Melphalan (Systemic)
Brand names: Evomela
Drug class:
Antineoplastic Agents
Usage of Melphalan (Systemic)
Multiple Myeloma
Used alone and as a component of various chemotherapeutic regimens in the treatment of multiple myeloma. Designated an orphan drug by FDA for use in multiple myeloma.
Various preparations and formulations are commercially available; indications and dosage recommendations differ between the different preparations.
Melphalan tablets and melphalan hydrochloride for injection are indicated for the palliative treatment of multiple myeloma.
Melphalan hydrochloride for injection (Evomela) is a propylene glycol-free parenteral formulation used as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation (HSCT) in patients with multiple myeloma and also as palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.
High-dose chemotherapy plus autologlous stem cell transplant (ASCT) is currently the preferred treatment of multiple myeloma in patients <65 years of age. For older patients and patients with clinically significant coexisting illnesses who are ineligible for transplant, combination treatment with newer drugs that have shown increased rates of survival are used.
A joint guideline published by the American Society of Clinical Oncology (ASCO) and Cancer Care Ontario recommends high-dose melphalan as a conditioning regimen for ASCT in transplant-eligible patients. For those who are transplant-ineligible, melphalan may be included as part of an initial combination regimen with daratumumab, Bortezomib, and prednisone.
Ovarian Cancer
Palliative treatment of nonresectable epithelial ovarian cancer.
Has been administered intraperitoneally† [off-label] for treatment of advanced ovarian cancer cOnfined to the peritoneal cavity and/or associated with malignant ascites.
Platinum-based chemotherapy is currently considered the standard of care chemotherapy for the treatment of ovarian cancer.
Melanoma
Has been used alone and in combination regimens for isolated limb perfusion† [off-label] or isolated limb infusion † [off-label] in patients with regionally recurrent melanoma not suitable for local or topical therapy.
Amyloidosis
Has been used with prednisone in the treatment of systemic light chain amyloidosis† [off-label].
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How to use Melphalan (Systemic)
General
Pretreatment Screening
Patient Monitoring
Premedication and Prophylaxis
Dispensing and Administration Precautions
Other General Considerations
Administration
Administer orally or by IV infusion. Has been administered by regional isolatedinfusion or perfusion† [off-label] (e.g., for melanoma†) and intraperitoneally† (e.g., for advanced ovarian cancer).
Oral Administration
Administer continuously (as single daily doses) or intermittently (via various dosage regimens).
IV Administration
Administer IV only by individuals experienced in administration of the drug.
Parenteral preparations are commercially available as lyophilized powders that must be reconstituted and diluted prior to IV administration.
Consult published protocols for specific information on parenteral dosage regimens using IV melphalan for specific diseases.
Reconstitution and DilutionMelphalan hydrochloride for injection: Reconstitute by adding 10 mL of the diluent provided by the manufacturer to a vial labeled as containing 50 mg of melphalan using a 20-gauge or larger needle to provide a solution containing 5 mg/mL. Dilute reconstituted dose further with 0.9% sodium chloride injection to a final concentration not exceeding 0.45 mg/mL.
Melphalan hydrochloride for injection (Evomela): Reconstitute by adding 8.6 mL of 0.9% sodium chloride injection to provide a solution containing 50 mg/10 mL (5 mg/mL). Dilute the required dose with an appropriate volume of 0.9% sodium chloride injection to a final concentration of 0.45 mg/mL.
Rate of AdministrationAdminister melphalan hydrochloride by IV infusion over 15–20 minutes. Complete administration within 60 minutes of reconstitution.
Infuse melphalan hydrochloride (Evomela) over 30 minutes via an injection port or a fast-running central venous catheter.
Dosage
Dosage of melphalan hydrochloride is expressed in terms of melphalan.
Adults
Multiple Myeloma OralUsual initial and maintenance dosage regimen: 6 mg daily for 2–3 weeks. Withhold therapy until leukocyte and platelet counts increase (i.e., up to 4 weeks) and then initiate maintenance therapy of 2 mg daily. Adjust dosage, as required, to maintain a degree of bone marrow depression.
Alternatively, 10 mg daily for 7–10 days. Withhold therapy until platelet and leukocyte counts exceed 100,000/mm3 and 4000/mm3, respectively, and then initiate maintenance therapy of 2 mg daily. Adjust dosage, as required, to between 1–3 mg daily, Depending on hematologic response.
Alternatively, 0.15 mg/kg daily for 7 days followed by a rest period of at least 14 days (or as long as 5 to 6 weeks). Maintenance therapy is initiated when the white blood cell and platelet counts are increasing, with a maintenance dose of 0.05 mg/kg/day or less, adjusted according to blood count.
Alternatively, 0.25 mg/kg daily for 4 days or 0.2 mg/kg daily for 5 days, with prednisone; administer at 4–6 week-intervals, if granulocyte and platelet counts are normal.
IVUsual dosage: 16 mg/m2 at 2-week intervals for 4 doses. After satisfactory recovery from toxicity, initiate maintenance therapy of 16 mg/m2 at 4-week intervals.
Melphalan hydrochloride (Evomela) as a high-dose conditioning treatment prior to ASCT (Day 0): 100 mg/m2 per day for 2 consecutive days (Day -3 and Day -2). For patients who weigh more than 130% of their ideal body weight, calculate body surface area (BSA) based on adjusted ideal body weight.
Ovarian Cancer OralUsual dosage: 0.2 mg/kg daily for 5 successive days; administer at intervals of 4–5 weeks.
Dosage Modification for ToxicityIf adverse effects occur, temporarily interrupt, reduce dose, and/or permanently discontinue drug.
