This drug is a powerful human teratogen that induces a high frequency of severe and life-threatening birth defects, even after a single dose. Mortality at or shortly after birth has been reported in about 40% of infants. Animals studies revealed no effects in mating and fertility indices in males or females; however, testicular degeneration occurred in males.

In the US, any suspected fetal exposure to this drug should be reported to the FDA via the MedWatch program at 1-800-FDA-1088 and to Celgene Corporation at 1-888-423-5436. Consult the manufacturer product information for details about the Thalidomide Celgene Pregnancy Prevention Programme (UK) and the i-access(R) risk management program (AU).

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 during pregnancy as this drug is a known human teratogen that can cause fetal harm.

AU TGA pregnancy category: X
US FDA pregnancy category: Not Assigned

Comments:
-Instruct patients to immediately discontinue this drug if pregnancy occurs or if pregnancy is suspected during treatment, if a menstrual period is missed, or if unusual menstrual bleeding is experienced; refer them to a physician experienced in reproductive toxicity/teratology for evaluation and consultation.
-Counsel patients monthly about the risks associated with this drug, and provide appropriate information to patients' sexual partners.
-Advise patients not to donate blood during treatment and for 1 to 4 weeks after treatment completion to prevent their blood from being given to a pregnant female.
FEMALES OF REPRODUCTIVE POTENTIAL:
-In some cases, this drug is contraindicated in this patient population; consult the manufacturer product information.
-Perform pregnancy tests prior to and during treatment, and after treatment discontinuation; consult the manufacturer product information for specific pregnancy testing requirements and timelines.
-Instruct these patients (even if they have amenorrhea) to avoid pregnancy through continuous abstinence from heterosexual sexual intercourse or by using 1 to 2 forms of effective contraception 4 weeks before initiating therapy, during therapy, during dose interruptions, and for 4 weeks after completing therapy.
-Educate these patients on suitable methods of effective contraception, and advise against the use of hormonal contraceptives (due to the increased thromboembolism risk), and intrauterine devices (IUDs)/implantable contraception (due to the increased risk for infection and bleeding at the time of insertion/use/removal as some patients may develop sudden, severe neutropenia and/or thrombocytopenia during treatment).
MALES:
-Due to the presence of this drug in semen, instruct these patients (even if they have undergone a successful vasectomy) not to donate any sperm and to always use a latex or synthetic/polyurethane condom during treatment, during dose interruptions, and for 1 to 4 weeks after treatment discontinuation if they engage in any sexual contact with pregnant women or females of reproductive potential.

See references

Discontinue breastfeeding during treatment with this drug.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-In some countries, breastfeeding is contraindicated during treatment with this drug.
-The effects in the nursing infant and on milk production are unknown.
-This drug is a lipophilic compound that has been detected in animal milk at concentrations up to 3.6 times the maternal plasma levels.

See references