Anyone using promacta for platelets?

[crossroadsec]

I DO want my full dose of interferon back. I haven't heard much discussion regarding raising platelets w promacta. I'm all good with procrit and am not looking to borrow trouble or fear.. I don't go there. But any thots regarding SE and results would be soo helpful. BTW - feeling great 1 week after Incivik! Week 15. Yay! Karen :)

[HectorSF]

Karen, I'm sure your doctor knows best. I have no medical training only my own limited experience with ESLD and HCC. But here is the info from the PROMACTA  label which is the most dangerous drug I have ever heard of for patients with cirrhosis including Child-Pugh Class A Cirrhosis (something know as early cirrhosis, before decompensation) which is the status of your liver.

There was great hope that this drug was going to be the answer to low platelet counts and cirrhosis when treating with HCV meds. Unfortunately, the drug can be TOXIC TO THE LIVER (hepatotoxicity). It is only to be prescribed for patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.

NOTE: This drug can have very serious side effects including life-threatening effects so it is restricted in it's use. You have to be registered to receive it. The program requires all patients to be educated about the potential risks involved and you have to sign a consent form releasing the doctor and drug company of the consequences if the drug harms you.
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5.8 PROMACTA Distribution Program

PROMACTA is available only through a restricted distribution program called PROMACTA CARES. Under PROMACTA CARES, only prescribers, pharmacies, and patients registered with the program are able to prescribe, dispense, and receive PROMACTA. This program provides educational materials and a mechanism for the proper use of PROMACTA. To enroll in PROMACTA CARES, call 1-877-9-PROMACTA (1-877-977-6622). Prescribers and patients are required to understand the risks of therapy with PROMACTA. Prescribers are required to understand the information in the prescribing information and be able to:

• Educate patients on the benefits and risks of treatment with PROMACTA, ensure that the patient receives the Medication Guide, instruct them to read it, and encourage them to ask questions when considering PROMACTA. Patients may be educated by the enrolled
prescriber or a healthcare provider under that prescriber’s direction.
• Review the PROMACTA CARES Prescriber Enrollment Forms, sign the form, and return the form according to PROMACTA CARES Program instructions.
• As part of the initial prescription process for PROMACTA, obtain the patient's signature on the Patient Enrollment and Consent form, sign it, place the original signed form in the patient's medical record, send a copy to PROMACTA CARES, and give a copy to the patient.
• Report any serious adverse events associated with the use of PROMACTA to PROMACTA CARES Call Center at 1-877-9-PROMACTA (1-877-977-6622) or to the FDA’s MedWatch Program at 1-800-FDA-1088.
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Because of the risk for hepatotoxicity and other risks, PROMACTA is available ONLY through a restricted distribution program.
To enroll in the restricted distribution program, PROMACTA CARES, call 1-877-9PROMACTA (1-877-977-6622).
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"HIGHLIGHTS OF PRESCRIBING INFORMATION"

PROMACTA® (eltrombopag) Tablets For oral use Initial U.S. Approval: 2008
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WARNING: RISK FOR HEPATOTOXICITY
See full prescribing information for complete boxed warning
PROMACTA may cause hepatotoxicity:
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Measure serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin prior to initiation of PROMACTA, every 2 weeks during the dose adjustment phase, and monthly following establishment of a stable dose. If bilirubin is elevated, perform fractionation.
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Evaluate abnormal serum liver tests with repeat testing within 3 to 5 days. If the abnormalities are confirmed, monitor serum liver tests weekly until the abnormality(ies) resolve, stabilize, or return to baseline levels.
●
Discontinue PROMACTA if ALT levels increase to ≥3X upper limit of normal (ULN) and are:
●
progressive, or
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persistent for ≥4 weeks, or
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accompanied by increased direct bilirubin, or
●
accompanied by clinical symptoms of liver injury or evidence for hepatic decompensation.
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----------------------------INDICATIONS AND USAGE--------------------PROMACTA is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
PROMACTA should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. PROMACTA should NOT be used in an attempt to normalize platelet counts.

-----------------------WARNINGS AND PRECAUTIONS----------------•
PROMACTA may cause hepatotoxicity. Increases in serum aminotransferase levels and bilirubin were observed. Liver chemistries must be measured before the initiation of treatment and regularly during treatment. (5.1)
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5 WARNINGS AND PRECAUTIONS

5.1 Risk for Hepatotoxicity

Reinitiating treatment with PROMACTA is not recommended. If the potential benefit for reinitiating treatment with PROMACTA is considered to outweigh the risk for hepatotoxicity, treatment with PROMACTA is not recommended. If the potential benefit for reinitiating treatment with PROMACTA is considered to outweigh the risk for hepatotoxicity, then cautiously reintroduce PROMACTA and measure serum liver tests weekly during the dose adjustment phase. If liver tests abnormalities persist, worsen or recur, then permanently
discontinue PROMACTA.

