This Web site does not take the place of careful discussions
with your doctor. You and your doctor should discuss your
treatment with PREZISTA™ (darunavir) the first time you
take your medicine and at regular checkups. You should remain
under a doctor's care when using PREZISTA™ and should not
change or stop treatment without first talking with a doctor.
What is PREZISTA™?
How does PREZISTA™
work?
Does PREZISTA™
cure HIV or AIDS?
Does PREZISTA™
reduce the risk of passing HIV to others?
What should I tell my
doctor before I take PREZISTA™?
Who should not take
PREZISTA™?
Can PREZISTA™ be
taken with other medications?
How should I take
PREZISTA™?
What are the
possible side effects of PREZISTA™?
What do
PREZISTA™ tablets look like?
How should I store
PREZISTA™ tablets?
What is PREZISTA™?
PREZISTA™ is an oral tablet used for the treatment of HIV
(Human Immunodeficiency Virus) infection in adults. HIV is the
virus that causes AIDS (Acquired Immune Deficiency Syndrome).
PREZISTA™ is a type of anti-HIV drug called a protease
(PRO-tee-ase) inhibitor.
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How does
PREZISTA™ work?
PREZISTA™ blocks HIV protease, an enzyme which is needed
for HIV to multiply. When used with other anti-HIV medicines,
PREZISTA™ may reduce the amount of HIV in your blood
(called "viral load") and increase your CD4 (T) cell count. HIV
infection destroys CD4 (T) cells, which are important to the
immune system. The immune system helps fight infection. Reducing
the amount of HIV and increasing the CD4 (T) cell count may
improve your immune system and, thus, reduce the risk of death
or infections that can happen when your immune system is weak
(opportunistic infections).
PREZISTA™ is always taken with and at the same time as 100
mg of ritonavir (Norvir), in combination with other anti-HIV
medicines. PREZISTA™ should also be taken with food.
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Does PREZISTA™
cure HIV or AIDS?
PREZISTA™ does
not cure HIV infection or AIDS. At present, there is no
cure for HIV infection. People taking PREZISTA™ may still
develop infections or other conditions associated with HIV
infection. Because of this, it is very important for you to
remain under the care of a doctor. Although PREZISTA™ is
not a cure for HIV or AIDS, PREZISTA™ can help reduce your
risks of getting illnesses associated with HIV infection (AIDS
and opportunistic infection) and eventually dying from these
conditions.
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Does
PREZISTA™ reduce the risk of passing HIV to others?
PREZISTA™ does
not reduce the risk of passing HIV to others through
sexual contact, re-using or sharing needles, or being exposed to
your blood. For your health and the health of others, it is
important to always practice safer sex by using a latex or
polyurethane condom or other barrier method to lower the chance
of sexual contact with any body fluids such as semen, vaginal
secretions, or blood. Never re-use or share dirty needles.
Ask your doctor if you have any questions on how to prevent
passing HIV to other people.
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What should I tell
my doctor before I take PREZISTA™?
Tell your doctor about all of your medical conditions,
including if you:
-
are allergic to sulfa medicines.
-
have diabetes. In general, anti-HIV medicines, such as
PREZISTA, might increase sugar levels in the blood.
-
have liver problems, including hepatitis B or C.
-
have hemophilia. Anti-HIV medicines, such as PREZISTA, might
increase the risk of bleeding.
-
are pregnant or planning to become pregnant. The effects of
PREZISTA on pregnant women or their unborn babies are not
known. You and your doctor will need to decide if taking
PREZISTA is right for you. If you take PREZISTA while you are
pregnant, talk to your doctor about how you can be included in
the Antiretroviral Pregnancy Registry.
-
are breastfeeding. Do not breastfeed if you are taking
PREZISTA. You should not breastfeed if you have HIV because of
the chance of passing HIV to your baby. Talk with your doctor
about the best way to feed your baby.
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Who should not take
PREZISTA™?*
Together with your doctor, you need to decide whether taking
PREZISTA™ is right for you.
Do not take PREZISTA™ if you:
-
are allergic to darunavir or any of the other ingredients in
PREZISTA™
-
are allergic to ritonavir (Norvir
®
)
-
take any of the following types of medicines because you could
experience serious side effects:
|
Type of Drug
|
Examples of Generic Names (Brand Names)
|
Antihistamines
(to treat allergy symptoms)
|
astemizole (Hismanal
®
)
terfenadine (Seldane
®
)
|
Ergot Derivatives
(to treat migraine and headaches)
|
dihydroergotamine (D.H.E. 45
®
, Migranal
®
)
ergonovine
ergotamine (Wigraine
®
, Ergostat
®
, Cafergot
®
, Ergomar
®
)
methylergonovine
|
Gastrointestinal Motility Agent
(to treat some digestive conditions)
|
cisapride (Propulsid
®
)
|
Neuroleptic
(to treat psychiatric conditions)
|
pimozide (Orap
®
)
|
Sedative/hypnotics
(to treat trouble with sleeping and/or anxiety)
|
midazolam (Versed
®
)
triazolam (Halcion
®
)
|
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Can PREZISTA™
be taken with other medications?*
Tell your doctor about all the medicines you take including
prescription and nonprescription medicines, vitamins, and herbal
supplements, including St. John's wort (
Hypericum perforatum). PREZISTA™ and many other
medicines can interact. Sometimes serious side effects will
happen if PREZISTA™ is taken with certain other medicines
(see "Who should not take PREZISTA™?").
