|
Quote:
When your info is given to TOUCH - they will confirm your benefits and find out what it will cost you. It isn't possible for anyone to give you that answer here. Even if you call the insurance company, they will want all sorts of codes and stuff (for the infusions, meds, etc.) - so it won't be easy for you to find out. However, your neuro's office and/or TOUCH can do it for you. Same pretty much follows thru for the other drugs. When I went on Copaxone - Shared Solutions contacted my insurance co, who put them in touch with the pharm that I had to use - and it was taken care of that way. This is big $$ - trust me - these people will help you. Good luck, ~Keri |
Thanks for the info. This is so not great. Another wait and see game. Well, I hope they use the fax lol. Thanks Again
|
Quote:
Anyway, it seems that my body decided to have it's first real asthma attack during the infusion. So was it a coincidence or did the Ty somehow trigger the attack or was it the Ty alone? Who knows? I do know that it was scary as hell. Now that I have experienced a few, I know what to expect so it's not as bad. So I have been getting benadryl and steroids before my infusion. Talk about a roller coaster! The benadryl brings you down and while the steroids are pumping you up. They really love steroids at my neuro. I've had a few infusions since and they are better though not trouble free. I think I get an MRI soon so I'll get a chance to see if this stuff is working at least as far as new lesions. |
insurance
Quote:
One of the most important things to look for is your maximum out of pocket. That's the most you will have to pay before your insurance company kicks in and pays in full for the rest of the year. I have Blue Cross. The initial outlay for the year is painful, but with this drug I very quikly reach the max and don't have to worry any more. Katty |
Thanks. I called my ins agent today. Looks like mine will be 4500. per yr. It hurts but it sure beats what it could have been. Oh, for those like me who have private ins - I was warned not to be one day late with payment. He said BCBS could look for a reason to cancel. Sheena:hug:
|
New Warning From FDA
I copied this from another forum...FYI.
Tysabri (natalizumab) Audience: Neurologists, other healthcare professionals, patients[Posted 02/27/2008] Biogen Idec, Elan and FDA notified healthcare professionals of reports of clinically significant liver injury, including markedly elevated serum hepatic enzymes and elevated total bilirubin, occurred as early as six days after the first dose of Tysabri. The combination of transaminase elevations and elevated bilirubin without evidence of obstruction is recognized as an important predictor of severe liver injury that may lead to death or the need for a liver transplant in some patients. Tysabri should be discontinued in patients with jaundice or other evidence of significant liver injury. Physicians should inform patients that Tysabri may cause liver injury. |
Quote:
Surely, regular (at least monthly) blood/liver checks are part of the monitoring protocol with Tysabri . . . aren't they? Cherie |
Let's get it all out there now, so people have the facts.
Letter sent today to Doctors: http://www.fda.gov/medwatch/safety/2...hcp_letter.pdf "FDA spokeswoman Sandy Walsh, however, said the letter does not reflect new cases but is simply a reiteration of a revised label the FDA approved Jan. 16 as part of the expanded use of the drug for the bowel disorder Crohn's disease." http://uk.reuters.com/article/hotSto...00898620080227 "Many other drugs are linked to liver injury, and it's possible rare cases that wouldn't be spotted are being found with Tysabri because it is closely monitored for infection risk" http://www.bloomberg.com/apps/news?p...AYvts&refer=uk You should ASK for your vial and box EVERY time you are infused. They are required to provide it for you if you request it. I get mine EVERY time. I want to SEE the changes they make to the label when they make them. I want to SEE what they are saying to people with Crohns disease who take Tysabri. They are changing the label so that doctors and patients are MORE aware that liver complications can result, especially in Crohns patients who have been on other biologic drugs. Look at the labeling for Avonex, Betaseron, Rebif AND Copaxone. All carry warnings about hepatotoxicity. For that matter, look at aspirin, tylenol, lipitor, etc, etc, etc. Knowledge is Power. Empower yourself. :) |
Thanks for the links, Riverwild.
