Black box warning on Rituxan

I notice that a number of posts refer to Rituxan treatments, but I don't see any comments on here about the black-box warning issued not too long ago by the FDA. My hema won't prescribe it any more, because they don't know the threshold amount that causes the problem, which is pretty serious: it turns your brain to jelly and then kills ya (those'd be the non-technical terms).

Just wondering, for those of you who are still on Rituxan - have you been apprised of the warnings, and decided to go ahead with it and take the risk because it works?

We discussed this a while ago when it first came out, and it is discussed when someone brings it up.

PML is a very serious complication, but it is very rare. It wasn't a known possibility when I had Rituxan or yes, I would have thought twice about it. It occurs more often in those who are immunosuppressed, so that isn't too much of a concern with ITP'ers unless they are asplenic or on strong immunosuppressants.

This is one reason why I tend to say that Rituxan isn't a treatment to be taken lightly, or overused.

arthritis.about.com/od/mabtherarituxan/a/PML.htm

www.hopkins-arthritis.org/arthritis-news/2007/genentech-PML.html

Hmm, to be honest with you when I signed the papers I hadn't a clue. I was warned about the risk of infection. A clinical guy witnessed the signature etc and whilst he told me of PML it was only the name. I wasn't worried as I knew it be a treatment on here and when I had my own copy to bring home I looked it up and found out more.

The way I got over it is that , the chances are that I could be knocked down and killed or severely injured is just as likely if not more likely than contracting PML. If by some fluke I did contract PML. I told people - anyone willing to listen, 7 year ago after I had septic shock that not to be 'miserable' at my funeral for I have had a life and enjoyed it as such. I have a very honest outlook about death. Yes, that don't stop me having some quelms about once dead. But has helped me deal with such scares.

Sandi, has anyone on this website posted they have started with PML after receiving Rituxan? (or their carer and do we know how a person is before they are diagnosed with it. ie the downhill signs and symptoms?

I am more than aware that this website is a very tiny percentage of people but it goes towards the discussion just how many thankfully don't get it.

So yes, my last rituxan dose was about 2 weeks ago and I don't have any fear of PML. By the way, I don't have a spleen. I have had heart surgery too as a child. Hole-in-heart. Yes that concerns me a little bit if I let it. But life is for living and I will die some time. If it be in the next half hour. next half of this year.... or any time in the next 40+ years..... If PML gets me then fine. If not that it be something. But then I probably have a strange outlook

But reading stuff, I am much more likely to die of shock through winning the lottery than PML - especially as I don't often buy tickets. That is pesonally how I view it. If I get PML in the next year I will try and tell you before it too mushy

No, we haven't had any reports of anyone here with PML. However, people come and go and if someone got a Rituxan response and then months later found out they had PML, I don't think they would make it a priority to come back and tell us.

and I am more than aware on how 'bad' they were they may physically be unable to report back on here of any PML issue?

Okay so its a 0.2% risk issue for people with comprimised immunities. And whilst it should not be taken lightly there are higher death rate risks that we do on a regular basis so putting this into perspective and for me like I have said, well-I am going to die at some point in my life if that don't get me, something will. And there is nothing to prove I wouldn't have lived longer than if I did contract PML... then I personally am happy enough with it.

If I do happen to be one of the few that contract PML then I promise that as far as I am able I will do a blog entry on here so you will all know what it is like as far as I am able to post or perhaps get someone to post on my behalf - if I am one of the extreme unfortunates who contract it. A living 'will' to be done before I contract it if am ever going to get it but chances are very slim even without a spleen. But if I do then 'so be it' as they say. Just remember me saying that I am happy that I have had a life and it be no shame to have contracted it. "To Die, one must be'en' alive". Rhiannon H. Rees (I think I would like that on my grave actually. No am not being morbid if anyone thinks that or naively silly. Its just that with my faith and my health experience I face death head on so to speak though I do admit to some quelms....

Hope all of that helps mngrrrl?

The treatment for PML is to reverse the immunosuppressed state and the problem with Rituxan is that you can't reverse the immunosuppressed state which tends to last for about a year.

I knew of someone who died with PML. He was a student where I worked and I don't know the circumstances at all, but it certainly concentrates the mind when treating with Rituxan is suggested. I never did have that particular treatment.

