Trustiva

Trustiva

Manufacturer:

Camber

Distributor:

Camber
Concise Prescribing Info
Contents
Efavirenz 600 mg, emtricitabine 200 mg, tenofovir disoproxil fumarate 300 mg (equiv to tenofovir disoproxil 245 mg)
Indications/Uses
HIV-1 infection in adults as monotherapy or in combination w/ other antiretrovirals.
Dosage/Direction for Use
Adult 1 tab once daily. Dose adjustment: Patients weighing ≥50 kg In combination w/ rifampicin: Additional 200 mg/day (800 mg total) of efavirenz.
Administration
Should be taken on an empty stomach: Take preferably at bedtime. Swallow whole.
Contraindications
Hypersensitivity. Patients w/ severe hepatic impairment (Class C). Concomitant use w/ terfenadine, astemizole, cisapride, midazolam, triazolam, pimozide, bepridil or ergot alkaloids (eg, ergotamine, dihydroergotamine, ergonovine & methylergonovine), herbal prep containing St. John's wort (Hypericum perforatum), voriconazole.
Special Precautions
Should not be administered concomitantly w/ other drugs containing any of the same active components of Trustiva, other cytidine analogues eg, lamivudine, adefovir dipivoxil, didanosine, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir, other antiretrovirals & Ginkgo biloba extr. Patients switching from a PI-based antiretroviral regimen should be carefully monitored for rises in viral load. Lactic acidosis. Discontinue treatment if symptomatic hyperlactataemia, metabolic/lactic acidosis, progressive hepatomegaly, or rapidly elevating aminotransferase levels; worsening of liver disease or persistent elevations of serum transaminases to >5 x ULN; severe rash associated w/ blistering, desquamation, mucosal involvement or fever occurs. Patients (especially obese women) w/ hepatomegaly, hepatitis or other known risk factors for liver disease & hepatic steatosis; co-infected w/ hepatitis C & treatment w/ α interferon & ribavirin. Closely observe patients for opportunistic infections. Mild to moderate liver disease. Perform laboratory tests to evaluate liver disease at periodic intervals. Patients w/ preexisting liver dysfunction including chronic active hepatitis. Monitor liver enzyme for all patients independent of preexisting hepatic dysfunction. Patients co-infected w/ HBV or HCV; treatment discontinuation is not recommended in patients w/ advanced liver cirrhosis.  QTc prolongation; patients at increased risk of Torsade de Pointes. Prior history of psychiatric disorders. Nervous system symptoms may occur. Periodically monitor plasma levels of patients who are receiving concomitant anticonvulsants eg, phentoin, carbamazepine & phenobarb. History of seizures. Moderate or severe renal impairment. Monitor renal function wkly in concomitant use w/ nephrotoxic drugs eg, aminoglycosides, amphotericin B, foscarnet, ganciclovir, pentamidine, vancomycin, cidofovir, interleukin-2. Monitor renal function (CrCl & serum phosphate) prior to initiating treatment, after 2-4 wk of treatment, after 3 mth, & every 3-6 mth thereafter. Re-evaluate renal function w/in 1 wk including blood glucose, blood K, & urine glucose conc if serum phosphate is <1.5 mg/dL (0.48 mmol/L) or CrCl decreased to <50 mL/min. Not recommended for patients who have had a life-threatening cutaneous reaction (eg, Stevens-Johnson syndrome) while taking NNRTIs. Wt gain & increase in blood lipid & glucose levels may occur. Mitochondrial dysfunction following exposure in utero. Immune reactivation syndrome. Osteonecrosis. May decrease bone mineral density. Avoid treatment in patients w/ HIV-1 harbouring K65R, M184V/I or K103N mutation. Fat redistribution. Patients on controlled Na diet. Women of childbearing potential should undergo pregnancy test prior to initiation of treatment. Patients must use contraceptive measures during treatment & for 12 wk after discontinuation. Avoid potentially hazardous task eg, driving & operating machinery. Pregnancy & lactation. Elderly. May have false-positive urine cannabinoid test results w/ screening assays in uninfected & HIV infected patients.
Adverse Reactions
Dizziness, nausea, abnormal dreams, rash, insomnia, fatigue, diarrhea, headache, somnolence. Anxiety, depression, vomiting, nasopharyngitis, sinusitis, upper resp tract infection.
Drug Interactions
Do not administer concomitantly w/ other drugs containing efavirenz, emtricitabine or tenofovir disoproxil as fumarate; other cytidine analogues eg, lamivudine; adefovir dipivoxil. May decrease plasma conc of compd that are CYP3A4, CYP2B6 & UGT1A1 substrates. Decreased plasma conc w/ compd or herbal prep that induce CYP3A4 or CYP2B6 (eg, Ginkgo biloba extr & St. John's wort). Increased exposure w/ CYP3A4 or CYP2B6 inhibitors (eg, ritonavir, grapefruit juice). Serious, life-threatening events may occur w/ terfenadine, astemizole, cisapride, midazolam, triazolam, pimozide, bepridil, or ergot alkaloids (eg, ergotamine, dihydroergotamine, ergonovine & methylergonovine). Voriconazole is contraindicated. Plasma levels may be reduced by St. John's wort. May lead to Torsade de Pointes w/ drugs known to prolong QTc interval eg, antiarrhythmics (classes IA & III), neuroleptics & antidepressants, antibiotics (eg, macrolides, fluoroquinolones, imidazole & triazole antifungals), certain non-sedating antihistaminics (eg, terfenadine, astemizole), cisapride, flecainide, certain antimalarials & methadone; atazanavir/ritonavir, didanosine, sofosbuvir/velpatasvir & sofosbuvir/velpatasvir/voxilaprevir. Serum conc may be increased w/ drugs that reduce renal function or compete for active tubular secretion (eg, cidofovir). Avoid concurrent use w/ nephrotoxic drugs eg, aminoglycosides, amphotericin B, foscarnet, ganciclovir, pentamidine, vancomycin, cidofovir or interleukin-2.
MIMS Class
ATC Classification
J05AR06 - emtricitabine, tenofovir disoproxil and efavirenz ; Belongs to the class of antivirals for treatment of HIV infections, combinations.
Presentation/Packing
Form
Trustiva FC tab
Packing/Price
30's
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