Elranatamab

Elranatamab is used to treat adults with multiple myeloma who have had at least 4 treatment regimens and their cancer has come back or did not respond to a previous treatment.

Elranatamab is available only from a certified pharmacy under a special program.

Elranatamab may also be used for reasons not included in this medication guide.

Call your doctor if you have symptoms of neurological problems such as:

• headache
• jerking muscle movements
• numbness and tingling
• tremor
• double vision
• problems walking
• hearing loss

Tell your medical caregivers if you have symptoms of a serious side effect, such as:

• fever
• chills
• trouble breathing
• vomiting
• severe tiredness

Tell your doctor if you have or have ever had:

• low white blood cell (WBC) counts;
• an active or recent infection; or
• abnormal liver function tests.

May harm an unborn baby. You may need a pregnancy test to make sure you are not pregnant. Use effective birth control while using elranatamab and for at least 4 months after your last dose. Tell your doctor if you become pregnant.

Do not breastfeed while using elranatamab, and for at least 4 months after your last dose.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Tell your medical caregivers if you have signs of cytokine release syndrome (CRS), which is a serious side effect: fever, chills, trouble breathing, confusion, severe vomiting or diarrhea, fast or irregular heartbeats, feeling light-headed or very tired.

Also call your doctor right away if you have:

• signs of infection—cold symptoms such as stuffy nose, sneezing, sore throat, fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, chest pain, pain in your side or lower back, painful urination, blood or pus in your urine;
• liver problems—loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• low white blood cell counts—fever, mouth sores, skin sores, sore throat, cough; or
• neurological problems—headache, jerking muscle movements, rigid muscles, feeling restless, numbness and tingling, confusion, problems speaking, muscle spasms, tremors, double vision, changes in handwriting, problems walking, muscle weakness in body or face, hearing loss, burning, throbbing, or stabbing pain.

Your cancer treatments may be delayed or permanently stopped if you have certain side effects.

Common side effects of elranatamab may include:

• bone pain, muscle pain;
• diarrhea, nausea;
• fever, rash, cough;
• loss of appetite;
• pain, bruising, swelling, or irritation where the medicine was injected; or
• tiredness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Follow all directions on your prescription label and read all medication guides or instruction sheets.

Read the Patient Wallet Card about serious side effects and learn what symptoms to watch for. Keep the card with you at all times.

Elranatamab is injected under the skin, usually in your abdomen. Another area of your body may also be used. A healthcare provider will give you this injection.

You will need to stay in the hospital between 24 to 48 hours after some doses of elranatamab. Talk with your doctor if you have any questions.

Your doctor will determine the right treatment schedule for you.

You will need frequent medical tests and your cancer treatments may be delayed or discontinued based on the results.

You may be given other medications to help prevent serious side effects. Keep taking these medicines for as long as your doctor has prescribed. Your doctor will monitor you for these side effects.

Call your doctor for guidance if you miss an appointment for your elranatamab injection.

In a medical setting, an overdose will be treated quickly.

Do not drive or engage in hazardous activities for 48 hours after receiving certain doses of elranatamab or until neurological symptoms disappear. Your reactions could be impaired.

Other drugs may affect elranatamab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.