raltegravir (Isentress)

following an abbreviated submission

raltegravir granules for oral suspension (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 adults, adolescents, children, toddlers and infants from the age of 4 weeks.

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 granules should be prescribed under the supervision of specialists in paediatric HIV.

The granules for oral suspension are licensed for use in patients weighing 3kg to 20kg and provide an alternative formulation for infants where chewable tablets are not suitable.

Because the formulations are not bioequivalent, neither the granules for oral suspension nor the
chewable tablets should be substituted for the 400 mg film-coated tablet.

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.