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Intelence (etravirine)

Articles on Intelence
Full US Prescribing Inormation

Patient Information
What is Intelence?
What is already known about Intelence?
What about drug interactions?
What is known about side effects?
www.intelence.com

INTELENCE™ should not be co-administered with the following antiretrovirals:
Tipranavir/ritonavir, fosamprenavir/ritonavir, atazanavir/ritonavir
Protease inhibitors administered without ritonavir
NNRTIs


Articles on Intelence


FDA approves new dosage strength for INTELENCE®
1-03-2011

Switching from Efavirenz to Etravirine Reduces Central Nervous System Side Effects
8-20-2010

The SENSE Trial: Etravirine (ETR) shows fewer Neuropsychiatric Adverse Events than
Efavirenz (EFV) in Treatment-na´ve HIV-1 Infected Patients
7-23-2010

Prevalence of genotypic and phenotypic susceptibility to etravirine in US samples received for routine resistance testing
7-23-2010

SWITCH-EE Study: A Randomized Cross-over Study to Compare Etravirine and
Efavirenz treatment
7-23-2010

Etravirine (Intelence) Demonstrates Safety and Efficacy in Traditional HAART and Novel Salvage Regimen
4-27-2010

Lack of Interaction between Etravirine
and Raltegravir plus Darunavir/Ritonavir when Combined in Treatment Experienced Patients:a Substudy of the ANRS 139 TRIO
3-16-2010

FDA Updates Etravirine (Intelence) Label with Additional Information on Drug Interactions
3-16-2010

Improved Genotypic Algorithm for Predicting Etravirine Susceptibility: Comprehensive List of Mutations Identified Through Correlation with Matched Phenotype

2-23-2010

Resistance Associated Mutations to Etravirine (TMC-125) in Antiretroviral Na´ve Patients infected with non-B HIV-1 subtypes
2-23-2010

Raltegravir (Isentress), Etravirine (Intelence), and Boosted Darunavir (Prezista)
Is Highly Effective for Treatment-experienced Adolescents
11-17-2009


Raltegravir (Isentress),
Etravirine (Intelence), and Ritonavir-boosted Darunavir (Prezista) Is a Safe and Successful Salvage Regimen
10-06-2009


Tibotec and FDA Issue New Safety Warning for NNRTI Etravirine (Intelence) regarding Severe Skin Rash and Hypersensitivity
9-01-2009

Newer Anti-HIV Drugs and How to Use Them: Part I

6-23-2009


Tibotec Applies for Traditional Approval of NNRTI Etravirine (Intelence)
2/10/09

Excellent Response with a PI- and NRTI-sparing Regimen of Raltegravir (Isentress), Maraviroc (Selzentry), and Etravirine (Intelence)
11/14/2008

Phenotypic Impact on Etravirine Susceptibility of Distinct Resistance Mutations in HIV Patients with Prior Failure to Non-Nucleoside Analogues
11/05/2008

Comparison of Etravirine Resistance and Efavirenz/Nevirapine Resistance among HIV-1 Infected Patients Who Experienced Virologic Failure with NNRTI-based Antiretroviral Therapy
11/05/2008

Reduction in AIDS-defining events/death with etravirine compared to placebo: pooled DUET 48-week results
11/05/2008

Pharmacokinetics and pharmacodynamics of etravirine in treatment-experienced HIV-1-infected patients: pooled 48-week results of DUET-1 and DUET-2
11/05/2008

Treatment Response among HIV Patients Co-enrolled in the Etravirine (ETR) and Raltegravir (RAL) Expanded Access Programs (EAPs) at Kaiser Permanente
11/05/2008

Durability of virologic response to etravirine is not affected by time to reach virologic response
11/05/2008

Next-generation NNRTI Etravirine (Intelence) Approved by European Medicines Agency
9/05/08

Virological Success with Raltegravir (Isentress) plus Etravirine (Intelence) plus Boosted Darunavir (Prezista) in Patients with Multidrug-resistant HIV: TRIO Trial
8/15/2008


DUET-1:Week 48 results of a Phase III randomized double-blind trial to evaluate the efficacy and safety of etravirine (ETR; TMC125) versus placebo in 612 treatment-experienced HIV-1-infected patients
2/20/08

DUET-2:Week 48 results of a Phase III randomized double-blind trial to evaluate the efficacy and safety of etravirine (ETR; TMC125) versus placebo in 591 treatment-experienced HIV-1-infected patients
2/20/08

Pharmacokinetics of the next-generation NNRTI etravirine (ETR; TMC125) in HIV-infected children between 6 and 17 years, inclusive
2/20/08




What is Intelence?

Intelence is a non-nucleoside reverse transcriptase inhibitor (NNRTI) manufactured by Tibotec, a subsidiary of Johnson & Johnson. It was approved by the U.S. Food and Drug Administration (FDA) in January 2008. Intelence is approved for treatment-experienced patients who have HIV strains that are resistant to multiple antiretroviral drugs, including other NNRTIs. It is not yet approved for people with drug-sensitive HIV strains, such as those starting antiretroviral therapy for the first time.

Intelence works by blocking HIV’s reverse transcriptase enzyme. After HIV's genetic material is deposited inside a cell, its RNA must be converted (reverse transcribed) into DNA. NNRTIs stop this process and prevent HIV from infecting the CD4 cell and producing new virus particles.

Intelence must be used in combination with other HIV drugs.




What is already known about Intelence?

The Intelence dose is two 100 mg tablets taken by mouth twice a day. It should be taken following a meal (e.g., breakfast and dinner).

