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ETRAVIRINE (ETR, BRAND NAME INTELENCE, FORMERLY KNOWN AS TMC125)
IS A DRUG USED FOR THE TREATMENT OF HIV. ETRAVIRINE IS A
NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR (NNRTI). UNLIKE
THE CURRENTLY AVAILABLE AGENTS IN THE CLASS, RESISTANCE TO
OTHERNNRTIS DOES NOT SEEM TO CONFER RESISTANCE TO ETRAVIRINE.
BRAND NAME INTRAVIR,I S A DRUG USED FOR THE TREATMENT OF HIV.
ETRAVIRINE IS A NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR (NNRTI).
UNLIKE THE CURRENTLY AVAILABLE AGENTS IN THE CLASS,
RESISTANCE TO OTHERNNRTIS DOES NOT SEEM TO CONFER RESISTANCE TO
INTRAVIR® (ETRAVIRINE), WHEN TAKEN WITH OTHER HIV MEDICINES, MAY
HELP TO DECREASE VIRAL LOAD IN PATIENTS WHO ARE ALREADY TAKING
OR HAVE TAKEN HIV MEDICINES, HAVE RESISTANCE TO NON-NUKES AND
OTHER HIV MEDICINES, AND WHOSE HIV INFECTION IS NOT UNDER
INTRAVIR® IS NOT RIGHT FOR EVERYONE. ASK YOUR HEALTHCARE
PROFESSIONAL IF INTRAVIR® IS RIGHT FOR YOU.
• INTRAVIR® (etravirine) is a prescription HIV (human
immunodeficiency virus) medicine that is used with other HIV
medicines to treat HIV infection in adults and children 6 years
of age and older. HIV is the virus that causes AIDS (Acquired
Immune Deficiency Syndrome). INTRAVIR® is a type of HIV medicine
called a non-nucleoside reverse transcriptase inhibitor (NNRTI),
also known as a non-nuke
• INTRAVIR® must be taken in combination with other HIV
medicines. INTRAVIR® is used in people who are already taking or
have taken an NNRTI and other HIV medicines and these medicines
are not controlling their HIV infection
o The use of other medicines active against your HIV in
combination with INTRAVIR®may increase the likelihood of your
overall treatment response. If a non-nuke regimen has stopped
working for you in the past, INTRAVIR® should not be taken with
only nucleoside/nucleotide reverse transcriptase inhibitors,
also known as nukes. Your healthcare professional will work with
you to find the right combination of HIV medicines to combine
o It is important that you remain under the care of your
healthcare professional during treatment with INTRAVIR®
• It is not known if INTRAVIR® is safe and effective in children
less than 6 years of age
INTRAVIR® does not cure HIV infection or AIDS. You must stay on
continuous HIV therapy to control your HIV infection and
decrease HIV-related illnesses.
Intravir is a drug used for the treatment of HIV. Intravir is
a non-nucleoside reverse transcriptase inhibitor (NNRTIs). Unlike
the currently available agents in the class, resistance to other
NNRTIs does not seem to confer resistance to Intravir.
Indications and dosage
Intravir, in combination with other anti-retrovirals, is indicated
for the treatment of human immunodeficiency virus type 1 (HIV-1)
infection in antiretroviral treatment-experienced adult patients,
who have evidence of viral replication and HIV-1 strains resistant
to a non-nucleoside reverse transcriptase inhibitor (NNRTI) and
other antiretroviral agents.
The recommended dose of Intravir is 200 mg (two 100 mg tablets)
taken twice daily following a meal. The type of food does not
affect the exposure to Intravir.
Intravir is a non-nucleoside reverse transcriptase inhibitor (NNRTI)
of human immunodeficiency virus type 1 (HIV-1). Reverse
transcriptase a viral DNA polymerase enzyme that HIV needs to
reproduce. Intravir blocks the enzymatic function of reverse
transcriptase and prevents completion of synthesis of the
double-stranded viral DNA ,thus preventing HIV from multiplying.
Intravir, in combination with other antiretroviral agents, is
specifically indicated for the treatment of human immunodeficiency
virus type 1 (HIV-1) infection in antiretroviral
treatment-experienced adult patients, who have evidence of viral
replication and HIV-1 strains resistant to a non-nucleoside
reverse transcriptase inhibitor (NNRTI) and other antiretroviral
Intravir is supplied as a tablet designed for oral administration.
