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Patient Information Sheet
Darunavir (marketed as Prezista)
This is a summary of the most important information about Prezista. For details, talk to your healthcare professional.
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 inhibitor.
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.
Prezista does not reduce the risk of passing
HIV to others through sexual contact, sharing needles, or being
exposed to your blood.
When used with other anti-HIV medicines,
Prezista may reduce the amount of HIV in your blood and increase
your CD4 cell count. Reducing the amount of HIV and increasing the
CD4 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.
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.
Who Should Not Take Prezista?
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:
- antihistamines (to treat allergy symptoms)
- ergot derivatives (to treat migraine and headaches)
- gastrointestinal motility agents (to treat some digestive conditions)
- neuroleptics (to treat psychiatric conditions)
- sedative/hypnotics (to treat trouble with sleeping and/or anxiety)
What Are The Risks?
The following are the major potential risks and side effects of Prezista therapy. However, this list is not complete.
- 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.
- 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.
- 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 that may occur with Prezista include:
diarrhea, nausea,
headache, and common cold.
What Should I Tell My Healthcare Professional?
Before you start taking Prezista, tell your healthcare professional 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.
Can Other Medicines Or Food Affect Prezista?
Prezista and certain other medicines can interact with each other. Tell your
healthcare professional about all the medicines you take including
prescription and non-prescription medicines, vitamins, and herbal
supplements, including St. John’s wort. Sometimes serious side
effects will happen if Prezista is taken with certain other
medicines. Know the medicines you take. Keep a list of them with
you to show your healthcare professional.
Especially tell your healthcare professional if you take:
- any of the medicines listed in “Who Should Not Take Prezista”
- estrogen-based contraceptives. You must take additional precautions for birth control such as a condom.
- other anti-HIV medicines. Prezista can be combined with some other anti-HIV medicines while other combinations are not recommended.
- antiarrhythmics (to treat abnormal heart rhythms)
- anticoagulants (to prevent the clotting of red blood cells called platelets)
- anticonvulsants (to
treat epilepsy and prevent seizures)
- antidepressants
- anti-infectives (to treat bacterial infections)
- antifungals (to treat fungal infections)
- antimycobacterials (to treat bacterial infections)
- calcium channel blockers (to treat heart disease)
- corticosteroids (to treat inflammation or asthma)
- HMG-CoA reductase inhibitors (to lower cholesterol levels)
- immunosuppressants (to prevent organ transplant rejection)
- narcotic analgesics
- PDE-5 inhibitors (to treat erectile dysfunction)
- selective serotonin reuptake inhibitors (SSRIs) (to treat depression, anxiety, or panic disorder)
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.
- Take Prezista and ritonavir (Norvir)
with food. The type of food is not important.
- Swallow the whole tablets with a drink such as water or milk. Do not chew the tablets.
- Continue taking Prezista and ritonavir (Norvir) unless your doctor tells you to
stop. Take the exact amount that your doctor tells you to take,
right from the very start. Do not skip doses or interrupt therapy.
- 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.
Prezista's Approved Labeling through Drugs@FDA 
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Date created: November 7, 2006, updated March 21, 2008
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