Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
Pifeltro is indicated, in combination with other antiretroviral medicinal products, for the treatment of adults, and adolescents aged 12 years and older weighing at least 35 kg infected with human immunodeficiency virus type 1 (HIV-1) without past or present evidence of resistance to the non-nucleoside reverse transcriptase inhibitors (NNRTI) class (see sections 4.4 and 5.1).
Therapy should be initiated by a physician experienced in the management of HIV infection.
The recommended dose is one 100 mg tablet taken orally once daily with or without food.
If Pifeltro is co-administered with rifabutin, one 100 mg tablet of Pifeltro should be taken twice daily (approximately 12 hours apart) (see section 4.5).
Co-administration of doravirine 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 of Pifeltro should be taken twice daily (approximately 12 hours apart).
If the patient misses a dose of Pifeltro within 12 hours of the time it is usually taken, the patient should take as soon as possible and resume the normal dosing schedule. If a patient misses a dose by more than 12 hours, the patient should not take the missed dose and instead take the next dose at the regularly scheduled time. The patient should not take 2 doses at one time.
No dose adjustment of doravirine is required in elderly patients (see section 5.2).
No dose adjustment of doravirine is required in patients with mild, moderate, or severe renal impairment. Doravirine has not been studied in patients with end-stage renal disease and has not been studied in dialysis patients (see section 5.2).
No dose adjustment of doravirine is required in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment. Doravirine has not been studied in patients with severe hepatic impairment (Child-Pugh Class C). It is not known whether the exposure to doravirine will increase in patients with severe hepatic impairment. Therefore, caution is advised when doravirine is administered to patients with severe hepatic impairment (see section 5.2).
Safety and efficacy of Pifeltro in children aged less than 12 years or weighing less than 35 kg have not been established. No data are available.
Pifeltro must be taken orally, once daily with or without food and swallowed whole (see section 5.2).
There is no information on potential acute symptoms and signs of overdose with doravirine.
30 months.
After first opening of the bottle use within 35 days.
Store in the original bottle and keep the bottle tightly closed in order to protect from moisture. Do not remove the desiccant. This medicinal product does not require any special temperature storage conditions. For storage conditions after first opening of the bottle see section 6.3.
Each carton contains a high density polyethylene (HDPE) bottle with a polypropylene child-resistant closure with silica gel desiccant.
The following pack sizes are available:
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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