What is Evomela?
Evomela is a prescription medicine used in people with a type of cancer called multiple myeloma:
- before receiving a stem cell transplant (conditioning treatment)
- as a part of care to support symptom relief (palliative treatment), in people who cannot take medicine by mouth
It is not known if Evomela is safe and effective in children.
Who should not use Evomela?
Do not receive Evomela if you are allergic to melphalan or any of the ingredients in Evomela. See the end of this guide for a complete list of ingredients in Evomela.
What should I tell my healthcare provider before using Evomela?
Before you receive Evomela, tell your doctor about all of your medical conditions, including if you:
- 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. 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.
- are breastfeeding or plan to breastfeed. It is not known if Evomela passes into your breast milk. You should not breastfeed during treatment with Evomela.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How should I use Evomela?
- Evomela is given to you into your vein through an intravenous (IV) line 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.
What are the possible side effects of Evomela?
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.
The most common side effects of Evomela include tiredness and low potassium level.
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.
General information about the safe and effective use of Evomela
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Evomela for a condition for which it was not prescribed. Do not give Evomela to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or doctor for information about Evomela that is written for health professionals.
How should I store Evomela?
Store Evomela at room temperature 25°C (77°F). Temperature excursions are permitted between 15-30°C (59-86°F). [see USP Controlled Room Temperature]
Evomela is light sensitive. Retain in original carton until use.
Melphalan is a cytotoxic drug. Follow special handling and disposal procedure.
What are the ingredients in Evomela?
Active ingredient: melphalan hydrochloride
Inactive ingredient: Betadex Sulfobutyl Ether Sodium
For more information, go to www.evomela.com or call 1-888-292-9617.