Drug Interaction:
Drug interactions-
Anticonvulsants eg carbamazepine, phenobarbital, phenytoin ) + Etravirine-
coadmi n may cause a significant decrease of etravirine plasma concentration
and therapeutic effect.
Antifingals eg fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole
+ Etravirine/ Etrvirine + antifungals -
coadmin of fluconazole, itraconazole, ketoconazole, posaconazole with etravirine
may increase plasma concentration of etravirine. Plasma concentration of
itraconazole, or ketoconazole may be decreasd by ertavirine. Dose ajustments
of itraconazole, ketoconazole or voriconazole may be necessary
Atazanavir/ritinaavir + etravarine / etravarine + atazanavir-
concomttant use of etrvarine with atazanavir/ritonavir may cause a significant decrease
in atanavir
Darunavir/ritonavir + etravarine -
may be coadministered without adjustment
Dexamethasone + etravarine-
use with caution or consider an alternative corticosteroid particularly if used for a long term
Indication:
HIV infections
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Etravarine Tablet 100mg 26-04-2012
In combination with other retroviral agents for the treatment of
Human Immunodeficiency Virus type 1 HIV Infection in
Anti-retroviral treatment -experienced adult patients who have
evidence of viral replication and HIV- strains resistent to HIV
strains resistent to an NNRTI and other anti-retroviral agents.
It should be used only in situations where other treatments have
failed or cannot be used because of side effects
Adverse Reaction:
Adverse reactions-
Cardiovascular - hypertension 2%
CNS - fatigue 3% headache 2% peripheral neuropathy 2%
Dermatologic - rash 8%
GI - abdominal pain 2% diarrhea 5% nausea 4% vomiting 2%
Contra-Indications:
Not known
Special precautions-
Skin - severe and potentially life threatening skin reactions have occured in patients taking
etravarine. If severe rash develops, discontinue treatment with etravarine and consider
alternate therapy
Renal function impairment - No dosage adjustment is reuired in patients with renal impairment.
Because etravarine is highly bound by plasma proteins it is unlilkely that it will significantly
removed by hemodialysis or peritonal dialysis.
Hepatic function impairment - no dosage adjustment of etravarine is required in patients
with mild or moderate hepatic function impairment
Pregnancy-use etravarine during pregnancy only if the potential benefit justifies the potential
risk to the fetus.
Lactation- instruct mothers not to breast feed if they are receiving etravarin
Children- safety and effectiveness in children not established
Elderly- dose selection in elderly patients should be cautious reflecting th greater freqency
of decreased hepatic, renal or cardiac function and of concomitant disease or other drug
therapy.
Dosages/ Overdosage Etc:
In combination with other retroviral agents for the treatment of
Human Immunodeficiency Virus type 1 HIV Infection in
Anti-retroviral treatment -experienced adult patients who have
evidence of viral replication and HIV- strains resistent to HIV
strains resistent to an NNRTI and other anti-retroviral agents.
It should be used only in situations where other treatments have
failed or cannot be used because of side effects
Indication-
HIV infection
Dosage-
200mg ( two 100mg tablets ) taken twice daily following a meal . The type of food dose not
affect exposure of etravine
Patients who are unable to swallow etravine tablets may disperse the tablets in a glass of water.
Once dispersed patients should stir the dispersion well and drink immediately.
The glass should be rinsed completely and each rinse completely swallowed to ensure
that the entire dose is consumed
Patient Information:
1. Inform patients that etravarine is not a cure for HIV infections.
2. Advice patients that etravarine dose not reduce the risk of passing HIV infections through
sexual contact. Advice patients to practice safe sex.
3. Advice patients to take etravarine following a meal twice a day as prescribed
4. Patients who are unable to swallow etravine tablets may disperse the tablets in a glass
of water. Once dispersed patients should stir the dispersion well and drink immediately.
The glass should be rinsed completely and each rinse completely swallowed to ensure
that the entire dose is consumed
Interaction with Food:
To taken following a meal
Pregnancy and lactation:
Pregnancy-
Use etravarine during pregnancy only if the potential benefit justifies the potential
risk to the fetus.
Lactation-
Instruct mothers not to breast feed if they are receiving etravarin
Children-
Safety and effectiveness in children not established
Elderly-
Dose selection in elderly patients should be cautious reflecting th greater freqency
of decreased hepatic, renal or cardiac function and of concomitant disease or other drug
therapy.