Classes
DEA Class; Rx
Common Brand Names; Emtriva
- HIV, NRTIs
Description
Nucleoside reverse transcriptase inhibitor
Used for the treatment of HIV infection in combination with other antiretroviral medications
Black Box Warning for patients coinfected with HIV and hepatitis B
Indications
Indicated for the treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents.
Contraindications
Hypersensitivity
Adverse Effects
- Frequencies based on combination treatment
- Diarrhea (21-25%)
- Dizziness (21-25%)
- Headache (21-25%)
- Insomnia (21-25%)
- Rash (21-25%)
- Asthenia (16-20%)
- Nausea (16-20%)
- Rhinitis (16-20%)
- Abdominal pain (11-15%)
- Abnormal dreams (11-15%)
- Increased CK (11-15%)
- Increased cough (11-15%)
- Neuritis (11-15%)
- Paresthesia (11-15%)
- 1-10%
- Depressive symptoms (6-10%)
- Dyspepsia (6-10%)
- Vomiting (6-10%)
- Increased triglycerides (6-10%)
- Myalgia (6-10%)
Warnings
All patients with HIV-1 should be tested for presence of chronic Hepatitis B virus (HBV) before initiating antiretroviral therapy; safety and efficacy of emtricitabine not established in patients coinfected with HBV and HIV-1; patients infected with HBV and treated with emtricitabine, the exacerbations of hepatitis B were associated with liver decompensation and liver failure; hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue therapy; if appropriate, initiation of anti-Hepatitis B therapy may be warranted
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, reported with use of nucleoside analogs, either alone or in combination with other antiretrovirals; suspend therapy in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations)
Should not be coadministered with combination antiretroviral agents containing emtricitabine or lamivudine
Dose reduction recommended in patients with impaired renal function
Risk of immune reconstitution syndrome if used in combination with other antiretroviral drugs; autoimmune disorders (such as Graves’ disease, polymyositis, and Guillain-Barré syndrome) reported to occur in the setting of immune reconstitution; however, time to onset is more variable, and can occur many months after initiation of treatment
Pregnancy and Lactation
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to drug during pregnancy
Based on published data, FTC has been shown to be present in human breast milk; it is not known if FTC affects milk production or has effects on breastfed child
Maximum Dosage
200 mg/day PO for capsules; 240 mg/day PO for oral solution.
200 mg/day PO for capsules; 240 mg/day PO for oral solution.
> 33 kg: 200 mg/day PO for capsules; 6 mg/kg/day, not to exceed 240 mg/day, PO for oral solution.
<= 33 kg: 6 mg/kg/day, not to exceed 240 mg/day, PO for oral solution; safety and efficacy of the capsule have not been established.
> 33 kg: 200 mg/day PO for capsules; 6 mg/kg/day, not to exceed 240 mg/day, PO for oral solution.
<= 33 kg: 6 mg/kg/day, not to exceed 240 mg/day, PO for oral solution; safety and efficacy of the capsule have not been established.
>= 3 months: 6 mg/kg/day, not to exceed 240 mg/day, PO for oral solution; safety and efficacy of the capsule have not been established.
< 3 months: 3 mg/kg/day PO for oral solution; safety and efficacy of the capsule have not been established.
3 mg/kg/day PO for oral solution; safety and efficacy of the capsule have not been established.
How supplied
Emtricitabine
capsule
- 200mg
oral solution
- 10mg/mL