Quote:
What does "ask for your vial and box" mean? Does this have anything to do with whether people's blood/liver is checked regularly? Cherie |
My neuro has not suggested bloodwork. I go for my 4th infusion next Wednesday. I do plan on asking about it.
|
Quote:
The responsibility of reporting what happened in the Tysabri trials lies with Biogen/Elan. I have never been a fan of those companies and have always questioned if we were being told everything about Tysabri. You start to hear information like this and it makes you wonder. I sure hope that MS patients are not again going to be subject to another possible therapy that may do more harm than good in the long run! Harry |
Quote:
Please do ask you Neuro and have a test soon, Barb..:hug: |
Quote:
Box= container that vial comes in. Date of expiration and Lot # are on box end Drug Monograph for Patient= That paper that is folded about twenty times and is tissue thin that gives every drop of scientific and FDA required information on and about drug. Found stuffed in every box of Tysabri. Not sure why that would have anything to do with someone being checked by their neurologist for liver function or blood"checks":confused: |
Quote:
Thanks Riverwild. I thought your "vial and box" comment was in answer to the question of whether people are currently having their blood/liver checked i.e. thought you were suggesting that people should be asking for a vial (of blood) to get it checked themselves. It doesn't seem the liver is being checked regularly as part of standard protocol? So, I suppose this letter was just to advise doctors of the risk, and to tell them to casually observe if their patients start turning yellow or getting very sick then. :confused: Cherie |
Quote:
Liver damage is a risk with Tylenol ....but millions upon millions of people take Tylenol. Liver damage was something I experienced on Avonex. Testing me every six months caught - in time - problems that could still be addressed and rectified: Severe liver damage within 6 days is quite another story. At least in my mind it is. I think it's a little cavalier (as Cherie seemes to suggest) to deal with this simply by suggesting people be on the look out for jaundice - something that indicates severe damage is already done. |
# 11 down
As usual, no problems, no concerns. Nothing to report, just a usual day. I did have a delicious blueberry muffin though!:p
|
My nuero told me he would be checking liver function ever other mo. I prob. could bump it to every mo. I'll think on that one. Thanks for the info.:p ~Sheena~
|
Final Draft of Tysabri Information Guide included with every vial of Tysabri
This information guide ( also known as a monograph) is included in every box of Tysabri. It is also included in the back pocket of the Tysabri Booklet " The Strength to Reach Your High Hopes " .
http://www.elan.com/ Click on "Full Prescribing Information and Medication Guide It's a PDF and it's long. It includes all new information added for Crohn's treatment. |
Quote:
From what I gather, liver damage with Tysabri has been openly discussed since the latter part of 2007. I have to assume it's on the radar longer than that... It also appears the damage can happen at any time during treatment (which is also the case with the inteferons, I experienced that :rolleyes:) but that it can be rather severe and fast moving so hopefully, this will lead to more aggressive testing for liver damage. Don't get me wrong - I love that Tysabri is an option for all of us - me included, even though I'm not considering it at present - but it's no silver bullet and it does come with a set of risks. Those risks are ever evolving and I think it's fair to be able to discuss them freely and honestly. becca44 |
Quote:
I also have a copy of a draft with corrections and blacked out areas found on the FDA website a few days ago dated Feb. 21st that contains all the information in the new published version. FYI- News first disseminated ahead of July advisory panel for Crohn’s. The FDA released slides ahead of the Jul 31 panel for Tysabri in Crohn’s showing 28 unduplicated cases of liver injury when using Tysabri, with 4 being serious despite no liver injury signal being identified in Tysabri clinical trials. All 4 patients with serious liver injury fully recovered, with no deaths or liver transplants. Importantly, during the actual Crohn’s panel, the members paid very little attention to the small liver risk, and ultimately approved the drug regardless. Liver risk included in label. Importantly, this news is no different from what is already included in the Tysabri label, which was updated upon the approval in Crohn’s disease on Jan 14. The updated label was based purely on the data at the Crohn’s panel, and included no new cases. The label specifically states that “TYSABRI should be discontinued in patients with jaundice or other evidence of significant liver injury (e.g., laboratory evidence)." |
Given that this is the sticky for those people who are contemplating Tysabri might review, it's probably as good a place as any to store all NMSS warnings/bulletins that come out along the way (like this recent liver one).
