Usual Adult Dose for HIV Infection

1 tablet orally once a day

Comments:

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

Use: As a complete regimen for the treatment of HIV-1 infection in patients with no prior antiretroviral treatment history or in patients virologically-suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen for at least 6 months who have no known substitutions associated with resistance to darunavir or tenofovir

Usual Pediatric Dose for HIV Infection

At least 40 kg: 1 tablet orally once a day

Comments:

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

Use: As a complete regimen for the treatment of HIV-1 infection in patients with no prior antiretroviral treatment history or in patients virologically-suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen for at least 6 months who have no known substitutions associated with resistance to darunavir or tenofovir

Renal Dose Adjustments

CrCl at least 30 mL/min: No adjustment recommended.
CrCl less than 30 mL/min: 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

US BOXED WARNING:

• POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B: Severe acute exacerbations of hepatitis B reported in patients coinfected with HIV-1 and HBV after stopping products containing emtricitabine and/or tenofovir disoproxil fumarate, and may occur when this drug is stopped. Hepatic function of HIV-1/HBV-coinfected patients should be closely monitored with clinical and laboratory follow-up for at least several months after stopping this drug. If appropriate, antihepatitis B therapy may be necessary.

CONTRAINDICATIONS:

• Coadministration with the following drugs due to potential for serious and/or life-threatening events or loss of therapeutic effect: alfuzosin, carbamazepine, phenobarbital, phenytoin, colchicine (in patients with renal and/or liver dysfunction), rifampin, lurasidone, pimozide, dronedarone, ivabradine, ranolazine, ergot derivatives (e.g., dihydroergotamine, ergotamine, methylergonovine), cisapride, St. John's wort, elbasvir-grazoprevir, lomitapide, lovastatin, simvastatin, naloxegol, sildenafil (for treatment of pulmonary arterial hypertension), oral midazolam, triazolam

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

Other Comments

Administration advice:

• Test patients for HBV infection before or when starting this drug.
• In all patients, assess serum creatinine, estimated CrCl, urine glucose, and urine protein before or when starting this drug, and during therapy with this drug as clinically appropriate; in patients with chronic kidney disease, also assess serum phosphorus.
• Administer with food.
• For patients unable to swallow the whole tablet, use a tablet-cutter to split it into 2 pieces; administer the entire dose immediately after splitting.

Storage requirements:

• Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F).
• Dispense only in original container; keep bottle tightly closed with desiccant inside to protect from moisture.

General:

• Each 4-drug fixed dose combination tablet contains cobicistat 150 mg, darunavir 800 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg.

Monitoring:

• 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); hepatic function of HIV-1/HBV-coinfected patients with clinical and laboratory follow-up (for at least several months after stopping therapy)
• Hypersensitivity: Patients with known sulfonamide allergy (after starting therapy)
• Infections/Infestations: For chronic HBV infection in all patients (before or when starting therapy)
• Metabolic: Serum phosphorus in patients with chronic kidney disease (before or when starting therapy and during therapy)
• Renal: Serum creatinine, estimated CrCl, urine glucose, and urine protein in all patients (before or when starting therapy and during therapy)

Patient advice:

• Read the US FDA-approved patient labeling (Patient Information).
• Do not alter the dose or stop this drug without consulting physician.
• If using a tablet-cutter, consume the entire dose immediately after splitting the tablet.
• 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.
• Avoid taking this drug with concurrent/recent use of nephrotoxic agents.
• Stop this drug if clinical symptoms suggesting lactic acidosis or pronounced hepatotoxicity develop.

Frequently asked questions

• What drugs are contained in the HIV treatment Symtuza?