raltegravir (Isentress)

following an abbreviated submission

raltegravir chewable tablets (Isentress®) are accepted for restricted use within NHS Scotland.

Indication under review: in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in children from the age of 4 weeks to <2 years.

SMC restriction: patients who are intolerant or resistant to non-nucleoside reverse transcriptase inhibitors (NNRTIs) or protease inhibitors (PIs) or when these options are compromised due to drug-drug interactions; raltegravir chewable tablets should be prescribed under the supervision of specialists in paediatric HIV.

The chewable tablets are not bioequivalent to the film-coated tablets and therefore are not interchangeable.

SMC has previously accepted raltegravir 25mg and 100mg chewable tablets and raltegravir 400mg film-coated tablets for restricted use in combination with other anti-retroviral medicinal products for the treatment of HIV-1 infection in adolescents and children aged 2 to 17 years and in adult patients. Raltegravir is listed in the British National Formulary for Children for the treatment of HIV infection.