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Important Facts About ZENBEXUS™ (iberdomide)

This is a summary of important information that you need to know about ZENBEXUS. Your healthcare team can work with you to help answer any questions you may have about this medication. Keep this information in a safe place so you can refer to it before and during your treatment.

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What is ZENBEXUS?

ZENBEXUS is a prescription medicine used in combination with other medicines (daratumumab and hyaluronidase-fihj and dexamethasone) to treat adults with multiple myeloma (MM), when:

you have tried one or more types of treatment, including a proteasome inhibitor and an immunomodulatory medicine, that have not worked or have stopped working.

It is not known if ZENBEXUS is safe and effective in children.

ZENBEXUS has been approved based on early minimal residual disease (MRD) data.

MRD refers to the small number of cancer cells that are left in the body during or after treatment. This data is used to predict how well the treatment has worked.

The use of ZENBEXUS to treat multiple myeloma is still being studied and may be subject to further review to confirm clinical benefit.

WARNING: RISK TO UNBORN BABIES

ZENBEXUS may cause serious side effects, including harm to an unborn baby.

If you are pregnant, you plan to become pregnant, or your partner plans to become pregnant, ZENBEXUS may harm your unborn baby.

If you are female (sex assigned at birth) and you are able to become pregnant:

You must not be pregnant and you must agree to stop sexual activity with a male or must use two highly effective forms of birth control at the same time, even if you have a history of infertility, unless you have had a hysterectomy:

  • for at least 4 weeks before starting ZENBEXUS
  • while taking ZENBEXUS
  • during any breaks (interruptions) in your treatment with ZENBEXUS
  • for at least 4 weeks after stopping ZENBEXUS

You must have 2 negative pregnancy tests before you start treatment with ZENBEXUS. 
You will also need pregnancy tests:

  • every week for the first 4 weeks of treatment with ZENBEXUS, followed by:
    • every 4 weeks if your menstrual cycle is regular OR
    • every 2 weeks if your menstrual cycle is irregular

If you miss your period or have irregular bleeding, you will need to have a pregnancy test and receive counseling.

Do not donate eggs during treatment and for 4 weeks after your last dose of ZENBEXUS.

Talk to your healthcare team about effective methods of birth control that are safe to use with ZENBEXUS.

Call your healthcare provider right away if you become pregnant or think you are pregnant during treatment with ZENBEXUS.

Stop taking ZENBEXUS right away if you become pregnant or think you are pregnant during treatment with ZENBEXUS.

If you are male (sex assigned at birth) with a female partner who can become pregnant:

ZENBEXUS may pass into human semen.

You should use latex or synthetic condoms during any sexual contact with a partner who is pregnant or able to become pregnant, and for at least 4 weeks after your last dose of ZENBEXUS, even if you have had a successful vasectomy, and you should not donate sperm:

  • while taking ZENBEXUS.
  • for at least 4 weeks after stopping ZENBEXUS

Call your healthcare provider right away if your partner becomes pregnant during treatment with ZENBEXUS.

If you are breastfeeding or plan to breastfeed:

Do not breastfeed during treatment with ZENBEXUS.

Talk to your healthcare team about the best way to feed your baby during this time.

Because of the risk of serious side effects, ZENBEXUS is only available through the ZENBEXUS Risk Evaluation and Mitigation Strategy (REMS) program.

Before you can take ZENBEXUS, you and your healthcare provider must be enrolled in the ZENBEXUS REMS Program. Your healthcare provider will explain the ZENBEXUS REMS Program to you.

You must:

  • Read and agree to all the instructions in the ZENBEXUS REMS.
  • Sign the Patient Enrollment Form.

ZENBEXUS is only available through pharmacies that participate in the ZENBEXUS REMS Program. Your healthcare provider will give you information about how to find a participating pharmacy.

Call the REMS Call Center at 1-888-423-5436:

  • if you or your partner become pregnant while taking ZENBEXUS and your healthcare provider is not available.
  • to enroll in the pregnancy exposure registry that monitors the outcomes of patients who take ZENBEXUS during pregnancy.

Healthcare providers and patients should report all cases of pregnancy to:

WARNING: RISK OF BLOOD CLOTS

ZENBEXUS can cause serious and life-threatening blood clots in the veins of your legs (deep vein thrombosis), lungs (pulmonary embolism), and in your heart or brain that can cause heart attack or stroke (arterial thromboembolic events).

Your healthcare provider may start you on medicine to help prevent blood clots if you have certain risk factors.

Call your healthcare provider right away if you get any of the following signs and symptoms of blood clots during treatment with ZENBEXUS:

  • swelling, pain, or tenderness in your legs
  • red or discolored skin on your leg
  • chest pain that may spread to the arms, neck, jaw, back, or stomach area
  • sudden shortness of breath
  • dizziness or lightheadedness
  • vomiting
  • feeling sweaty
  • sudden numbness or weakness in the face, arm, or leg, especially on one side of the body
  • severe headache or confusion
  • problems with vision, speech, or balance

What should I discuss with my healthcare team before receiving ZENBEXUS?

Talk to your healthcare team about all of your medical conditions, including:

  • heart problems (including blood clots, heart attacks, stroke, or other heart problems)
  • high cholesterol
  • high blood pressure
  • smoking
  • a current infection
  • kidney problems

Talk to your healthcare team about all the medicines you are taking, including:

  • prescription
    medicines
  • over-the-counter 
    medicines
  • vitamins
  • herbal supplements

Certain medicines may affect how ZENBEXUS works or cause side effects.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

What are the possible side effects of ZENBEXUS?