I am aware of two other warnings that have come out previously: Research Bulletins Bulletins Archive Researchers Report that Stopping Tysabri Increased MRI-Detected Disease Activity in Some Patients, September 14, 2007 Researchers from one site involved in the pivotal studies of Tysabri® (natalizumab, Biogen Idec and Elan Pharmaceuticals) in relapsing forms of MS report that stopping the drug may lead to an increase in the number of new and enlarging lesions (areas of damage or disease activity) detected on magnetic resonance imaging scans. They compared before-treatment scans with scans from a 15-month period after 21 participants stopped taking the drug. No substantial increase of clinical activity, such as relapses, was noted. These findings of “rebound” activity occurring in a small sample of patients warrant confirmation in independent, larger groups of people before recommendations can be made concerning Tysabri administration. Drs. Machteld Vellinga, Chris Polman (VU University Medical Center, Amsterdam, the Netherlands) and colleagues report the findings in the online edition of the journal Neurology (published online September 12, 2007). Background: Tysabri was approved by the FDA for relapsing MS based on its ability to slow disability progression and reduce relapses in two pivotal clinical trials, called AFFIRM (which compared Tysabri alone to inactive placebo in 942 people with relapsing MS) and SENTINEL (which tested Tysabri plus interferon beta-1a or Tysabri plus placebo in 1171 people with relapsing MS). Detailed results were published in The New England Journal of Medicine 2006;354:899-910 and 2006;354:911-923). These studies were suspended when two cases of PML (progressive multifocal leukoencephalopathy, a rare and frequently fatal disease of the central nervous system) were diagnosed in those on combination therapy. One of those cases was fatal. A third case of PML, also fatal, was uncovered in another person who had taken Tysabri during a clinical trial for Crohn’s disease. “Rebound” findings: When dosing was suspended in these studies at the VU University Medical Center in Amsterdam, the neuroradiologist reviewing post-treatment MRI scans noticed an increase in lesions among participants. The team analyzed “T2” lesions, which show cumulative damage, from 21 people who had MRI scans of their brains taken before taking Tysabri and again within a 15-month interval after discontinuing the drug. Participants were divided into two groups: one group took the drug for an average of three years, and the other group took the drug for an average of two months. Their findings show that the total group of participants developed more than three times as many lesions in the 15-month period after discontinuing the drug than before they started taking it. This increase was mainly driven by those who took the drug for an average of two months, who experienced five times as many brain lesions after stopping the drug. Clinical relapses did not increase following suspension of the drug. These findings of “rebound” activity occurred in a small sample of patients, and warrant confirmation in independent, larger groups of people so that their potential significance to clinical practice in terms of the administration of Tysabri can be determined. http://www.nationalmssociety.org/sit...rch_2007sept14 Research Bulletins Bulletins Archive Two Cases of Melanoma (Skin Cancer) Reported in People Taking Tysabri for MS, February 7, 2008 Physicians in Boston have reported two cases of melanoma (skin cancer) that developed in women in their practice who were administered Tysabri® (natalizumab, Biogen Idec and Elan Pharmaceuticals) to treat their multiple sclerosis. John T. Mullen, MD, and two colleagues (Beth Israel Deaconess Hospital, Boston) reported the cases in the New England Journal of Medicine (2008;358[6]:647-8). The melanomas developed early in the course of treatment, but it cannot be confirmed from these case reports that Tysabri caused them. However, the authors advise against treating individuals with Tysabri when there is a personal or family history of melanoma or in patients with atypical moles or ocular nevus (spot at the back of the eye). Background: Tysabri is a laboratory-produced monoclonal antibody that is approved for patients with relapsing forms of MS to delay the accumulation of physical disability and reduce the frequency of clinical exacerbations. It is designed to hamper movement of potentially damaging immune cells from the bloodstream, across the "blood-brain barrier" into the brain and spinal cord. Details: Dr. Mullen’s team reports that a 46-year-old woman developed a melanoma shortly after receiving her first dose of Tysabri, and an ocular nevus developed into a melanoma after several doses in a 45-year-old woman with a family history of melanoma . A case of melanoma also appeared in the AFFIRM study which involved 942 individuals with relapsing MS, who received either Tysabri or inactive placebo by intravenous infusions every four weeks for more than two years in a patient with a history of malignant melanoma. It cannot be confirmed from these reports that there is a causal link between Tysabri administration and the occurrence of melanoma. However, given these occurrences, the authors recommend that Tysabri not be administered to people with a history or family history of melanoma. “These reports raise concern and they underscore the importance of carefully tracking patients on powerful medications like Tysabri,” said Dr. John R. Richert, executive vice president of research and clinical programs at the National MS Society. “This drug is relatively new to the market, and as experience grows we are bound to learn more about its benefits as well as possible adverse events,” Dr. Richert added. http://www.nationalmssociety.org/sit...earch_2008feb7 Previous conversation here about this topic: http://neurotalk.psychcentral.com/sh...hlight=tysabri Cherie |
