Black box warning for Procrit

article in today's news regarding new FDA warnings for the use of Procrit and Procrit type products.

http://www.medpagetoday.com/ProductAlert/Prescriptions/tb/5231

[jmjm530]

Thanks for posting. So far I only glanced at the article but it's another important reminder that the drugs we're taking aren't candy and a lot of thought should go into weighing the risks versus benefits of ALL these drugs.

I do quibble though with this exerpt:

"Moreover, the FDA said that there has never been any evidence to support claims made in direct-to-consumer advertising that treatment with darbepoetin (Aranesp), epoetin alfa (Epogen), or epoetin alfa (Procrit) could increase energy or ease fatigue in patients undergoing cancer therapy."

Not up to date on cancer studies, but we all know that Procrit does make it possible for many of us to continue on treatment at our current ribavirin dose. And in fact, at least one study has been posted recently to support the notion that the administration of Procrit (epo) helps treatment compliance which therefore translates into better odds of SVR. Personally, I never would have been able to continue on 1200mg/day of ribavirin without Procrit. Just no way.

--Jim

[Forseegood]

yes, I'm just hearing about this on the NBC news...I was wondering who was going to post it, you are so conscientious...

I guess that is why so many doctors are so conservative in it's use, and only use it if it's really needed..

[FlGuy]

Thanks for the article. Just found out yesterday will likely start procrit this week. One more cbc to confirm trend.  Gee, next we'll read that interferon and ribavirin are unhealthy. Being sick is not as easy as it used to be.

[DoubleDose]

I hope your comment about interferon and ribavirin someday being called 'possibly unhealthy' was said with tongue planted firmly in cheek!  Because I got a kick out of it.  I think its a little like: Wow! if we ONLY knew!  All the interferon and ribavirin and procrit that many of us have endured for many, many months...and we wonder why we often have serious post tx problems?

I saw my GP the other day, and just like clockwork, the post-tx blood pressure continues to elevate.  I never had anything close to high blood pressure before tx, but during the latter months of tx, and for the last three years (since becoming SVR) my blood pressure has been more and more elevated.  Of course this is only one of a whole bevy of post-tx issues that developed after finishing therapy that I have been patiently dealing with.  My post tx issues are similar to many others who have posted about similar problems, here on the forum.

Now some people may chime in that these things have not been 'documented' to be absolutely 'caused by' interferon, but I think that is only because the in-depth post tx studies are still a work in progress,(a very slow work) and nobody on the medical/ pharmaceutical side of things has any huge motivation to be closely exploring these sorts of issues.  And I don't think any of us should hold our breath waiting for these types of studies to be compiled.  

My GP said after the BP/Cardio exam..."well I guess its from all that interferon that you took!"  Nice!
A little like Jim's hepatologist throwing in the comment about Metabolic Syndrome being caused by tx.  Oh Gee, isn't that nice!

I get the feeling that interferon side effects are a little like 'insider information' with the doctors.  They know a lot, but they are not saying very much out loud.

There is so much to sort out, with interferon, procrit, ribavirin, that they can all point at each other and say 'well, maybe that is what caused the after effects'.
Kind of a 'he said - she said' approach.  

I guess after ten or fifteen more years of documentation and mounting after-effects, the FDA will someday issue a similar proclamation about interferon:  "Why watch out son, its some dangerous stuff.  Don't use too much or it'll fry ya"   But by then the docs will be using something else for HCV.  "Why don't ya worry son, we don't use that **** anymore.  That stuff, it'll wreck ya!"

Just staying in touch folks.  Here in sunny after-effect land!  Have a great weekend to all of you!

DoubleDose  

[mauilady]

Interferon and Ribavirin ARE unhealthy; we gotta get worse before we get better.... go figure.  As long as it works and I don't end up brain-dead in the process... ;-)

[mauilady]

Sorry... I got your nickname wrong....

