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Pomalyst and Pregnancy Risks

Because of the risks associated with using this product during pregnancy, the medicine is only available through a special program. The healthcare provider who prescribes Pomalyst for you, and the pharmacy that supplies the medication, must be enrolled in this program. Your healthcare provider will ask you to sign an agreement form that outlines the requirements for taking Pomalyst.
It is very important that women of childbearing potential, and men with partners of childbearing potential, follow the instructions for safely using Pomalyst. In particular, women who can become pregnant must:
  • Have two negative pregnancy tests before starting Pomalyst -- one within 10 to 14 days before starting treatment, and one within 24 hours of starting treatment.
  • Have weekly pregnancy tests during the first month of treatment, and then monthly (if you have a regular period) or every two weeks (if your periods are irregular).
  • Abstain from sex or use two forms of birth control starting at least four weeks before Pomalyst treatment, and continuing for at least four weeks after treatment ends. One of the forms of birth control should be considered highly effective, such as intrauterine devices (IUDs), hormonal birth control (such as pills, patches, and implants), or tubal ligation.
In addition, you should stop taking the drug and contact your healthcare provider immediately if you become pregnant, may be pregnant, miss your monthly menstrual period, have irregular bleeding, or stop using birth control. You will need a pregnancy test.
You should also not donate blood if you take Pomalyst, or if you have taken it within the past month. This is because the blood may be given to a pregnant woman, which could harm the woman's unborn child.

Pomalyst Use in Men

Pomalyst can pass into semen. Therefore, men who have female partners of childbearing potential should use a latex or synthetic condom during Pomalyst treatment and for at least 28 days after their last dose. This is true even for men who have had a vasectomy, as vasectomies are not 100 percent effective for preventing pregnancy.
In addition, men should not donate sperm during Pomalyst treatment, or for a month after treatment ends. Like women, men should also not donate blood during that same period, as the blood could be given to a pregnant woman and cause birth defects.
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
Last updated/reviewed:
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