Doravirine, Lamivudine and Tenofovir disoproxil

DELSTRIGO ® is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg: with no prior antiretroviral treatment history, OR to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of DELSTRIGO.

DELSTRIGO is a fixed-dose combination of the antiretroviral drugs doravirine, lamivudine, and TDF.

Testing: Prior to or when initiating DELSTRIGO, test for HBV infection. Prior to or when initiating DELSTRIGO, and during treatment with DELSTRIGO, on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorus. Recommended dosage: One tablet taken orally once daily with or without food in adults and pediatric patients weighing at least 35 kg. Renal impairment: Not recommended in patients with estimated creatinine clearance below 50 mL per minute. Dosage adjustment with rifabutin: Take one tablet of DELSTRIGO once daily, followed by one tablet of doravirine 100 mg (PIFELTRO) approximately 12 hours after the dose of DELSTRIGO.

DELSTRIGO is contraindicated when co-administered with drugs that are strong cytochrome P450 (CYP)3A enzyme inducers as significant decreases in doravirine plasma concentrations may occur, which may decrease the effectiveness of DELSTRIGO. These drugs include, but are not limited to, the following: - the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, phenytoin - the androgen receptor inhibitor enzalutamide - the antimycobacterials rifampin, rifapentine - the cytotoxic agent mitotane - St. John's wort ( Hypericum perforatum) DELSTRIGO is contraindicated in patients with a previous hypersensitivity reaction to lamivudine.

Boxed warning (posttreatment acute exacerbation of hepatitis b): Severe acute exacerbations of hepatitis B (HBV) have been reported in people with concomitant HIV-1 and HBV who have discontinued lamivudine or tenofovir disoproxil fumarate (TDF), which are components of DELSTRIGO. Severe skin reactions, including Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN), and Drug Rash with Eosinophilia and Systemic Symptoms (DRESS), have been reported. Discontinue DELSTRIGO immediately if signs or symptoms of severe skin reactions develop. New onset or worsening renal impairment: Prior to or when initiating DELSTRIGO, and during treatment with DELSTRIGO, on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. Avoid administering DELSTRIGO with concurrent or recent use of nephrotoxic drugs.

The following adverse reactions are discussed in other sections of the labeling: Skin and Hypersensitivity Reactions Severe Acute Exacerbation of Hepatitis B in people with concomitant HIV-1 and HBV New Onset or Worsening Renal Impairment Bone Loss and Mineralization Defects Immune Reconstitution Syndrome Most common adverse reactions (incidence greater than or equal to 5%, all grades) are dizziness, nausea, and abnormal dreams.

Because DELSTRIGO is a complete regimen, co-administration with other antiretroviral medications for treatment of HIV-1 infection is not recommended. Consult the full prescribing information prior to and during treatment for important potential drug-drug interactions.

Store DELSTRIGO at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Store DELSTRIGO in the original bottle. Keep the bottle tightly closed to protect from moisture.