I remember the first time I took Rituxan and they handed me that warning with the waiver to sign. My wife (a physician) was sitting there and asked me what the warning said, I responded: "it says they might stick the needle in and I would fall over dead." My wife said: "well, maybe you'd have better luck becoming a heroin addict. Do you want to try that?"

Love her sense of humor (and her).

All interesting answers. My hema won't even prescribe it any longer... thanks, all.

I guess I'm headed to Nplate. I crashed again yesterday, down to 7,000... Meeting today with my hema and will ask about Promacta instead of Nplate - I really don't like the thought of being tied to that weekly shot. My family lives in an area that likely doesn't have a doc registered to give the injection, and that'd be a real pain in the tuchus.

I am interested to know what your heamo reply back would be if one said most people die in bed, and does that mean we shouldn't go to bed any longer....?

again my sense of humour but my consultant would allow me to actually joke it and he would be able to reply back equally from what I have seen of him....

besides which I have been officially told that Britain now does NPlate and next time they drop I may well be on that. Not quite sure having read the instructions about having tried other treatments first whether that means within that drop or other times? Who cares because I can't be bothered questioning every turn... there is more to life than analysing each detail. I see in the USA you have a NPLate program that you sign up to etc online and track platelet count etc which I find rather pointless unless you are able to do FBC and give yourself NPlate at home? But may help some of you to feel in control.


Every treatment carries risks....

You're right, of course, that she could be being overly careful, but in the end we'll look at the available treatments and pick the one that (a) is the most effective while (b) posing the fewest risks.

I am registered for Nplate, and my health insurer will cover the cost. I will go that route if there is no other. I want to learn more about Promacta, because it's a pill and doesn't tie the patient to being at a registered physician's office ever week. The patient cannot self-administer Nplate because the algorithm for dosage is complex and dependent upon a current (same-day) CBC. So, one hies oneself to the doctor's office, gets a platelet count, gets weighed, and then they very precisely measure and administer the sub-cu shot. Could be easily self-done, just like an insulin injection, were it not for the dosage calculation piece.

My problem is what one does on vacation. The Nplate program will provide the names and assist with the connections for physicians located in the areas to which one might travel, but that would put the service 'out of network' and make the very expensive injection at least 20% billable to the patient - maybe more. I suppose we will just have to calculate that into the cost of a holiday. However, every year I take my mother to visit her family in a remote region in the mountains, and I'll be surprised if there's anyone close by who is certified to do the shot. (I'll be surprised if there is anyone close by who can spell "ITP.)

mngrrrl wrote: I am registered for Nplate, and my health insurer will cover the cost. I will go that route if there is no other. I want to learn more about Promacta, because it's a pill and doesn't tie the patient to being at a registered physician's office ever week. The patient cannot self-administer Nplate because the algorithm for dosage is complex and dependent upon a current (same-day) CBC. So, one hies oneself to the doctor's office, gets a platelet count, gets weighed, and then they very precisely measure and administer the sub-cu shot. Could be easily self-done, just like an insulin injection, were it not for the dosage calculation piece.

I've been self-injecting Nplate for over 2 years. Now just going for a blood test every 8 weeks. I don't understand why you guys aren't allowed to self-inject in the US. Seems odd but I expect it will come eventually.

I been told next time the count drops I be given nplate. Ann, you say you self administer. Does that happen to everyone in England? I did read somewhere that one is in hospital to learn how to and sent home per se.

How do you know the CBC count etc to know when to give it. Or is your count always low? It the first time this year over 17 years I had any real issue with low counts other than a fortnight.

Certainly better than being an inpatient....

Rhiannon, what normally happens is that you go each week to have a count done and the dose adjusted until you're stable on whatever dose and then you have so many doses to take home. I was going in every 4 weeks for a count until recently and now it's every 8 weeks. During the first few weeks they teach you how to do the injection. Of course they have to be satisfied that you can do it yourself before letting you go.

First off I had normal syringes and needles and vials of water but now get an all in one pack with a strange giving system in it. The instructions for giving the injection are at the bottom of this page if you want to see. www.medicines.org.uk/EMC/medicine/23117/SPC/Nplate+with+Reconstitution+Pack/