Efatrio

Rx

Indications

Efatrio is indicated for the treatment of HIV-1 infection in adults and adolescents (from 12 years of age and weighing ≥ 40 kg) with virologic suppression to HIV-1 RNA levels of < 50 copies/ml on their current combination antiretroviral therapy for more than three months. Patients must not have experienced virological failure on any prior antiretroviral therapy. The choice of Efatrio to treat antiretroviral experienced patients with HIV-1 infection should be based on individual viral resistance testing and/or the treatment history of the patient.

Dosage

• Adults and adolescents (from 12 years of age and weighing ≥ 40 kg): One tablet once daily.
• Children below 12 years of age: The drug is not recommended.
• Renal impairment: The drug is not recommended for patients with moderate or severe renal impairment (creatinine clearance CrCl < 50 ml/min).\
• Hepatic impairment: The pharmacokinetics of Efatrio has not been studied in patients with hepatic impairment. Patients should be monitored carefully for adverse reactions, especially nervous system symptoms related to efavirenz.

Usage

Should be swallowed whole with water on an empty stomach. In reduce the undesirable effects on the nervous system, bedtime dosing is recommended.

• Patients with hypersensitivity to tenofovir, lamivudine, efavirenz or to any of the excipients contained in the formula.
• Severe renal, hepatic disease.

Very common

• Increases in fasting triglycerides, total cholesterol, high and low density lipoprotein cholesterol, hypophosphataemia, dizziness, rash, diarrhoea, nausea, vomiting.

Common

• Cough, nasal symptoms, abnormal dreams, disturbance in attention, headache, insomnia, somnolence, anxiety and depression, elevation of liver enzymes, pruritus, hair loss, arthralgia, myalgia, abdominal pain, flatulence, fatigue, malaise, fever.

• Caution in elderly patients; patients with a history of seizures or psychiatric disorders including depression.
• Treatment with Efatrio should be stopped if hepatotoxicity is symptomatic, or if the transaminase levels are > 10 times the upper limit of normal; severe rash or erythema, including Stevens-Johnson syndrome; clinical signs, symptoms or laboratory abnormalities suggestive of pancreatitis occur.
• Monitoring of serum lipids and blood-glucose may be considered during efavirenz treatment.
• Lactic acidosis may occur after a few to several months of NRTI treatment. Patients with hyperlactataemia may be asymptomatic, critically ill, or may have non-specific symptoms such as dyspnoea, fatigue, nausea, vomiting, diarrhoea and abdominal pain. Risk factors for NRTI-related lactic acidosis include female gender and obesity.
• Redistribution or accumulation of body fat, including central obesity, dorsocervical fat enlargement (“buffalo hump”), peripheral wasting, facial wasting, breast enlargement, and general Cushingoid appearance, has been reported with antiretroviral therapy.
• Immune reactivation syndrome: In HIV infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
• Bone monitoring should be considered for HIV-infected patients who have a history of pathologic bone fracture or are at substantial risk for osteopenia.
• Hepatic function should be closely monitored with clinical and laboratory follow-up for at least several months after tenofovir is discontinued in patients with HBV and HIV coinfection.
• Opportunistic infections: Patients receiving Efatrio or any other antiretroviral therapy may continue to develop opportunistic infections and other complications of HIV infection.
• Transmission of HIV: Treatment with Efatrio has not been shown to eliminate the risk of transmission of HIV infection. Patients should continue to use appropriate precautions to prevent transmission of HIV.
• Efatrio should not be used during the first trimester of pregnancy, and only used during the subsequent trimester if the benefit is considered to outweigh the risk. It is recommended that HIV infected women do not breast feed their infants under any circumstances in order to avoid transmission of HIV.
• Patients should avoid potentially hazardous tasks such as driving or operating machinery.