STRIBILD Rx

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STRIBILD

Viral infections
Only 4 drugs may be compared at once

Generic Name and Formulations:

Elvitegravir 150mg, cobicistat 150mg, emtricitabine 200mg, tenofovir disoproxil fumarate (DF) 300mg; tabs.

Select therapeutic use:

Indications for STRIBILD:

As a complete regimen for the treatment of HIV-1 infection in patients who are antiretroviral treatment-naïve or to replace current antiretroviral (ARV) regimen in virologically-suppressed (HIV-1 RNA <50 copies/mL) patients on a stable ARV regimen for ≥6 months with no history of treatment failure or no known substitutions associated with resistance to any component of Stribild.

Adults and Children:

<12yrs or <35kg: not established. ≥12yrs (≥35kg): 1 tab once daily with food. Renal impairment (CrCl <70mL/min): not recommended; if CrCl declines to <50mL/min during therapy, discontinue; also in children: no data available. Severe hepatic impairment: not recommended.

Contraindications:

Concomitant alfuzosin, carbamazepine, phenobarbital, phenytoin, rifampin, ergots, cisapride, St. John’s wort, lovastatin, simvastatin, lurasidone, pimozide, sildenafil (when dosed for PAH), triazolam, oral midazolam.

Warnings/Precautions:

Suspend therapy if lactic acidosis or hepatotoxicity (eg, hepatomegaly, steatosis) occurs. Not for treating chronic hepatitis B; test for HBV before starting therapy. Monitor patients co-infected with HBV and HIV closely during and for several months after stopping treatment (acute exacerbations of hepatitis B may occur); may initiate anti-hepatitis B therapy if warranted esp. in advanced liver disease or cirrhosis. Assess SCr, serum phosphorus, CrCl, urine glucose, urine protein before initiating and during therapy. History of pathologic fracture or risk factors of osteoporosis or bone loss: consider bone mineral density (BMD) assessment; supplementation with calcium/Vit. D may be beneficial. Elderly. Pregnancy. Nursing mothers: not recommended.

Interactions:

See Contraindications. Not recommended with other antiretroviral agents, rifabutin, rifapentine, or ledipasvir/sofosbuvir. Avoid with concurrent or recent use of nephrotoxic agents (eg, high-dose or multiple NSAIDs). Concomitant drugs that reduce renal function or compete for active tubular secretion may potentiate emtricitabine, tenofovir (eg, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, gentamicin). Separate antacids by at least 2hrs. May potentiate antiarrhythmics, digoxin, clarithromycin (reduce dose by 50% if CrCl 50–60mL/min), clonazepam, ethosuximide, SSRIs, TCAs, trazodone, ketoconazole (max 200mg/day), itraconazole (max 200mg/day), voriconazole, beta-blockers, calcium channel blockers, fluticasone (use alternatives), atorvastatin, immunosuppressants (monitor), buprenorphine, sedatives/hypnotics, PDE5 inhibitors (see full labeling for dose adjustments), antipsychotics, quetiapine (reduce dose by ⅙ or consider alternative antiretrovirals). Antagonized by oxcarbazepine, systemic dexamethasone. Concomitant colchicine (see full labeling); not recommended in renal or hepatic impairment. Discontinue use of bosentan at least 36hrs prior to initiation of Stribild; after at least 10 days following initiation, resume bosentan. Concomitant salmeterol: not recommended; increased risk of cardiovascular events. Use alternative non-hormonal methods of contraception. Monitor INR with warfarin.

Pharmacological Class:

HIV-1 integrase strand transfer inhibitor (INSTI) + pharmacokinetic enhancer + nucleos(t)ide analogue reverse transcriptase inhibitors.

Adverse Reactions:

Nausea, diarrhea; acute renal failure, decreased BMD, mineralization defects, fat redistribution, immune reconstitution syndrome.

Metabolism:

Hepatic (CYP3A, 2D6).

Elimination:

Fecal (major); renal.

Generic Availability:

NO

How Supplied:

Tabs—30

STRIBILD 150mg/150mg/200mg/300mg tablets (Qty:30)

appx. price $2931.00