Following administration of a single oral dose of 750 mg 14C-telaprevir in healthy subjects, 90% of total radioactivity was recovered in feces, urine and
expired air within 96 hours post-dose. The median recovery of the administered radioactive dose was approximately 82% in the feces, 9% in exhaled air and
1% in urine. The contribution of unchanged 14C-telaprevir and the R-diastereomer of telaprevir towards total radioactivity recovered in feces was 31.9% and
18.8%, respectively. After oral administration, the apparent total clearance (Cl/F) was estimated to be 32.4 L/h with an inter-individual variability of 27.2%.
The mean elimination half-life after single-dose oral administration of telaprevir 750 mg typically ranged from about 4.0 to 4.7 hours. At steady state, the
effective half-life is about 9 to 11 hours.
A you can probally tell from the time of post I am having trouble sleeping as well. It took about 10 days for me to start feeling better after the incivek but now my anxiety has kicked into high gear and insomnia seems to be gitting worse. I have been thinking it is because the incivek keep me feeling worn out and tired, I was on promethazine as well and stopped when I finished the incivek which also made me tired now that I am not taking those anymore I feel like the sx of the Inf/riba are more prevalent. Just a thought and what I am expiriencing.
i talked about withdrawal sx from incivek too...thats what it felt like to me...i had a few good days right after stopping the incivek then tanked...took a full couple weeks to kind of level off....there doesn't seem to be much info on this problem yet...but since i went through it i've see others say the same type of stuff...good luck.....billy
Oh Gosh Dee, I surely hope I dont have this to look forward to also. Tomorrow is my last day of INC and I am happy but somehow dreading it. During the last 12 weeks, I could always tell a difference in me about the time a new dose was ready to take. Seems like I get more anxious until I take it, and it wasnt that way in the beginning but only for the last 4 weeks. I think I will slowly decrease the fat or at least keep at least 10-15 grams with each dosage with Riba afterwards and slowly deplete it. I know today I havent drank enough water because I am so flippin nauseated and I will be dry mouth in the morning, so I am not looking forward to that either.
I havent had to hit any rescue drugs either for low cbc, so for that I am greatful. Hopefully my labs will be UND as well.
Congrats to you girl and I hope it gets better. Keep us informed as I am right behind you. C
Incivek? Taper to reduce sx?
NO. INCIVEK should NEVER be stopped or tapered during treatment. All clinic trial data is based on stopping, not tapering. Even in the PROVE 3 24 week arm.
"HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use INCIVEK safely and effectively."
"2.2 Dose Reduction
To prevent treatment failure, the dose of INCIVEK must not be reduced or interrupted. Refer to the respective prescribing information for dose modification of peginterferon alfa and ribavirin [see Warnings and Precautions (5.7)]."
INCIVEK must not be administered as monotherapy and must only be prescribed with both peginterferon alfa and ribavirin. Therefore, the prescribing information for peginterferon alfa and ribavirin must be consulted before starting treatment with INCIVEK.
There are no clinical data on re-treating patients who have failed an HCV NS3/4A protease inhibitor-based treatment, nor are there data on repeated courses of INCIVEK [see Microbiology (12.4)]."
i just stopped cold turkey. No one ever said to taper off after completing the 12 weeks. certainly like hector said not before the last day of the 12th week.
If I was having withdraws Iwouldnt have known it because I just felt like [email protected]
It was a week or two before I felt better and it just got a little better each day.
Thanks so much, I thought I had done something wrong I am feeling a little better I had no one to ask
Thank you for commenting, I have been feeling really bad since a couple of days after taking the last dose of Incivek and was looking for any information
Thank you so much
It was about a week and a half before I started feeling better too. I think the incivek sx had started to really peak a week or so before I finished and my system was very taxed so part of this may have been my system recovering a little. The riba rage is hitting me harder now and I think I would cry at pics of puppy dogs. It may be without the incivek hitting me so hard I now am alert enough to react to the rest of the meds.
