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raltegravir (Isentress®)


Reference No. 1609

Publication date:
03/12/2013


Appraisal information

raltegravir (Isentress®) 25 mg chewable tablet
raltegravir (Isentress®) 100 mg chewable tablet
raltegravir (Isentress®) 400 mg film-coated tablet


Company: Merck Sharp & Dohme Ltd
BNF category: Infections
NMG meeting date: 11/09/2013
AWMSG meeting date: 16/10/2013
   
   
Submission Type: Limited Submission
Status: Recommended with restrictions
Advice No: 2913
Ministerial ratification: 02/12/2013

Current Progress


Submission
received
NMG
meeting
AWMSG
meeting
Ministerial
Ratification

AWMSG advice

Raltegravir (Isentress®) 25 mg and 100 mg chewable tablets, in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in children are recommended as an option for restricted use within NHS Wales. Raltegravir (Isentress®) 400 mg film-coated tablets, in combination with other anti-retroviral medicinal products for the treatment of HIV-1 infection in adolescents and children from the age of 6 years and weighing ≥ 25 kg, are recommended as an option for restricted use within NHS Wales. Raltegravir (Isentress®) 25 mg and 100 mg chewable tablets and 400 mg film-coated tablets should be restricted for use in patients who are resistant or intolerant to non-nucleoside reverse transcriptase inhibitors (NNRTIs) or protease inhibitors (Pis), or for whom these options are compromised due to drug–drug interactions.
Final Appraisal Recommendation (FAR)
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AWMSG Secretariat Appraisal Report (ASAR)
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Clinical Expert (CE) Summary
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