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SYMFI LO
Viral infections
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Drug Name:

SYMFI LO Rx

Generic Name and Formulations:
Efavirenz 400mg, lamivudine 300mg, tenofovir disoproxil fumarate 300mg; tabs.

Company:
Mylan Inc.

Therapeutic Use:

Indications for SYMFI LO:

A complete regimen for the treatment of HIV-1 infection in adults and children weighing ≥35kg.

Adults and Children:

<35kg: not established. Take on empty stomach. ≥35kg: 1 tab once daily (preferably at bedtime). Concomitant rifampin (≥50kg): give additional 400mg/day of efavirenz.

Contraindications:

Concomitant elbasvir/grazoprevir.

Boxed Warning:

Post-treatment acute exacerbations of hepatitis B.

Warnings/Precautions:

Not for treating chronic HBV infection; test for HBV before starting therapy and closely monitor patients co-infected with HBV and HIV for several months after stopping treatment (discontinuing therapy may exacerbate HBV infection); if appropriate, resumption of anti-hepatitis B therapy may be warranted. Underlying hepatitis B or C, or use of hepatotoxic drugs; monitor for hepatotoxicity. Monitor LFTs prior to and during therapy; consider discontinuing if serum transaminases elevated to >5XULN or, discontinue if accompanied by hepatitis or hepatic decompensation. Suspend therapy if lactic acidosis or hepatotoxicity (eg, hepatomegaly, steatosis) occurs. Monitor CrCl (in all patients), serum creatinine, serum phosphorus, urine glucose and urine protein prior to initiation and periodically during therapy in patients at risk for renal impairment. Promptly evaluate if serious psychiatric symptoms occur. History of pancreatitis; discontinue immediately if occurs. History of seizures. Perform lipid tests prior to and periodically during therapy. History of pathologic fracture or risk factors of osteoporosis or bone loss: consider monitoring bone mineral density (BMD); calcium/vitamin D supplement may be beneficial. Moderate or severe hepatic or renal impairment (CrCl<50mL/min) or ESRD requiring hemodialysis: not recommended. Elderly. Pregnancy (esp. 1st trimester); avoid. Obtain negative pregnancy test before initiation. Females of reproductive potential should use effective contraception (barrier and hormonal) during and for 12 weeks after discontinuing treatment. Nursing mothers: not recommended.

See Also:

SYMFI

Pharmacological Class:

Non-nucleoside reverse transcriptase inhibitor + reverse transcriptase inhibitors (nucleoside + nucleotide analogue).

Interactions:

See Contraindications. Avoid concomitant other antiretrovirals, adefovir dipivoxil, atovaquone, posaconazole, boceprevir, pibrentasvir/glecaprevir, proguanil, simeprevir, sorbitol, sofosbuvir/velpatasvir, voxilaprevir. Additive CNS effects with alcohol, psychoactive drugs. Caution with drugs metabolized by, or that affect activity of CYP3A, CYP2B6, OCT. Monitor for toxicity (eg, hepatic decompensation) with interferon-alfa ± ribavirin; reduce or discontinue one or both drugs as needed. Tenofovir levels increased by ledipasvir/sofosbuvir; monitor. Antagonized by phenobarbital, carbamazepine, phenytoin, rifampin (see Adult). May antagonize bupropion, CCBs (eg, diltiazem, felodipine, nicardipine, nifedipine, verapamil), methadone, rifabutin (increase dose), sertraline, statins, ethinyl estradiol/norgestimate, etonogestrel implant, immunosuppressants (eg, cyclosporine, sirolimus, tacrolimus), itraconazole, ketoconazole (consider alternative antifungals). Closely monitor warfarin, anticonvulsants (decreased levels of phenytoin, phenobarbital, carbamazepine), rifabutin, immunosuppressants, methadone, others. Avoid concomitant or recent use of nephrotoxic agents. Monitor drugs that decrease renal function or compete for renal tubular secretion (eg, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides, high-dose or multiple NSAIDs); consider alternatives to NSAIDs. Concomitant drugs with a known risk for Torsade de Pointes (eg, clarithromycin, artemether/lumefantrine); consider alternatives. Efavirenz may cause false (+) cannabis screening test.

Adverse Reactions:

Rash (may be severe, eg, Stevens-Johnson; discontinue if occurs), headache, pain, diarrhea, depression, fever, nausea, abdominal pain, asthenia, anxiety, insomnia, dizziness; hepatotoxicity, hypersensitivity reactions, pancreatitis, CNS and psychiatric effects, decreased BMD, new onset or worsening renal impairment, lipid elevations, immune reconstitution syndrome, QT prolongation, fat redistribution.

Generic Availability:

NO

How Supplied:

Tabs—30

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