[jmjm530]

DD: I hope your comment about interferon and ribavirin someday being called 'possibly unhealthy' was said with tongue planted firmly in cheek!
---------------------
From where I sit, FlGuy may need the Jaws-of-Life to get that tongue
back wagging. LOL. Good to see ya DD. Check out the research article posted above on sunless tanning. If you're gonna go down the tubes, mine as well look great :)

-- Jim

[l-horn]

You know, I've been having pain in the back of one of my calfs like a muscle pull which I was told can be a sign of deep vein thrombosis. It started a few days ago but has 'kind of' gone away so I've been doing the 'wait and see'.  I noticed in this warming that it says: 'Explain to patients that the FDA found there is evidence that increasing hemoglobin to more than 12 g/dL can increase the risk of thrombotic events.'

I'll be calling my doctor on Monday.

thanks for posting this

[GoofyDad]

I tried to write off the persistent brain slog to age, and my hepo said, "A lot of my [post tx] patients say that. But you're 48, not 78. You shouldn't be experiencing this".

BTW, it seems to be improving. I'm certainly putting the thinker through it's paces these days.

[friole]

Woke up to read this as breaking news on AOL.  I suppose the FDA warning on anemia drugs is justifiable, but my fear is that it is going to really hurt our little community who desperately need these blood boosters.  

I do think any one of us who takes one of these needs weekly CBC's.  I do agree with the warnings that we need to take the minimum dose possible.  However, I wonder how this is going to impact the practices of the normal GI who takes on hep C patients without much knowledge and without the desire to learn much.

I read that the panel of FDA advisers is going to meet May 10 to decide about the labeling requirements.  Of further note, it was mentioned that the experts were concerned that MEDICARE was overusing Epogen.  Think about that folks -- what if you are waiting until you turn 65 to treat and they cut off payments for Epogen?  That could end up to be a really costly treatment.  

I am not happy to see this.

[poetic_wax]

LOL, black box sounds like an airplane or something. What is this all about?

[Evannescence]

I live in the UK.  Is Procrit used here?  

[l-horn]

Yeah but it doesn't say 'don't use it'. It says don't use it in a certain way.
It says, if I understand it, to not raise the hgb to more than 12 as it can increase thrombotic events AND actually stimulate cancer growth, which makes sense if you think about it, and to dose in a manner which slowly raises the hgb levels to the target range of 12 and to not exceed 12. Further, it says that procrit will not increase energy or relieve fatigue as it is advertised, which I agree with. I've been taking it for 13 weeks now and I feel pretty damn fatigued. Bottom line is procrit is used to raise hgb levels because low hgb has it's own problems, not to 'make us feel better' as most seem to think that's its purpose.

[FL_Gal]

l-horn, I agree with you 100%.  I believe that Procrit can be safe if used responsibly and only as needed, and if labs are monitored properly.

All of these drugs that we take (not just the HCV ones) need to be balanced very carefully, and the rewards need to be measured against the risks.

[2irish]

Yes, it is used in the uK.  Sorry I don't know the name of it but think it is made by something like orto biotek co.?? Sorry, I am not clear on it...but it is in use!.   P.s. read your old post on vision probs. and I had the same thing.  my eyes are worse now after tx but it it tx or age related?  I lived on murine tears day and night.  good luck!   irish  p.s. where are youin UK?  my son-in-law hails from manchester.  I LOVE England, course i'm a half & half!

[Proactive]

Saw you mentioned you were from the UK..and remembered I had a link to a hep forum in which many posters appear to be from your side of the pond. Thought if you didn't already have it, I'd post it for you...My "Hep C" folder is packed with links G
http://www.ronmetcalfe.com/hepcforum/index.php

[l-horn]

The place to find out is on the Ron Metcalf hepc blog/forum. It's been a while since I've been there, but if I recall there is some issue with the public health care system and procrit in the UK. It's been so long since I've been there I can't remember but they would know, for sure.

[MissMiss]

This article scares me.  You may remember that I had the weird heart things going on that started after taking the Neumega and my hgb tanked to the 7's.  My procrit was increased to 120 a week at that time and I continued on that dose for about 6-7 weeks, then slowly dropped it down down to nothing.  The heart things continued and I had the heart cath showing a healthy heart.  They shook their heads and assumed maybe it was from my thyroid being elevated.

This makes me concerned about my legs pains, even tho I was dx'd with myopathy in the legs.  There are times when I get pains right where they went in for the cath but I get it on both legs!  I think I will make an appt asap to discuss this with my GP.  