Serious side effects

ZENBEXUS can increase the risk of serious side effects. A serious side effect is a side effect that can sometimes become life-threatening and can lead to death. The side effects of ZENBEXUS include:

Harm to an unborn baby (embryo-fetal toxicity). If you are pregnant, you plan to become pregnant, or your partner plans to become pregnant, ZENBEXUS may harm your unborn baby.

Increased risk of blood clots. ZENBEXUS can cause serious and life-threatening blood clots in the veins of your legs (deep vein thrombosis), lungs (pulmonary embolism), and in your heart or brain that can cause heart attack or stroke (arterial thromboembolic events). Your healthcare provider may start you on medicine to help prevent blood clots if you have certain risk factors.

Severe low white blood cell counts (neutropenia). Your healthcare provider will do blood tests during treatment with ZENBEXUS. Tell your healthcare provider if you have a fever.

Infections. ZENBEXUS can cause serious infections, including life-threatening infections or death. Tell your healthcare provider if you get signs and symptoms of an infection before or during treatment with ZENBEXUS, including fever, chills, or flu-like symptoms.

New cancers (secondary cancers). Your healthcare provider will monitor you for new cancers.

Most common side effects

The most common side effects of ZENBEXUS in combination with the medicines (daratumumab and hyaluronidase-fihj and dexamethasone) are:

  • decreased white blood cell count (neutropenia)
  • decreased white blood cells (leukopenia) and lymphocytes (lymphopenia)
  • decreased platelets (thrombocytopenia)
  • decreased hemoglobin (anemia)
  • upper respiratory infections
  • tiredness
  • muscle and joint pain
  • pneumonia
  • diarrhea
  • trouble controlling your body movements (motor dysfunction)
  • rash
  • sleep problems such as insomnia or restless leg syndrome
  • abnormally low levels of antibodies (hypogammaglobulinemia)
  • COVID-19
  • constipation

These are not all the possible side effects of ZENBEXUS.

Call your healthcare provider right away if you have any symptoms of side effects.

Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with ZENBEXUS if you have certain side effects. 

ZENBEXUS may affect fertility in females and males, which may affect the ability to have children.

Talk to your healthcare provider if this is a concern for you.

You are encouraged to report side effects to FDA at 1-800-FDA-1088.

How should I take ZENBEXUS?

Take ZENBEXUS exactly as your healthcare provider tells you and follow all the instructions of the ZENBEXUS REMS program. You will take ZENBEXUS with other medicines (daratumumab and hyaluronidase-fihj and dexamethasone). Your healthcare provider will give you instructions on how to take these other medicines. If you develop certain side effects, your healthcare provider may pause your treatment or decrease your dose. Your healthcare provider may tell you to take ZENBEXUS differently if you take certain other medications.


You will take ZENBEXUS in treatment cycles that repeat. Each treatment cycle will last 4 weeks (28 days).

  • During weeks 1, 2, and 3 (days 1-21): Take ZENBEXUS by mouth, 1 time each day
  • During week 4 (days 22-28): Do not take any ZENBEXUS
Do take ZENBEXUS with or without food.

Do take ZENBEXUS once a day.

Do take ZENBEXUS at about the same time each day, such as morning or evening.*

Do take ZENBEXUS capsules whole with water.

*Setting an alarm or calendar notification is a great way to remember to take medication.

Do not open, break, or chew ZENBEXUS capsules.

Do not remove the ZENBEXUS capsule from the bottle until you are ready to take it.

Do not give ZENBEXUS to other people, even if they have the same symptoms that you have. It may harm them and may cause birth defects.

Do not donate blood while taking ZENBEXUS and for 4 weeks after stopping ZENBEXUS.

ZENBEXUS is available in two different capsules. Your healthcare provider will tell you which dose is right for you.

ZENBEXUS 1 mg is a capsule with a light-gray cap imprinted with “BMS” in white ink and an ivory body imprinted with “1 mg” in black ink.

OR

ZENBEXUS 0.75 mg is a capsule with a light-gray cap imprinted with “BMS” in white ink and a dark-brown body imprinted with “0.75 mg” in white ink.

Note: Images do not represent actual capsule sizes.

Inactive ingredients:

  • All ZENBEXUS capsules contain: anhydrous lactose, pregelatinized starch, stearic acid, titanium dioxide, iron oxide black, iron oxide yellow, and hypromellose.
  • The 0.75 mg capsule coating also contains: iron oxide red.

The powder inside ZENBEXUS capsules should not come into contact with your skin. If you touch a broken capsule or if the powder comes into contact with your skin, wash the area of your body right away with soap and water.

What if I miss a dose?

Do not take two doses at the same time.

If it has been less than 12 hours since your regular time:

  • take your missed dose as soon as you remember
  • take your next dose of ZENBEXUS at your regularly scheduled time the next day

If it has been more than 12 hours since your regular time:

  • skip your missed dose
  • take your next dose of ZENBEXUS at your regularly scheduled time the next day
  • do not take 2 doses at the same time

Call your healthcare provider right away if you take too much ZENBEXUS.

For more information, please see the U.S. Full Prescribing Information, including Boxed WARNINGS and Medication Guide for ZENBEXUS. Talk to your healthcare provider for more information about this medication.

2070-US-2600028 08/26

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