ody in white ink
4 mg: Dark blue opaque cap and blue opaque body, imprinted “POML” on the cap and “4 mg” on the body in white ink
Contraindications
Pregnancy
Pomalyst can cause fetal harm when administered to a pregnant female [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)]. Pomalyst is contraindicated in females who are pregnant. Pomalidomide is a thalidomide analogue, and is teratogenic in both rats and rabbits when administered during the period of organogenesis. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.
Warnings and Precautions
Embryo-Fetal Toxicity
Pomalyst is a thalidomide analogue and is contraindicated for use during pregnancy. Thalidomide is a known human teratogen that causes severe birth defects or embryo-fetal death [see Use in Specific Populations (8.1)]. Pomalyst is only available through the Pomalyst REMS program [see Warnings and Precautions (5.2)].
Females of Reproductive Potential
Females of reproductive potential must avoid pregnancy while taking Pomalyst and for at least 4 weeks after completing therapy.
Females must commit either to abstain continuously from heterosexual sexual intercourse or to use two methods of reliable birth control, beginning 4 weeks prior to initiating treatment with Pomalyst, during therapy, during dose interruptions and continuing for 4 weeks following discontinuation of Pomalyst therapy.
Two negative pregnancy tests must be obtained prior to initiating therapy. The first test should be performed within 10-14 days and the second test within 24 hours prior to prescribing Pomalyst therapy and then weekly during the first month, then monthly thereafter in women with regular menstrual cycles or every 2 weeks in women with irregular menstrual cycles [see Use in Specific Populations (8.6)].
Males
Pomalidomide is present in the semen of patients receiving the drug. Therefore, males must always use a latex or synthetic condom during any sexual contact with females of reproductive potential while taking Pomalyst and for up to 28 days after discontinuing Pomalyst, even if they have undergone a successful vasectomy. Male patients taking Pomalyst must not donate sperm [see Use in Specific Populations (8.6)].
Blood Donation
Patients must not donate blood during treatment with Pomalyst and for 1 month following discontinuation of the drug because the blood might be given to a pregnant female patient whose fetus must not be exposed to Pomalyst.
Pomalyst REMS ™ Program
Because of the embryo-fetal risk [see Warnings and Precautions (5.1)], Pomalyst is available only through a restricted program under a Risk eva luation and Mitigation Strategy (REMS) called “Pomalyst REMS.”
Required components of the Pomalyst REMS program include the following:
•Prescribers must be certified with the Pomalyst REMS program by enrolling and complying with the REMS requirements.
•Patients must sign a Patient-Prescriber agreement form and comply with the REMS requirements. In particular, female patients of reproductive potential who are not pregnant must comply with the pregnancy testing and contraception requirements [see Use in Specific Populations (8.6)] and males must comply with contraception requirements [see Use in Specific Populations (8.6)].
•Pharmacies must be certif |
