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SYMTUZA
Viral infections
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Drug Name:

SYMTUZA Rx

Generic Name and Formulations:
Darunavir 800mg, cobicistat 150mg, emtricitabine 200mg, tenofovir alafenamide 10mg; tabs.

Company:
Janssen Pharmaceuticals, Inc.

Therapeutic Use:

RECENT UPDATES

Monograph added.

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 initiation. 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, ranolazine, dronedarone, carbamazepine, phenobarbital, phenytoin, colchicine (in renal/hepatic impairment), rifampin, lurasidone, pimozide, ergots, cisapride, St. John’s wort, elbasvir/grazoprevir, lovastatin, simvastatin, sildenafil (for PAH), oral midazolam, triazolam.

Boxed Warning:

Post-treatment acute exacerbation of hepatitis B.

Warnings/Precautions:

Test for HBV before starting antiretroviral therapy. Discontinuation of emtricitabine and/or tenofovir disoproxil 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 those with 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. New onset or worsening renal impairment. Assess SCr (monitor closely if >0.4mg/dL), estimated CrCl, urine glucose, urine protein in all patients, and serum phosphorus (in chronic kidney disease) before initiating and during therapy. Suspend therapy if lactic acidosis or hepatotoxicity (eg, hepatomegaly, steatosis) occurs. Sulfonamide allergy. Diabetes (may need insulin or oral hypoglycemics dose adjusted). Immune reconstitution syndrome. Fat redistribution. Hemophilia. Elderly. Pregnancy (use alternatives), nursing mothers: not recommended.

Pharmacological Class:

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

Interactions:

See Contraindications. Not recommended with other antiretroviral agents, rivaroxaban, voriconazole, rifabutin, rifapentine, simeprevir, everolimus, salmeterol, avanafil, ticagrelor. 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; 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; lab abnormalities.

Note:

Enroll pregnant patients exposed to Symtuza in the Antiretroviral Pregnancy Registry (APR) at (800) 258- 4263.

Generic Availability:

NO

How Supplied:

Tabs—30

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