I don't know how bad the victrelis sx are but I am glad I started with the big bang with incivek from the start, but only taking for 12 weeks. It makes the second half of treatment seem so much easier.
Hang in there, there seems to be a pattern with feeling better within 10 days to 2 weeks. Hopefully this will hold true for you too.
Thank you so very much I have been very afraid, I did not go through this when I did a triple trial back in 2008. Of course I relapsed but my point is that I am just so afraid, I appreciate any responses. @ Hector Thanks again, as always you are spot on.
@ Hrswspr Thank you
Hang in there. That hemoblobin has to be getting you down. I think you did everything like you were supposed to and you should be seeing some relief soon. There is no tapering with Incevik. That is clear from the dosing information and the FDA submission information. Hector and Horsepwr have provided that.
You should be feeling better but, Dee, how anemic did you get with your first treatment? It could be that you may need some rescue drugs for your last 12 weeks. I think what all the doctors are doing is thinking that since there are only 12 weeks left that the patient can get through it without them. However, first, are you getting weekly CBCs? If not request another one now and push for the results the next day. Ask you doctor for Procrit if it is still in the 9s -- you still have a long way to go.
Thank you all for your responses, I did not know where to turn, I saw my doc on Wednesday and he said many people were experiencing problems and they did not know why. So, that is when I realized how low my HGB was (the day I saw him) I bet he was not worried cause he feels it wil now go up without the Incivek. I am calling this morning to get blood work. Last night I could not get enough oxygen and thought I was having a a stroke or something. No they are only doing every 4 weeks draws, last draw Nov 23 showed 9.9 hgb as well as low everything else.
Thank you so very much. I thought I had planned this out but obviusly I did not and you are right I still have a way to go and can't do a thing now, I thought it would get better without Incivek. Yes I did get anemic on last tx however I continued to work, no rescue drugs were allowed.
Thank you so very much
Hector / hrsepwrguy
Thank you for your responses.
I believe as the anecdotal reports of the PIs additional sx become more widely reported it's inevitable that people are going to start playing with their dosing. If FDA approval took into consideration the risk of creating resistant strains of HCV, I believe it was done with the assumption of full compliance. Maybe not a reasonable assumption.
Perhaps the doctors who Rx these drugs need to be made more responsible for educating their patients. It certainly isn't practical to dispense them one dose at a time, ala methadone maintanence.
I realize this is an old post however just saw this. Wanted to agree with you that doctors need to be more responsible with the medication and not prescribe until they know what to expect and how to help.
I am much better, still UND, now and know much more than I did, all thanks to this forum and the assistant at my docs office.
Tapering off is a good question for someone here to answer.Do you taper off before or after tx?My wife told me after stopping Incevek that I looked like I was withdrawing from some drug.The after effects I had after Incevek were short lived.From a few days to a week.If longer I would of called my Dr.My senses returned back to normal and I had to return to taking my high blood pressure pills(sadly to say) when I got headaches and dizziness.Wishing you SVR.
Just wanted to come back and say that I am now SVR, 10 months post and think I got in to trouble because I was the first patient that my doctor treated with Incivek.
He did not have a clue how to help me so I had to help myself.
Thank God for the Speciaty Pharmacist who had the latest drug interactions (which my doc did not) and they helped me realize it was the medications I was on.
I did recover, slowly, my sense of time really got messed up. I felt I was moving so slowly while those around me were buzzing around.
It took close to 3 weeks for me to recover from that.
I appreciate everyone who answered this post. I was in the midst of a real crisis and would not have made it without all of these comments.
Great news 10 months out. Happy New Year to you! I'm at week 11 and really struggling. My last peg injection is this Friday and then I will finish incevik and ribavirin on January 10th In the last two weeks my rash has gotten out of control I have medication from a derm but its not helping. The rash is absolutely everywhere and now is creeping up onto my face. I also just found out that my B12 is extremely low. Must explain why I've spent the last 10 days lying on the sofa. Frankly I'm so miserable I'm not sure I can hang in there one more day let alone one more week! Any words of advice or encouragement would be appreciated. Thanks!
