Evomela

Evomela is a prescription medication used to treat multiple myeloma (a type of cancer of the bone marrow). It belongs to a group of drugs called alkylating agents. It works by stopping or slowing the growth of cancer cells in your body.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Common side effects decrease in blood counts, diarrhea, and nausea. Evomela can also make you feel tired. Do not drive or drive heavy machinery until you know how this medication affects you. 

Evomela is a prescription medication used as:

• Conditioning treatment for multiple myeloma (MM) patients undergoing autologous stem cell transplantation (ASCT)
• Palliative treatment of patients with MM in which oral therapy is not appropriate

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Evomela is part of the drug class:

• Nitrogen mustard analogues

No drug interactions have been determined by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

If Evomela is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Melphalan injection is used to treat multiple myeloma (bone marrow cancer) and as a conditioning treatment before a bone marrow transplantation procedure in patients with multiple myeloma. Melphalan belongs to the group of medicines called alkylating agents (cancer medicines). It works by interfering with the growth of cancer cells, which are eventually destroyed by the body. Since the growth of normal cells may also be affected by melphalan, other unwanted effects will also occur. Before you begin treatment with melphalan, talk to your doctor about the benefits as well as the risks of using it.

This medicine is to be given only by or under the direct supervision of your doctor.

This section provides information on the proper use of a number of products that contain melphalan. It may not be specific to Evomela. Please read with care.

You will receive this medicine in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins.

This medicine should come with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Bone Marrow Suppression

For patients receiving Evomela as part of a conditioning regimen, myeloablation occurs in all patients. Do not begin the conditioning regimen if a stem cell product is not available for rescue. Monitor complete blood counts, provide supportive care for infections, anemia and thrombocytopenia until there is adequate hematopoietic recovery.

For patients receiving Evomela as palliative treatment, if the bone marrow has been compromised by prior irradiation, prior chemotherapy or is recovering from chemotherapy, the risk of severe myelosuppression with Evomela is increased. Perform periodic complete blood counts during the course of treatment with Evomela. Provide supportive care for infections, bleeding, and symptomatic anemia [see Adverse Reactions (6.1)].

Gastrointestinal Toxicity

For patients receiving Evomela as part of a conditioning regimen, nausea, vomiting, mucositis, and diarrhea may occur in over 50% of patients. Use prophylactic antiemetic medication. Provide supportive care for nausea, vomiting, diarrhea, and mucositis. The frequency of grade 3/4 mucositis in clinical studies was 13%. Provide nutritional support and analgesics for patients with severe mucositis. [see Dosage and Administration (2.1) and Adverse Reactions (6.1)].

For patients receiving Evomela as palliative treatment, nausea and vomiting, diarrhea, and oral ulceration may occur. Use prophylactic antiemetics. Provide supportive care for nausea, vomiting, diarrhea and mucositis.

Hepatotoxicity

Hepatic disorders ranging from abnormal liver function tests to clinical manifestations such as hepatitis and jaundice have been reported after treatment with melphalan. Hepatic veno-occlusive disease has also been reported. Monitor liver chemistries.

Hypersensitivity

Acute hypersensitivity reactions, including anaphylaxis, have occurred in approximately 2% of patients who received an intravenous formulation of melphalan. Symptoms may include urticaria, pruritus, edema, and skin rashes and, in some patients, tachycardia, bronchospasm, dyspnea, and hypotension. Discontinue treatment with Evomela for serious hypersensitivity reactions.

Secondary Malignancies

Melphalan has been shown to cause chromatid or chromosome damage in humans. Secondary malignancies such as myeloproliferative syndrome or acute leukemia have been reported in multiple myeloma patients treated with melphalan-containing chemotherapy regimens. The potential benefit of Evomela therapy must be considered against the possible risk of the induction of a secondary malignancy.

Embryo-Fetal Toxicity

Based on its mechanism of action, Evomela can cause fetal harm when administered to a pregnant woman. Melphalan is genotoxic, targets actively dividing cells, and was embryolethal and teratogenic in rats. Advise females of reproductive potential to avoid pregnancy during and after treatment with Evomela. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, advise the patient of potential risk to the fetus [see Use in Specific Populations (8.1, 8.3)].

Infertility

Melphalan-based chemotherapy regimens have been reported to cause suppression of ovarian function in premenopausal women, resulting in persistent amenorrhea in approximately 9% of patients. Reversible or irreversible testicular suppression has also been reported [see Use in Specific Populations (8.3)].

Manufactured for:

Spectrum Pharmaceuticals, Inc.

Irvine, CA 92618