Drug Class: Antiviral combinations
Usual Adult Dose for HIV Infection
1 tablet orally once a day
Use: As a complete regimen for the treatment of HIV-1 infection
Usual Pediatric Dose for HIV Infection
1 tablet orally once a day
Comments:
- Symfi Lo(TM) is approved for patients weighing at least 35 kg.
- Symfi(TM) is approved for patients weighing at least 40 kg.
- Recommended for pediatric patients who can swallow a solid tablet
Use: As a complete regimen for the treatment of HIV-1 infection
Renal Dose Adjustments
CrCl less than 50 mL/min: Not recommended.
Liver Dose Adjustments
Mild liver dysfunction: No adjustment recommended; careful monitoring recommended.
Moderate or severe liver dysfunction (Child-Pugh B or C): Not recommended.
Dose Adjustments
Concomitant rifampin:
- Patients weighing at least 50 kg: Increase efavirenz dose to 800 mg once a day.
Precautions
US BOXED WARNING:
- POSTTREATMENT ACUTE EXACERBATIONS OF HEPATITIS B: Severe acute exacerbations of hepatitis B reported in patients coinfected with HBV and HIV-1 who have stopped lamivudine or tenofovir disoproxil fumarate, 2 components of this drug. Hepatic function of HBV/HIV-1-coinfected patients should be monitored closely; if appropriate, antihepatitis B therapy should be started.
CONTRAINDICATIONS:
- Previous hypersensitivity reaction (e.g., Stevens-Johnson syndrome, erythema multiforme, or toxic skin eruptions) to any active component or any of the ingredients
- Coadministration with elbasvir-grazoprevir
Safety and efficacy have not been established in patients weighing less than 35 kg (Symfi Lo[TM]) or less than 40 kg (Symfi[TM]).
Consult WARNINGS section for additional precautions.
Dialysis
ESRD requiring hemodialysis: Not recommended.
Other Comments
Administration advice:
- Test patients for HBV infection before starting this drug.
- In all patients, assess serum creatinine, serum phosphorus, estimated CrCl, urine glucose, and urine protein before starting this drug and during therapy as clinically appropriate.
- Monitor liver function before and during therapy.
- Administer on an empty stomach, preferably at bedtime; dosing at bedtime may improve tolerability of nervous system symptoms.
Storage requirements:
- Store below 30C (86F); keep bottle tightly closed.
- Dispense in original bottle.
General:
- Symfi Lo(TM): Each 3-drug fixed-dose combination tablet contains efavirenz 400 mg, lamivudine 300 mg, and tenofovir disoproxil fumarate 300 mg.
- Symfi(TM): Each 3-drug fixed-dose combination tablet contains efavirenz 600 mg, lamivudine 300 mg, and tenofovir disoproxil fumarate 300 mg.
Monitoring:
- General: Pregnancy testing in females of reproductive potential (before starting therapy)
- Hepatic: Liver enzymes in all patients (before and during therapy); hepatic function of HIV-1/HBV-coinfected patients with clinical and laboratory follow-up (for at least several months after stopping therapy)
- Infections/Infestations: For chronic HBV infection in all patients (before starting therapy)
- Metabolic: Serum phosphorus in patients at risk of renal dysfunction (before starting and periodically during therapy); cholesterol and triglycerides (before starting and periodically during therapy)
- Musculoskeletal: Bone mineral density in patients with history of pathologic bone fracture or other risk factors for osteoporosis or bone loss
- Renal: Estimated CrCl in all patients (before starting and as clinically appropriate during therapy); estimated CrCl, urine glucose, and urine protein in patients at risk of renal dysfunction (before starting and periodically during therapy)
Patient advice:
- Read the US FDA-approved patient labeling (Patient Information).
- Avoid taking this drug with concurrent/recent use of nephrotoxic agents.
- Seek medical evaluation at once if severe psychiatric side effects develop.
- This drug may impair mental abilities needed to perform potentially hazardous tasks (e.g., driving, operating machinery); CNS effects may be additive if used with alcohol or psychoactive drugs. Avoid potentially hazardous tasks if CNS symptoms (e.g., dizziness, impaired concentration, drowsiness) occur.
- Contact physician without delay if rash occurs.
- Watch for signs of liver inflammation/failure (early signs: fatigue, weakness, lack of appetite, nausea/vomiting; later signs: jaundice, confusion, abdominal swelling, discolored feces); consult healthcare provider without delay if such symptoms occur.
- Monitor pediatric patients for signs/symptoms of pancreatitis.
- Notify healthcare provider at once of any symptoms of infection.
Frequently asked questions
- What is the difference between HIV treatments Symfi and Symfi Lo?
- What drugs are contained in the HIV treatment Symfi Lo?
