EMAIL Comment: Not only the 30 minutes warm-up time, but the fact that the drug - once removed from the fridge - has to be used within 24 hours. If not it has to be discarded - expensive! Many NHS MS patients are not very reliable in their attendance so this will be a problem.
Subsequently heard that the FDA wants more than just immunogenicity data, but also a phase 3 trial showing the SC formulation is as effective as the IV formulation. No short-cuts allowed with the FDA - it is all about data.
Really interesting stuff. I’m currently IV and considering whether to switch to S/C. This info about the FDA has made me reflect some more. Also on my Tysabri forum there have been reports of people who have been on IV for years, getting serious adverse reactions after switching and then not being allowed back on IV. That’s a gamble I’m unwilling to take but would be happy to consider a faster IV infusion rate.
Mar 26, 2022·edited Mar 26, 2022Liked by Gavin Giovannoni
Thank you for another excellent, bold article. Long story short - I am not convinced by the "data" about switching to S/C Natalizumab. Let's remember, Tysabri goes to people who, by definition, are likely to have had a pretty rough experience - In my own case, if it ain't broke, I do NOT want to try to fix it...
The idea of choice is nice, but wouldn't it be even harder for NHS teams to manage things, if some people are on IV, some are on subcutaneous, different durations/timings etc...?!
Mar 26, 2022·edited Mar 27, 2022Liked by Gavin Giovannoni
Thank you for this…very interesting. . I have been on Tysabri for 11 years and I am unwilling to switch to s/c at present. I am also reluctant to try a shorter infusion time as during the pandemic I had it a couple of times over 45 mins and felt quite unwell with a bad headache and palpitations. Incidentally in the first six months of Tysabri I had the infusion over 90 minutes to prevent severe headache.
I think I would find s/c very hard to tolerate. Also, I love my “Magic Juice” Infusion Club!
I apologize… NMSS is in the US; I’m not sure what organizations are in the UK. Plus your medical care is nationalized healthcare and here in the US it’s privatized. I should have incorporated that into my reply post… sorry.
My original reply post is missing. It took me a few hours to type, and it was really important. Did I misspeak too much off topic or something? Was it deleted?
Thank you for this post. I'm on Tysabri and drive 2.5 hours one way to get the infusion. Back in late 2020 or maybe early 2021 My neuro mentioned that SC version of Tysabri was in the works. I was interested, mainly because I assumed it would/could be administered like the other SC meds (saving that drive for every infusion would be nice). Reading this article makes me glad that the FDA didn't green light it (and I'm glad for the I do about what is actually invovled with getting SC doses - no thank you).
Personally I've no issues with the infusion, mine is 2 hours due to asking for extra flush to help with headaches
What I find interesting personally regarding Tysabri commentary is how polarising it is for some neurologists
I've found the US/Canadian ones bar Aaron Boster to be put off or not recommend Tysabri vs the Australian neurologists I have spoken to who still rate it highly and push it as first DMT alongside Ocrevus, lemtrada etc
Is this the same in UK/Europe where it's "ocrevus this ocrevus that". Has the useage of Tysabri gone down? Because if I speak to patients on support groups many love the drug and absolutely hate ocrevus but the neurologists feel the opposite
I’ve been on NZ since Jan 2017, typically have a mild headache and some body ache after, but easily managed with ibuprofen or aleve . This past Dec I was accidentally given my infusion as a bolus, whole bag in under 10 minutes. They kept me there to monitor for an hour, extra bag fluids and BP checks to make sure ok. BP and HR were fine but. I had the worst headache of my life after, drugs did not help, had light sensitivity, lasted about 24hrs.
I've been on monthly IV for almost a year. My third DMT after Rebif and Ocrevus fails. I seem stable for the most part, but doc is now talking about switching to Lemtrada as I'm JCV+ (value 1.58) also HSV-1, VZV, HPV, EBV... you name it... 🤷♀️. I've been hesitant, but sounds like perhaps I should consider it.
At my clinic (Southampton) we were changed to s/c, most were happy to change and were told after 6 months we could leave immediately after, however now we’re at this stage we’re being told we still have to wait an hour. Regardless I am glad I changed, my veins are terrible and it was a real struggle to get the needle in for the infusion. I’ve been on Tysabri ever since it was available, and been on s/c 7 months now and had no problems
Really interesting post. I was aware of the situation when I started natalizumab last year and spent time searching to see if there were any theories as to why the FDA rejected it, I wondered whether it had anything to do with the same dose but lower bioavailability; now it makes sense.
My centre only started using the SC formulation 2 months ago, and only available to those who had been stable for 1 year, so not an option for treatment-naive. The rest were told they must try the SC at least once, in reality there was no problem if someone refused, as did happen. I know at least one person opted to go back to IV due to stinging from the SC, but others like it. I don't think it saves time as most people travel some distance, or are on patient transport, so often sit around having a cup of tea. Our Biogen nurse had her last day in March, a real shame as she was so knowledgeable.
Thank you Dr. Giovanni! Here in the US, many PWMS on Tysaberi receive financial assistance from Biogen. When I took it 4 years ago, I did too. Do your expect this financing structure to change in future? With generic competition, could costs come down but the ultimate expense borne by PWMS be greater? With much appreciation....pf
EMAIL Comment: Not only the 30 minutes warm-up time, but the fact that the drug - once removed from the fridge - has to be used within 24 hours. If not it has to be discarded - expensive! Many NHS MS patients are not very reliable in their attendance so this will be a problem.
