Indications for: SYMTUZA
As a complete regimen for the treatment of HIV-1 infection in patients ≥40kg who have no prior antiretroviral treatment history or virologically-suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen for ≥6 months and have no known substitutions associated with resistance to darunavir or tenofovir.
Adults and Children:
<3yrs: darunavir, not recommended; or <40kg: not established. Test for HBV infection prior to or at initiation. ≥40kg: 1 tab once daily with food. May split tab into 2 pieces if unable to swallow; consume entire dose immediately.
Concomitant drugs that are highly dependent on CYP3A for clearance and for which altered plasma levels are associated with serious and/or life-threatening events (narrow therapeutic index) or loss of therapeutic effect (eg, alfuzosin, carbamazepine, phenobarbital, phenytoin, colchicine [in renal/hepatic impairment], rifampin, lurasidone, pimozide, dronedarone, ivabradine, ranolazine, ergots, cisapride, St. John’s wort, elbasvir/grazoprevir, lomitapide, lovastatin, simvastatin, naloxegol, sildenafil [for PAH], oral midazolam, triazolam).
Post-treatment acute exacerbation of hepatitis B.
Discontinuation of emtricitabine- and/or tenofovir-containing products may be associated with severe acute exacerbations of hepatitis B. Closely monitor patients co-infected with HBV and HIV for several months after stopping treatment; if appropriate, anti-HBV therapy may be warranted (esp. in advanced liver disease or cirrhosis). Underlying chronic hepatitis, cirrhosis, or pre-treatment elevated transaminases: consider increased AST/ALT monitoring; interrupt or discontinue if evidence of new or worsening liver dysfunction occurs. Discontinue immediately if severe skin reactions develop. Assess SCr, estimated CrCl, urine glucose, urine protein in all patients, and serum phosphorus (in chronic kidney disease) prior to or when initiating, and during therapy. Discontinue if significant renal dysfunction or Fanconi syndrome occurs. Suspend therapy if lactic acidosis or pronounced hepatotoxicity (eg, hepatomegaly, steatosis) occurs. Sulfonamide allergy (monitor). Diabetes (may need insulin or oral hypoglycemics dose adjusted). Hemophilia. Severe renal (CrCl <30mL/min) or severe hepatic impairment: not recommended. Elderly. Pregnancy (use alternatives), nursing mothers: not recommended.
HIV-1 protease inhibitor + CYP3A inhibitor + nucleoside analog reverse transcriptase inhibitors.
See Contraindications. Concomitant other antiretroviral agents, rivaroxaban, voriconazole, rifabutin, rifapentine, glecaprevir/pibrentasvir, everolimus, irinotecan (unless no alternatives), salmeterol, avanafil, ticagrelor, clopidogrel: not recommended. Concomitant drugs that reduce renal function or compete for active tubular secretion may potentiate emtricitabine, tenofovir (eg, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides, high-dose or multiple NSAIDs). May potentiate antiarrhythmics, digoxin, dasatinib, nilotinib (see full labeling), apixaban, clonazepam, SSRIs, TCAs, trazodone, itraconazole, ketoconazole, colchicine (see full labeling), antipsychotics, quetiapine (consider alternative antiretrovirals; if necessary, reduce quetiapine to ⅙ of current dose and monitor), β-blockers, calcium channel blockers, fentanyl, oxycodone, immunosuppressants, tramadol (reduce dose), PDE5 inhibitors (see full labeling), sedatives/hypnotics, IV midazolam, fesoterodine (max 4mg/day), solifenacin (max 5mg/day); monitor. Concomitant other statins (eg, atorvastatin (max 20mg/day), fluvastatin, pitavastatin, pravastatin, rosuvastatin (max 20mg/day): start at low dose, titrate and monitor. Concomitant antibacterials (eg, clarithromycin, erythromycin, telithromycin), CYP3A-inducing anticonvulsants that are not contraindicated (eg, eslicarbazepine, oxcarbazepine), CYP3A-inducing corticosteroids (eg, systemic dexamethasone or others): consider alternatives. Concomitant vincristine, vinblastine: consider temporarily withholding cobicistat-containing regimen if significant hematologic or GI adverse events develop. Concomitant hormonal contraceptives (eg, drosperinone): monitor for hyperkalemia; other estrogen based contraceptives: consider additional or alternative (non-hormonal) contraception. Discontinue bosentan ≥36hrs prior to initiation of Symtuza; resume after ≥10 days following initiation. Concomitant artemether/lumefantrine; monitor effects. Concomitant buprenorphine, buprenorphine/naloxone, methadone; use lowest initial or maintenance dose and titrate. Monitor INR with warfarin.
Diarrhea, rash, nausea, fatigue, headache, abdominal discomfort, flatulence; immune reconstitution syndrome, fat redistribution.
To enroll pregnant patients exposed to Symtuza in the Antiretroviral Pregnancy Registry (APR), call (800) 258-4263.
Generic Drug Availability: