Pomalyst Pregnancy Warnings
Use is contraindicated.
AU TGA pregnancy category: X
US FDA pregnancy category: Not assigned.
Risk Summary: Based on the mechanism of action and findings from animal studies, this drug can cause embryofetal harm when administered to a pregnant female and is contraindicated during pregnancy.
Comments:
-A pregnancy exposure registry is available. Consult the manufacturer summary of product characteristics for the conditions of the pregnancy prevention program that must be fulfilled for all patients in your locality unless there is evidence that the patient does not have childbearing potential.
-Two negative pregnancy tests must be obtained prior to therapy initiation. The first test should be performed within 10 to 14 days and the second test within 24 hours prior to therapy initiation, 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.
-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 2 forms of contraception, beginning 4 weeks prior to therapy initiation, during therapy, during dose interruptions, and continuing for 4 weeks following therapy discontinuation.
-If pregnancy occurs, a female patient misses her period, or if there is any abnormality in a female patient's menstrual bleeding, immediately discontinue therapy. 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 therapy and for 28 days after therapy completion.
-Patients must not donate blood during therapy and for 1 month following therapy discontinuation to prevent their blood from being given to a pregnant female.
This drug 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 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.
To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Consult the manufacturer product insert for information by country.
AU TGA pregnancy category X: Drugs which have such a high risk of causing permanent damage to the fetus that they should not be used in pregnancy or when there is a possibility of pregnancy.
US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.
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