Home' South Florida Gay News : SFGN 121615 Contents 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
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