Amgen announces modifications to US prescribing information for use of erythropo

[okarol]

Amgen announces modifications to US prescribing information for use of erythropoiesis-stimulating agents in CKD

Thousand Oaks, California
Tuesday, June 28, 2011, 16:00 Hrs  [IST]
Amgen announced that the US Food and Drug Administration (FDA) has approved modified language in the prescribing information for the use of Erythropoiesis-Stimulating Agents (ESAs), including Aranesp (darbepoetin alfa) and Epogen (Epoetin alfa), in patients with Chronic Kidney Disease (CKD). The modified language, including changes to the Boxed Warning, provides important new information for the treatment of patients with CKD who are on dialysis, as well as those not on dialysis, to inform prescribers and patients of safety risks that have been identified in clinical trials. In recognition of the different benefit-risk profiles of ESA therapy in patients on dialysis compared to patients not on dialysis, the modified labelling provides separate treatment guidance for these two CKD populations.

Specifically, for patients on dialysis, the label advises physicians to initiate ESA therapy when the haemoglobin level is less than 10 g/dL and guides physicians to reduce or interrupt the dose when the haemoglobin approaches or exceeds 11 g/dL. For patients not on dialysis, physicians are asked to consider initiating ESA therapy when the haemoglobin level is below 10 g/dL, when reducing red blood cell transfusion-related risks is a clinical goal and when the rate of haemoglobin decline suggests a transfusion will be likely. Further, for those not on dialysis, physicians should reduce or interrupt the dose when the haemoglobin exceeds 10 g/dL. This guidance replaces the previous label language specifying a haemoglobin target range of 10-12 g/dL for both populations. The modified prescribing information continues to recognize the benefit of reducing the need for transfusions in CKD patients.

In addition, the Boxed Warning, Warnings and Precautions and Clinical Studies sections have been modified to advise that the use of ESAs to target a haemoglobin level of greater than 11 g/dL increases the risk of serious adverse cardiovascular reactions.

“Amgen supports the modified ESA prescribing information as it informs physicians of important safety information,” said Roger M Perlmutter, MD, PhD, executive vice president of research and development at Amgen. “The revised label also provides physicians with more individualized treatment guidance by distinguishing between patients undergoing dialysis as compared with those who are not on dialysis.”

The language in the prescribing information was informed by the results from clinical trials, including TREAT (the Trial to Reduce Cardiovascular Events with Aranesp Therapy), which targeted high haemoglobin levels (13 g/dL) in CKD patients who were not on dialysis and found an increased risk of stroke in the patients treated with ESAs compared to those receiving placebo. While TREAT was a study of patients who were not on dialysis, the modified Boxed Warning and other warnings in the label apply to all CKD patients.

Amgen is informing healthcare professionals about the revisions to the prescribing information through a joint “Dear Healthcare Professional” letter with Janssen Products, LP and will post the letter, along with the modified prescribing information on Amgen's website, www.amgen.com.

Amgen is in ongoing discussions with the FDA regarding additional post-marketing required studies to further understand the benefit-risk profile of ESAs in CKD patients on dialysis and not on dialysis.

Aranesp is indicated for the treatment of anaemia due to CKD, including patients on dialysis and not on dialysis.

Epogen is indicated for the treatment of anaemia due to CKD, including patients on dialysis and not on dialysis to decrease the need for Red Blood Cell (RBC) transfusions.

Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient.
 
http://www.pharmabiz.com/NewsDetails.aspx?aid=63669&sid=2

[tyefly]

Sorry to see this.... I feel pretty good when my hemoglobin is in the 11  and  I dont feel good when its below 11... I was at 12.3 and I was told to completely stop epo and in two weeks I went from 12.3 to 10.1.... and then I had to start again...   its really hard to start and stop and never know where you hemoglobin is and you feel tired and then you dont...  I hate this stuff....

[Jie]

So, it goes for 10-11. I thought 11-12 worked very well for me. 

[plugger]

I know a former dialyzor who says she refused to take epo because it made her sick.  I understand the clinic screamed, hollered and got all blue in the face - but she stuck to her guns.  I can't remember what her numbers were or if she still had some kidney function, but that story amazed me and I'm not recommending anybody try it.

But I'll have to get more details.  I just talked to her a few days ago.  We should be talking again here shortly, so hang on.

(I say former dialyzor since she has a transplant now)

[Desert Dancer]

Thank you for this, okarol; my clinic just emailed me to re-start my Epo because my Hgb is 11.3 and I was able to point them to this press release and say "Ahh.... no".  Hopefully they don't give me too much crap about it.

[plugger]

I did talk to my friend who refused to take epo.  She claims she had no kidney function, but said she exercised and took an over-the-counter iron supplement.  She didn't know her hemoglobin number, but said she couldn't get her hematocrit much above 20% - a number I understand is pretty darn low.

Sounds like she didn't feel on top of the world, but apparently it was better than how she felt on epo.  We both want to emphasize we aren't promoting not taking epo, but I thought it was an amazing story of someone with kidney disease managing to get away with not taking it.  I have to wonder if someone else getting sick from epo could at least get away with smaller doses - under a doctor's supervision of course.

[plugger]

Just thought I ought to post a reminder of what high doses of epo can do:

"High doses of Epogen and similar drugs can lead to increased risk for death, strokes and heart attacks in kidney dialysis patients, which is why the FDA following the study issued a black box warning to advise doctors that they should use only the lowest dose necessary."
http://whatifpost.com/dialysis-treatment-a-punch-in-the-kidneys.htm

[tyefly]

Would like to know what amount in considered high dose....

 Has anyone read the warning on Heparin....

[Jie]

I don't understand the epo issue is that the study before shows the risks increase with HGB 13 or higher. The target range was suggested for 11-12. Now with the new payment system, suddenly the target range is lowered to 10-11. I wonder this low range is more to do with money (payment changes) than the risks. 

[drgirlfriend]

The hematologist told us that cancer patients who are over 12 are considered at risk for bad side effects. Perhaps this is bringing everyone in line with that.