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Lenalidomide Pregnancy and Breastfeeding Warnings

Lenalidomide is also known as: Revlimid

Lenalidomide Pregnancy Warnings

This drug is a structural analog of thalidomide, a known human teratogen that causes embryo-fetal death and a high frequency of life-threatening human birth defects. Mortality at or shortly after birth has been reported in about 40% of infants. 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. However, no adverse effects on fertility have been observed. 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 Australia, consult the manufacturer product information for details about the i-access(R) Program conditions for pregnancy prevention. In the United Kingdom, consult the manufacturer product information for details about the Pregnancy Prevention Programme. 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.

Based on the mechanism of action and findings from animal studies indicating this drug can cause embryo-fetal harm, use of this drug is contraindicated during pregnancy. AU TGA pregnancy category: X US FDA pregnancy category: Not Assigned Comments: -Direct all patients not to donate blood during treatment and for 1 to 4 weeks after treatment completion because their blood might be given to a pregnant female whose fetus should not be exposed to this drug. FEMALES OF REPRODUCTIVE POTENTIAL: -Obtain 2 negative pregnancy tests prior to treatment initiation; consult the manufacturer product information for pregnancy testing instructions. -Instruct patients to avoid pregnancy through continuous abstinence from heterosexual sexual intercourse or by using 1 to 2 forms of effective contraception for at least 4 weeks before therapy, during therapy, during dose interruptions, and for 4 weeks after completing therapy. -Educate patients on suitable methods of effective contraception (e.g., medroxyprogesterone acetate depot, tubal sterilization, ovulation inhibitory progesterone-only pills); advise against use of combined oral contraceptive pills (due to the increased risk of venous thromboembolism, which continues 4 to 6 weeks after discontinuing this type of contraception) and copper-releasing intrauterine devices (due to potential risk of infection at the time of insertion and menstrual blood loss, which may compromise patients with neutropenia or thrombocytopenia). -Advise patients to immediately discontinue this drug if pregnancy occurs during treatment or during the first week after treatment discontinuation, and refer them to a physician experienced in reproductive toxicity/teratology for further evaluation and consultation. MALES: -Due to the presence of this drug in the semen of male patients, instruct these patients not to donate any sperm and to always use a latex or synthetic condom during any sexual contact with females of reproductive potential during treatment, during dose interruptions, and for 7 to 28 days after treatment discontinuation (even if they have undergone a successful vasectomy).

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Lenalidomide Breastfeeding Warnings

Breastfeeding is not recommended during treatment with this drug. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: The effects in the nursing infant and on milk production are unknown.

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References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Revlimid (lenalidomide)." Celgene Corporation, Summit, NJ.

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Revlimid (lenalidomide)." Celgene Corporation, Summit, NJ.

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