GLATIRAMER
Drugs in Pregnancy and Lactation.
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Name: GLATIRAMER
Class: Immunologic Agent (Immunosuppressive)
Risk Factor: BM
Fetal Risk Summary
Glatiramer (copolymer-1) is an immunosuppressant agent given by SC injection to reduce the frequency of relapses in patients with relapsing-remitting multiple sclerosis. It is the acetate salts of synthetic polypeptides containing four naturally occurring amino acids: L-glutamic acid, L-alanine, L-lysine, and L-tyrosine (1). Chemically, glatiramer is designated glutamic acid polymer with L-alanine, L-lysine, and L-tyrosine (1).
Reproduction studies during organogenesis have been conducted in rats and rabbits at SC doses up to 18 and 36 times the human dose of 20 mg on a body surface area basis (HD), respectively (1). No adverse fetal effects were observed in either species. Pregnant rats were also given glatiramer at doses up to approximately 18 times the HD from gestational day 15 and throughout lactation. No significant effects were observed on delivery or pup growth or development (1). Multigeneration fertility and reproductive performance studies conducted in rats at SC doses up to 18 times the HD revealed no adverse effects on reproductive parameters (1).
It is not known if glatiramer crosses the human placenta to the fetus. The molecular weights of the polypeptides average 4,700 to 11,000, suggesting that they do not cross by simple diffusion.
No published reports on the use of glatiramer during human pregnancy have been found. Based solely on animal data, the drug does not appear to present a significant risk to the fetus. Among 979 patients treated during premarketing clinical trials or in the postmarketing period, vaginal hemorrhage occurred with a frequency of at least 1/100 and abortions with a frequency between 1/100 and 1/1,000 (1). Although the cause of these outcomes is unknown, they may have occurred by chance or from the disease and may not be specifically related to glatiramer.
In spite of the uncertainty surrounding the use of glatiramer during pregnancy, the benefits of the drug in reducing the number of relapses of multiple sclerosis appears to outweigh the potential risks to the fetus. The patient should be advised of the lack of human data and the potential risk of abortion. If she consents, starting therapy after the 1st trimester, if possible, and after confirming that she has a viable pregnancy is probably the safest course.
Breast Feeding Summary
No reports describing the use of glatiramer during lactation have been located. Because of the high molecular weight (4,700–11,000), it is doubtful that the unmetabolized agent is excreted into breast milk.
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