Quote:
Not a study. It's a sampling. What other drugs were they on for treatment after Tysabri was withdrawn from market? Were they on any treatment at all? We don't know. Why not? Because it wasn't a SCIENTIFIC STUDY. Does this show that a national organization purported to be an organization to disseminate facts to MS patients is doing anything but re-publishing unscientific data based on a sampling?? YUP. Study #2 Not a study. Two letters from two doctors from the same neurology department at the same hospital, published in the letters section of the NEJM. Both patients had a family history of MM or actually HAD MM prior to being treated with Tysabri. First made public by a financial analyst before the magazine was even in mailboxes. Show me studies, show me science, don't throw me rumor, Cherie. While both of the articles you got from NMSS may turn out to be more, at this time there are NO substantiated scientific studies associated with either of them. |
I'm with RW on this. I don't think that every scare story that comes down the pike, should be entered here....Only the recognized relevent studies that have actually been recognized by the FDA and added to the Warning label.
So many things are said, but not all are directly attributed to Tysabri and shouldn't just be thrown in here, without proper explaination. Thanks, RW, for doing that. Cherie, we all appreciate your knowledge of such things, but please explain about scientific proof. Remember all the scare tactics from LDN naysayers???:eek:.....All turned out NOT to be true.:) Thanks,:grouphug: |
Often we hear about this information through the media as it occurs, and those "rumors" are still out there when people start researching their options. However, I think it makes sense to reference these concerns from a reasonably reliable source such as the NMSS. If there is ANY merit (or not) to the rumors, the NMSS will publicize what they think is necessary . . . and they have.
That is true of LDN as well. When I was looking at the various options, I went to the MSS sites to see what was written so that I could objectively evaluate this alternative option. There were no "scientific studies" to validate the concerns expressed about LDN . . . but I definitely considered the NMSS's perspective on the topic. I think this input is as important a consideration as "anecdotal evidence" about how someone's shot of the month went, or how they think they are doing better. Both pieces of information are valuable, when considering Tysabri (in this case) and/or any other alternative. Cherie |
Fascinating article...
I find this fascinating. I remember hearing about the increase in lesion bulletin - but kinda just kept moving on - and said, "well - all the more reason to stay on Tysabri if it works for me..."... ;) - note: i havent started it yet - I am waiting for the TOUCH people to get their acts together. Anyhow - I find this interesting: Their findings show that the total group of participants developed more than three times as many lesions in the 15-month period after discontinuing the drug than before they started taking it. This increase was mainly driven by those who took the drug for an average of two months, who experienced five times as many brain lesions after stopping the drug. Clinical relapses did not increase following suspension of the drug. If you REALLY read that part of the statement (that is - If I am reading it correctly - but you know, I have holes in my brain, so some days I'm more "off" than not!) - you see that the people MOST affected were the ones who ONLY took Tysabri for TWO months! - "this increase was mainly driven by those who took the drug for an average of two months" - Also - as RW said - this isn't scientific - and we don't know cause-and-effect here - and as MS is a DEGENERATIVE disease - it makes sense that after a year of suspending a treatment that more lesions were found - especially if we do not know if a new treatment was started after Ty stopped. We also don't know if by the time Ty was stopped if any of the people tested had changed classification from RRMS to something more progressive, that could account for the quicker increase in lesions. EVEN IF we can say that they are rebound lesions - then wouldn't we also have to argue that Ty prevented them from forming while on treatment - and so that those participants who were on Ty for three years - did not have an increase in lesions during treatment - and as we've heard reports from many people on Ty - one might be led to believe that in the years they were on Ty - that they had QUALITY of life - the Ty helped grant them that. ISN'T THAT THE POINT OF THE TREATMENT - at this point in time - as so far - no one has made any claim to be a cure for MS? Okay, so I admit - it does kinda suck that the increase of lesions after stopping treatment is so large and it is a little alarming! I am a supporter of the med - but I'm also not an ignoramus! LOL Will it stop me from taking Ty? No, probably not. If Ty works for me - would it make me very upset if they pull it from the market? YOU BET. Then we'd have to show the FDA that pulling it from the market does more harm than good. ;) Alright, time for me to call TOUCH and see if they're getting my paperwork in order. Cherie - I am glad you posted the article - I believe in INFORMED CONSENT - buyer beware - know what you are getting into before you get in! ~Keri |
Well, as someone who's seriously weighing the risk vs. benefit of all of the therapies currently available to me, I don't find this infomation particularly ...rumor-esque.
