What is the most important information I should know about pomalidomide?
Both men and women taking this medicine should use effective birth control to prevent pregnancy. Even one dose of pomalidomide can cause severe, life-threatening birth defects if the mother or the father is using this medicine.
Pomalidomide may cause blood clots. Call your doctor at once if you have symptoms such as chest pain, shortness of breath, sudden numbness or weakness, problems with vision or speech, or swelling or redness in an arm or leg.
What is pomalidomide?
Pomalidomide affects the immune system. It promotes immune responses to help slow tumor growth.
Pomalidomide is used to treat multiple myeloma (cancer resulting from a progressive blood disease). Pomalidomide is usually given after at least two other medications have been tried without success.
Pomalidomide is available only from a certified pharmacy under a special program. You must be registered in the program and agree to use birth control measures as required.
Pomalidomide may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking pomalidomide?
You should not use pomalidomide if you are allergic to it, or if you are pregnant.
Pomalidomide can cause severe, life-threatening birth defects if the mother or father is taking this medicine at the time of conception or during pregnancy. Even one dose of pomalidomide can cause major defects of the baby's arms and legs, bones, ears, eyes, face, and heart.
For women (if you have not had a hysterectomy): Do not use pomalidomide if you are pregnant. Use two forms of birth control beginning 4 weeks before you start taking pomalidomide and ending 4 weeks after your last dose.
The birth control method must be proven highly effective (birth control pills, intrauterine device, tubal ligation, sex partner's vasectomy). The extra form must be a barrier method such as a latex condom, a diaphragm, or a cervical cap.
Stop using pomalidomide and call your doctor at once if you quit using birth control, if your period is late, or if you think you might be pregnant.
For men: Use a condom to prevent pregnancy while taking pomalidomide, and for up to 28 days after your last dose. Always use a latex condom 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 your sex partner may be pregnant.
Tell your doctor if you have ever had:
- liver disease (especially hepatitis B);
- kidney disease (or if you are on dialysis);
- risk factors for coronary artery disease (such as high blood pressure, high cholesterol, diabetes, menopause, smoking, a family history of coronary artery disease, being overweight, or being older than 40 and a man);
- if you also use pembrolizumab (Keytruda); or
- if you smoke (smoking may make pomalidomide less effective and may increase your risk of a stroke or blood clot while taking this medicine).
Pomalidomide may cause other types of cancer, such as leukemia or lymphoma. Ask your doctor about this risk.
You should not breast-feed while using this medicine.
How should I take pomalidomide?
Never this medicine with another person.
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Take each dose with a full glass of water. Take the medicine at the same time each day, with or without food. Swallow the capsule whole.
Do not break, chew, or open a pomalidomide capsule. The medicine from a broken pill can be dangerous if it gets in your mouth, eyes, or nose, or on your skin. If this happens, wash your skin with soap and water or rinse your eyes with water. Ask your pharmacist how to safely dispose of a broken pill.
You may need frequent blood tests.
Store at room temperature away from moisture and heat. Return any unused pomalidomide to your doctor, or as directed.
What happens if I miss a dose?
Use 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.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking pomalidomide?
Do not donate blood or sperm while you are using pomalidomide.
Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.
This medicine can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.
What are the possible side effects of pomalidomide?
Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).
Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, flu-like symptoms, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.
Call your doctor at once if you have:
- numbness, tingling, or burning pain in your hands or feet;
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heart attack symptoms --chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
-
low blood cell counts --fever, chills, tiredness, mouth sores, skin sores, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;
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signs of a stroke --sudden numbness or weakness (especially on one side of the body), severe headache, slurred speech, balance problems;
-
signs of a blood clot in the lung --chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;
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signs of a blood clot in your leg --swelling, warmth, or redness in an arm or leg; or
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signs of tumor cell breakdown --confusion, weakness, muscle cramps, nausea, vomiting, fast or slow heart rate, decreased urination, tingling in your hands and feet or around your mouth.
Common side effects may include:
- fever, weakness or feeling tired;
- nausea, diarrhea, constipation;
- cold symptoms such as stuffy nose, sneezing, sore throat;
- back pain; or
- feeling short of breath.
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.
What other drugs will affect pomalidomide?
Taking pomalidomide with other drugs that cause dizziness or confusion can worsen these effects. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.
Other drugs may affect pomalidomide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
Where can I get more information?
Your pharmacist can provide more information about pomalidomide.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2020 Cerner Multum, Inc. Version: 3.01. Revision date: 5/4/2018.
