Viral infections:

Indications for SYMTUZA:

As a complete regimen for the treatment of HIV-1 infection in adults who are antiretroviral treatment-naïve 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.

Adult:

Test for HBV infection prior to and at initiation. ≥18yrs: 1 tab once daily with food. May split tab into 2 pieces if unable to swallow; consume entire dose immediately. Severe renal (CrCl <30mL/min) or severe hepatic impairment: not recommended.

Children:

<18yrs: not established.

Contraindications:

Concomitant 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.

Boxed Warning:

Post-treatment acute exacerbation of hepatitis B.

Warnings/Precautions:

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. Monitor SCr (closely if increases >0.4mg/dL), CrCl, urine glucose, urine protein, and serum phosphorus (in chronic kidney disease) prior to 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. Diabetes (may need insulin or oral hypoglycemics dose adjusted). Hemophilia. Elderly. Pregnancy (use alternatives), nursing mothers: not recommended.

Pharmacologic Class:

HIV-1 protease inhibitor + CYP3A inhibitor + nucleoside analog reverse transcriptase inhibitors.

Interactions:

See Contraindications. Concomitant other antiretroviral agents, rivaroxaban, voriconazole, rifabutin, rifapentine, glecaprevir/pibrentasvir, simeprevir, everolimus, irinotecan (unless no alternatives), salmeterol, avanafil, ticagrelor: 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.

Adverse Reactions:

Diarrhea, rash, nausea, fatigue, headache, abdominal discomfort, flatulence; immune reconstitution syndrome, fat redistribution.

Note:

To enroll pregnant patients exposed to Symtuza in the Antiretroviral Pregnancy Registry (APR), call (800) 258-4263.

Generic Availability:

NO

How Supplied:

Tabs—30

Pricing for SYMTUZA

800mg/150mg/200mg/10mg tablet (Qty: 30)
Appx. price $3692
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