Tell your doctor if you are taking estrogen-based
contraceptives. PREZISTA™ might reduce the effectiveness
of estrogen-based contraceptives. You must take additional
precautions for birth control such as a condom.
Tell your doctor if you take other anti-HIV medicines.
PREZISTA™ can be combined with some other anti-HIV
medicines while other combinations are not recommended.
Tell your doctor if you are taking any of the following
medicines:
|
Type of Drug
|
Examples of Generic Names (Brand Names)
|
Antiarrhythmics
(to treat abnormal heart rhythms)
|
bepridil (Vascor
®
)
lidocaine (Lidoderm
®
)
quinidine
amiodarone (Cordarone
®
)
digoxin (Lanoxin
®
)
|
Anticoagulants
(to prevent the clotting of red blood cells called platelets)
|
warfarin (Coumadin
®
)
|
Anticonvulsants
(to treat epilepsy and prevent seizures)
|
carbamazepine (Tegretol
®
, Carbatrol
®
)
phenobarbital
phenytoin (Dilantin
®
, Phenytek
®
)
|
|
Antidepressants
|
trazodone (Desryrel
®
)
|
Antifungals
(to treat fungal infections)
|
ketoconazole (Nizoral
®
)
itraconazole (Sporanox
®
)
voriconazole (Vfend
®
)
|
Anti-infectives
(to treat bacterial infections)
|
clarithromycin (Biaxin
®
)
|
Antimycobacterials
(to treat bacterial infections)
|
rifabutin (Mycobutin
®
)
rifampin (Rifadin
®
Rifater
®
, Rifamate
®
)
|
Calcium Channel Blockers
(to treat heart disease)
|
felodipine
nifedipine (Adalat
®
)
nicardipine (Cardene
®
)
|
Corticosteroids
(to treat inflammation or asthma)
|
dexamethasone (Decadron
®
)
fluticasone propionate (Advair Diskus
®
, Cutivate
®
, Flonase
®
, Flovent Diskus
®
)
|
HMG-CoA Reductase Inhibitors
(to lower cholesterol levels)
|
atorvastatin (Lipitor
®
) lovastatin (Mevacor
®
)
pravastatin (Pravachol
®
)
simvastatin (Zocor
®
)
rosuvastatin (Crestor
®
)
|
Immunosuppressants
(to prevent organ transplant rejection)
|
cyclosporine (Sandimmune
®
, Neoral
®
)
tacrolimus (Prograf
®
)
sirolimus (Rapamune
®
)
|
|
Narcotic Analgesics
|
methadone
|
PDE-5 Inhibitors
(to treat erectile dysfunction)
|
sildenafil (Viagra
®
)
vardenafil (Levitra
®
)
tadalafil (Cialis
®
)
|
Selective Serotonin Reuptake Inhibitors (SSRIs)
(to treat depression, anxiety, or panic disorder)
|
paroxetine (Paxil
®
)
sertraline (Zoloft
®
)
|
Tell your doctor if you are taking any medicines that you
obtained without a prescription.
This is
not a complete list of medicines that you should tell
your doctor that you are taking. Know and keep track of all the
medicines you take and have a list of them with you. Show this
list to all of your doctors and pharmacists any time you get a
new medicine. Both your doctor and your pharmacist can tell you
if you can take these other medicines with PREZISTA™. Do
not start any new medicines while you are taking PREZISTA™
without first talking with your doctor or pharmacist. You can
ask your doctor or pharmacist for a list of medicines that can
interact with PREZISTA™.
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How should I take
PREZISTA™?
Take PREZISTA™ tablets every day exactly as
prescribed by your doctor. You must take ritonavir (Norvir
®
) at the same time as PREZISTA™. The usual dose is 600 mg
(two 300 mg tablets or one 600 mg tablet) of PREZISTA™,
together with 100 mg (one 100 mg capsule) of ritonavir (Norvir
®
), twice daily every day. It may be easier to remember to take
PREZISTA™ and ritonavir (Norvir
®
) if you take them at the same time every day. If you have
questions about when to take PREZISTA™ and ritonavir
(Norvir
®
), your doctor can help you decide which schedule works for you.
Take PREZISTA™ and ritonavir (Norvir
®
) with food. The type of food is not important. Swallow the
tablets whole with a drink such as water, milk, or any other
nutritional drink. Do not chew the tablets.
Continue taking PREZISTA™ and ritonavir (Norvir
®
) unless your doctor tells you to stop. Take the exact amount of
PREZISTA™ and ritonavir (Norvir
®
) that your doctor tells you to take, right from the very start.
