Description
Iberdomide is used together with daratumumab and hyaluronidase-fihj combination and dexamethasone to treat multiple myeloma in patients who have received at least 1 previous treatment (eg, proteasome inhibitor and an immunomodulatory agent).
This medicine is available only under a restricted distribution program called the Zenbexus™ REMS (Risk Evaluation and Mitigation Strategy) program.
This product is available in the following dosage forms:
- Capsule
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional 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
Appropriate studies have not been performed on the relationship of age to the effects of iberdomide in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of iberdomide in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Blood clots, history of or
- Heart attack, history of or
- Stroke, history of—Use with caution. May make these conditions worse.
- Hyperlipidemia (high cholesterol or fats in the blood) or
- Hypertension (high blood pressure) or
- Smoking—May increase risk for more serious side effects.
- Infection, active or uncontrolled—May decrease your body's ability to fight infections.
- Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use
Medicines used to treat cancer are very strong and can have many side effects. Before using this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
It is very important that you understand the rules of the Zenbexus™ REMS program and become familiar with the Zenbexus™ Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.
You may take this medicine with or without food at the same time each day.
Swallow the capsule whole with water. Do not open, break, or chew it.
If you touch a broken capsule or the medicine inside the capsule, wash the area right away with soap and water.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (capsules):
- For multiple myeloma:
- Adults—1 milligram (mg) once a day on Days 1 to 21 of a 28-day cycle. Your doctor may adjust your dose as needed and tolerated.
- Children—Use and dose must be determined by your doctor.
- For multiple myeloma:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
If you miss a dose of this medicine and it is less than 12 hours since your regular time, take it as soon as you can, then take your next dose at the normal time. If it is more than 12 hours, skip the missed dose and take your next dose at the regular time.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Keep this medicine in its original container. Do not remove the capsule from the bottle until you are ready to take it. Do not remove the desiccant (drying agent).
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Female patients should take necessary precautions to avoid pregnancy while taking iberdomide. Begin 2 forms of effective birth control together 4 weeks before starting treatment, during treatment, even if the dose is stopped for a short time, and for at least 4 weeks after your last dose. Talk to your doctor about the most effective forms of birth control for you and your partner. Call your doctor right away if you think you are pregnant.
Female patients who can get pregnant must have 2 negative pregnancy tests before starting treatment with this medicine. Pregnancy tests may be done weekly for the first month during treatment, and then every 2 weeks if your menstrual cycle is not regular or every 4 weeks if your menstrual cycle is regular.
Males who are sexually active must protect their female partner from getting pregnant. Iberdomide will appear in the semen of male patients. If you are sexually active, you must use a latex or synthetic condom every time you have sex with a female who could get pregnant. If you have had a vasectomy, you still have to use a latex condom during sex. You must continue to use a condom during treatment, even if the dose is stopped for a short time, and for at least 4 weeks after your last dose. Call your doctor right away if you think your sexual partner may be pregnant.
Do not donate blood, eggs, or sperm while you are taking this medicine and for at least 4 weeks after your last dose.
This medicine may increase your risk of having blood clots, a heart attack, or stroke. Check with your doctor right away if you have anxiety, chest pain, confusion, difficulty with speaking, dizziness or lightheadedness, double vision, fainting, fast heartbeat, inability to move the arms, legs, or facial muscles, leg pain or swelling, slow speech, or trouble breathing.
Iberdomide can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:
- If you can, avoid people with infections. Check with your doctor right away if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
- Check with your doctor right away if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
- Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
- 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 the meantime.
- Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
- Avoid contact sports or other situations where bruising or injury could occur.
This medicine may cause serious infections. Check with your doctor right away if you have fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
This medicine may increase the risk of secondary cancers. Talk to your doctor if you have concerns about this.
Some men and women who use this medicine have become infertile (unable to have children). Talk with your doctor before using this medicine if you plan to have children.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Anxiety
- bleeding gums
- bloody urine
- blurred vision
- body aches or pain
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- burning, numbness, tingling, or painful sensations
- change in vision
- changes in skin color
- chest pain, discomfort, or tightness
- chills
- clay colored stools
- cough
- coughing up blood
- decreased amount of urine
- diarrhea
- difficulty in speaking
- difficulty swallowing
- dizziness or lightheadedness
- double vision
- ear congestion
- fever
- headache
- inability to move the arms, legs, or facial muscles
- inability to speak
- increased blood pressure
- increased menstrual flow or vaginal bleeding
- increased thirst
- irregular heartbeat
- loss of appetite
- loss of taste or smell
- loss of voice
- lower back or side pain
- muscle or bone pain
- muscle spasm, tenderness, wasting, or weakness
- nausea or vomiting
- nosebleeds
- pain, redness, swelling, or tenderness in the arm, foot, or leg
- pain or discomfort in the jaw, back, or neck
- painful or difficult urination
- pale skin
- paralysis
- prolonged bleeding from cuts
- red or black, tarry stools
- shakiness and unsteady walk
- sneezing
- sore throat
- stomach pain or tenderness
- stuffy or runny nose
- sweating
- swelling of the face, fingers, or lower legs
- trouble breathing
- ulcers, sores, or white spots in mouth
- unsteadiness, trembling, or other problems with muscle control or coordination
- unsteadiness or awkwardness
- unusual bleeding or bruising
- unusual tiredness or weakness
- vomiting of blood or material that looks like coffee grounds
- weakness in the arms, hands, legs, or feet
- weight gain
- yellow eyes or skin
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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with 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
- Aching or discomfort in the lower legs or sensation of crawling in the legs
- constipation
- skin rash
- trouble sleeping
- unable to sleep
Other side effects not listed may also occur in some patients. If you notice any other effects, check with 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.
DRG-80011970