The tablets should be swallowed whole, with liquid such as water. The tablets should not be chewed. If you are unable to swallow the tablets whole, you can dilute the tablets in a glass of water. Stir the water well, until it looks milky, then drink the mixture immediately. Make sure that there's no medication residue remaining in the glass (add additional water and then mix and swallow again).

Intelence is active against HIV strains resistant to other antiretrovirals, including many strains that are resistant to the NNRTIs Sustiva (efavirenz), Viramune (nevirapine) and Rescriptor (delavirdine). Drug-resistance testing can be used to determine how effective Intelence will be against HIV, if other NNRTIs have been used in the past.

Intelence is not yet approved for people with HIV that have no, or limited, resistance to other available antiretroviral drugs. This includes HIV-positive people beginning treatment for the first time. However, a clinical trial evaluating Intelence's safety and effectiveness in first-time treatment takers is being conducted.

Intelence is not yet approved for use in HIV-positive children. To learn more about treatment options for children, click here.



What about drug interactions?

Because of the way Intelence is metabolized (broken down) in the body, it can interact with many other medications used to treat HIV, AIDS-related complications and other diseases. Intelence may cause blood levels of other medications to become too low (which can decrease their effectiveness) or high (which can increase the risk of side effects). Similarly, other medications may cause blood levels of Intelence to become too low or high.

At the time of Intelence's approval in January 2008, there were no known "contraindications," meaning that there were no known medications that must be avoided while taking Intelence. However, there are a number of medications that are not yet recommended for use in combination with Intelence, due to serious drug interactions, until additional dosing studies are successfully completed.

Intelence can interact with several HIV medications. Intelence should not be combined with the following: Norvir (ritonavir)-boosted Aptivus (tipranavir), Norvir-boosted Lexiva (fosamprenavir) or Norvir-boosted Reyataz (atazanavir); any protease inhibitors given without a boosting dose of Norvir; or any of the other approved NNRTIs.

Intelence can be combined with any of the approved nucleoside reverse transcriptase inhibitors (NRTIs). It can also be combined with Norvir-boosted Prezista (darunavir) or Norvir-boosted Invirase (saquinavir) without having to adjust the doses of any of the drugs being used. Intelence can also be combined with the integrase inhibitor Isentress (raltegravir), without requiring dose adjustments.

Kaletra (lopinavir plus ritonavir) should be used cautiously with Intelence, given that it can raise Intelence blood levels 85 percent and potentially increase the risk of Intelence side effects. While it is possible that Intelence can be combined with Selzentry (maraviroc), official dosing recommendations have not yet been made (if using Intelence without a Norvir-boosted protease inhibitor, the Selzentry dose will likely be 600 mg, taken twice a day; if using Intelence with a Norvir-boosted protease inhibitor, the Selzentry dose will likely be 150 mg, taken twice a day).

Intelence can interact with Biaxin (clarithromycin), Rifadin (rifampin), Priftin (rifapentine) and Mycobutin (rifabutin)—medications used to treat TB, MAC, and other bacterial infections. Zithromax (azithromycin) should be used as an alternative to Biaxin. Because Rifadin and Priftin can greatly reduce levels of Intelence in the bloodstream, they should not be used at the same time. If Intelence is being used with a Norvir-boosted protease inhibitor, Mycobutin should not be used. If Intelence is being used without a Norvir-boosted protease inhibitor, a Mycobutin dose of 300 mg twice a day is recommended.

Intelence can interact with several medications used to treat thrush (candidiasis) and other fungal infections, including Diflucan (fluconazole), Sporanox (itraconazole), Nizoral (ketoconazole), Noxafil (posaconazole) and Vfend (voriconazole). Dose adjustments of antifungal medications may need to be altered if used in combination with Intelence.

Methadone, commonly used to treat drug addiction, can be taken with Intelence.

Intelence can interact with a number of heart medications, including Vascor (bepridil), Tambocor (flecainide) and Rythmol (propafenone). Intelence can reduce levels of these medications in the bloodstream, potentially making them less effective. Monitoring blood levels of these heart medications is recommended if using them in combination with Intelence.

The anticonvulsants Tegretol (carbamazepine), Luminal (phenobarbital) and Dilantin (phenytoin) should not be used in combination with Intelence.

Cholesterol-lowering drugs, also known as "statins," can interact with Intelence. Intelence may decrease blood levels of Zocor (simvastatin) and Mevacor (lovastatin). Lescol (fluvastatin) may increase levels of Intelence in the blood stream. Intelence can be given with Lipitor (atorvastatin), although it may be necessary to adjust the dose of Lipitor if cholesterol levels do not improve. It is not expected that Intelence will interact with Pravachol (pravastatin) or Crestor (rosuvastatin).

Viagra (sildenafil), Levitra (vardenafil) and Cialis (tadalafil) levels in the bloodstream may decrease when combined with Intelence. Doses of these medications may need to be adjusted.

Herbal products can also interact with Intelence. St. John's wort should not be used with Intelence, since it can reduce the amount of Intelence in the bloodstream.

Other drug interactions are possible. Be sure to tell your doctor about all the medications you are taking (or plan to take), including those you buy over the counter at your pharmacy or health-food store, while taking Intelence.



What is known about side effects?

The most common side effects reported in clinical trials using Intelence were rash (16.9 percent) and nausea (13.9 percent). If you develop a rash while taking Intelence, notify your health care provider.

Other possible side effects of Intelence include diarrhea, vomiting, abdominal pain, tiredness, tingling or pain in hands or feet, numbness, headache and high blood pressure.