It is approved in the US effective April 2013.
I was recommended to start BG 12 upon it's release after Betaseron complications, and then Copaxone Complications.
It was expected to come out in May 2013, and apparently, was released in April 2013.
When I came in for a problem visit with my Neuro's PA, they were eager to start me on BG12, aka, Tecfidera. I was in to let them know that my endocrinologist had found me to have elevated calcium levels, and of course the typical MS patient, LOW VIT. D levels, and I had been Dx. with Primary HyperParaTHryoidism. I wanted my Neuro to know this, because I had been being put on High dose Vit. D for the 2+years prior for persistent Low Vit. D, and I had learned that Primary HPT patients should NOT TAKE VIT D SUPPLEMENTS, and wanted to know what the association with MS and PHPT was. Technically, it irritated the PA that I asked so many questions and, he did not have the answers to my questions.
Because of new spasticity complaints and recurrent nerve pain in my face, it was recommended I start BG12. They signed me up that day. Before the next 2 weeks were out, I was getting a call from the specialty pharmacy letting me know that I was approved to get the med with Pt. Assistance at $10/month!
My research uncovered that PML had been in 4 patients taking this medicine. And, what I learend was that the JC VIrus is what is the cause of PML and that you should KNOW FIRST if you are NEGATIVE OR POSITIVE for the JC Virus (John Cunningham Virus) before you start a drug like BG12 or Tysarbri(sp?). Sadly, none of my doctors have ever tested me for the JC Virus, so, my faith in them was reduced after reading about this. I am even a medical person, who always does my research, and I had never head of JC Virus.
I also learned that the people who had complications with this drug also had some issues with their lymphocytes. Interestingly, I too, had some abnormalities with my lymphocytes a year ago, and no one even discussed that with me before eagerly putting me on BG12.
I decided I wanted to get another Neuro opinion, before I started on some new expensive name brand drug, that had such a quick way to get my costs down for their new drug.
I was surprised when the 'new' neuro told me that he was concerned that so many docs were jumping on the Tecfidera bandwagon, when the 'pure form of the drug was available for $8/month vs. $$thousands/month. The pure form being, "dimethyl fumarate".
I am hoping to get some reading done on the 'pure form' this week, and learn more.
Any other researching MS patient out there feeling the same?