The recommended initial dose of the drug is 200 mg (two 100 mg
tablets) taken twice daily following a meal. If a patient is
unable to swallow a tablet whole, it may be dispersed in a glass
FDA approval of Intravir was based on pooled 24-week results of
two ongoing, identical phase III trials. These randomized,
double-blinded, placebo-controlled studies were dubbed DUET-1
(TMC125-C206) and DUET-2 (TMC125-C216). The trials were designed
to evaluate the safety and antiretroviral activity of Intravir in
combination with a background regimen (BR) as compared to placebo
in combination with a BR. Randomization was stratified by the
intended use of enfuvirtide (ENF) in the BR, previous use of
darunavir/ritonavir (DRV/rtv), and screening viral load. All study
subjects received DRV/rtv as part of their BR, and at least two
other investigator-selected antiretroviral drugs (N[t]RTIs with or
without ENF. The endpoint was virologic response, defined as
undetectable viral load (< 50 HIV-1 RNA copies/mL) at 24 weeks. At
Week 24, 74% of Intellence-treated subjects achieved HIV-1 RNA <
400 copies/mL as compared to 51.5% of placebo-treated subjects.
The mean decrease in plasma HIV-1 RNA from baseline to Week 24 was
-2.37 log10 copies/mL for Intravir-treated subjects and -1.68
log10 copies/mL for placebo-treated subjects. The mean CD4+ cell
count increase from baseline for Intravir-treated subjects was 81
cells/mm3 and 64 cells/mm3 for placebo-treated subjects. Of the
population who either re-used or did not use ENF, 56.7% of
Intravir-treated subjects and 32.7% of placebo-treated subjects
achieved HIV-1 RNA < 50 copies/mL. Of the study population using
ENF for the first time, 68.6% of Intravir-treated subjects and
61.3% of placebo-treated subjects achieved HIV-1 RNA < 50 copies/mL.
Adverse events associated with the use of Intravir may include,
but are not limited to, the following:
Mechanism of Action
Intravir is a non-nucleoside reverse transcriptase inhibitor (NNRTI)
of human immunodeficiency virus type 1 (HIV-1). Intravir binds
directly to reverse transcriptase and blocks the RNA-dependent and
DNA-dependent DNA polymerase activities by causing a disruption of
the enzyme's catalytic site. Intravir does not inhibit the human
DNA polymerases alpha, beta, and gamma.
Important Safety Information
Intravir does not cure HIV infection or AIDS, and does not prevent
passing HIV to others.
* Severe skin rash has been reported with Intravir;
Stevens-Johnson Syndrome has been rarely (<0.1 percent) reported.
Treatment with Intravir should be discontinued if severe rash
develops. In general, rash was mild to moderate, occurred
primarily in the second week of therapy, and was infrequent after
Week 4. Rash generally resolved within 1-2 weeks on continued
therapy. Discontinuation rate due to rash was 2 percent.
* No dose adjustment is required in patients with mild or moderate
hepatic impairment (Child-Pugh Class A or B). The pharmacokinetics
of Intravir have not been studied in patients with severe hepatic
impairment (Child-Pugh Class C). Therefore, Intravir should be
used with caution in patients with severe hepatic impairment.
* Based upon the safety profile, no dose adjustment is necessary
in patients co-infected with hepatitis B and/or C virus.
* Redistribution and/or accumulation of body fat have been
observed in patients receiving. ARV therapy. The causal
relationship, mechanism, and long-term consequences of these
events have not been established.
* Immune reconstitution syndrome has been reported in patients
treated with ARV therapy, including Intravir.
* The most frequently reported adverse events (>10 percent) of any
intensity that occurred at a higher rate than placebo were rash
(17 percent), diarrhoea (15 percent) and nausea (13.9 percent).
Note :This product information is intended only
for residents of the India. Taj Pharmaceuticals Limited,
medicines help to treat and prevent a range of conditions—from the
most common to the most challenging—for people around the world.
Information for Health Care Professionals
*** Please consult local Prescribing
Information for any product before use. This website is an
international information resource for healthcare professionals
with an interest in disease management. This website is not
intended to replace the advice of a qualified healthcare
professional. Above brand is a trademark of the Taj group of
companies (Taj Pharmaceuticals Limited).
