Glatiramer
Risk Factor: BM
Class: Immunologic agents
/ Immunosuppressants
Contents of this page:
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 (4,70011,000), it is doubtful that the unmetabolized agent is excreted into breast milk.
References
-
Product information. Copaxone. TevaMarion Partners, 2000.
Questions and Answers
Glatiramer acetate (Copaxone) vs. interferon (Avonex, Rebif, Betaseron)...which is better?,
I have only had experience with Copaxone. Using it for one and half years. From what I have heard other people that use the various therapies is that some only are used with certain types of MS. Some you have to get blood work done every so often.
my uncle has had multiple sclerosis for 3 years and he lives in Cuba, can I help?, He has relapsing remitting multiple sclerosis and he has to walk with a cane, and even then he has difficulty, he lives in Cuba and the usual treatment such as interferons and glatiramer aren't available. We try to help, his doctors presribed Prozac for depression and we've always sent it to him but it is clearly not designated for ms. I don't know what to do, is there anything that I can do to help him?
I too have had relapsing remitting MS for 10 years now and have been on the interferons for 9 years...There are lots of things he can do to help himself. The first massive one is to look at his diet...He must begin to treat the root cause of MS and not the symptoms and after extensive research and trying different thinks I am personally convinced that diet has everything to do with it. Our bodies have become too acidic due to the change in diet over the last 100 years and need to be balanced out again...Repair is possible and don't forget no matter where he is in the world the one thing he CAN control is his diet...Ultimately what he puts in his mouth is his decision..Take a look at my website for some more information on MS and Diet...There is a link to a book there that I know will help him...It will also give him a focus and great motivation...It did for me anyway...I'd be happy to talk with him if you think it would help...
