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 adults 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.

Adult:

1 tab once daily with food. Renal impairment (CrCl <70mL/min): not recommended; if CrCl declines to <50mL/min during therapy, discontinue. Severe hepatic impairment: not recommended.

Children:

<18yrs: not established.

Contraindications:

Concomitant alfuzosin, carbamazepine, phenobarbital, phenytoin, rifampin, ergots, cisapride, St. John’s wort, lovastatin, simvastatin, 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 and closely monitor patients co-infected with HBV and HIV during and for several months after stopping treatment (discontinuing therapy may exacerbate HBV infection). Monitor CrCl, urine glucose, urine protein, serum phosphorus (for patients at risk for renal impairment). History of pathologic fracture or risk factors of osteoporosis or bone loss: consider monitoring bone mineral density (BMD). Elderly. Pregnancy (Cat.B). Nursing mothers: not recommended.

Interactions:

See Contraindications. 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). Do not administer with other antiretroviral agents (eg, cobicistat, elvitegravir, adefovir dipivoxil, or products containing emtricitabine, tenofovir DF, lamivudine, or ritonavir), antimycobacterials (eg, rifabutin, rifapentine) or ledipasvir/sofosbuvir. 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), neuroleptics, sedatives/hypnotics, PDE5 inhibitors (see full labeling for dose adjustments), quetiapine (reduce dose by ⅙ or consider alternative antiretrovirals). Antagonized by carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifapentine, systemic dexamethasone. Concomitant colchicine (see full labeling); do not coadminister to patients with 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 + pharmacokinetic enhancer + nucleos(t)ide analog reverse transcriptase inhibitors.

Adverse Reactions:

Nausea, diarrhea; acute renal failure, decreased BMD, 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 $2718.00