First, you have posted in an older thread. You may get more responses if you start a new thread. Go to the top and click on the orange rectangular bar and then pick a subject title and post your question.
Also, I am not understanding something about your treatment.
Are you Genotype 1?
If you are Genotype 1, then why are you treating for only 12 weeks?
The normal treatment protocol for those with Genotype 1, who do not have cirrhosis, and who are treatment naive is 12 weeks of Interferon, Ribavirin, and Incivek followed by another 12 weeks of Interferon and Ribavirin. I do not understand why your treatment is only 12 weeks long.
The other issue is your rash. I do not know how bad it is. I know you said it is everywhere, but that does not tell us the degree, a few bumps everywhere and many bumps running together everywhere. Is it hives or fine rash or blisters. As far as the rash is concerned, if it was me, I would get an urgent appt with the derm doc for tomorrow and get back in to see him/her and get something stronger for the rash. Depending on how severe it is, they may pull you off the Incivek or possible all drug. But that depends on the severity.
My rash never got under control until I was on Hydroxyzine 50 mg every 6 hours, and Fluocinonide ointment and clobetesol solution. All prescriptions. Some people have needed steroids but you cannot take Incivek and oral or injection steroids. Topical steroids are fine.
So you probably need some stronger drugs to get your rash under control.
Here is a chart/photos to show you the Mild, Moderate, and Severe rashes.
Pick the top site on the list. When you get there just check that you are a health care professional. (Otherwise you won't get to see the photos.)
Then click the lower right hand corner box, continue to HCP site. Then you can see the photos. They changed that site. You used to be able to go directly to the photos. Now you have to go through all of these additional steps.
You will note that the rash can be severe and in some rare cases fatal so please call your derm doc tomorrow and get seen tomorrow so you can obtain treatment.
Alao, talk to your treating doc about the low B12.
Best of luck.
Thanks so much for your info. I went on the Incivek website and I think Im in the moderate to severe stage of the rash. I will call the study doc tomorrow and have them see me. The study I'm involved in is triple therapy for 12 weeks then off the Incivek and possibly randomized to continue peg and ribavin for another 12. I am genotype 1b and I've decided to stop all meds after 12 weeks.Though the study docs do not know this yet. They have already reduced the ribavirin from 5 pills a day to 3. I haven't noticed any difference. I'm just seriously tired of whining about this!
Well, I was moderate pushing severe, LOL, and I can tell you that I was using topical steroids with some localized relief but it took forever. Once I got on the Hydroxyzine 50 mg every 6 hours, the rash finally got under control and I was not longer miserable. The topical stuff helps but only where you put it and only for a short time. Most of these rashes are systemic rashes, allergic reactions, and most need some systemic intervention. The Hydroxyzine workes on the entire body because it is oral and it is an antihistamine. It prevents the rash and itching. I don''t know what I would have done without it. I was truly miserable before i finally got on it.
I am not saying it would work perfectly for you, but if there is some way you can control that rash and stay on the drugs, you have a better chance for SVR. It would be a shame for you to have to stop the medications when maybe all the docs have to do is order something to control your rash. There have been many on this forum who were able to stay on the drugs after getting appropriate rash treatment. Unfortunately others had to stop treatment because their docs did not get on top of the rash fast enough and order something (like Hydroxyzine) to control the rash. As I said before, some have even gone on oral steroids and a couple had steroid injections but they were able to complete their treatment and attain SVR. Hopefully your doctor will get you the appropriate treatment for your rash. It would make all the difference in the world. It did for me.
Thanks again for the info and encouragement. I will ask them about the hydroxyzine tomorrow. Keep you posted.
You may want to take a look at this thread because it deals with one person's rash saga. Not only does she post several times in the thread, so do many others and I think the thread may be very helpful to you.
And this thread:
And this thread:
These threads are all about the same rash but it gives you an idea how things progressed.
By the way, she finished treatment and is now SVR.