Basic
Informations
Agenerase is an anti-HIV
medication. It is in a category of HIV medications called protease
inhibitors (PIs). Agenerase prevents T-cells that have been infected
with HIV from producing new HIV.
Agenerase is manufactured by GlaxoSmithKline Pharmaceuticals and was
originally developed by Vertex Pharmaceuticals. The U.S. Food and
Drug Administration (FDA) approved it for the treatment of HIV
infection in 1999.
The manufacturer of Agenerase has also developed Lexiva (fosamprenavir),
a "prodrug" of Agenerase. This means that fosamprenavir must be
broken down inside the body before it can become active. Doing so
increases the amount of drug in the blood, while at the same time
decreasing the number of pills that must be swallowed every day.
Lexiva was approved by the FDA in October 2003 and is now the
preferred form of amprenavir.
Agenerase is no longer available in the
United States. Because Lexiva is now the preferred form
of amprenavir, GlaxoSmithKline began phasing out the sale and
distribution of the 150mg Agenerase capsules beginning in late 2004.
In October 2007, GSK ended the U.S. sale and distribution of the
50mg capsules and the liquid version of Agenerase, on account of the
June 2007 approval of a liquid version of Lexiva. Liquid Agenerase
will remain available in countries where liquid Lexiva is not yet
available.
Drugs
Interactions
Agenerase is broken down
(metabolized) by the liver, like many medications used to treat HIV
and AIDS. This means that Agenerase can interact with other
medications. Agenerase can lower or raise the levels of other
medications in the body. Similarly, other medications can lower or
raise the levels of Agenerase in the body. While many interactions
are not a problem, some can cause your medications to be less
effective or increase the risk of side effects.
Tell your doctors and pharmacists about all medicines you take. This
includes those you buy over-the-counter and herbal or natural
remedies, such as St. John’s Wort. Bring all your medicines when you
see a doctor, or make a list of their names, how much you take, and
how often you take them. Your doctor can then tell you if you need
to change the dosages of any of your medications.
The following medications should not be taken while you are being
treated with Agenerase:
-
Acid reflux/heartburn
medications: Propulsid (cisapride)
-
Antibiotics: Priftin (rifapentine)
and Rifadin (rifampin)
-
Antimigraine medications:
Ergostat, Cafergot, Ercaf, Wigraine (ergotamine) or D.H.E. 45 (dihydroergotamine)
-
Antihistamines: Hismanal (astemizole)
or Seldane (terfenadine)
-
Calcium channel blockers:
Vascor (bepridil)
-
Cholesterol-lowering drugs
(statins): Zocor (simvastatin) and Mevacor (lovastatin)
-
Antipsychotics: Orap
(pimozide)
-
Sedatives: Versed (midazolam)
and Halcion (triazolam)
Anticonvulsants, such as
Tegretol ( carbamazepine), Luminal (phenobarbital), and Dilantin (phenytoin),
may decrease the amount of Agenerase in the bloodstream. It might be
necessary to increase your dose of Agenerase if you are taking any
of these drugs.
Anti-HIV protease inhibitors can interact with Agenerase. Norvir (ritonavir),
Kaletra (lopinavir/ritonavir), Reyataz (atazanavir), Crixivan (indinavir),
and Viracept (nelfinavir) can all increase Agenerase levels in the
bloodstream. If Agenerase is combined with either Norvir or Kaletra,
the Agenerase dose should be reduced. Invirase (saquinavir) can
decrease the amount of Agenerase in the bloodstream. At the same
time, if Agenerase is combined with Kaletra, the Kaletra dose may
need to be increased (Agenerase may decrease the amount of lopinavir
in the bloodstream). If Agenerase is combined with Invirase,
low-dose Norvir may be necessary to maintain Agenerase levels in the
bloodstream.
Anti-HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs)
can also interact with Agenerase. Sustiva (efavirenz) and Viramune (nevirapine)
can decrease the amount of Agenerase in the bloodstream (adding
Norvir will be necessary to maintain Agenerase levels). A third
NNRTI, Rescriptor (delavirdine), can increase levels of Agenerase in
the bloodstream (Agenerase can significantly decrease Rescriptor
levels in the bloodstream if they are used together). The
combination of Rescriptor and Agenerase is not recommended.
Ziagen (abacavir), an NRTI, can increase Agenerase levels in the
bloodstream. However, there is no need to change the dose of either
drug.
Agenerase can interact with some medications used to treat TB, MAC,
and other bacterial infections. Rifadin (rifampin) can decrease
Agenerase levels (these drugs should not be used together).
Agenerase can increase Mycobutin (rifabutin) levels and Mycobutin
may decrease Agenerase levels (the Mycobutin dose will need be
reduced). Biaxin (clarithromycin) increases Agenerase levels,
although no dosing changes are necessary.
Agenerase can interact with some medications used to treat thrush (candidiasis)
and other fungal infections. Agenerase can increase Nizoral (ketoconazole)
levels in the bloodstream. Similarly, Nizoral can increase Agenerase
levels in the bloodstream. However, no dosing changes are necessary.
It is not known what effect Agenerase has on oral
contraceptives/birth-control pills. To reduce the risk of pregnancy,
barrier protection (e.g., condoms) should be used.
Cholesterol-lowering drugs, also known as "statins," can interact
with Agenerase. The two statins that are considered to be the safest
in combination with Agenerase are Pravachol (pravastatin) and Lescol
(fluvastatin). It is also possible to take Agenerase with Lipitor (atorvastatin),
Zocor (simvastatin) and Mevacor (lovastatin), although Agenerase can
increase levels of these three drugs in the bloodstream. If Lipitor,
Zocor, or Mevacor are prescribed, it's best to begin treatment with
the lowest possible dose of the drug and then increase the dose if
necessary. Little is known about the newest statin, Crestor (rosuvastatin),
although it is not expected to have any serious drug interactions
with Agenerase or the other protease inhibitors.
Viagra (sildenafil), Levitra (vardenafil) and Cialis (tadalafil)
levels in the bloodstream may increase when combined with Agenerase.
In turn, it is best to use a lower dose of these drugs in order to
reduce the risk of side effects.
Agenerase contains high amount of vitamin E. To avoid unnecessary
side effects of vitamin E, HIV-positive individuals taking this drug
should avoid taking vitamin E supplements.
Herbal products can also interact with Agenerase. St. John's wort
should not be used with Agenerase, since it can greatly reduce the
amount of Agenerase in the bloodstream. HIV-positive people should
also be cautious about using garlic supplements or milk thistle with
Agenerase—test tube studies suggest that both herbal products can
interact with the same liver enzyme system (cytochrome P450 3A4)
responsible for metabolizing Agenerase. This may alter the amount of
Agenerase in the bloodstream. These and other herbal products should
be used with caution, until further studies are conducted.
A number of other negative drug interactions are possible if
Agenerase is combined with Norvir (ritonavir).
Side
Effects
Short-term side effects
include rash, appetite loss, headaches, feeling crummy (malaise),
diarrhea, nausea, and vomiting. Another possible side effect is
numbness/tingling around the mouth (perioral paresthesias). Very
often, these side effects improve within a few months/weeks of
starting Agenerase.
Anti-HIV drug regimens containing protease inhibitors, including
Agenerase, can cause increased fat levels (cholesterol and
triglycerides) in the blood, abnormal body-shape changes
(lipodystrophy; including increased fat around the abdomen, breasts,
and back of the neck, as well as decreased fat in the face, arms,
and legs), and diabetes.
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