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Use in Prostatic cancer

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http://news.bbc.co.uk/2/hi/health/8110103.stm Najafhaider (talk) 19:42, 20 June 2009 (UTC)[reply]

Reuters news

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http://www.reuters.com/article/idUSTRE64K64D20100521 --Nevit (talk) 22:34, 21 May 2010 (UTC)[reply]

From FDA MedWatch

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Yervoy (ipilimumab): Risk Evaluation and Mitigation Strategy (REMS) - Severe Immune-Mediated Adverse Reactions

ISSUE: Bristol-Myers Squibb informed healthcare professionals about the risk evaluation and mitigation strategy (REMS), developed in collaboration with FDA, that is required to ensure that the benefits of Yervoy outweigh the risks of severe and fatal immune-mediated adverse reactions. The Yervoy REMS consists of a Communication Plan to inform healthcare professionals of the serious risks of Yervoy, to facilitate early identification of these risks, and an overview of recommended management of patients with moderate or more severe immune-mediated adverse reactions. BACKGROUND: Yervoy was approved March 2011 with the Prescribing Information including a Boxed Warning stating that use of the product can result in severe and fatal immune-mediated adverse reactions due to T-cell activation and proliferation. These immune-mediated reactions may involve any organ system; however, the most common severe immune-mediated adverse reactions are enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy. The majority of these immune-mediated reactions initially manifested during treatment; however, a minority occurred weeks to months after discontinuation of Yervoy.

RECOMMENDATION: Healthcare providers were advised to read the boxed warning and accompanying full Prescribing Information for a complete description of these risks and their management and were advised to discuss the risks that may be associated with therapy with patients and their caregivers. Clinicians were advised to: • permanently discontinue Yervoy and initiate systemic high dose corticosteroid therapy for indentified severe immune-mediated reactions. • assess patients for signs and symptoms of enterocolitis, dermatitis, neuropathy and endocrinopathy and evaluate clinical chemistries including liver function tests and thyroid function tests at baseline and before each dose. —Preceding unsigned comment added by 72.37.171.28 (talk) 14:36, 7 April 2011 (UTC)[reply]

Cost

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Can we confirm the cost ? eg "Yervoy costs about $120,000 for a course of treatment" - Rod57 (talk) 06:40, 9 July 2011 (UTC)[reply]

WP:MOSMED says "Do not include dose, titration or pricing information except when they are extensively discussed by secondary sources...". --ἀνυπόδητος (talk) 13:10, 12 July 2011 (UTC)[reply]
It also suggests an economics subsection. In the case of ipilimumab the £18,000 per course of treatment is discussed in the UK press while awaiting a NICE decision in Feb 2012. - Rod57 (talk) 12:36, 23 August 2011 (UTC)[reply]
The £18,000 course gains an average 4 months of life suggesting approx £54,000 per QALY gained. - Rod57 (talk) 23:52, 26 August 2011 (UTC)[reply]
WP:MEDMOS continues "or necessary for the discussion in the article." This is one of those very expensive drugs, where cost is a policy issue. This issue is extensively discussed in the secondary literature. In the U.K., NICE might not accept it. In the U.S., patients might not be able to afford it. The fact that a drug costs $120,000 is notable. --Nbauman (talk) 10:53, 27 June 2012 (UTC)[reply]
OK, I agree it is notable under these circumstances. Have you got a reliable source for the costs and their discussion in literature and media? --ἀνυπόδητος (talk) 11:27, 27 June 2012 (UTC)[reply]
I just did a Google search for "Yervoy cost" and found lots of WP:RSs, including the New York Times, and Fierce Biotech, which linked to 3 more WP:RS stories, including some on the NICE reaction. The pharmaceutical companies seem to be pricing every drug that extends life by a few months at $100,000 or more.
http://www.nytimes.com/2011/03/26/business/26drug.html
http://www.fiercepharma.com/story/120k-price-tag-yervoy-hailed-potential-blockbuster/2011-03-28
http://www.fiercepharma.com/story/nice-bmss-yervoy-cost-too-darn-high/2011-10-14
I'll come back when I've finished this week's NEJM. --Nbauman (talk) 13:52, 27 June 2012 (UTC)[reply]
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Bristol-Myers Squibb Medical (BMS Medical) suggests the addition of these links to independent regulatory authorities for the following countries for inclusion in your external links site:

USA: http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=2265ef30-253e-11df-8a39-0800200c9a66

UK: http://www.medicines.org.uk/emc/medicine/24779/SPC/YERVOY+5+mg+ml+concentrate+for+solution+for+infusion

Canada: http://webprod5.hc-sc.gc.ca/dpd-bdpp/start-debuter.do?lang=eng

Australia: https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/PICMI?OpenForm&t=PI&q=yervoy&r=/ BMSMedical (talk) 19:57, 28 April 2014 (UTC)[reply]

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Pregnancy categories

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The FDA is phasing out the pregnancy categories A, B, C, D, and X for drugs. The US section of the "Pregnancy category" section needs to be updated. Firestar464 (talk) 11:48, 7 September 2020 (UTC)[reply]

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