Iberdomide

Iberdomide is used to treat multiple myeloma (a type of blood cancer). Iberdomide is used together with daratumumab and hyaluronidase-fihj and dexamethasone in adults who have received at least 1 prior treatment that included a proteasome inhibitor and an immunomodulatory medicine.

Iberdomide is available only through a special program. You must be registered in the program and understand the risks and benefits of iberdomide.

Iberdomide may also be used for purposes not listed in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Iberdomide is usually taken once per day. Follow your doctor's instructions.

You may take iberdomide with or without food, but take it at the same time each day.

Swallow the capsule whole with water and do not crush, chew, break, or open it.

Avoid contact with the contents of a broken capsule. If you come into contact with the capsule contents, wash the affected area right away with soap and water.

You will need frequent blood tests before and during treatment with iberdomide. Your treatment may be delayed, reduced, or permanently 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.

Store tightly closed at room temperature, away from moisture and heat.

Keep the capsules in the original container, along with the packet of moisture-absorbing preservative. Do not remove a capsule from the original container until you are ready to take your dose.

Never take iberdomide if you are pregnant. Iberdomide can harm an unborn baby and can cause birth defects or death of an unborn baby.

Use birth control to prevent pregnancy, whether you are a man or a woman. For women: Use two forms of birth control starting 4 weeks before you begin taking iberdomide and continuing for 4 weeks after you stop taking it. For men: Use a condom to prevent pregnancy while you are taking iberdomide, and for up to 4 weeks after you stop taking it.

Stop taking iberdomide and tell your healthcare provider right away if you become pregnant, miss a period, have unusual bleeding, stop using birth control, or think you may be pregnant.

Iberdomide may cause serious and life-threatening blood clots. Call your doctor at once if you have symptoms such as chest pain, shortness of breath, dizziness, sudden numbness or weakness, problems with vision or speech, or swelling, pain, or tenderness in an arm or leg.

You should not use iberdomide if you are pregnant or planning to become pregnant.

Iberdomide can cause severe and life-threatening birth defects or death of an unborn baby if either parent is taking this medicine at the time of conception or during pregnancy. Stop taking this medicine and inform your doctor immediately if you become pregnant, miss your period, have unusual bleeding, stop using birth control, or think you might be pregnant.

For Women: If you have not had a hysterectomy, you must use two reliable forms of birth control starting 4 weeks before you begin taking iberdomide and continuing until 4 weeks after you stop taking it. This requirement applies even if you have fertility problems. You also need to have a negative pregnancy test within 10 to 14 days before treatment and again within 24 hours before starting treatment. While taking iberdomide, you will have a pregnancy test every 2 to 4 weeks.

Your birth control method must be highly effective, such as birth control pills, an intrauterine device (IUD), a tubal ligation, or a partner's vasectomy. The second form of birth control must be a barrier method, such as a condom, diaphragm, cervical cap, or contraceptive sponge.

Stop using iberdomide and contact your doctor immediately if you stop using birth control, if your period is late, or if you think you might be pregnant. Not having sexual intercourse (abstinence) is the most effective way to prevent pregnancy.

For Men: Use a condom to prevent pregnancy during your treatment and for up to 4 weeks after you stop taking it. You must always use latex or synthetic condoms when having sex with a woman who can get pregnant, even if you have had a vasectomy. Contact your doctor if you have had unprotected sex, even once, or if you think your female partner may be pregnant.

Iberdomide may affect fertility in both men and women. However, it is very important to use birth control to prevent pregnancy because iberdomide can harm an unborn baby.

If you are pregnant, your name may be added to a pregnancy registry to monitor the effects of iberdomide on the baby.

Tell your doctor if you have or have ever had:

• heart problems such as a heart attack, stroke, or blood clot;
• high cholesterol;
• high blood pressure;
• a hysterectomy;
• an infection;
• if you smoke; or
• kidney disease (or if you are on dialysis).

Using iberdomide may increase your risk of developing other cancers. Ask your doctor about this risk.

You should not breastfeed while using iberdomide.

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

Iberdomide may cause serious side effects. Call your doctor immediately if you have:

• low white blood cell counts--mouth sores, skin sores, sore throat, cough;
• signs of infection--fever, chills, body aches, unusual tiredness, loss of appetite, bruising or bleeding;
• signs of a stroke--sudden numbness or weakness (especially on one side of the body), severe headache, slurred speech, problems with vision or balance;
• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
• signs of a blood clot in the lung--sudden cough or shortness of breath, dizziness, coughing up blood; or
• signs of a blood clot deep in the body--pain, swelling, or warmth in one leg.

Your healthcare provider may change your dose, delay treatment, or permanently stop iberdomide if you have certain side effects.

Common side effects of iberdomide may include:

• low blood cell counts;
• low antibody levels;
• pneumonia;
• trouble controlling body movements;
• cold symptoms such as stuffy nose, sneezing, sore throat;
• sleep problems such as insomnia, restless leg syndrome;
• tiredness;
• constipation, diarrhea;
• skin rash;
• coronavirus infection; or
• muscle or joint pain.

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.

Take the medicine as soon as you can, but skip the missed dose if you are more than 12 hours late for the dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

You must not donate blood, eggs, or sperm while you are taking iberdomide, and for at least 4 weeks after your last dose. Avoid exposing another person to your blood or semen through casual or sexual contact.

Sometimes it is not safe to use certain medicines together. Some drugs can change the levels of other drugs in your blood, which may increase side effects or make the medicines less effective.

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