MELPHALAN (Systemic)

Some commonly used brand names are:

In the U.S.?

• Alkeran

In Canada?

• Alkeran

Other commonly used names are L-PAMand phenylalanine mustard.

Category

• Antineoplastic

Description

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

Melphalan interferes with the growth of cancer cells, which are eventuallydestroyed. 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 reportedto your doctor. Other effects may not be serious but may cause concern. Someeffects may not occur for months or years after the medicine is used.

Before you begin treatment with melphalan, you and your doctor should talkabout 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 followingdosage 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 willdo. This is a decision you and your doctor will make. For melphalan, the followingshould be considered:

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

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

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

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

Children?Although there is no specific information comparinguse of melphalan in children with use in other age groups, this medicine isnot expected to cause different side effects or problems in children thanit does in adults.

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

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingmelphalan, it is especially important that your health care professional knowif 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 3to 4 weeks?Melphalan may increase the effects of these medicines orradiation therapy on the blood

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

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

• Chickenpox (including recent exposure) or
• Herpes zoster (shingles)?Risk of severe disease affecting otherparts of the body

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

• Infection?Melphalan decreases your body's ability to fightinfection

• 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 orless of it, do not take it more often, and do not take it for a longer timethan your doctor ordered. The exact amount of medicine you need has been carefullyworked out. Taking too much may increase the chance of side effects, whiletaking too little may not improve your condition.

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

While you are using melphalan, your doctor may want you to drink extrafluids so that you will pass more urine. This will help prevent kidney problemsand 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 youbegin to feel ill. Ask your health care professional for ways to lessen theseeffects.

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

Dosing?The dose of melphalan will be different fordifferent 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, whetherthe medicine is being given by mouth or by injection, and whether or not othermedicines are also being taken. If you are taking orreceiving melphalan at home, follow your doctor's orders or the directionson 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 takethe missed dose at all and do not double the next one. Instead, go back toyour 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 otherdamp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be surethat 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 atregular visits to make sure that this medicine is working properlyand to check for unwanted effects.

While you are being treated with melphalan, and after you stop treatmentwith it, do not have any immunizations (vaccinations)without your doctor's approval. Melphalan may lower your body's resistanceand there is a chance you might get the infection the immunization is meantto prevent. In addition, other persons living in your household should nottake or should not have taken oral polio vaccine within the last several monthssince there is a chance they could pass the polio virus on to you. Also, avoidother persons who have taken oral polio vaccine. Do not get close to themand do not stay in the same room with them for very long. If you cannot takethese precautions, you should consider wearing a protective face mask thatcovers 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 numberof platelets, which are necessary for proper blood clotting. If this occurs,there are certain precautions you can take, especially when your blood countis low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Checkwith your doctor immediately if you think you are getting an infectionor 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 ifyou notice any unusual bleeding or bruising; black, tarry stools; blood inurine 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 yourteeth and gums. Check with your medical doctor before having any dental workdone.
• Do not touch your eyes or the inside of your nose unless you havejust washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects suchas a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injurycould occur.

Side Effects of This Medicine

Along with their needed effects,medicines like melphalan can sometimes cause unwanted effects such as bloodproblems 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 thatthey might cause other unwanted effects that may not occur until months oryears after the medicine is used. These delayed effects may include certaintypes of cancer, such as leukemia. Discuss these possible effects with yourdoctor.

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

Check with your doctorimmediately if any of the following side effects occur:

Less common

Black, tarry stools; blood in urineor stools; cough or hoarseness, accompanied by feveror chills; fast or irregular heart beat; fever or chills; lower back or sidepain, accompanied by fever or chills; painful ordifficult urination, accompanied by fever or chills; pinpoint red spots on skin; redness and/or sorenessat the infusion site; shortness of breath; skin rash or itching (sudden); troubledbreathing; unusual bleeding or bruising

Check withyour doctor as soon as possible if any of the following side effects occur:

Less common or rare

Diarrhea; difficulty swallowing; joint pain; redness and/or sorenessin arm or leg; sores in mouth and on lips; swelling of feet or lower legs

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

Less common

Nausea and vomiting

After you stop taking melphalan, it may stillproduce 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 urineor stools; cough or hoarseness, accompanied by feveror 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; unusualbleeding or bruising

Other side effectsnot listed above may also occur in some patients. If you notice any othereffects, check with your doctor.

Additional Information

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

• Cancer of the breast
• Waldenstr?m's macroglobulinemia (a certain type of cancer ofthe blood)
• Cancer of the blood and lymph system
• Cancer of the endometrium
• Malignant melanoma (a type of skin cancer that has spread to otherparts of the body)

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