Symtuza Dosage/Direction for Use

Therapy should be initiated by a physician experienced in the management of HIV-1 infection.
Posology: The recommended dose regimen in adults and adolescents aged 12 years and older, weighing at least 40 kg, is one tablet taken once daily with food.
ART-naïve patients: The recommended dose regimen is one film-coated tablet of Symtuza once daily taken with food.
ART-experienced patients: One film-coated tablet of Symtuza once daily taken with food may be used in patients with prior exposure to antiretroviral medicinal products but without darunavir resistance associated mutations (DRV-RAMs)* and who have plasma HIV-1 RNA < 100,000 copies/mL and CD4+ cell count ≥ 100 cells x 10⁶/L (see Pharmacology: Pharmacodynamics under Actions).
* DRV-RAMs: V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V, L89V.
Advice on missed doses: If a dose of Symtuza is missed within 12 hours of the time it is usually taken, patients should be instructed to take the prescribed dose of Symtuza with food as soon as possible. If a missed dose is noticed later than 12 hours of the time it is usually taken, it should not be taken and the patient should resume the usual dosing schedule.
In case a patient vomits within 1 hour of taking the medicine, another dose of Symtuza should be taken with food as soon as possible. If a patient vomits more than 1 hour after taking the medicine, the patient does not need to take another dose of Symtuza until the next regularly scheduled time.
Special populations: Elderly: Limited information is available in this population, and, therefore, Symtuza should be used with caution in patients above 65 years of age (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: No dose adjustment of Symtuza is required in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment, however, Symtuza should be used with caution in these patients, as the darunavir and cobicistat components of Symtuza are metabolised by the hepatic system.
Symtuza has not been studied in patients with severe hepatic impairment (Child-Pugh Class C), therefore, Symtuza must not be used in patients with severe hepatic impairment (see Contraindications, Precautions, and Pharmacology: Pharmacokinetics under Actions).
Renal impairment: No dose adjustment of Symtuza is required in patients with estimated glomerular filtration rate according to the Cockcroft-Gault formula (eGFR_CG) ≥ 30 mL/min.
Symtuza should not be initiated in patients with eGFR_CG < 30 mL/min, as there are no data available regarding the use of Symtuza in this population (see Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions).
Symtuza should be discontinued in patients with eGFR_CG that declines below 30 mL/min during treatment (see Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions).
Paediatric population: The safety and efficacy of Symtuza in children aged 3-11 years, or weighing < 40 kg, have not yet been established. No data are available.
Symtuza should not be used in paediatric patients below 3 years of age because of safety concerns (see Precautions and Pharmacology: Toxicology: Preclinical safety data under Actions).
Pregnancy and postpartum: Treatment with darunavir/cobicistat (two of the components of Symtuza) during pregnancy results in low darunavir exposure (see Precautions and Pharmacology: Pharmacokinetics under Actions). Therefore, therapy with Symtuza should not be initiated during pregnancy, and women who become pregnant during therapy with Symtuza should be switched to an alternative regimen (see Precautions and Use in Pregnancy & Lactation).
Method of administration: Symtuza should be taken orally, once daily with food (see Pharmacology: Pharmacokinetics under Actions). The tablet should not be crushed.