Antineoplastic
PREGNANCY RECOMMENDATION: No Human Data—No Relevant Animal Data
BREASTFEEDING RECOMMENDATION: No Human Data—Potential Toxicity
PREGNANCY SUMMARY
No reports describing the use of alemtuzumab in human or animal pregnancies have been located. It is not known if the antibody crosses the placenta but, if it did, a potential fetal consequence of this exposure could be the depletion of B and T lymphocytes (1). Because of the potential for embryo and fetal harm, the antibody should be avoided, if possible, during pregnancy. In addition, based on the very long half-life, a woman should not conceive for several months after the last dose. The manufacturer recommends that men of reproductive potential and women of childbearing potential should use effective contraceptive methods during treatment and for a minimum of 6 months after therapy is stopped (1). However, leukemia can be fatal, so if a woman requires alemtuzumab and informed consent is obtained, it should not be withheld because of pregnancy. If an inadvertent pregnancy occurs, the woman should be advised of the potential risk for severe adverse effects in the embryo and fetus.
FETAL RISK SUMMARY
Alemtuzumab is a recombinant DNA-derived humanized monoclonal antibody (Campath-1H) that is given by IV infusion. It is indicated for the treatment of B-cell chronic lymphocytic leukemia. The mean plasma half-life changes with time, increasing from 11 hours (range 2–32 hours) after the first 30 mg dose to 6 days (range 1–14 days) after the last 30 mg dose (1).
Alemtuzumab may cause severe, infusion-related toxicity, including hypotension and other adverse effects. Premedication with acetaminophen and antihistamines is recommended (1). Hypotension in a pregnant woman could have deleterious effects on placental perfusion resulting in embryo and fetal harm.
Animal reproduction studies have not been conducted with alemtuzumab. Neither have studies been conducted for carcinogenicity, mutagenicity, or fertility (1).
It is not known if alemtuzumab crosses the human placenta. The very high molecular weight (about 150,000 for the Campath-1H antibody) suggests that it will not cross. However, human immunoglobulin G (IgG) does cross and, therefore, alemtuzumab may also cross (1).
BREASTFEEDING SUMMARY
No reports describing the use of alemtuzumab during lactation have been located. The very high molecular weight (about 150,000 for the Campath-1H antibody) suggests that it will not be excreted into breast milk. However, human IgG is excreted into milk and, therefore, alemtuzumab may also be excreted (1). The effects of this potential exposure on a nursing infant are unknown, but immunosuppression and other severe adverse effects are potential complications.
Reference
1.Product information. Campath. Genzyme, 2012.