**********************************************************************
Pharmacokinetic evaluations in patients with hepatic impairment show that plasma eltrombopag AUC(0-τ) increases with increasing degree of hepatic impairment (as measured by Child-Pugh). Exercise caution when administering PROMACTA to patients with hepatic
impairment (Child-Pugh Class A, B, C). Use a lower starting dose of PROMACTA in patients with any degree of hepatic impairment and monitor closely.

Karen, you have Child-Pugh Class A cirrhosis.

8.6 Hepatic Impairment

The disposition of PROMACTA following a single 50 mg dose in patients with mild,moderate, and severe hepatic impairment was compared to subjects with normal hepatic function. The degree of hepatic impairment was based on Child-Pugh score. Plasma eltrombopag AUC0-∞ was 41% higher in patients with mild hepatic impairment (Child-Pugh A) compared to subjects with normal hepatic function. Plasma eltrombopag AUC0-∞ was approximately 2-fold higher in patients with moderate (Child-Pugh B) and severe hepatic impairment (Child-Pugh C). The half-life of PROMACTA was prolonged 2-fold in these patients. This clinical study did not evaluate protein binding effects. Similar results were seen in a population pharmacokinetic (PK) analysis in thrombocytopenic patients with chronic liver disease following repeat doses of eltrombopag. However, compared to healthy volunteers, the population PK analysis demonstrated that mild
hepatic impairment resulted in an 87% to 110% higher plasma eltrombopag AUC(0-τ) and patients with moderate hepatic impairment had approximately 141% to 240% higher plasma eltrombopag AUC(0-τ) values. The half-life of PROMACTA was prolonged 3-fold in patients with mild hepatic impairment and 4-fold in patients with moderate hepatic impairment. This clinical study
did not evaluate protein binding effects.

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022291s001lbl.pdf

Best
Hector

[crossroadsec]

TX nurse is reassuring. Said they'll monitor it closely and keep me on a minumum dose. I go to a transplant hospital and she said she's used it as a measure to keep people on tx. I've got 33 weeks to go.
Insurance company said 3 months worth is all they'll go for now. I'm glad for their conservative approach. I've been at 1/2 dose interferon for what???? 6 or 8 weeks now? G4/S4 and undetected?? I just wanna finish the race. Sigh. We'll do anything, right?
lol just looked at all my question marks. A real indicator of my concern. Thank you. Once again, you have such a heart to sooth others anxiety.
xoxoxo Take care.. Karen :)
Oh and I just found where Spectda inquired about it. Trying to open some old posts. The archives are FAT!

[eureka254]

Whoa, you got approved for Promacta? You definitely got juice, girl!
My husband's tx docs refused to write the script, so it never even got to the insurance/pharmacy stage.  The tx nurse, part of the TP center my husband goes to wouldn't prescribe it because of poor trial results and risk for stroke (see ELEVATE trial).  They did consider plt transfusion, but he never got so low as to have plt transfusion.

http://www.newsinferno.com/pharmaceuticals/promacta-study-halted-over-safety-concerns/

There are, however guidelines for administration because of low plts due to cirrhosis, so I guess you managed to get in under those guidelines:

http://www.drugs.com/pro/promacta.html

[crossroadsec]

Thanks. Why did they turn ur husband down on promacta?
I've got reaserch going. My platelets just got UP into the 30's after transfusion. Insurance co approved both this week... Hmmm. We wanna see how fast they drop. I tens not to research cuz I hate fear.. Diving in. Aaahhh! Karen :)

[eureka254]

I only remember a couple of people ever getting it prescribed for low plts... maybe they'll pop in, but very few and far between I believe.  I know from my own experience with my husband, it was an absolute NO, even when plts were down in the 30s, it was dose reduction.  Having low plts won't give you "side effects" like having anemia does... the only risk would be injury or bleeding, you really wouldn't "feel" any side effect.  I would expect, though, if your insurance gave you resistance on Procrit, it will be doubly so for Promacta... not approved for anything other than ITP as I understand it.  There was a trial last year using Promacta on hcv tx patients that had to be stopped because of adverse events, so something to keep in mind.

Glad you're feeling great... keep that feeling going!