Indications for SYMFI LO:
As a complete regimen for the treatment of HIV-1 infection in adults and children weighing ≥35kg.
Adults and Children:
<35kg: not established. Test for HBV infection prior to initiation. Take on empty stomach. ≥35kg: 1 tab once daily (preferably at bedtime). Concomitant rifampin (≥50kg): give additional 400mg/day of efavirenz.
SYMFI LO Contraindications:
Post-treatment acute exacerbations of hepatitis B.
SYMFI LO Warnings/Precautions:
Discontinuation of anti-HBV therapy (including 3TC, TDF-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 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 >5×ULN or, discontinue if accompanied by hepatitis or hepatic decompensation. Suspend therapy if lactic acidosis or pronounced hepatotoxicity (eg, hepatomegaly, steatosis) occurs. New onset or worsening renal impairment. Assess SCr, estimated CrCl, urine glucose, urine protein in all patients prior to initiation and during therapy. 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 for 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. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception (barrier and hormonal) during and for 12 weeks after discontinuing treatment. Potential risk of neural tube defects: perform pregnancy testing prior to initiation. Pregnancy (esp. 1st trimester), nursing mothers: not recommended.
SYMFI LO Classification:
Non-nucleoside reverse transcriptase inhibitor + reverse transcriptase inhibitors (nucleoside + nucleotide analogue).
SYMFI LO 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. Tenofovir levels increased by ledipasvir/sofosbuvir; monitor. Antagonized by phenobarbital, carbamazepine, phenytoin, rifampin (see Adults). 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.
Rash (may be severe, eg, Stevens-Johnson; discontinue if occurs), headache, pain, diarrhea, depression, fever, nausea, abdominal pain, asthenia, anxiety, insomnia, dizziness; hypersensitivity reactions, pancreatitis, CNS and psychiatric effects, lipid elevations, decreased BMD, QT prolongation, immune reconstitution syndrome, fat redistribution, late-onset neurotoxicity (eg, ataxia, encephalopathy).
Generic Drug Availability:
Symfi Lo tabs—30, 90; Symfi tabs—30