 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.
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