Usual Adult Dose for HIV Infection

1 tablet orally once a day with food

Comments:

• This drug is not recommended during pregnancy due to considerably lower exposures of darunavir and cobicistat during the second and third trimesters of pregnancy.
• This drug should not be started in pregnant patients; patients who become pregnant during therapy with this drug should be switched to an alternative regimen.

Use: In combination with other antiretroviral agents, for the treatment of HIV-1 infection in therapy-naive and therapy-experienced patients without darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V)

Usual Pediatric Dose for HIV Infection

At least 40 kg: 1 tablet orally once a day with food

Comments:

• This drug is not recommended during pregnancy due to considerably lower exposures of darunavir and cobicistat during the second and third trimesters of pregnancy.
• This drug should not be started in pregnant patients; patients who become pregnant during therapy with this drug should be switched to an alternative regimen.

Use: In combination with other antiretroviral agents, for the treatment of HIV-1 infection in therapy-naive and therapy-experienced patients without darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V)

Renal Dose Adjustments

No adjustment recommended.

Estimated CrCl less than 70 mL/min: Coadministration with tenofovir disoproxil fumarate (DF) is not recommended.

Liver Dose Adjustments

Mild or moderate liver dysfunction (Child-Pugh A or B): No adjustment recommended.
Severe liver dysfunction (Child-Pugh C): Not recommended.

Precautions

CONTRAINDICATIONS:
Coadministration with alfuzosin, ranolazine, dronedarone, ivabradine, carbamazepine, phenobarbital, phenytoin, colchicine (in patients with renal and/or liver dysfunction), rifampin, lurasidone, pimozide, ergot derivatives (e.g., dihydroergotamine, ergotamine, methylergonovine), cisapride, St. John's wort, elbasvir-grazoprevir, lomitapide, lovastatin, simvastatin, naloxegol, oral midazolam, triazolam, sildenafil (for treatment of pulmonary arterial hypertension)

Safety and efficacy have not been established in pediatric patients weighing less than 40 kg.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Comments:

• The components of this drug are highly protein-bound; significant removal via dialysis is not likely.

Other Comments

Administration advice:

• Perform HIV genotypic testing before starting this drug in antiretroviral therapy-experienced patients. If HIV genotypic testing is not feasible, use this drug in protease inhibitor-naive patients only; do not use in protease inhibitor-experienced patients.
• Before starting this drug, assess estimated CrCl (cobicistat decreases estimated CrCl by inhibiting tubular secretion of creatinine without affecting actual renal glomerular function); when used with tenofovir DF, assess estimated CrCl, urine glucose, and urine protein at baseline.
• Administer with other antiretroviral agents.
• Administer with food.
• Administer didanosine 1 hour before or 2 hours after this drug.
• Consult the manufacturer product information regarding missed doses.

Storage requirements:

• Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F).

General:

• Each fixed dose combination tablet contains cobicistat 150 mg and darunavir 800 mg.

Monitoring:

• General: HIV genotypic testing in antiretroviral therapy-experienced patients (before starting therapy)
• Hepatic: Appropriate laboratory testing (before starting and during therapy); AST/ALT in patients with underlying chronic hepatitis, cirrhosis, or pretreatment transaminase elevations (increased during therapy, particularly during first several months of therapy)
• Hypersensitivity: Patients with known sulfonamide allergy (after starting therapy)
• Metabolic: Serum phosphorus in patients with or at risk of renal dysfunction (when used with tenofovir DF)
• Renal: Estimated CrCl (before starting therapy); for renal safety (if serum creatinine increases more than 0.4 mg/dL from baseline); estimated CrCl, urine glucose, and urine protein (at baseline and routinely during therapy [when used with tenofovir DF])

Patient advice:

• Read the US FDA-approved patient labeling (Patient Information).
• Take this drug with food on a regular dosing schedule; do not miss or skip doses as resistance may develop.
• Do not alter the dose or stop therapy without consulting physician.
• Contact healthcare provider at once if signs/symptoms of liver problems or severe skin reactions (including but not limited to severe rash or rash with fever, general malaise, fatigue, muscle/joint aches, blisters, oral lesions, and/or conjunctivitis) develop.
• Notify healthcare provider at once of any symptoms of infection.

Frequently asked questions

• What drugs are contained in the HIV treatment Symtuza?