Evomela

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).

It is not known if Evomela is safe and effective in children.

Description

Evomela contains melphalan hydrochloride, an alkylating drug, as the active ingredient. The chemical name of melphalan hydrochloride is 4-[bis(2-chloroethyl)amino]-L-phenylalanine hydrochloride. Its molecular formula is C13H18Cl2N2O2 • HCl and the molecular weight is 341.67. The structural formula is:

Melphalan hydrochloride is a white to off-white powder, with a melting range of 199°C − 201°C. It is practically insoluble in water, but freely soluble in 1 N HCl and methanol.

Evomela (melphalan) for injection is supplied as a sterile white to off-white lyophilized powder in a single-dose vial for intravenous use. Each vial contains 50 mg melphalan free base equivalent to 56 mg melphalan hydrochloride and 2700 mg Betadex Sulfobutyl Ether Sodium, NF.

Mechanism of Action

Melphalan is an alkylating agent of the bischloroethylamine type. As a result, its cytotoxicity appears to be related to the extent of its interstrand cross-linking with DNA, probably by binding at the N7 position of guanine. Like other bifunctional alkylating agents, it is active against both resting and rapidly dividing tumor cells.

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 leaflet for a complete list of ingredients in Evomela.

What should I tell my healthcare provider before using Evomela?

Before you receive Evomela, tell your healthcare provider 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.
  • Females who can become pregnant:
    • You should not become pregnant during treatment with Evomela.
    • You should use effective birth control (contraception) during treatment and for 6 months after your last dose of Evomela.
    • Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Evomela.
  • Males with female partners who can become pregnant:
    • You should use effective birth control (contraception) during treatment and for 3 months after your last dose of 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 healthcare provider 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 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 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 healthcare provider will do blood tests as needed to check your blood counts during your treatment with Evomela.
  • Low platelet counts: Tell your healthcare provider right away if you have unusual bleeding or bruising under your skin.
  • Low red blood cell counts: Tell your healthcare provider 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 healthcare provider 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). Mucositis is common during treatment with Evomela, and can sometimes be severe. Mucositis may cause discomfort or pain.Your healthcare provider will tell you about ways to maintain nutrition and help control the discomfort from mucositis, and may prescribe medicines if needed.
• Nausea, vomiting, and diarrhea are common with Evomela and can sometimes be serious. Tell your healthcare provider if you get nausea, vomiting, or diarrhea. Your healthcare provider may prescribe medicines to help prevent or treat these side effects.
• Liver problems. Your healthcare provider will check you for liver problems during treatment with Evomela. Tell your healthcare provider right away if you get any of the following signs or symptoms:
  • yellowing of your skin or the whites of your eyes
  • pain on the right side of your stomach-area (abdomen)
  • severe nausea or vomiting
  • dark urine (tea colored)
• Serious Allergic reactions. Tell your healthcare provider right away if you get any of the following signs or symptoms:
  • skin reactions, including welts, rash, itching, and redness
  • fast heartbeat
  • shortness of breath or trouble breathing
  • feel lightheaded or dizzy
  • blurry vision
  • swelling of your face, tongue, or throat
  • chest tightness
  • wheezingYour healthcare provider may need to discontinue treatment with Evomela if you have a serious allergic reaction.
  • 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 healthcare provider if this is a concern for you. In females, your menstrual periods may stop due to treatment with Evomela.

The most common side effects of Evomela includetiredness 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. You can ask your pharmacist or healthcare provider for information about Evomela that is written for health professionals.

What are the ingredients in Evomela?

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

Label

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

• Evomela Carton Label
• NDC 68152-109-00
• Evomela ® (melphalan) for Injection
• 50 mg per vial*
• For Intravenous Infusion Only
• Single-Use Vial
• Discard Unused Portion
• Sterile
• *Each vial contains 50 mg melphalan free base equivalent to 56 mg melphalan hydrochloride.
• Spectrum Pharmaceuticals

 

• Evomela Vial Label
• NDC 68152-109-00
• Evomela ® (melphalan) for Injection
• 50 mg per vial*
• For Intravenous Infusion Only
• Single-Use Vial Discard Unused Portion
• Sterile
• *Each vial contains 50 mg melphalan free base equivalent to 56 mg melphalan hydrochloride.
• Rx only

 

SRC: NLM .