Thank you for posting the info!  But, no matter what, I am undetectable at 7 mo post tx.  

miss

[cigaso]

I brought this thread up so I could get some feedback from "the panel" (the panel is anyone who responds). I am in a fight with my insurance company regarding their refusal in authorizing the specialty pharmacy to ship Procrit and Nuepogen. My insurance company says the FDA considers these drugs to be experimental and will not authorize their use. The insurance review board from my insurance company says that "their" doctors and nurses recommend decreasing my dosages of Riba and Inteferon. My ANC is 800 and my Hemoglobin is 9.5. I know these are not Medicare low, but they have been decreasing steadily over the last month.  My dr has dropped my riba from 1200 to 900ml a day. I think I am compromising my tx because my dr doesn't seem to want go against my insurance company. I know starting out tx I have a 50 to 50 chance of SVR. If I drop riba to 900 a day I wonder how much lower my chances would be. I am being tx by a large teaching Hospital. I don't know if I should continue fighting the insurance company or just be okay with the drop in meds.

I have done an internet search and the FDA, Medicare and Congress are seriously putting the clamps on the use of Procrit, Aranesp and Epogin. Just in case anyone is interested Johnson & Johnson sells procrit outside of the USA as Eprex.

[kcmike]

I had a problem when I switched pharmacies mid-tx.  Medco had no problem filling scripts, but Pharmacare said it was not specifically indicated for HCV treatment.  My doctor had to file an appeal with insurance that stated it was specifically indicated for cancer patients w/ anemia, and that's what we were fighting, anemia.  The appeal was granted but I had to borrow 4-40k vials to continue tx w/out discontinuing riba.  I am at a large research hospital also and they should have staff to take care of this.  Your doctor won't even see the appeal form until he signs them!

Mike

[pigeonca]

If you have dropped to 9.5 in a short period after starting tx, it seems to me that you definitely need one of these drugs.  As I understand it, doctors can fight the insurance companies and win, but it's up to you to do some convincing or even arm-twisting if necessary before your doctor will probably respond.  Procrit, Epo, Aranesp etc. can cause problems after one's hgb returns to a normal level (I believe 12.0 or so).  But it is perfectly safe, indeed quite necessary, when administered for anemia.

It's late and past my bedtime, but you can google the names of the drugs plus "black box" and you should be able to find some journal references to support your argument.  If you have genotype 1, I would think you want to keep your riba intake at as high a level as possible.  Remind your doctor that a liver transplant is way more expensive than Procrit, because the restriction - despite any excuses they may give you at the insurance company - is mostly monetary.  Good luck...

[jmjm530]

From my experience, your doctor is the one who has to be the strong advocate for a particular drug, as patients can only go so far in the process. I've been denied several drugs by a national insurance company, but in each case my doctor(s) contacted the insurance companies, made the case, and the drug was approved. The people you will end up speaking on the phone are probably just reading from a fact sheet/directive. Your doctor will speak to a different department who hopefully will have the authority to allow certain drugs on a case by case basis. If your doctor wont' go to bat for you, one alterntive is to switch doctors.

All the best,

-- Jim

[FlGuy]

The 'formula' that has worked for me is using the services of a Hematologist/Oncologyst.  They run the blood labs there (not pcrs or lfts) and provide instant results while I wait.  Then, depending on what's low they will administer Aranesp (this tx) or Neupogen (prior tx) and send me on my way.  They submit to insurance and there is no need for a prescription. And, there is never a co=pay like there is for my prescribed peg and riba.  I was told that since it's a clinical setting that there are different rules that might apply to the meds - from the insurnace Co.'s perspective.  It's faily easy for me, the office is close to home and the staff are really good at getting me in and out of the office quickly.  They realize that many of their other daily patientts are there for several hours and they sort of have an 'express lane' for labs only.

[jmjm530]

Just want to add that often it's as simple as your doctor using the correct diagnosis code. For example, the code for Hep C, may not work with Procrit (epo), but the code for anemia might. Again, a doctor who has significant experience in treating Hep C patients and who advocates helper drugs like Procrit, should be able to facilitate these things. A doctor without this experience or advocacy, will probably simply go by the basic insurance company's basic guidelines. You and your doctor should view these basic guidelines as simply a first step in negotiating with them, not as the final say.

