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Evomela (Intravenous)

Generic Name: melphalan (Intravenous route)

MEL-fa-lan

Intravenous route(Powder for Solution)

Alkeran(R): Melphalan should be administered 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. Controlled trials comparing intravenous (IV) to oral melphalan have shown more myelosuppression with the IV formulation. Hypersensitivity reactions, including anaphylaxis, have occurred in approximately 2% of patients who received the IV formulation. Melphalan is leukemogenic in humans. Melphalan produces chromosomal aberrations in vitro and in vivo and, therefore, should be considered potentially mutagenic in humans

Intravenous route(Powder for Solution)

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

Commonly used brand name(s)

In the U.S.

  • Alkeran IV
  • Evomela

Available Dosage Forms:

  • Powder for Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Alkylating Agent

Chemical Class: Nitrogen Mustard

Uses For Evomela

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.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, melphalan is used in certain patients with the following medical conditions:

  • Retinoblastoma (cancer of the retina in the eye).

Before Using Evomela

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of melphalan injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of melphalan injection in the elderly.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Measles Virus Vaccine, Live
  • Mumps Virus Vaccine, Live
  • Rotavirus Vaccine, Live
  • Rubella Virus Vaccine, Live
  • Varicella Virus Vaccine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Adenovirus Vaccine
  • Bacillus of Calmette and Guerin Vaccine, Live
  • Cholera Vaccine, Live
  • Influenza Virus Vaccine, Live
  • Poliovirus Vaccine, Live
  • Smallpox Vaccine
  • Typhoid Vaccine
  • Yellow Fever Vaccine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Buthionine Sulfoximine
  • Nalidixic Acid

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Anemia or
  • Bone marrow suppression or
  • Leukopenia (low white blood cells) or
  • Liver disease or
  • Thrombocytopenia (low platelets in the blood)—Use with caution. May make these conditions worse.
  • Infection—May decrease your ability to fight an infection.
  • Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of melphalan

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.

Precautions While Using Evomela

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control during and after treatment to keep from getting pregnant. Men should also use effective contraception to prevent pregnancy in a sexual partner during and after treatment. If you think a pregnancy has occurred with this medicine, tell your doctor right away.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, hives, hoarseness, lightheadedness or fainting, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are receiving this medicine.

Melphalan can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

  • If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
  • Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
  • Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
  • Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
  • Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
  • Avoid contact sports or other situations where bruising or injury could occur.

While you are being treated with melphalan, and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Melphalan may lower your body's resistance and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.

Melphalan can cause diarrhea, nausea or vomiting, or sores or ulcers in the mouth, sometimes even after you receive medicine to prevent these effects. Ask your doctor or nurse about ways to control these symptoms.

Tell your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Using this medicine may increase your risk of getting other types of cancer. Talk to your doctor if you have concerns about this risk.

Some men and women using this medicine have become infertile (unable to have children). This medicine might make a woman stop having menstrual periods temporarily. Talk with your doctor if this is a concern.

Evomela Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common
  • Chest pain
  • chills
  • cough or hoarseness
  • fever
  • lower back or side pain
  • painful or difficult urination
  • shortness of breath
  • sores, ulcers, or white spots on the lips or in the mouth
  • swollen glands
  • unusual bleeding or bruising
  • unusual tiredness or weakness
Incidence not known
  • Abdominal or stomach pain
  • absent, missed, or irregular menstrual periods
  • back or leg pains
  • bleeding gums
  • bloated abdomen or stomach
  • blurred vision
  • clay-colored stools
  • confusion
  • dark urine
  • difficult or labored breathing
  • difficulty with swallowing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fast, pounding, or irregular heartbeat or pulse
  • general body swelling
  • headache
  • hives, itching, or rash
  • indigestion
  • light-colored stools
  • loss of appetite
  • nausea and vomiting
  • noisy breathing
  • nosebleeds
  • pain and fullness in right upper abdomen or stomach
  • pale skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • reddening of the skin, especially around the ears
  • sore throat
  • sweating
  • swelling of eyes, face, hands, ankles, feet, or lower legs
  • tightness in the chest
  • unpleasant breath odor
  • unusual lumps or masses
  • vomiting of blood
  • weight gain or loss
  • yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common
  • Indigestion
  • passing of gas
  • stomach fullness
Incidence not known
  • Blue-green to black skin discoloration
  • hair loss or thinning of the hair
  • pain, redness, soreness, or sloughing of the skin at the injection site
  • sores, welting, or blisters

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

See also: Side effects (in more detail)

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