Iberdomide

Iberdomide may cause serious or life-threatening blood clots in your legs, lungs, or other parts of your body. Blood clots can lead to heart attacks, strokes, or death. Tell your doctor if you have or have ever had a blood clot in your lungs or legs; a stroke; high blood pressure; high levels of cholesterol in your blood; a slow, fast, or irregular heartbeat; peripheral vascular disease (narrowing of blood vessels in feet, legs, or arms causing numbness, pain, or coldness in that part of the body); a heart attack; diabetes; or heart disease. Also tell your doctor if you smoke or use tobacco. Your doctor may prescribe other medication to be taken along with iberdomide to decrease this risk. If you experience any of the following symptoms, call your doctor immediately: chest pain; shortness of breath; dizziness or fainting; sudden confusion or trouble speaking or understanding; sudden numbness or weakness of face, arm, or leg on one side of the body; sudden severe headache; sudden severe stomach pain; leg, arm, back, neck, or jaw pain; feeling of warmth in the lower leg; or swelling of the feet, ankles, or lower legs.

Do not take iberdomide if you are pregnant or plan to become pregnant. If you become pregnant while taking iberdomide, call your doctor immediately. Iberdomide may harm the fetus. You may need to have 2 negative pregnancy tests before starting iberdomide. You should use 2 forms of effective birth control to prevent pregnancy or not engage in sexual activity that may lead to pregnancy during your treatment and for 4 weeks after your final dose. Talk to your doctor about the best birth control method for you. If you become pregnant or suspect you have become pregnant while taking iberdomide, stop your treatment and call your doctor immediately.

A program called ZENBEXUS REMS has been set up to make sure that pregnant women do not take iberdomide and that women do not become pregnant while taking iberdomide. All patients can get iberdomide only if they are registered with ZENBEXUS REMS, have a prescription from a doctor who is registered with ZENBEXUS REMS, and fill the prescription at a pharmacy that is registered with ZENBEXUS REMS.

You will be given the Medication Guide. Read the information carefully and ask your doctor or pharmacist if you have any questions.

Iberdomide is used to treat certain types of multiple myeloma (a type of cancer of the bone marrow. Iberdomide is in a class of medications called immunomodulatory agents. It works by helping the bone marrow to produce normal blood cells and by killing abnormal cells in the bone marrow.

Iberdomide comes as a capsule to take by mouth. Take with or without food once a day for the first 21 days of a 28 day cycle. Take iberdomide at around the same time every day. Your doctor will determine how many cycles you will receive.

Take iberdomide exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the capsules whole with water; do not split, chew, or crush them.

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

Before taking iberdomide,

• tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• you should know that some medications should not be taken with iberdomide. Other medications may cause dosing changes or extra monitoring when taken with iberdomide. Make sure you have discussed any medications you are currently taking or plan to take before starting iberdomide with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking iberdomide, please get the advice of your doctor or pharmacist.
• you should know the following nonprescription or herbal products may interact with iberdomide: St. John's Wort. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking iberdomide. Do not start any of these medications while taking iberdomide without discussing with your healthcare provider.
• tell your doctor if you have or have ever had any other type of cancer or kidney disease.
• you should know that iberdomide may decrease your ability to fight infection from bacteria, viruses, and fungi and increase the risk that you will get a serious infection. Tell your doctor if you often get any type of infection or if you have or think you may have any type of infection now. Also tell your doctor if you have or if you have ever had hepatitis B virus infection (HBV; an ongoing liver infection), tuberculosis infection, Human Immunodeficiency Virus (HIV) infection, or Herpes Simplex Virus (HSV) infection. If you experience any of the following symptoms during or shortly after your treatment with iberdomide, call your doctor immediately: fever, sweats, or chills; sore throat; cough; warm, red, or painful skin or sores on your body; frequent, urgent, or painful urination; or other signs of infection.
• do not breastfeed while taking iberdomide.
• Iberdomide may pass into semen. Partners of patients who ejaculate should not become pregnant while their partner is taking iberdomide and for 4 weeks after the final dose. Talk to your doctor about effective birth control for and your partner to prevent pregnancy during treatment and for 4 weeks after your final dose. Or do not engage in sexual activity that may result in pregnancy during iberdomide treatment or for 4 weeks after the final dose. If your partner becomes pregnant while you are taking iberdomide, call your doctor immediately. Iberdomide may harm the fetus.
• you should know that you should not donate sperm or blood during iberdomide treatment or for 4 weeks after the final dose.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking iberdomide.
• do not have any vaccinations without talking to your doctor.

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medication.

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

Take the missed dose as soon as you remember it. However, if it has been more than 12 hours since the missed dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

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

• tiredness
• bone and joint aches and pains
• diarrhea
• sneezing, runny nose or congestion, watery eyes, cough, fever, sore throat
• balance difficulties, feeling of off balance or changes in stride, muscle cramps or spasms
• rash
• trouble sleeping
• constipation

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 or get emergency medical treatment:

• fever, cough with sputum ("wet cough"), shortness of breath, sleepiness, chills

Iberdomide may cause secondary malignancies (unrelated cancers) to develop. Talk to your doctor about the risks of taking this medication.

Iberdomide 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 (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in with desiccant (package placed in bottle to protect from moisture), tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Iberdomide is considered a hazardous drug meaning it could be unsafe for others to come in contact with it. For safe use, do the following:

• Keep the capsules in the bottle it comes in until ready to take
• Wear the gloves while handling iberdomide capsules.
• Wash hands before and after handling iberdomide.
• Ask your local pharmacy how to dispose of iberdomide safely.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

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.

Keep all appointments with your doctor and the laboratory.

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

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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