For oral melphalan tablets, discontinue therapy if leukocyte count falls below 3000/mm3 or platelet count falls below 100,000/mm3. May restart therapy after blood cell counts have recovered. Consider dose adjustment on the basis of blood counts at the nadir and day of treatment.
For IV melphalan hydrochloride, in some controlled clinical studies in patients with multiple myeloma, dosage reductions of 25% were employed when platelet counts were 75,000–99,999/mm3 or leukocyte counts were 3000–3999/mm3 and dosage reductions of 50% were used when platelet counts were 50,000–74,999/mm3 or leukocyte counts were 2000–2999/mm3; IV melphalan was discontinued when platelet or leukocyte counts fell below 50,000/mm3 or 2000/mm3, respectively.
Do not readminister oral or IV melphalan if a hypersensitivity reaction occurs.
Special Populations
Hepatic Impairment
No specific dosage recommendations.
Renal Impairment
OralIn patients with moderate to severe renal impairment, consider reducing initial dosage; however, no specific dosage recommendations.
IVIn patients with renal impairment (BUN ≥30 mg/dL), reduce dosage by 50%.
When used as a conditioning treatment (Evomela), dosage adjustment not necessary.
Geriatric Patients
No specific dosage recommendations. In general, start dose selection at low end of dosing range.
Warnings
Contraindications
Warnings/Precautions
Warnings
Adequate Patient Evaluation and MonitoringAdminister under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Severe bone marrow suppression with resulting infection or bleeding may occur. Hypersensitivity reactions, including anaphylaxis, have occurred. Melphalan is leukemogenic in humans. (See Boxed Warning.)
Mutagenicity and CarcinogenicityProduces chromosomal aberrations in vitro and in vivo; considered potentially mutagenic in humans.
Sensitivity Reactions
Hypersensitivity ReactionsAcute hypersensitivity reactions, including anaphylaxis, have been reported with IV melphalan administration. Symptoms may include urticaria, pruritus, edema, and skin rash. Tachycardia, bronchospasm, dyspnea, and hypotension have also been observed. If a serious hypersensitivity reaction occurs, discontinue treatment.
Other Warnings and Precautions
ThrombocytopeniaThrombocytopenia, which may lead to hemorrhage, occurs commonly. Frequent platelet counts are essential to determine dosage and avoid toxicity.
Monitor platelet counts at baseline, during treatment, and as clinically indicated. Consider dose adjustment on the basis of platelet counts at the nadir and day of treatment, as well as based on signs and symptoms of bleeding. Therapy may be withheld until recovery of platelet count.
Neutropenia/LeukopeniaNeutropenia/leukopenia, which may lead to infection, occurs commonly. Frequent monitoring of WBC counts essential to determine dosage and avoid toxicity.
Monitor WBC counts at baseline, during treatment, and as clinically indicated. Consider dose adjustment on the basis of WBC counts at the nadir and day of treatment. Therapy may be withheld until recovery of WBC count.
AnemiaAnemia occurs commonly. Frequent monitoring of RBC counts essential to determine dosage and avoid toxicity.
Monitor RBC counts at baseline, during treatment, and as clinically indicated. Consider dose adjustment on the basis of RBC counts. Therapy may be withheld until recovery of RBC count.
InfectionsMonitor patients closely for signs and symptoms of infection and consider antimicrobials as clinically appropriate.
Secondary MalignanciesSecondary malignancies (e.g., myelodysplastic syndromes, acute leukemia) may occur. Monitor patients long-term for potential development of secondary malignancies.
GI ToxicityNausea, vomiting, mucositis, and diarrhea may occur. Administer prophylactic antiemetics and provide supportive care as necessary.
HepatotoxicityAbnormal liver function tests as well as instances of hepatitis, jaundice, and hepatic veno-occlusive disease reported. Monitor liver chemistries as appropriate.
Fetal/Neonatal Morbidity and MortalityCan cause fetal harm. Avoid pregnancy during therapy. Advise females of reproductive potential and males with female partners of reproductive potential to use an effective method of contraception during and for a period of time after melphalan treatment.
Specific Populations
PregnancyMay cause fetal harm.
LactationNot known whether melphalan is distributed into human milk; breastfeeding is not recommended.
Females and Males of Reproductive PotentialVerify pregnany status prior to initiation of therapy in females of reproductive potential. Advise such females and males with female partners of reproductive potential to use effective contraception during and for a period after treatment.
Pediatric UseSafety and efficacy not established.
Geriatric UseFor oral melphalan, insufficient number of patients ≥65 years of age were included in studies. For IV melphalan (Evomela), no differences in safety or effectiveness observed relative to younger adults.
Hepatic ImpairmentNo specific dosage recommendations for patients with hepatic impairment.
Renal ImpairmentFor oral melphalan, no specific dosage recommendations for patients with renal impairment. Consider a dose reduction in patients with renal insufficiency receiving IV melphalan for palliative treatment.
Common Adverse Effects
Adverse effects in patients receiving oral melphalan include bone marrow suppression, nausea, vomiting, diarrhea, oral ulceration, hepatic disorders, pulmonary fibrosis, interstitial pneumonitis, rash, vasculitis, alopecia, hemolytic anemia, allergic reactions.
Adverse effects (≥50%) in patients receiving IV melphalan (Evomela) include decreased neutrophil, decreased WBC counts, decreased lymphocyte counts, decreased platelet counts, diarrhea, nausea, fatigue, hypokalemia, anemia, vomiting.
What other drugs will affect Melphalan (Systemic)
Specific Drugs
Drug
Interaction
Comments
Possible reduced threshold for carmustine-induced pulmonary toxicity with IV melphalan
Cisplatin
Possible decreased clearance of melphalan secondary to cisplatin-induced renal impairment
Cyclosporine
Possible increased risk of cyclosporine-induced nephrotoxicity
Monitor renal function
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