I'm a big proponent of the therapies available, no matter how frustrated I am sometimes. I had liver damage with Avonex and body dents by Copaxone; yet I STILL wouldn't take back my decisions to take those drugs when I did. As to the after market data on Tysabri, we're not talking about "studies" per se. There are no studies specifically designed (double blind w/placebo using control groups) to specifically measure how many people will develop or die from PML, malignant moles or suffer liver damage: those things just happened along the way. They're noted. They're documented. And they're significant enough that the FDA and the manufacturer of the drug communicated to doctors and patients that they happened . They're not sounding the fire alarm here, but they ain't just whistling Dixie, either. This is significant information. Why on earth would we not talk about these things? I have personal doubts about taking this drug. I don't have doubts about the people who've chosen to take this drug ...because I trust they're doing exactly the right thing for themselves ...but I do get a little frustrated that some of us are criticized for not being cheerleaders where this drug is concerned. My opinion is what it is. |
RedP,
You are talking about a drug here that plays big time with one's immune system. It prevents certain parts of one's immune cells from crossing the blood-brain barrier and doing what they normally do. Now, for whatever reason, the patient has to stop taking Tysabri because the nasty side-effects can become life threatening. Now these immune system cells, after being prevented from doing their thing for a long period of time, start to go into the brain again. In reported cases, some patients are getting a huge increase in the number of brain lesions! All the MS drug trials hang their claim to fame that they reduce the number of these lesions. Now the drug they can't take anymore could possibly cause their MS to speed up tremendously. First it was stopping the drug resulting a large increase in lesions, then it was problems with melanoma and moles and now it's possible severe liver damage happening very quickly. Do you not think that Biogen may have rushed this drug out the door a bit too quickly??!! Here is a company (Biogen/Elan) that along with the FDA, rushed the approval process by one year. They combined it with Avonex in a trial BEFORE the drug was approved on its own. They published a part of their marketing plan on the internet, stating how many $ billions they would make and how huge a chunk of the MS drug market they would gain BEFORE the drug got approved. I just can't trust these people to be telling us what else they don't want us to know about Tysabri. Harry |
I think that you have to weigh the pros and cons with tysabri just as you do with any drug therapy. In my case I am allergic to interferons and had too many bad reactions to copaxone. (5 serious IPIRs in 4 1/2 months) So I decided to go on tysabri after alot of deliberation. I did not make this decision blindly. It is true that no one know the long term side effects of this drug. That is true of all new drug therapies. So I could wait a few more years, take nothing, and have my MS progress. Or I could try to get into a study where I may be taking a placebo and the drug being studied may also have potential problems associated with it. I know that tysabri is not the "silver bullet" but I
am willing to take the risk. Quality of life is more important to me. Oh, I have scheduled an appointment with a dermatologist for a full body mole check and I am planning to ask my neuro about bloodwork at my 4th tysabri appointment on Wednesday. I also am experiencing less fatigue and I am using my cane less. |
Quote:
|
Quote:
:) becca |
Upcoming AAN Conference in Chicago
Here is the link to abstracts for the upcoming AAN Conference.
