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Pomalidomide Pregnancy and Breastfeeding Warnings

Pomalidomide is also known as: Pomalyst

Pomalidomide Pregnancy Warnings

Contraindicated during pregnancy. US FDA pregnancy category: X Comments: -Even when there has been a history of infertility (unless due to hysterectomy), females of reproductive potential must avoid pregnancy by abstaining from heterosexual sex or using 1 form (AU, UK) or 2 forms (US) of contraception, beginning 4 weeks prior to treatment initiation, during treatment, during dose interruptions, and continuing for 4 weeks following treatment discontinuation. -Two negative pregnancy tests must be obtained prior to treatment initiation. The first test should be performed within 10 to 14 days and the second test within 24 hours prior to treatment, then weekly during the first 4 weeks, and every 4 weeks thereafter in women with regular menstrual cycles or every 2 weeks in women with irregular menstrual cycles. (US) -With the exception of confirmed sterilization cases, pregnancy tests with a minimum sensitivity of 25 mIU/mL should be performed at least 3 days prior to treatment initiation then every 4 weeks including 4 weeks after the end of treatment. (AU, UK) -If pregnancy occurs, a female patient misses her period, or if there is any abnormality in a female patient's menstrual bleeding, immediately discontinue treatment. Refer patients to a physician who specializes in reproductive toxicity for further evaluation and counseling. -This drug is present in the semen of male patients; they must not donate semen or sperm. Even if they have undergone a successful vasectomy, male patients must always use a latex or synthetic condom during any sexual contact with females during treatment and for 7 days (AU, UK) or 28 days (US) after treatment completion. -Patients must not donate blood during treatment and for 7 days (AU, UK) or 1 month (US) following treatment discontinuation to prevent their blood from being given to a pregnant female. -Patients with myeloma are permanently excluded from donating blood. (AU) -Consult the manufacturer summary of product characteristics for the conditions of the i-access(R) Program (AU) or Pregnancy Prevention Programme (UK) that must be fulfilled for all patients unless there is evidence that the patient does not have childbearing potential.

Pomalidomide is an analog of thalidomide, a known human teratogen that causes a high frequency of severe and life-threatening birth defects and mortality at or shortly after birth in about 40% of infants. Animal studies with pomalidomide have revealed evidence of teratogenicity when administered during the period of organogenesis. This drug crossed the placenta and was detected in fetal blood. There is also animal study data of adverse effects on fertility, reproductive functions, and number of pregnancies. There are no controlled data in human pregnancy. Physicians and pregnant women are encouraged to report suspected fetal exposure to this drug by calling Celgene Corporation at 1-888-423-5436. US FDA pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

Pomalidomide Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Yes Comments: The effects in the nursing infant are unknown.

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