To help make sure you will benefit from PREZISTA™ and
ritonavir (Norvir
®
), you must not skip doses or interrupt therapy. If you don't
take PREZISTA™ and ritonavir (Norvir
®
) as prescribed, the beneficial effects of PREZISTA™ and
ritonavir (Norvir
®
) may be reduced or even lost.
If you miss a dose of PREZISTA™ or ritonavir
(Norvir
®
) by more than 6 hours, wait and then take the next dose of
PREZISTA™ and ritonavir (Norvir
®
) at the regularly scheduled time. If you miss a dose of
PREZISTA™ or ritonavir (Norvir
®
) by less than 6 hours, take your missed dose of PREZISTA™
and ritonavir (Norvir
®
) immediately. Then take your next dose of PREZISTA™ and
ritonavir (Norvir
®
) at the regularly scheduled time.
You should always take PREZISTA™ and ritonavir (Norvir
®
) together with food.
If a dose of PREZISTA™ or ritonavir (Norvir
®
) is skipped, do not double the next dose. Do not take more or
less than your prescribed dose of PREZISTA™ or ritonavir
(Norvir
®
) at any one time.
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What are the
possible side effects of PREZISTA™?
Like all prescription drugs, PREZISTA™ can cause
side effects. The following is not a complete list of side
effects reported with PREZISTA™ when taken either alone or
with other anti-HIV medicines. Do not rely on this website alone
for information about side effects. Your doctor can discuss with
you a more complete list of side effects.
Your healthcare professional should do blood tests prior to
initiating combination treatment including PREZISTA. Patients
with liver diseases such as hepatitis B and hepatitis C may have
worsening of their liver disease with PREZISTA™ and may
need more frequent monitoring of blood tests. PREZISTA™
has been reported to cause liver problems which may be
life-threatening. It was not always clear if PREZISTA™
caused these liver problems because some patients had other
illnesses or were taking other medicines.
Mild to moderate rash has been reported in 7% of subjects
receiving PREZISTA™. In some patients, PREZISTA has been
reported to cause a severe or life-threatening rash. Contact
your healthcare provider if you develop a rash. Your healthcare
provider will advise you whether your symptoms can be managed on
therapy or whether PREZISTA™ should be stopped.
As with other protease inhibitors, PREZISTA may cause side
effects, including:
-
high blood sugar (hyperglycemia) and diabetes. This can happen
in patients taking PREZISTA™ or other protease inhibitor
medicines. Some patients have diabetes before starting
treatment with PREZISTA™ which gets worse. Some patients
get diabetes during treatment with PREZISTA™. Some
patients will need changes in their diabetes medicine. Some
patients may need new diabetes medicine.
-
increased bleeding in patients with hemophilia. This may happen
in patients taking PREZISTA™ as it has been reported with
other protease inhibitor medicines.
-
changes in body fat. These changes can happen in patients
taking anti-HIV medicines. The changes may include an increased
amount of fat in the upper back and neck, breast, and around
the back, chest, and stomach area. Loss of fat from the legs,
arms, and face may also happen. The exact cause and long-term
health effects of these conditions are not known.
-
immune reconstitution syndrome. In some patients with advanced
HIV infection (AIDS) and a history of opportunistic infection,
signs and symptoms of inflammation from previous infections may
occur soon after anti-HIV treatment is started. It is believed
that these symptoms are due to an improvement in the body's
immune response, enabling the body to fight infections that may
have been present with no obvious symptoms.
The most common side effects include diarrhea, nausea, headache,
and common cold.
Tell your doctor promptly about these or any other unusual
symptoms. If the condition persists or worsens, seek medical
attention.
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What do
PREZISTA™ tablets look like?
PREZISTA 300 mg tablets are orange, oval-shaped, film-coated
tablets mentioning "300" on one side and "TMC114" on the other
side.
PREZISTA 600 mg tablets are orange, oval-shaped, film-coated
tablets mentioning "600" on one side
and "
" (curved triangle
with a dot) on the other side.
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How should I
store PREZISTA™ tablets?
Store PREZISTA™ tablets at room temperature (77°F
(25°C)). Short-term exposure to higher or lower temperatures
[from 59°F (15°C) to 86°F (30°C)] is acceptable.
Ask your doctor or pharmacist if you have any questions about
storing your tablets.
This medication is prescribed for your particular
condition. Do not use it for any other condition or give it to
anybody else. Keep PREZISTA™ and all of your medicines
out of the reach of children. If you suspect that more than the
prescribed dose of this medicine has been taken, contact your
local poison control center or emergency room immediately.
This Web site provides a summary of information about
PREZISTA™. If you have any questions or concerns about
either PREZISTA™ or HIV, talk to your doctor.
For additional information, you may also call Tibotec
Therapeutics at 1-800-325-7504.
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* The brands listed are the registered trademarks of their
respective owners and are not trademarks of Tibotec, Inc.
