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|Alkeran

MELPHALAN (Systemic)

Some commonly used brand names are:

In the U.S.—

• Alkeran

In Canada—

• Alkeran

Other commonly used names are L-PAM and phenylalanine mustard .

Category

• Antineoplastic

Description

Melphalan (MEL-fa-lan) belongs to the group of medicines called alkylating agents. It is used to treat cancer of the ovaries and a certain type of cancer in the bone marrow.

Melphalan interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by melphalan, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects may not be serious but may cause concern. Some effects may not occur for months or years after the medicine is used.

Before you begin treatment with melphalan, you and your doctor should talk about the good this medicine will do as well as the risks of using it.

Melphalan is available only with your doctor"s prescription, in the following dosage form:

• Oral
• Tablets (U.S. and Canada)

• Parenteral
• Injection (U.S. and Canada)

Before Using This Medicine

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 melphalan, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to melphalan or chlorambucil.

Pregnancy—Tell your doctor if you are pregnant or if you intend to have children. There is a chance that this medicine may cause birth defects if either the male or female is taking it at the time of conception or if it is taken during pregnancy. In addition, many cancer medicines may cause sterility which could be permanent. Sterility has been reported with melphalan and the possibility should be kept in mind.

Be sure that you have discussed this with your doctor before taking this medicine. It is best to use some kind of birth control while you are taking melphalan. Tell your doctor right away if you think you have become pregnant while taking melphalan.

Breast-feeding—Tell your doctor if you are breast-feeding or if you intend to breast-feed during treatment with this medicine. Because melphalan may cause serious side effects, breast-feeding is not recommended while you are taking it.

Children—Although there is no specific information comparing use of melphalan in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing the use of melphalan in the elderly with use in other age groups.

Other 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 taking melphalan, it is especially important that your health care professional know if you are taking any of the following:

• Amphotericin B by injection (e.g., Fungizone) or
• Antithyroid agents (medicine for overactive thyroid) or
• Azathioprine (e.g., Imuran) or
• Chloramphenicol (e.g., Chloromycetin) or
• Colchicine or
• Flucytosine (e.g., Ancobon) or
• Ganciclovir (e.g., Cytovene) or
• Interferon (e.g., Intron A, Roferon-A) or
• Plicamycin (e.g., Mithracin) or
• Zidovudine (e.g., AZT, Retrovir) or
• If you have been treated with x-rays or cancer medicines within 3 to 4 weeks—Melphalan may increase the effects of these medicines or radiation therapy on the blood

• Probenecid (e.g., Benemid) or
• Sulfinpyrazone (e.g., Anturane)—Melphalan may raise the concentration of uric acid in the blood, which these medicines are used to lower

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

• Chickenpox (including recent exposure) or
• Herpes zoster (shingles)—Risk of severe disease affecting other parts of the body

• Gout (history of) or
• Kidney stones (history of)—Melphalan may increase levels of a chemical called uric acid in the body, which can cause gout or kidney stones

• Infection—Melphalan decreases your body"s ability to fight infection

• Kidney disease—Risk of toxic effects on the blood may be increased

Proper Use of This Medicine

Take melphalan only as directed by your doctor . Do not take more or less of it, do not take it more often, and do not take it for a longer time than your doctor ordered. The exact amount of medicine you need has been carefully worked out. Taking too much may increase the chance of side effects, while taking too little may not improve your condition.

Melphalan is sometimes given together with certain other medicines. If you are using a combination of medicines, it is important that you receive each one at the proper time. If you are taking some of these medicines by mouth, ask your health care professional to help you plan a way to remember to take your medicine at the right times.

While you are using melphalan, your doctor may want you to drink extra fluids so that you will pass more urine. This will help prevent kidney problems and keep your kidneys working well.

This medicine may cause nausea, vomiting, and loss of appetite. However, it is very important that you continue to receive the medicine, even if you begin to feel ill. Ask your health care professional for ways to lessen these effects.

If you vomit shortly after taking a dose of melphalan, check with your doctor. You will be told whether to take the dose again or to wait until the next scheduled dose.

Dosing—The dose of melphalan will be different for different patients. The dose that is used may depend on a number of things, including what the medicine is being used for, the patient"s weight, whether the medicine is being given by mouth or by injection, and whether or not other medicines are also being taken. If you are taking or receiving melphalan at home, follow your doctor"s orders or the directions on the label . If you have any questions about the proper dose of melphalan, ask your doctor.

Missed dose—If you miss a dose of this medicine, do not take the missed dose at all and do not double the next one. Instead, go back to your regular dosing schedule and check with your doctor.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store in the original glass container away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

While you are being treated with melphalan, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor"s approval . Melphalan may lower your body"s resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take or should not have taken oral polio vaccine within the last several months since there is a chance they could pass the polio virus on to you. Also, avoid other persons who have taken oral polio vaccine. Do not get close to them and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

Melphalan can lower the number of white blood cells in your blood temporarily, 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 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.

Side Effects of This Medicine

Along with their needed effects, medicines like melphalan can sometimes cause unwanted effects such as blood problems and other side effects. These and others are described below. Also, because of the way these medicines act on the body, there is a chance that they might cause other unwanted effects that may not occur until months or years after the medicine is used. These delayed effects may include certain types of cancer, such as leukemia. Discuss these possible effects with your doctor.

Although not all of these side effects may occur, if they do occur they may need medical attention.

Other 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 the following side effects continue or are bothersome or if you have any questions about them:

After you stop taking melphalan, it may still produce some side effects that need attention. During this period of time, check with your doctor if you notice any of the following side effects:

Black, tarry stools; blood in urine or stools; cough or hoarseness, accompanied by fever or chills; fever or chills; lower back or side pain, accompanied by fever or chills; painful or difficult urination, accompanied by fever or chills; pinpoint red spots on skin; unusual bleeding or bruising

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

Additional Information

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 conditions:

• Cancer of the breast
• Waldenström"s macroglobulinemia (a certain type of cancer of the blood)
• Cancer of the blood and lymph system
• Cancer of the endometrium
• Malignant melanoma (a type of skin cancer that has spread to other parts of the body)

Other than the above information, there is no additional information relating to the proper use, precautions, or side effects of this medicine for these uses.

Revised: 03/10/2004

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