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What should I tell my healthcare provider before
Before taking GENVOYA, tell your healthcare provider if you:
• have liver problems including hepatitis B infection
• have kidney or bone problems
• have any other medical conditions
• are pregnant or plan to become pregnant. It is not known if GENVOYA can harm
your unborn baby. Tell your healthcare provider if you become pregnant while
Pregnancy registry: there is a pregnancy registry for women who take HIV-1
medicines during pregnancy. The purpose of this registry is to collect information
about the health of you and your baby. Talk with your healthcare provider about
how you can take part in this registry.
• are breastfeeding or plan to breastfeed. Do not breastfeed if you take GENVOYA.
-- You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1
to your baby.
-- At least one of the medicines in GENVOYA can pass to your baby in your breast
milk. It is not known if the other medicines in GENVOYA can pass into your
-- Talk with 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. Other
medicines may affect how GENVOYA works.
Some medicines may interact with GENVOYA. Keep a list of your medicines and show
it to your healthcare provider and pharmacist when you get a new medicine.
• You can ask your healthcare provider or pharmacist for a list of medicines that
interact with GENVOYA.
• Do not start a new medicine without telling your healthcare provider.
Your healthcare provider can tell you if it is safe to take GENVOYA with
How should I take GENVOYA?
• Take GENVOYA exactly as your healthcare provider tells you to take it. GENVOYA is
taken by itself (not with other HIV-1 medicines) to treat HIV-1 infection.
• GENVOYA is usually taken 1 time each day.
• Take GENVOYA with food.
• If you need to take a medicine for indigestion (antacid) that contains aluminum and
magnesium hydroxide or calcium carbonate during treatment with GENVOYA, take
it at least 2 hours before or after you take GENVOYA.
• Do not change your dose or stop taking GENVOYA without first talking with your
healthcare provider. Stay under a healthcare provider's care when taking GENVOYA.
• Do not miss a dose of GENVOYA.
• If you take too much GENVOYA, call your healthcare provider or go to the nearest
hospital emergency room right away.
• When your GENVOYA supply starts to run low, get more from your healthcare
provider or pharmacy. This is very important because the amount of virus in your
blood may increase if the medicine is stopped for even a short time. The virus
may develop resistance to GENVOYA and become harder to treat.
What are the possible side effects of GENVOYA?
GENVOYA may cause serious side effects, including:
• See “What is the most important information I should know about
• Changes in body fat can happen in people who take HIV-1 medicine. These
changes may include 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 any new
symptoms after starting your HIV-1 medicine.
• New or worse kidney problems, including kidney failure. Your healthcare
provider should do blood and urine tests to check your kidneys before you start
and while you are taking GENVOYA. Your healthcare provider may tell you to stop
taking GENVOYA if you develop new or worse kidney problems.
• Bone problems can happen in some people who take GENVOYA. Bone problems
may include bone pain, softening or thinning (which may lead to fractures). Your
healthcare provider may need to do tests to check your bones.
The most common side effect of GENVOYA is nausea.
Tell your healthcare provider if you have any side effect that bothers you or that
does not go away.
• These are not all the possible side effects of GENVOYA. For more information,
ask your healthcare provider or pharmacist.
• Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use
Medicines are sometimes prescribed for purposes other than those listed in a Patient
Information leaflet. Do not use GENVOYA for a condition for which it was not prescribed.
Do not give GENVOYA to other people, even if they have the same symptoms you have.
It may harm them.
This Brief Summary summarizes the most important information about GENVOYA.
If you would like more information, talk with your healthcare provider. You can ask
your healthcare provider or pharmacist for information about GENVOYA that is
written for health professionals.
For more information, call 1-800-445-3235 or go to www.GENVOYA.com.
Keep GENVOYA and all medicines out of reach of children.
Issued: November 2015
EMTRIVA, GENVOYA, the GENVOYA Logo, GILEAD, the GILEAD Logo, GSI, TYBOST, and
VITEKA are trademarks of Gilead Sciences, Inc., or its related companies. All other
marks referenced herein are the property of their respective owners.
© 2015 Gilead Sciences, Inc. All rights reserved. GENC0002 11/15
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