Revlimid Pregnancy Warnings
Animal studies revealed this drug crossed the placenta and caused maternal and developmental toxicity as well as teratogenicity (e.g., thalidomide-type limb abnormalities) in offspring. Limb malformations were seen at all doses tested. If pregnancy does occur during therapy, immediately discontinue the drug. Refer the patient to an obstetrician/gynecologist experienced in reproductive toxicity for further evaluation and counseling. Mortality at or shortly after birth has been reported in about 40% of infants.
To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by calling Celgene Corporation at 1-888-423-5436:
-In the U.S., any suspected fetal exposure to this drug should be reported to the FDA via the MedWatch program at 1-800-FDA-1088 and also to Celgene Corporation at 1-888-423-5436.
-In the United Kingdom, consult the manufacturer product information for details about the Pregnancy Prevention Programme.
-In Australia, consult the manufacturer product information for details about the i-access(R) Program conditions for pregnancy prevention.
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.
Use is contraindicated.
AU TGA pregnancy category: X
US FDA pregnancy category: Not assigned.
Risk Summary: Based on its 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. It is a thalidomide analog. Thalidomide is a human teratogen, inducing 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 (including anotia, micropinna, small or absent external auditory canals), facial palsy, eye abnormalities (anophthalmos, microphthalmos), and congenital heart defects. Alimentary tract, urinary tract, and genital malformations have been documented and mortality at or shortly after birth has been reported in about 40% of infants. It causes thalidomide-type limb defects in monkey offspring. It crossed the placenta after administration to pregnant rabbits and rats.
Comments:
-A pregnancy exposure registry is available.
-This drug can harm a developing fetus.
-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 harm to the fetus.
-Females of reproductive potential should avoid pregnancy for at least 4 weeks before beginning therapy, during therapy, during dose interruptions, and for at least 4 weeks after.
-Females should commit either to abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control, beginning 4 weeks prior to initiating therapy, during therapy, during dose interruptions, and for 4 weeks after.
-Two negative pregnancy tests should be obtained prior to initiating therapy. The first test should be performed within 10 to 14 days and the second test within 24 hours prior to initiating therapy and then weekly during the first month, then monthly thereafter in females with regular menstrual cycles or every 2 weeks in females with irregular menstrual cycles.
-This drug is present in the semen of patients receiving the drug; therefore, males should always use a latex or synthetic condom during any sexual contact with females of reproductive potential while taking this drug and for up to 4 weeks after, even if they have undergone a successful vasectomy.
-Male patients taking this drug should not donate sperm.
See references
