Doravirine

eMC SPC §4.2 (Pifeltro 100 mg film-coated tablets). Therapy should be initiated by a physician experienced in the management of HIV infection. DOSE ADJUSTMENT FOR INTERACTIONS: if co-administered with rifabutin, one 100 mg tablet should be taken TWICE daily (approximately 12 hours apart). Co-administration with other moderate CYP3A inducers has not been evaluated but decreased doravirine concentrations are expected; if co-administration with other moderate CYP3A inducers (e.g. dabrafenib, lesinurad, bosentan, thioridazine, nafcillin, modafinil, telotristat ethyl) cannot be avoided, one 100 mg tablet should be taken twice daily (approximately 12 hours apart). MISSED DOSE: if missed within 12 hours of the usual time, take as soon as possible and resume the normal schedule; if missed by more than 12 hours, skip it and take the next dose at the regularly scheduled time - do not take 2 doses at one time. ELDERLY: no dose adjustment required. HEPATIC IMPAIRMENT: no dose adjustment in mild (Child-Pugh A) or moderate (Child-Pugh B) impairment; not studied in severe impairment (Child-Pugh C) and it is not known whether exposure will increase, so caution is advised. SEVERE CUTANEOUS ADVERSE REACTIONS (§4.4): Stevens-Johnson syndrome / toxic epidermal necrolysis have been reported post-marketing with doravirine-containing regimens - withdraw immediately if suggestive signs or symptoms appear, and never restart a doravirine-containing regimen in a patient who has developed a serious reaction such as TEN. Tablets contain lactose monohydrate. RESISTANCE: there is insufficient clinical evidence to support use in patients infected with HIV-1 with evidence of resistance to the NNRTI class. PAEDIATRIC: safety and efficacy in children aged less than 12 years or weighing less than 35 kg have not been established (no data) - verify any under-18 use against a children's formulary. NOTE ON US LABELLING: the openFDA label in this bundle is for a different product (IDVYNSO) and was not used for the dose.