Basic
Informations
Intelence is a non-nucleoside
reverse transcriptase inhibitor (NNRTI) manufactured by Tibotec
Therapeutics, a division of Centocor Ortho Biotech products, LP. 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 an NNRTI and
other HIV drugs. It is not yet approved for people 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.
Drugs
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.
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 once 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 made 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) levels may be
increased 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.
Side
Effects
The most common side effects
reported in clinical trials using Intelence were rash (16.9 percent)
and nausea (13.9 percent). Most rashes with Intelence are minor, and
usually go away without any change in treatment. In a small number
of patients, rash may be serious. If you develop rash after starting
Intelence, call your health care provider as soon as possible.
Other possible side effects of Intelence include diarrhea, nausea,
vomiting, abdominal pain, tiredness, tingling or pain in hands or
feet, numbness, headache and high blood pressure.
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