[cigaso]

kcmike,
This is what puzzles me. Since I am not a transplant patient, I see a NP once a month who heads up tx for HCV patients. I also talk to her about 1-2 times a week on the phone concerning my labs. I am being tx as an outpatient. I was recommended and passed on to the Transplant Center by the GI ( we all know that GI can't prescribe Procrit/Neupogen). At the transplant center they have hepitologist, but I never see them. I have only talked to the NP. When my insurance company went through the review and appeal process to considering authorization my NP said that my insurance needed to talk to my dr's. She said that would never happen. She said they were to busy in the opperating room transplanting organs. This is when I picked up the appeal process and was declined 3 times. Now I need procrit and my NP reduces my Riba instead of fighting my insurance. Thanks.

FlGuy,
I did exactly what you said last week. I tried to do an end around and go to a Hematologist that tx me for anemia, luekopenia and neutropenia when I was on my first round of tx. He tried to get a presciption authorized through my insurance company for anemia and they declined again. Thanks for the input.

jmjm,
Thanks for the insight. I'll pursue my NP to offer a different code. Who knows it just may slip through the cracks and get approved. Also, please read my repsonse to kcmike and let me know if you have any ideas.

[FlGuy]

Maybe it's the many differences among insurance companies and the policies they issue.  When I get Aranesp (this time)or had Neup/Neulasta (last tx) it was filed as a claim against the medical portion of coverage, not prescription.  Which , I think, is part of that 'clinical setting' thing.  When things get paid, other than by me, I tend not  to ask many questions.  Good luck.  As if there are not enough obstacles with hcv, getting well should not be one of them.

[kcmike]

Jim might be on to something, change the code, don't even mention HCV.  As I mentioned my doctors appeal said we are treating anemia.  It has got to be fixable.  It's a shame that they just shrugg their shoulders and don't know what else to do.  If your Hgb continues to drop you'll be facing an interruption of all Riba around 8.5 or so.  Maybe it's time to find a new doc.  How many weeks into treatment are you?  

Perhaps someone else will jump in with the name of a prescription assist line that can help you out until you can square things away with your pharmacy.  I hope you find an advocate at the insurance company soon.

Mike

[cigaso]

Pigeonca,
I think the common advice is to have my drs fight this battle. Thanks.

Flguy,
Yes, I tried that with my hematologist and the insurance company turned it down. I must be red flagged. Fighting my insurance is exhausting.

kcmike,
I'm on my 2nd round and I have been on for 18 weeks. Good point. I don't want to and will not stop taking the Riba. If I do, I'll probably relapse. I do not want to go to a third round.

[orleans]

Hey, If one were to pay for procrit out of pocket would that end the problem? I know it is costly, anyone know how much and how long it is used? thanks, jm

[jmjm530]

If insurance allows, I'd collect all my records and make an appointment with an experienced liver specialist (hepatologist) who will sit down, talk with you, and work with you.

If that is impossible, and you're stuck with this group, I would document everything that the NP is telling you and then yell bloody murder in the form of of calls, letters, etc, to the head of the hepatology department. She can't in one breath tell you that your insurance company will only talk to the doctor, and in the other breath tell you that isn't ever going to happen. Hopefully, once you break through this nurse's maginot line, things will get better.

-- Jim

[cigaso]

orleans,
It is expensive and way out of my budget.

jmjm,
Thanks for your candor and fire. Here is a little background: I was fired from the company I worked for 3 months after I told them I had Hep C and was going on tx. As soon as my "fun pack" came in I was let go. This brings up another can of worms , which I am working with the EEOC. Since I had been approved for tx from my employer's insurance company I had to retain them on Cobra. This leaves me with few options. I could go with other drs, but they would have to be in the insurance's network. It seems everything goes back to the insurance company. If you or anyone else has any ideas, please let me know.

I just got off the phone with my NP and she gave me the results of my PCR RNA <5 Heptimax and my VL is 20(IU) after 16 weeks. VL has gone down every month. I say this because I maybe headed in your direction of 72 weeks of tx. She wants to tack on 24 weeks onto my 48. I take a PCR RNA test once a month. I'm hoping I will be und by September so I may only have to do 56 weeks.