cell transplantation (ASCT, Day 0).

Administration:

• Evomela is given to you into your vein through an intravenous (IV) line over 30 minutes.
• Your healthcare provider will do blood tests before and during your treatment with Evomela.
• Your healthcare provider will prescribe medicines to help prevent nausea.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 50 mg per vial, lyophilized powder in a single-dose vial for reconstitution.

This medicine is available in fallowing brand namesː Evomela

What side effects can this medication cause?

The most common side effects of this medicine include:

• tiredness
• low potassium level

Evomela may cause serious side effects, including:

• Low blood cell counts
• mucositis
• Nausea, vomiting, and diarrhea
• Liver problems
• Serious Allergic reactions
• Secondary cancers
• Infertility

What special precautions should I follow?

• For patients receiving Evomela as part of a conditioning regimen, myeloablation occurs in all patients. Monitor complete blood counts, provide supportive care for infections, anemia and thrombocytopenia until there is adequate hematopoietic recovery.
• Nausea, vomiting, diarrhea or oral mucositis may occur; provide supportive care using antiemetic and antidiarrheal medications as needed.
• Hepatic disorders ranging from abnormal liver function tests to clinical manifestations such as hepatitis and jaundice have been reported after treatment with melphalan.
• Acute hypersensitivity reactions, including anaphylaxis, have occurred in approximately 2% of patients who received an intravenous formulation of melphalan. Discontinue treatment with Evomela for serious hypersensitivity reactions.
• Secondary malignancies such as myeloproliferative syndrome or acute leukemia have been reported in multiple myeloma patients treated with melphalan-containing chemotherapy regimens.
• Melphalan can cause fetal harm. Advise females of reproductive potential and males with female partners of reproductive potential of the potential risk to a fetus and to use effective contraception.
• Melphalan may cause ovarian function suppression or testicular suppression.
• Advise women not to breastfeed during treatment with Evomela and for one week after the last dose.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• nausea
• vomiting
• decreased consciousness
• convulsions
• muscular paralysis
• cholinomimetic effects
• mucositis
• stomatitis
• colitis
• diarrhea
• hemorrhage of the gastrointestinal tract
• Elevations in liver enzymes
• veno-occlusive disease
• hyponatremia
• Nephrotoxicity
• adult respiratory distress syndrome
• bone marrow suppression

Treatment of overdosage:

• 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.

Can this medicine be used in pregnancy?

• Based on its mechanism of action, Evomela can cause fetal harm when administered to a pregnant woman.
• Advise a pregnant woman of the potential risk to a fetus.

Can this medicine be used in children?

• Safety and effectiveness have not been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

• Active ingredient: melphalan hydrochloride
• Inactive ingredient: Betadex Sulfobutyl Ether Sodium

Who manufactures and distributes this medicine?

Manufactured for:

• Spectrum Pharmaceuticals, Inc.
• Irvine, CA

What should I know about storage and disposal of this medication?

• Store Evomela at room temperature 25°C (77°F).
• Temperature excursions are permitted between 15- 30°C (59-86°F).
• Evomela is light sensitive.
• Retain in original carton until use.
• Melphalan is a hazardous drug.
• Follow applicable special handling and disposal procedures.

• Dailymed label info on Melphalan hydrochloride
• FDA Melphalan hydrochloride

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