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Pomalidomide Pregnancy and Breastfeeding Warnings

Pomalidomide is also known as: Pomalyst

Pomalidomide Pregnancy Warnings

FDA pregnancy category: X Use of pomalidomide is contraindicated. Comments: Abstinence or use of adequate methods of contraception should be encouraged while taking pomalidomide and for at least 4 weeks after completing therapy

Animal studies have revealed evidence of embryofetotoxicity. Pomalidomide is a thalidomide analog. Thalidomide is a human teratogen that is known to induce a high frequency of severe and life-threatening birth defects such as amelia (absence of limbs), phocomelia (short limbs), hypoplasticity of the bones, absence of bones, external ear abnormalities, facial palsy, eye abnormalities, and congenital heart defects. Alimentary tract, urinary tract, and genital malformations have also been documented and mortality at or shortly after birth has been reported in about 40% of infants. 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, during therapy, during dose interruptions and continuing for 4 weeks following discontinuation of pomalidomide. 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 pomalidomide 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. 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 pomalidomide and for up to 28 days after discontinuing treatment, even if they have undergone a successful vasectomy. Male patients taking pomalidomide must not donate sperm. 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 breast-feeding 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 The effects in the nursing infant are unknown.

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