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Composition
(fosamprenavir calcium)
Each tablet contains
fosamprenavir calcium 700 mg
Indication and Usage
FEXVIA treats HIV infection in
adults. It should always be used
in combination with other HIV
medicines. These medicines do
not cure HIV infection/AIDS or
prevent passing HIV to others.
Important Safety Information
* You should not take FEXVIA if
you have had an allergic
reaction to FEXVIA or AGENERASE®
(amprenavir)
* High blood sugar, diabetes or
worsening of diabetes, and
bleeding in hemophiliacs have
occurred in some patients taking
protease inhibitors
* When you start taking HIV
medicines, your immune system
may get stronger and could begin
to fight infections that have
been hidden in your body, such
as pneumonia, herpes virus, or
tuberculosis. If you have new
symptoms after starting your HIV
medicines, be sure to tell your
doctor
* Changes in body fat may occur
in some patients taking
antiretroviral therapy. The
cause and long-term health
effects of these conditions are
not known at this time
* Skin rashes can occur in
patients taking FEXVIA. Rarely,
rashes were severe or life
threatening
* Opportunistic infections can
develop when you have HIV and
your immune system is weak. It
is very important that you see
your healthcare provider
regularly while you are taking
FEXVIA to discuss any side
effects or concerns
* Most common side effects in
clinical studies were diarrhea,
headache, nausea, rash, and
vomiting. In most cases, these
side effects did not cause
people to stop taking their
medicine
DRUG INTERACTIONS
* FEXVIA should not be taken
with: AGENERASE® (amprenavir),
Halcion® (triazolam), ergot
medications (Cafergot®, Migranal®,
D.H.E. 45®, and others),
Propulsid® (cisapride), Versed®
(midazolam), Orap® (pimozide),
Zocor® (simvastatin), Mevacor® (lovastatin),
Rifadin® (rifampin), Rescriptor®
(delavirdine mesylate), or St.
John's wort (Hypericum
perforatum). If you are taking
Norvir® (ritonavir), you should
not take Tambocor® (flecainide),
or Rythmol® (propafenone
hydrochloride)
* Serious and/or
life-threatening events could
occur between FEXVIA and other
medications, including Cordarone®
(amiodarone), lidocaine
(intravenous only), Elavil® (amitriptyline
HCl) and Tofranil® (imipramine
pamoate), tricyclic
antidepressants, and Quinaglute®
(quinidine)
* Women who use birth control
should choose a different kind
of contraception. FEXVIA can
affect the safety and
effectiveness of birth control
pills.
* Patients taking Viagra® (sildenafil
citrate) or LEVITRA® (vardenafil
HCl) with FEXVIA may be at an
increased risk of side effects
* This list of drug interactions
is not complete. Be sure to tell
your healthcare provider about
all medicines you are taking or
plan to take, including
over-the-counter drugs,
vitamins, and herbals
You can take FEXVIA with
ritonavir once a day in the
following ways:
- FEXVIA (two 700 mg
tablets) plus ritonavir (one
100 mg tablet)
- FEXVIA (two 700 mg
tablets) plus ritonavir (two
100 mg tablets)
Presentation
FEXVIA
Blister pack of 30 tablets
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Pharmaceuticals Limited. 2003-2008
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