http://www.abstracts2view.com/aan2008chicago/index.php Check box ( I understand and agree) and click submit under Guest Access. You can search for specific drug studies by name in the search box at the top of the page. Tysabri ( Natalizumab) has 18 matches. |
http://www.medpagetoday.com/ProductA...ptions/dh/8522
A small paraphrased section from this link I got from Sassy follows: Quote:
The reason I ask is because I've been having worsening heartburn that now includes what I thought was stomach pain? My PCP has been doing tests to find out why Nexium and Prilosec OTC is not relieving it. I also gave up coffee and spicy foods. I suppose I could also give up chocolate and my daily glass of wine. :icon_mad: I had blood tests last week, and today, an ultrasound of my liver, gallbladder and pancreas. I have to have a stress test on a treadmill on Friday. :( I don't think my heart has a problem, but who knows? I really hope the PCP is just being overly dramatic. :rolleyes: They're going to try to get the ultrasound results by tomorrow, because I'm due for my next infusion on Wednesday afternoon. I'm also supposed to have new MRI's on Wednesday at noon. I doubt there's anything seriously wrong, because I take good care of myself, but I'm a little bit concerned. Wish me luck with all this! I don't want to give up the Tysabri, but I kind of like my internal organs too! |
Quote:
Sorry to hear you are having problems. I certainly hope it turns out to be minor! Having to take all those tests just bites, especially when they are all in such a short span of time! It seems to leave no time for the enjoyable things in life! I'd not give up the chocolate and the daily dose of resveratrols until the doc said they have to go! One must have SOME vices! (The "evidence of other significant liver injury" would be the blood tests they run, the scan they do on your liver, etc.) Please let us know how it goes for you and I hope you feel better!:hug: |
Hey 'Wiz,
Evidence of other significant liver injury can be itching, jaundice, yellowing of the whites of ones' eyes, abdominal swelling, pain... becca44 |
Thanks Becca,
I know, I found that out yesterday. This is going to bug me until I find out what, if anything, is wrong. I saw the dermatologist last week to get a baseline check for moles and such. She said all of my moles are normal and healthy. :Scratch-Head: But I also asked for something for the crown of my head. It's been itching madly. She gave me a strong shampoo made for people with psoriasis, though all she saw was a tiny bit of dandruff. The shampoo costs $200+ for 4 oz. before insurance. So all I have is that itching and the abdominal pain. I don't know if the PCP ordered a liver panel last week or not. I'll ask today when I talk to his nurse. I hope I'm just worrying over nothing. It does say on the package insert for Tysabri that abdominal pain can be a side effect. I think it also mentions pruritis (sp?) which I think means itching. I'm pretty careful to have a healthy diet with lots of carcinogen fighters, so I doubt it's anything serious. |
I Hope everything turns out OK for you, Wiz. That's a bit scary...:hug:
|
I hope everything turns out ok, too, Wiz! Keep us all posted!
|
Whew! The liver is A-OK! :) My PCP called me late today. He said that the gallbladder is slightly enlarged, and I have high calcium levels in my blood. Those are the only two abnormalities.
I still have to have the stress test on Friday, then likely a scope of my esophagus and stomach. They also might do a CAT scan of the gallbladder. He said there was no sign of gallstones. :) So I can quit worrying about my liver! I can have a glass of wine tonight, and go for my infusion tomorrow! :trampoline: I also get a set of brain MRI's tomorrow, and the facility is right by the neuro's office, so I'll have the results at my appointment. Wow. I had myself worked up, worrying about pancreatic cancer and other such nightmares. :o |
Quote:
I was suspicious of inflammation of the gallbladder but I ain't a gastro doc. I brought in quite a few patients with gall bladder attacks and it ain't pretty when it's inflamed. Do you have the pain after eating fats? Also please ask your gastro doc to test for h. pylori if he hasn't already. It would suck if it was something as simple as that, after all the worrying you have been through, and it's a simple breath/saliva test depending on which one he uses. |
Quote:
Good news, Ewizabeth! "It is never normal to have high calcium levels in your blood. Over 98% of ALL people who have a blood test that shows too much calcium will have a parathyroid problem. ... it is (also) possible for a person to take too much vitamin D so that they absorb too much calcium from their diet and hold on to too much calcium in their kidneys... and their calcium goes high." http://www.parathyroid.com/high-calcium.htm Cherie |
| All times are GMT -5. The time now is 01:05 PM. |
Powered by vBulletin • Copyright ©2000 - 2025, Jelsoft Enterprises Ltd.
vBulletin Optimisation provided by
vB Optimise (Lite) -
vBulletin Mods & Addons Copyright © 2025 DragonByte Technologies Ltd.