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.

• Spectrum Pharmaceuticals, Inc.

Common side effects of Evomela include the following:

• decrease in blood counts
• fatigue (feeling tired)
• nausea
• vomiting
• diarrhea
• low potassium

This is not a complete list of Evomela side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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.

Evomela may cause serious side effects, including:

• Low blood cell counts are common with Evomela and can be serious. Your doctor will do blood tests as needed to check your blood counts during your treatment with Evomela.
• Low platelet counts: Tell your doctor right away if you have unusual bleeding or bruising under your skin.
• Low red blood cell counts: Tell your doctor if you are feeling weak, tired, or you get tired easily, you look pale, or you feel short of breath.
• Low white blood cell counts: A low white blood cell count can cause you to get infections, which may be serious. Tell your doctor right away if you have symptoms of infection, such as fever, chills, cough, pain, or burning during urination.
• Redness and sores of the lining of the mouth, lips, throat, stomach, and genitals (mucositis). Discomfort or pain due to mucositis may happen during treatment with Evomela. Your doctor will tell you about ways to maintain nutrition and help control the discomfort from mucositis.
• Nausea, vomiting, and diarrhea are common with Evomela and can sometimes be serious. Tell your doctor if you get nausea, vomiting, or diarrhea. Your doctor may prescribe medicines to help prevent or treat these side effects.
• Liver problems. Your doctor will check you for liver problems during treatment with Evomela. Tell your doctor right away if you get any of the following signs or symptoms:
  • yellowing of your skin or the whites of your eyes
  • severe nausea or vomiting
  • pain on the right side of your stomach-area (abdomen)
  • dark urine (tea colored)
• Allergic reactions. Tell your doctor right away if you get any of the following signs or symptoms:
  • skin reactions, including welts, rash, itching, and redness
  • feel lightheaded or dizzy
  • blurry vision
  • fast heartbeat
  • swelling of your face, tongue, or throat
  • shortness of breath or trouble breathing
• Secondary cancers. New cancers have happened in people who have been treated with Evomela.
• Infertility. Evomela may cause fertility problems in males and females. Talk to your doctor if this is a concern for you.

These are not all the possible side effects of Evomela. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Do not receive Evomela if you are allergic to Evomela or to any of its ingredients. 

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Evomela, there are no specific foods that you must exclude from your diet when receiving this medication.

Before you receive Evomela, tell your doctor about all of your medical conditions, including if you:

• are allergic to Evomela or to any of its ingredients 
• have an infection
• have had chemotherapy treatment
• have nausea, vomiting, or diarrhea
• have liver or kidney problems
• are pregnant or plan to become pregnant. Evomela can harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if Evomela passes into your breast milk. 

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

Based on its mechanism of action, Evomela can cause fetal harm when administered to a pregnant woman. 

You should not become pregnant during and after treatment with Evomela. Tell your doctor right away if you become pregnant during treatment with Evomela.

• Females who are able to become pregnant should use effective birth control during and after treatment with Evomela. Talk with your doctor about how long to use birth control after treatment with Evomela.
• Males who have female partners who are able to become pregnant should use effective birth control during and after treatment with Evomela. Talk with your doctor about how long to use birth control after treatment with Evomela.

In some serious situations, the benefit of using this medication may be greater than the risk of harm to the baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known whether Evomela is present in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Evomela, breastfeeding is not recommended during treatment with Evomela. 

Receive Evomela exactly as prescribed.

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

It will be administered over 15 to 30 minutes.

Your doctor will do blood tests before and during your treatment with Evomela.

Your doctor may prescribe medicines to help prevent nausea.

The recommended dose Evomela for conditioning treatment is 100 mg/m2/day administered over 30 minutes for 2 consecutive days (Day -3 and Day -2) prior to autologous stem cell transplantation (ASCT, Day 0).

The recommended dose Evomela for palliative treatment is 16 mg/m2/day administered as a single infusion over 15-20 minutes at 2-week intervals for 4 doses, then, after adequate recovery from toxicity, at 4-week intervals.

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.

WARNING: SEVERE BONE MARROW SUPPRESSION, HYPERSENSITIVITY, and LEUKEMOGENICITY

• Severe bone marrow suppression with resulting infection or bleeding may occur. Controlled trials comparing intravenous (IV) melphalan to oral melphalan have shown more myelosuppression with the IV formulation. Monitor hematologic laboratory parameters.
• Hypersensitivity reactions, including anaphylaxis, have occurred in approximately 2% of patients who received the IV formulation of melphalan. Discontinue treatment with EVOMELA for serious hypersensitivity reactions.
• Melphalan produces chromosomal aberrations in vitro and in vivo. EVOMELA should be considered potentially leukemogenic in humans.