Pomalidomide can cause severe birth defects or death in unborn babies if taken during pregnancy. Therefore, it is important to prevent pregnancy while taking this medication. Women must use 2 reliable forms of birth control or avoid sexual intercourse for 4 weeks before starting treatment, during treatment and breaks, and for at least 4 weeks after stopping treatment. Women must also have 2 negative pregnancy tests before starting treatment, the first test 10 to 14 days before the first dose and the second test within 24 hours before the first dose. Women must also continue to have pregnancy tests regularly during treatment. (See also Notes section.) If you become pregnant or think you may be pregnant, stop taking pomalidomide and tell your doctor right away. Consult your doctor or pharmacist for more information.
Men who are taking pomalidomide must use latex or synthetic condoms during any sexual contact with female partners while on treatment, during breaks, and for at least 4 weeks after stopping treatment even if they have had a vasectomy. If your partner becomes pregnant or thinks she may be pregnant, tell your doctor right away.
For patients to receive this medication, all doctors, pharmacists, and patients must understand, agree to, and carefully follow the requirements of the Pomalyst REMS program, developed by the U.S. Food and Drug Administration. These requirements apply in the United States. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.
Although unlikely, pomalidomide may cause very serious blood clots (such as heart attack, stroke, blood clots in the legs/lungs). Get medical help right away if you develop symptoms of blood clots, including chest/jaw/left arm pain, unusual sweating, weakness on one side of the body, vision changes, trouble speaking/breathing, or sudden pain/swelling/redness in the groin/calf. Your doctor should prescribe you medications such as "blood thinners" (examples include aspirin, warfarin) to prevent blood clots.
How to use Pomalidomide Capsule
This medication must be used only within the Pomalyst REMS guidelines in order to avoid any possible exposure of an unborn baby to the drug. Consult your doctor or pharmacist for more information. See also Warning section.
Read the Medication Guide provided by your pharmacist before you start taking pomalidomide and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth with or without food as directed by your doctor, usually once daily for 21 days, then stopping the medication for 7 days. This is one cycle of treatment. Continue taking the medication this way as directed by your doctor.
Swallow the capsules whole with water. Do not open, break, crush or chew the capsules or handle them more than needed. If any of the powder from the capsule gets on your skin, wash the area with soap and water.
The dosage is based on your medical condition, response to treatment, laboratory test results, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Take this medication regularly to get the most benefit from it. Remember to take it at the same time each day that you are scheduled to take it.
Do not increase your dose or take this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.
Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules.
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CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.