Drug Detail:Lamivudine and tenofovir (Lamivudine and tenofovir [ la-miv-ue-deen-and-ten-of-oh-vir ])
Drug Class: Antiviral combinations
Usual Adult Dose for HIV Infection
1 tablet orally once a day
Use: In combination with other antiretroviral agents, for the treatment of HIV-1 infection
Usual Pediatric Dose for HIV Infection
At least 35 kg: 1 tablet orally once a day
Use: In combination with other antiretroviral agents, for the treatment of HIV-1 infection
Renal Dose Adjustments
CrCl less than 50 mL/min: Not recommended.
Liver Dose Adjustments
Data not available
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, components of this drug. Hepatic function of HBV/HIV-1-coinfected patients should be monitored closely with clinical and laboratory follow-up for at least several months; if appropriate, antihepatitis B therapy should be started.
CONTRAINDICATIONS:
Previous hypersensitivity reaction to either active component or to any of the ingredients
Safety and efficacy have not been established in patients weighing less than 35 kg.
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, estimated CrCl, urine glucose, and urine protein before starting this drug and during therapy as clinically appropriate; in patients with chronic kidney disease, also assess serum phosphorus.
- May administer with or without food
Storage requirements:
- Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F).
- Dispense and store only in original bottle.
- Keep bottles tightly closed to protect from moisture; do not remove desiccant.
General:
- Each 2-drug fixed-dose combination tablet contains lamivudine 300 mg and tenofovir disoproxil fumarate 300 mg.
Monitoring:
- Hepatic: 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 with chronic kidney disease (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: Serum creatinine, estimated CrCl, urine glucose, and urine protein in all patients (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.
- 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 Cimduo?
