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Biotech / Medical : Myogen (MYOG)
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To: tuck who wrote (47)1/23/2007 9:04:44 AM
From: kenhott   of 50
 
Still catching up on reading. You were looking around these issues.

From the EU label for Thelin:

CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
EFFECTIVE USE OF THE MEDICINAL PRODUCT

The MAH shall set up a surveillance programme to collect information on: the demographics of patients prescribed Thelin, any adverse reactions and reasons for discontinuation of Thelin. Details of such a surveillance programme should be agreed with the National Competent Authorities in each
member state and put in place prior to marketing of the product.

The MAH must agree the details of a controlled distribution system with the National Competent Authorities and must implement such programme nationally to ensure that, prior to prescribing, all doctors who intend to prescribe Thelin are provided with a physician information pack containing the
following:
• Product information
• Physician information about Thelin
• Patient information card
• Partner of patient information card
The physician information about Thelin should contain the following key elements:
• That Thelin is teratogenic
o Need for pregnancy testing prior to first and subsequent prescriptions
o Use of effective contraception in women of child bearing age
o Possible interaction with oral contraceptives and increased risk of thromboembolism
o Need to advise female patients about teratogenicity, need for pregnancy testing and contraception, what to do if they become pregnant
o Referral of patients who become pregnant to a physician specialised or experienced in teratology and its diagnosis for evaluation and advice
• That Thelin is hepatotoxic
o Need for liver function tests prior to and during treatment
o Contraindication in patients with pre-existing hepatic disease
o Discontinue sitaxentan sodium immediately if liver enzymes rise above 5 x ULN
o Need for close monitoring if liver enzymes measure between 3 and 5 x ULN, with discontinuation if a repeat analysis is above 3 x ULN, and not restarted until levels have returned to below 3 x ULN
• That treatment with Thelin often causes a decrease in haemoglobin and related red cell parameters
o Need for full blood count prior to use and monitoring at clinically appropriate intervals
• That there is an increased risk of bleeding with Thelin
o Interaction with warfarin and vitamin K antagonists leading to an increased INR
o Need to decrease established dose of vitamin K antagonist upon starting sitaxentan therapy
o Start vitamin K antagonists treatment at a reduced dose if already on sitaxentan sodium
o Need for regular monitoring of INR
o Co-prescription with sildenafil may increase the risk of haemorrhage
o Be aware of the potential for haemorrhage and investigate as appropriate
• That there is an interaction with cyclosporin A which may lead to higher blood concentration of Thelin and hence an increased risk of adverse reactions.
• That the safety database of Thelin is limited and physicians are encouraged to enrol patients in a surveillance programme to increase knowledge about the incidence of important adverse
drug reactions (ADRs). The surveillance programme should prompt doctors to report serious ADRs and certain selected ADRs as below immediately and other non-serious ADRs at three
monthly intervals.

<cut>------------------------------------------

Competitive interaction/safety issues in label: contraception, sildenafil, warfarin.

A comment on contraception: Bosentan lowers the effectiveness of oral contraceptions. Another form of contraception is NECESSARY. I believe this is a Bosentan only problem.

A comment on Sildenafil: Here was/is ENCY position on Sildenafil/Sitaxsentan: Interaction Data Preliminary Analysis- No clinically relevant effect on sildenafil Cmax - increased 18% and AUC - increased 28% No effect on n-desmethyl sildenafil No effect of sildenafil on sitaxsentan.
Insight: Not a clinically relevant interaction.

Bonsentan also interacts with Sildenafil.
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