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• Pregnancy Registry: There is a pregnancy registry for women who take
antiretroviral medicines during pregnancy. The purpose of the registry is
to collect information about the health of you and your baby. Talk to your
healthcare provider about how you can take part in this registry.
• are breastfeeding or plan to breastfeed. Do not breastfeed if you take
• You should not breastfeed if you have HIV-1 because of the risk of passing
HIV to your baby.
• It is not known if PREZCOBIX can pass into your breast milk.
• Talk to your healthcare provider about the best way to feed your baby.
Tell your healthcare provider about all the medicines you take, including
prescription and over-the-counter medicines, vitamins, and herbal supplements.
Some medicines interact with PREZCOBIX. Keep a list of your medicines to
show your healthcare provider and pharmacist.
• You can ask your healthcare provider or pharmacist for a list of medicines
that interact with PREZCOBIX.
• Do not start taking a new medicine without telling your healthcare provider.
Your healthcare provider can tell you if it is safe to take PREZCOBIX with
How should I take PREZCOBIX?
• Take PREZCOBIX exactly as your healthcare provider tells you.
• Do not change your dose or stop taking PREZCOBIX without talking to your
• Take PREZCOBIX 1 time a day with food.
• If you miss a dose of PREZCOBIX by less than 12 hours, take your missed dose
of PREZCOBIX right away. Then take your next dose of PREZCOBIX at your
regularly scheduled time.
• If you miss a dose of PREZCOBIX by more than 12 hours, wait and then take
the next dose of PREZCOBIX at your regularly scheduled time.
• If a dose of PREZCOBIX is skipped, do not double the next dose. Do not take
more or less than your prescribed dose of PREZCOBIX at any one time.
• If you take too much PREZCOBIX, call your healthcare provider or go to the
nearest hospital emergency room right away.
What are the possible side effects of PREZCOBIX?
PREZCOBIX may cause serious side effects including:
• See “What is the most important information I should know about
• Diabetes and high blood sugar (hyperglycemia). Some people who take
protease inhibitors including PREZCOBIX can get high blood sugar, develop
diabetes, or your diabetes can get worse. Tell your healthcare provider if you
notice an increase in thirst or urinate often while taking PREZCOBIX.
• Changes in body fat can happen in people who take HIV-1 medications. The
changes may include an increased amount of fat in the upper back and neck
(“buffalo hump”), breast, and around the middle of your body (trunk). 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.
• Changes in your immune system (Immune Reconstitution Syndrome) can
happen when you start taking HIV-1 medicines. Your immune system may get
stronger and begin to fight infections that have been hidden in your body for
a long time. Tell your healthcare provider right away if you start having new
symptoms after starting your HIV-1 medicine.
• Increased bleeding for hemophiliacs. Some people with hemophilia have
increased bleeding with protease inhibitors including PREZCOBIX.
The most common side effects of darunavir, one of the medicines in PREZCOBIX,
• stomach area (abdominal) pain
Tell your healthcare provider if you have any side effect that bothers you or that
does not go away.
These are not all of the possible side effects of PREZCOBIX. For more information,
ask your health care provider.
Call your doctor for medical advice about side effects. You may report side
effects to FDA at 1-800-FDA -1088.
How should I store PREZCOBIX?
• Store PREZCOBIX tablets at room temperature between 68°F to 77°F (20°C to
Keep PREZCOBIX and all medicines out of reach of children.
General information about PREZCOBIX
Medicines are sometimes prescribed for purposes other than those listed in a
Patient Information leaflet. Do not use PREZCOBIX for a condition for which it
was not prescribed. Do not give PREZCOBIX to other people, even if they have
the same symptoms that you have. It may harm them.
If you would like more information, talk with your healthcare provider. You can
ask your healthcare provider or pharmacist for information about PREZCOBIX
that is written for health professionals.
For more information call 1-800-526-7736.
What are the ingredients in PREZCOBIX?
Active ingredients: darunavir and cobicistat
Inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose,
magnesium stearate, and silicified microcrystalline cellulose. The tablets are
film-coated with a coating material containing iron oxide black, iron oxide red,
polyethylene glycol, polyvinyl alcohol (partially hydrolyzed), talc, and titanium
Janssen Ortho LLC, Gurabo, PR 00778
Janssen Therapeutics, Division of Janssen Products, LP, Titusville NJ 08560
Issued: January 2015
© Janssen Pharmaceuticals, Inc. 2015
IMPORTANT PATIENT INFORMATION
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