Intelence

Intelence

etravirine

Manufacturer:

Janssen

Distributor:

DCH Auriga - Healthcare
/
Four Star
Concise Prescribing Info
Contents
Etravirine
Indications/Uses
In combination w/ other antiretroviral agents, for the treatment of HIV-1 infection in treatment-experienced adult patients who have evidence of viral replication & HIV-1 strains resistant to NNRTI & other antiretroviral agents.
Dosage/Direction for Use
Administration
Should be taken with food: Swallow whole, do not chew/crush. For patients w/ swallowing difficulties, disperse tab in a glass of water & drink immediately. Rinse the glass w/ water several times & drink each rinse completely.
Special Precautions
Severe skin & hypersensitivity reactions. Fat redistribution. Immune reconstitution syndrome. In patients who have experienced virologic failure on an NNRTI-containing regimen, do not use Intelence in combination w/ only N[t]RTIs. Patients w/ severe hepatic impairment. Pregnancy. Do not breastfeed while receiving treatment. Elderly. Childn.
Adverse Reactions
Rash; peripheral neuropathy; laboratory abnormalities (increased pancreatic amylase, creatinine, total cholesterol, LDL, triglycerides, glucose levels, ALT, AST; decreased Hb, WBC count, neutrophils, platelet count).
Drug Interactions
Altered therapeutic effect or adverse reaction profile w/ drugs that induce or inhibit CYP3A, CYP2C9 & CYP2C19. Altered therapeutic effect or adverse reaction profile of drugs that are substrates of CYP3A, CYP2C9 & CYP2C19 or are transported by P-glycoprotein. Reduced plasma conc w/ dolutegravir (mitigated when co-administered w/ atazanavir/ritonavir, darunavir/ritonavir, or lopinavir/ritonavir). Should not be co-administered w/ other NNRTIs; fosamprenavir/ritonavir. Should not be co-administered w/o low-dose ritonavir: indinavir, nelfinavir. Decreased plasma conc & loss of therapeutic effect w/ nevirapine or efavirenz; ritonavir (600 mg bd); tipranavir/ritonavir; CYP450 inducers (eg, carbamazepine, phenobarb, or phenytoin, rifampin, rifapentine); systemic dexamethasone (CYP3A inducer); St. John's wort. When initiating a combination w/ digoxin, start w/ the lowest dose. Decreased conc of maraviroc [w/o a potent CYP3A inhibitor (eg, ritonavir-boosted PI)]; antiarrhythmics (eg, amiodarone, bepiridil, disopyramide, flecainide, lidocaine (systemic), mexiletine, propafenone, quinidine); itraconazole or ketoconazole; lovastatin & simvastatin. Increased conc of warfarin; diazepam; fluvastatin & pitavastatin. Increased plasma conc w/ posaconazole, itraconazole, ketoconazole, fluconazole, voriconazole. Decreased exposure of clarithromycin but increased conc of 14-hydroxy-clarithromycin leading to altered overall activity against Mycobacterium avium complex (MAC). Potential decreased antimalarial efficacy of artemether/lumefantrine. Potential for significant reductions in etravirine exposure w/ rifabutin + darunavir/ritonavir, lopinavir/ritonavir or saquinavir/ritonavir. Co-administration w/ boceprevir in the presence of other drugs which may further decrease etravirine exposure is not recommended. Dose of atorvastatin may need to be altered based on clinical response. Possible effect on plasma conc of cyclosporine, sirolimus or tacrolimus. Clinical monitoring of w/drawal symptoms is recommended as buprenorphine (or buprenorphine/naloxone) or methadone maintenance therapy may need to be adjusted in some patients. Dose of sildenafil may need to be altered based on clinical effect. Decreased activation of clopidogrel to its active metabolite.
MIMS Class
ATC Classification
J05AG04 - etravirine ; Belongs to the class of non-nucleoside reverse transcriptase inhibitors. Used in the systemic treatment of viral infections.
Presentation/Packing
Form
Intelence tab
Packing/Price
100 mg x 1's
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