(mel' fa lan)

Brand Name(s): Alkeran^® Tablets

Other Name(s): Phenylalanine mustard

IMPORTANT WARNING:

Melphalan can cause a severe decrease in the number of blood cells in your bone marrow. This may cause certain symptoms and may increase the risk that you will develop a serious infection or bleeding. If you experience any of the following symptoms, call your doctor immediately: fever, sore throat, ongoing cough and congestion, or other signs of infection; unusual bleeding or bruising; bloody or black, tarry stools; bloody vomit; or vomiting blood or brown material that resembles coffee grounds.

Keep all appointments with your doctor and the laboratory. Your doctor will order laboratory tests regularly before and during your treatment to see if your blood cells are affected by this drug.

Melphalan may increase the risk that you will develop other cancers. Talk with your doctor about the risks of taking melphalan.

WHY is this medicine prescribed?

Melphalan is used to treat multiple myeloma (a type of cancer of the bone marrow). Melphalan is also used to treat a certain type of ovarian cancer (cancer that begins in the female reproductive organs where eggs are formed). Melphalan is in a class of medications called alkylating agents. It works by stopping or slowing the growth of cancer cells in your body.

Are there OTHER USES for this medicine?

Melphalan is also sometimes used to treat breast cancer. It is also sometimes used to treat amyloidosis (a disease in which abnormal proteins build up in tissues and organs in the body). Talk to your doctor about the risks of using this medication for your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Melphalan comes as a tablet to take by mouth. It is usually taken on an empty stomach once a day. The length of treatment depends on the types of drugs you are taking, how well your body responds to them, and the type of cancer you have. Take melphalan at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take melphalan exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor may need to delay your treatment or adjust your dose of melphalan depending on your response to treatment and any side effects that you experience. Talk to your doctor about how you are feeling during your treatment. Do not stop taking melphalan without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before taking melphalan,

• tell your doctor and pharmacist if you are allergic to melphalan, any other medications, or any of the ingredients in melphalan tablets. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: carmustine (BICNU, BCNU), cimetidine (Tagamet), cisplatin (Platinol AQ), cyclosporine (Sandimmune, Gengraf, Neoral), or interferon alfa (Intron A, Infergen, Alferon N).

• tell your doctor if you have taken melphalan before, but your cancer did not respond to the medication. Your doctor will probably tell you not to take melphalan.

• tell your doctor if you have received radiation therapy or other chemotherapy recently or if you have or have ever had kidney disease.

• you should know that melphalan may interfere with the normal menstrual cycle (period) in women and may temporarily or permanently stop sperm production in men. Melphalan may cause infertility (difficulty becoming pregnant); however, you should not assume that you cannot get pregnant or that you cannot get someone else pregnant. Women who are pregnant or breast-feeding should tell their doctors before they begin taking this drug. You should not plan to have children while receiving chemotherapy or for a while after treatments. (Talk to your doctor for further details.) Use a reliable method of birth control to prevent pregnancy. Melphalan may harm the fetus.

• do not have any vaccinations without talking to your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Melphalan may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• vomiting
• loss of appetite or weight
• sores in the mouth and throat
• missed menstrual periods (in girls and women)
• joint, muscle, or back pain

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• rash
• hives
• itching
• difficulty breathing or swallowing
• pale skin
• excessive tiredness
• fainting
• fast, irregular, or pounding heartbeat
• yellowing of the skin or eyes
• pain in the upper right part of the stomach
• dark colored urine
• unusual lumps or masses

Melphalan may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it in the refrigerator and away from light.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• vomiting
• diarrhea
• sores in the mouth and throat
• black, tarry, or bloody stools
• bloody vomit or vomited material that looks like coffee grounds
• unusual bruising or bleeding
• sore throat, cough, fever, or other signs of infection

What OTHER INFORMATION should I know?

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: May 15, 2017.