Subsequently heard that the FDA wants more than just immunogenicity data, but also a phase 3 trial showing the SC formulation is as effective as the IV formulation. No short-cuts allowed with the FDA - it is all about data.
Really interesting stuff. I’m currently IV and considering whether to switch to S/C. This info about the FDA has made me reflect some more. Also on my Tysabri forum there have been reports of people who have been on IV for years, getting serious adverse reactions after switching and then not being allowed back on IV. That’s a gamble I’m unwilling to take but would be happy to consider a faster IV infusion rate.
Thanks for this post. Ive been on Tysabri for 13 years...love the care I get at Infusion center. I have ZERO interest in trying S/C
Thank you for another excellent, bold article. Long story short - I am not convinced by the "data" about switching to S/C Natalizumab. Let's remember, Tysabri goes to people who, by definition, are likely to have had a pretty rough experience - In my own case, if it ain't broke, I do NOT want to try to fix it...
The idea of choice is nice, but wouldn't it be even harder for NHS teams to manage things, if some people are on IV, some are on subcutaneous, different durations/timings etc...?!
Thank you for this…very interesting. . I have been on Tysabri for 11 years and I am unwilling to switch to s/c at present. I am also reluctant to try a shorter infusion time as during the pandemic I had it a couple of times over 45 mins and felt quite unwell with a bad headache and palpitations. Incidentally in the first six months of Tysabri I had the infusion over 90 minutes to prevent severe headache.
I think I would find s/c very hard to tolerate. Also, I love my “Magic Juice” Infusion Club!
I apologize… NMSS is in the US; I’m not sure what organizations are in the UK. Plus your medical care is nationalized healthcare and here in the US it’s privatized. I should have incorporated that into my reply post… sorry.
My original reply post is missing. It took me a few hours to type, and it was really important. Did I misspeak too much off topic or something? Was it deleted?
Nothing deleted. Not sure what happened. There is a comment below from you.
I'm not on natalizumab but it's interesting to read about it and about the pharmaceutical companies' patent strategies.
Thank you for this post. I'm on Tysabri and drive 2.5 hours one way to get the infusion. Back in late 2020 or maybe early 2021 My neuro mentioned that SC version of Tysabri was in the works. I was interested, mainly because I assumed it would/could be administered like the other SC meds (saving that drive for every infusion would be nice). Reading this article makes me glad that the FDA didn't green light it (and I'm glad for the I do about what is actually invovled with getting SC doses - no thank you).
Personally I've no issues with the infusion, mine is 2 hours due to asking for extra flush to help with headaches
What I find interesting personally regarding Tysabri commentary is how polarising it is for some neurologists
I've found the US/Canadian ones bar Aaron Boster to be put off or not recommend Tysabri vs the Australian neurologists I have spoken to who still rate it highly and push it as first DMT alongside Ocrevus, lemtrada etc
Is this the same in UK/Europe where it's "ocrevus this ocrevus that". Has the useage of Tysabri gone down? Because if I speak to patients on support groups many love the drug and absolutely hate ocrevus but the neurologists feel the opposite
I’ve been on NZ since Jan 2017, typically have a mild headache and some body ache after, but easily managed with ibuprofen or aleve . This past Dec I was accidentally given my infusion as a bolus, whole bag in under 10 minutes. They kept me there to monitor for an hour, extra bag fluids and BP checks to make sure ok. BP and HR were fine but. I had the worst headache of my life after, drugs did not help, had light sensitivity, lasted about 24hrs.
I've been on monthly IV for almost a year. My third DMT after Rebif and Ocrevus fails. I seem stable for the most part, but doc is now talking about switching to Lemtrada as I'm JCV+ (value 1.58) also HSV-1, VZV, HPV, EBV... you name it... 🤷♀️. I've been hesitant, but sounds like perhaps I should consider it.
At my clinic (Southampton) we were changed to s/c, most were happy to change and were told after 6 months we could leave immediately after, however now we’re at this stage we’re being told we still have to wait an hour. Regardless I am glad I changed, my veins are terrible and it was a real struggle to get the needle in for the infusion. I’ve been on Tysabri ever since it was available, and been on s/c 7 months now and had no problems
I do find these types of posts interesting!
Really interesting post. I was aware of the situation when I started natalizumab last year and spent time searching to see if there were any theories as to why the FDA rejected it, I wondered whether it had anything to do with the same dose but lower bioavailability; now it makes sense.
My centre only started using the SC formulation 2 months ago, and only available to those who had been stable for 1 year, so not an option for treatment-naive. The rest were told they must try the SC at least once, in reality there was no problem if someone refused, as did happen. I know at least one person opted to go back to IV due to stinging from the SC, but others like it. I don't think it saves time as most people travel some distance, or are on patient transport, so often sit around having a cup of tea. Our Biogen nurse had her last day in March, a real shame as she was so knowledgeable.
I would be happy to try a faster infusion.
Thank you Dr. Giovanni! Here in the US, many PWMS on Tysaberi receive financial assistance from Biogen. When I took it 4 years ago, I did too. Do your expect this financing structure to change in future? With generic competition, could costs come down but the ultimate expense borne by PWMS be greater? With much appreciation....pf