Home' South Florida Gay News : SFGN 010616 Contents 4 • 01.06.2016
Brief Summary of Patient Information
(elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) tablets
Important: Ask your healthcare provider or pharmacist about medicines that should
not be taken with GENVOYA.
There may be new information about GENVOYA. This information is only a summary and
does not take the place of talking with your healthcare provider about your medical condition
What is the most important information I should know
GENVOYA can cause serious side effects, including:
• Build-up of lactic acid in your blood (lactic acidosis).
Lactic acidosis may happen in some people who take GENVOYA. Lactic acidosis is a
serious medical emergency that can lead to death. Lactic acidosis can be hard to identify
early, because the symptoms could seem like symptoms of other health problems. Call
your healthcare provider right away if you get any of the following symptoms,
which could be signs of lactic acidosis:
• feel very weak or tired
• have unusual (not normal) muscle pain
• have trouble breathing
• have stomach pain with nausea or vomiting
• feel cold, especially in your arms and legs
• feel dizzy or lightheaded
• have a fast or irregular heartbeat
• Severe liver problems. Severe liver problems may happen in people who take
GENVOYA. In some cases, these liver problems can lead to death. Your liver may become
large and you may develop fat in your liver.
Call your healthcare provider right away if you get any
of the following symptoms of liver problems:
• your skin or the white part of your eyes turns yellow (jaundice)
• dark “tea-colored” urine
• light-colored bowel movements (stools)
• loss of appetite for several days or longer
• stomach pain
• You may be more likely to get lactic acidosis or severe liver problems if you are
female, very overweight (obese), or have been taking GENVOYA for a long time.
• Worsening of Hepatitis B infection. GENVOYA is not for use to treat chronic hepatitis B
virus (HBV). If you have HBV infection and take GENVOYA, your HBV may get worse (flare-
up) if you stop taking GENVOYA. A “flare-up” is when your HBV infection suddenly returns
in a worse way than before.
• Do not run out of GENVOYA. Refill your prescription or talk to your healthcare provider
before your GENVOYA is all gone.
• Do not stop taking GENVOYA without first talking to your healthcare provider.
• If you stop taking GENVOYA, your healthcare provider will need to check your health
often and do blood tests regularly for several months to check your HBV infection.
Tell your healthcare provider about any new or unusual symptoms you may have
after you stop taking GENVOYA.
What is GENVOYA?
GENVOYA is a prescription medicine that is used without other HIV-1 medicines to
treat HIV-1 in people 12 years of age and older:
• who have not received HIV-1 medicines in the past or
• to replace their current HIV-1 medicines in people who have been on the same HIV-1
medicines for at least 6 months, have an amount of HIV-1 in their blood (“viral load”)
that is less than 50 copies/mL, and have never failed past HIV-1 treatment
HIV-1 is the virus that causes AIDS.
GENVOYA contains the prescription medicines elvitegravir (VITEKTA®), cobicistat
(TYBOST®), emtricitabine (EMTRIVA®) and tenofovir alafenamide.
It is not known if GENVOYA is safe and effective in children under 12 years of age.
When used to treat HIV-1 infection, GENVOYA may:
• Reduce the amount of HIV-1 in your blood.
This is called “viral load”.
• Increase the number of CD4+ (T) cells in your blood that help fight off other infections.
Reducing the amount of HIV-1 and increasing the CD4+ (T) cells in your blood may help
improve your immune system. This may reduce your risk of death or getting infections
that can happen when your immune system is weak (opportunistic infections).
GENVOYA does not cure HIV-1 infection or AIDS. You must stay on continuous HIV-1
therapy to control HIV-1 infection and decrease HIV-related illnesses.
Avoid doing things that can spread HIV-1 infection to others:
• Do not share or re-use needles or other injection equipment.
• Do not share personal items that can have blood or body fluids on them, like
toothbrushes and razor blades.
• Do not have any kind of sex without protection. Always practice safer sex by using
a latex or polyurethane condom to lower the chance of sexual contact with semen,
vaginal secretions, or blood.
Ask your healthcare provider if you have any questions about how to prevent passing
HIV-1 to other people.
Who should not take GENVOYA?
Do not take GENVOYA if you also take a medicine that contains:
• alfuzosin hydrochloride (Uroxatral®)
• carbamazepine (Carbatrol®, Epitol®, Equetro®, Tegretol®, Tegretol-XR®, Teril®)
• cisapride (Propulsid®, Propulsid Quicksolv®)
• ergot-containing medicines, including: dihydroergotamine mesylate (D.H .E . 45®,
Migranal®), ergotamine tartrate
(Cafergot®, Migergot®, Ergostat®, Medihaler Ergotamine®, Wigraine®, Wigrettes®),
and methylergonovine maleate (Ergotrate®, Methergine®)
• lovastatin (Advicor®, Altoprev®, Mevacor®)
• midazolam, when taken by mouth
• phenobarbital (Luminal®)
• phenytoin (Dilantin®, Phenytek®)
• pimozide (Orap®)
• rifampin (Rifadin®, Rifamate®, Rifater®, Rimactane®)
• sildenafil (Revatio®), when used for treating lung problems
• simvastatin (Simcor®, Vytorin®, Zocor®)
• triazolam (Halcion®)
• the herb St. John’s wort or a product that contains St. John’s wort
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
VITEKTA 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
12/4/15 4:13 PM
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