Melphalan (Oral)

Melphalan is part of a group of medicines called alkylating agents. It is used to treat cancer of the ovaries and a specific type of cancer in the bone marrow.

Melphalan works by interfering with the growth of cancer cells, which are ultimately destroyed. Because melphalan can also affect the growth of normal body cells, it may lead to other effects. Some of these effects can be serious and need to be reported to your doctor. Other effects may not be serious but could cause concern. Some effects may not appear for months or years after using the medicine.

Before starting treatment with melphalan, you and your doctor should discuss the benefits of this medicine as well as the risks involved.

Melphalan is available only with your doctor's prescription.

It is very important that your doctor checks your progress at regular visits to make sure 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 that the immunization is meant to prevent. Additionally, other people 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 people 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 your nose and mouth.

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 happens, 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 doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your 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 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.

In deciding to use a medicine, you need to consider the risks of taking it against the benefits it may provide. This decision is made together with your doctor. For this medicine, please consider the following:

Allergies

Let your doctor know if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also inform your healthcare professional about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There is no specific information comparing the use of melphalan in children to other age groups, but this medicine is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

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

Breast Feeding

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

Interactions with Medicines

Some medicines should never be used together, while others may be used together even if an interaction might happen. In such cases, your doctor may want to adjust the dose or take other precautions. It is especially important that your healthcare professional knows if you are taking any of the following medicines while using this medicine. The following interactions have been selected based on 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, Live
• Zoster Vaccine, Live

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.

• Abciximab
• Aceclofenac
• Acemetacin
• Adenovirus Vaccine
• Alfuzosin
• Amlodipine
• Amtolmetin Guacil
• Anagrelide
• Apixaban
• Aranidipine
• Aspirin
• Bacillus of Calmette and Guerin Vaccine, Live
• Benazepril
• Bepridil
• Bromfenac
• Bufexamac
• Bunazosin
• Captopril
• Celecoxib
• Cholera Vaccine, Live
• Choline Salicylate
• Cilnidipine
• Cilostazol
• Clevidipine
• Clonixin
• Clopidogrel
• Dabigatran Etexilate
• Dapiprazole
• Dengue Tetravalent Vaccine, Live
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Diltiazem
• Dipyridamole
• Dipyrone
• Doxazosin
• Droxicam
• Edoxaban
• Enalapril
• Enalaprilat
• Eptifibatide
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Felodipine
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Fosinopril
• Ibuprofen
• Indomethacin
• Influenza Virus Vaccine, Live
• Isradipine
• Ketoprofen
• Ketorolac
• Lercanidipine
• Lisinopril
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Manidipine
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Moexipril
• Morniflumate
• Moxisylyte
• Nabumetone
• Naproxen
• Nepafenac
• Nicardipine
• Nifedipine
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Nimodipine
• Nisoldipine
• Nitrendipine
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Perindopril
• Phenoxybenzamine
• Phentolamine
• Phenylbutazone
• Piketoprofen
• Piroxicam
• Poliovirus Vaccine, Live
• Pranoprofen
• Prasugrel
• Prazosin
• Proglumetacin
• Propyphenazone
• Proquazone
• Quinapril
• Ramipril
• Rivaroxaban
• Rofecoxib
• Salicylic Acid
• Salsalate
• Silodosin
• Smallpox Vaccine
• Sodium Salicylate
• Sulfinpyrazone
• Sulindac
• Tamsulosin
• Tenoxicam
• Terazosin
• Tiaprofenic Acid
• Ticagrelor
• Ticlopidine
• Tirofiban
• Tolfenamic Acid
• Tolmetin
• Trandolapril
• Treprostinil
• Trimazosin
• Typhoid Vaccine, Live
• Urapidil
• Valdecoxib
• Verapamil
• Vorapaxar
• Warfarin
• Yellow Fever Vaccine

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both medicines 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

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around the time of eating food or certain types of food since interactions may happen. Using alcohol or tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how you use this medicine. Be sure to inform your doctor if you have any other medical issues, especially:

• Bone marrow suppression or
• Leukopenia (low white blood cells in the blood) or
• Thrombocytopenia (low platelets in the blood)—May worsen these conditions.

• Chickenpox, including recent exposure or
• Herpes zoster (shingles)—May raise the risk of severe disease in other parts of the body.

• Gout, history of or
• Kidney stones, history of—May raise uric acid levels, which can lead to gout or kidney stones.

• Infection—May lower your body's ability to fight an infection.

• Kidney disease—Use cautiously. The effects of this medicine may be increased due to slower removal from the body.

Along with their intended 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 how these medicines work in the body, there is a chance that they might cause other unwanted effects that may not show up until months or years after the medicine is used. These delayed effects may include certain types of cancer, such as leukemia. Talk to your doctor about these possible effects.

A medicine may cause some unwanted effects along with its intended effects. Not all of these side effects may occur, but if they do, they may require medical attention.

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

Less common

• Black, tarry stools
• blood in urine or stools
• cough or hoarseness, along with fever or chills
• fast or irregular heartbeat
• fever or chills
• lower back or side pain, along with fever or chills
• painful or difficult urination, along with fever or chills
• pinpoint red spots on skin
• shortness of breath
• sudden skin rash or itching
• troubled breathing
• unusual bleeding or bruising

Rare

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

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. Your health care professional may also be able to tell you how 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

• Nausea and vomiting

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.

In the U.S.

• Alkeran

Available Dosage Forms:

• Tablet

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Alkylating Agent

Chemical Class: Nitrogen Mustard

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 this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.