INTRAVIR® (ETRAVIRINE) DOSING INFORMATION
INTRAVIR® MUST BE TAKEN IN COMBINATION WITH OTHER HIV MEDICINES
AS PRESCRIBED BY YOUR HEALTHCARE PROFESSIONAL
• THE DOSE IS 200 MG (ONE 200-MG TABLET) OF INTRAVIR® TWICE A
DAY, EVERY DAY (A TOTAL OF 2 TABLETS EACH DAY)
o 100-MG TABLETS ARE STILL AVAILABLE. THE DOSE IS 200 MG (TWO
100-MG TABLETS) OF INTRAVIR® TWICE A DAY, EVERY DAY (A TOTAL OF
4 TABLETS EACH DAY)
• TAKE INTRAVIR® TWICE A DAY FOLLOWING A MEAL. THE TYPE OF
FOOD IS NOT IMPORTANT. DO NOT TAKE INTRAVIR® ON AN EMPTY
STOMACH, AS IT MAY NOT WORK AS WELL AS IT SHOULD
• SWALLOW THE TABLETS WHOLE WITH WATER. DO NOT CHEW THE TABLETS
Important Safety Information
What are the possible side effects of INTRAVIR®?
INTRAVIR® can cause serious side effects including:
• Severe skin rash and allergic reactions. Skin rash, in general, is
a common side effect of INTRAVIR® and was seen more commonly in
children than adults in clinical studies. Rash was also seen more
commonly in females than males. Rash can be serious and may
potentially lead to death. If you get a rash with any of the
following symptoms, stop taking INTRAVIR® and call your healthcare
professional right away: hives or sores in your mouth, or your skin
blisters and peels; trouble swallowing or breathing; swelling of
your face, eyes, lips, tongue, or throat; fever; yellowing of the
skin or whites of the eyes; dark urine; or pain on the right side of
the stomach area (abdominal pain)
• Changes in body shape or body fat. The cause and long-term health
effects of these conditions are not known at this time
• Changes in your immune system can happen when you start taking HIV
medicines. Your immune system may get stronger and begin to fight
infections that have been hidden
• In adults, common side effects of INTRAVIR® include tingling,
numbness, or pain in hands or feet
• In children, diarrhea is a common side effect of INTRAVIR®
This is not a complete list of all side effects. If you experience
these or other symptoms, contact your healthcare professional right
What should I tell my doctor before I take INTRAVIR®?
• Before taking INTRAVIR®, tell your healthcare professional if you
have liver problems, including hepatitis B or C, have any other
medical conditions, or if you are pregnant, planning to become
pregnant, or breastfeeding
o It is not known if INTRAVIR® can cause harm to your unborn baby.
Do not breastfeed if you are taking INTRAVIR®. You should not
breastfeed if you have HIV because of the risk of passing HIV to
• Tell your healthcare professional about all the medicines you
take, including prescription and nonprescription medicines,
vitamins, and herbal supplements
• Taking INTRAVIR® with certain medicines may cause serious side
effects or may result in loss of its effectiveness (which could
increase your risk for developing resistance to INTRAVIR® or other
HIV medicines). Dolutegravir (Tivicay®, Triumeq®) is one HIV
medication that may have loss of effectiveness when taken with
INTRAVIR®. Tell your healthcare professional about all other HIV
medications you are taking
• Do not take INTRAVIR® if you are taking the following medicines:
o HIV: tipranavir/ritonavir (Aptivus®), fosamprenavir/ritonavir (Lexiva®),
full-dose ritonavir (Norvir® 600 mg twice a day), unboosted protease
inhibitors (without ritonavir), nevirapine (Viramune®), efavirenz (Sustiva®),
or delavirdine (Rescriptor®)
o Other: carbamazepine (Tegretol®, Tegretol-XR®, Carbatrol®, Equetro®,
Teril®, Epitol®), phenobarbital (Luminal®, Solfoton®), phenytoin (Dilantin®,
Dilantin-125®, Phenytek®), rifabutin (Mycobutin®), rifampin (Rifadin®,
Rifater®, Rifamate®, Rimactane®), rifapentine (Priftin®), or
products containing St. John’s wort (Hypericum perforatum)