Melphalan Flufenamide (MEL-fa-len floo-FEN-a-mide)

Treats multiple myeloma.

Brand Name(s):

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through an IV placed in a vein. This medicine must be given slowly, so the needle will need to stay in place for at least 30 minutes.
• You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine.
• You may receive medicines to help prevent nausea before and during treatment with this medicine.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 6 months after the last dose. Males who are receiving this medicine, with female partners who can become pregnant, must use effective birth control during treatment and for at least 3 months after the last dose.
• Do not breastfeed during treatment and for at least 1 week after the last dose.
• Tell your doctor if you have kidney disease, liver disease, or any infection
• This medicine may cause the following problems:
  • Increased risk for serious infections (including respiratory tract infection, pneumonia, sepsis)
  • Increased risk for other types of cancer (including myelodysplastic syndromes, acute leukemia)
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• Cancer medicine can cause nausea or vomiting, sometimes even after you receive medicine to prevent these effects. Ask your doctor or nurse about other ways to control any nausea or vomiting that might happen.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Bone, joint, back, arm, or leg pain
• Chest pain, trouble breathing
• Dry mouth, increased thirst, muscle cramps, nausea or vomiting, uneven heartbeat
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Rapid weight gain, swelling in your hands, ankles, or feet
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Constipation, diarrhea, loss of appetite
• Dizziness, headache
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed
• Tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor

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