raltegravir (Isentress)

following an abbreviated submission:

raltegravir (Isentress®) is 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 adolescents and children aged 2 to 17 years.

SMC restriction: to 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 should to be prescribed under the supervision of specialists in paediatric HIV.

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

SMC has previously accepted raltegravir 400mg film-coated tablets for restricted use in combination with other anti-retroviral medicinal products for the treatment of HIV-1 infection in adult patients. Raltegravir is listed in the British National Formulary for Children for the treatment of HIV infection.