Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
Delstrigo is indicated for the treatment of adults 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, lamivudine, or tenofovir (see sections 4.4 and 5.1).
Delstrigo is also indicated for the treatment of adolescents aged 12 years and older weighing at least 35 kg who are infected with HIV-1 without past or present evidence of resistance to the NNRTI class, lamivudine, or tenofovir and who have experienced toxicities which preclude the use of other regimens that do not contain tenofovir disoproxil (see sections 4.4 and 5.1).
Therapy should be initiated by a physician experienced in the management of HIV infection.
The recommended dose of Delstrigo is one 100/300/245 mg tablet taken orally once daily with or without food.
If Delstrigo is co-administered with rifabutin, the doravirine dose should be increased to 100 mg twice daily. This is achieved by adding one 100 mg tablet of doravirine (as a single agent), to be taken approximately 12 hours apart from the dose of Delstrigo (see section 4.5).
Co-administration ofdoravirine 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 doravirine should be taken daily, approximately 12 hours after the dose of Delstrigo (see section 4.5).
If the patient misses a dose of Delstrigo within 12 hours of the time it is usually taken, the patient should take Delstrigo as soon as possible and resume the normal dosing schedule. If a patient misses a dose of Delstrigo 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.
There are limited data available on the use of doravirine, lamivudine, and tenofovir disoproxil in patients aged 65 years and over. There is no evidence that elderly patients require a different dose than younger adult patients (see section 5.2). Special care is advised in this age group due to age associated changes such as decreases in renal function (see section 4.4).
No dose adjustment of Delstrigo is required in patients with estimated creatinine clearance (CrCl) ≥50 mL/min.
Delstrigo should not be initiated in patients with estimated CrCl <50 mL/min (see sections 4.4 and 5.2). Delstrigo should be discontinued if estimated CrCl declines below 50 mL/min (see section 4.4). Patients with moderate or severe renal impairment require a dose interval adjustment of lamivudine and tenofovir disoproxil that cannot be achieved with the combination tablet (see sections 4.4 and 5.2).
No dose adjustment of doravirine/lamivudine/tenofovir disoproxil 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/lamivudine/tenofovir disoproxil is administered to patients with severe hepatic impairment (see section 5.2).
Safety and efficacy of Delstrigo in children aged less than 12 years or weighing less than 35 kg have not been established. No data are available.
Delstrigo 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.
Because a negligible amount of lamivudine was removed via (4-hour) haemodialysis, continuous ambulatory peritoneal dialysis, and automated peritoneal dialysis, it is not known if continuous haemodialysis would provide clinical benefit in a lamivudine overdose event.
Tenofovir disoproxil is efficiently removed by haemodialysis with an extraction coefficient of approximately 54%. Following a single 245 mg dose of tenofovir disoproxil, a 4-hour haemodialysis session removed approximately 10% of the administered tenofovir dose.
30 months.
Store in the original bottle and keep the bottle tightly closed to protect from moisture. Do not remove the desiccant. This medicinal product does not require any special temperature storage conditions.
Each carton contains a high density polyethylene (HDPE) bottle with a polypropylene child-resistant closure with silica gel desiccants.
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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