Melphalan flufenamide (Intravenous)

Melphalan flufenamide injection is used along with dexamethasone to treat multiple myeloma (bone marrow cancer) in patients whose cancer has returned and who have had at least 4 previous treatments (for example, a CD38-directed monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent) that did not work well.

Melphalan flufenamide is part of a group of medicines called alkylating agents (cancer medicines). It works by disrupting the growth of cancer cells, which are eventually eliminated by the body.

This medicine is to be given only by or under the supervision of your doctor.

It is very important that your doctor closely monitors your progress while you are receiving this medicine to ensure it is working properly. Blood tests may be necessary to check for unwanted effects.

Receiving this medicine while you are pregnant can harm your unborn baby. If you are a woman who can become pregnant, your doctor may perform a pregnancy test before you begin using this medicine to confirm that you are not pregnant. Use an effective form of birth control while you are receiving this medicine and for at least 6 months after your last dose to prevent pregnancy. Men receiving this medicine, with female partners who can become pregnant, must use effective birth control during treatment and for at least 3 months after their last dose. If you think you might be pregnant while using this medicine, inform your doctor immediately.

Some men and women who use this medicine have become infertile (unable to have children). Discuss with your doctor before using this medicine if you plan to have children.

This medicine can temporarily reduce the number of white blood cells in your blood, increasing your risk of getting an infection. It can also lower the number of platelets, which are needed 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 possible, avoid people with infections. Contact your doctor immediately if you think you might be getting an infection or if you develop a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Contact your doctor immediately if you notice any unusual bleeding or bruising, black or tarry stools, blood in your urine or stools, or pinpoint red spots on your skin.
• Be cautious when using a regular toothbrush, dental floss, or toothpick. Your doctor, dentist, or nurse may suggest other methods to clean your teeth and gums. Consult with your doctor before any dental work.
• 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 between.
• Be careful not to cut yourself when using sharp objects such as a safety razor or fingernail or toenail clippers.
• Avoid contact sports or other situations where bruising or injury could happen.

This medicine may cause serious infections (e.g., respiratory tract infection, pneumonia, sepsis). Contact your doctor immediately if you experience chest pain, chills, confusion, cough, dizziness or lightheadedness, fainting, fast heartbeat, fever, sneezing, sore throat, tightness in the chest, or trouble breathing.

Using this medicine may increase your risk of developing other types of cancer (e.g., myelodysplastic syndromes, acute leukemia). Discuss your concerns about this risk with your doctor.

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine against the benefits it may provide. For this medicine, keep the following in mind:

Allergies

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

Pediatric

Studies have not been done to understand how age affects the use of melphalan flufenamide injection in children. Safety and effectiveness have not been established.

Geriatric

Studies conducted so far have not shown any age-related problems that would limit the use of melphalan flufenamide injection in older adults.

Interactions with Medicines

Some medicines should not be taken together at all, while in other cases, two different medicines can be used together even if there may be an interaction. In these situations, your doctor may need to adjust the dose or take other precautions. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around the time of eating or with specific types of food due to possible interactions. Using alcohol or tobacco with some medicines may also lead to interactions. Talk with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

• Anemia or
• Neutropenia (low number of white blood cells) or
• Thrombocytopenia (low number of platelets)—Use with caution. May worsen these conditions.

• Infection—May reduce your ability to fight an infection.

Along with its benefits, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they might require medical attention.

Contact your doctor or nurse right away if any of the following side effects occur:

More common

• Back, arm, or leg pain
• black, tarry stools
• bleeding gums
• blood in the urine or stools
• bone pain
• chest pain or tightness
• constipation
• cough
• decreased appetite
• decreased urine
• diarrhea
• difficulty in moving
• dry mouth
• fever or chills
• increased thirst
• loss of appetite
• lower back or side pain
• mood or mental changes
• muscle pain, cramps, or stiffness
• nausea
• numbness or tingling in the hands, feet, or lips
• pain in the joints
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• seizures
• sleeplessness
• sneezing
• sore throat
• stomach cramps
• swelling of the hands, ankles, feet, or lower legs
• tremor
• trouble breathing
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting

Less common

• Confusion
• coughing up blood
• difficulty in swallowing
• dizziness
• fainting
• fast heartbeat
• headache
• increased menstrual flow or vaginal bleeding
• lightheadedness
• nosebleeds
• paralysis
• prolonged bleeding from cuts
• red or dark brown urine
• red or black, tarry stools

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 provide ways to prevent or lessen some of these side effects. Contact your health care professional if any of the following side effects continue or are bothersome, or if you have any questions about them:

More common

• Skin itching, rash, or redness
• swelling of the face, throat, or tongue
• trouble sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, contact 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.

• Pepaxto

Pharmacologic Class: Alkylating Agent

Chemical Class: Nitrogen Mustard

A nurse or other trained health professional will give you this medicine in a hospital. It is given through a needle placed into one of your veins. This medicine must be given slowly, so the IV tube will need to stay in place for at least 30 minutes. It is usually given one time for 28 days.

This medicine should come with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

You may receive medicines to help prevent nausea before and during treatment with this medicine.