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GENVOYA- elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide tablet


  1. Patient Information
  2. Genvoya Can Cause Serious Side Effects, Including:
  3. Genvoya Is A Prescription Medicine That Is Used Without Other Antiviral Medicines To Treat Human Immunodeficiency Virus-1 (hiv-1) In Adults And Children Who Weigh At Least 55 Pounds (25 Kg):
  4. Do Not Take Genvoya If You Also Take A Medicine That Contains:
  5. Before Taking Genvoya, Tell Your Healthcare Provider About All Of Your Medical Conditions, Including If You:
  6. How Should I Take Genvoya?
  7. Genvoya May Cause Serious Side Effects, Including:
  8. Active Ingredients:
  9. Inactive Ingredients:
  10. Active Ingredient(s):
  11. Inactive Ingredient(s):
  12. Revised: 12/2018document Id:

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Drug Interactions

GENVOYA may interact with many drugs; therefore, advise patients to report to their healthcare provider the use of any other prescription or non-prescription medication or herbal products including St. John's wort[

Genvoya Can Cause Serious Side Effects, Including: 

  • Worsening of Hepatitis B infection. If you have hepatitis B virus (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.

For more information about side effects,

Genvoya Is A Prescription Medicine That Is Used Without Other Antiviral Medicines To Treat Human Immunodeficiency Virus-1 (hiv-1) In Adults And Children Who Weigh At Least 55 Pounds (25 Kg): 

  • who have not received anti-HIV-1 medicines in the past,or
  • to replace their current anti-HIV-1 medicines for people whose healthcare provider determines that they meet certain requirements.

HIV-1 is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).

GENVOYA contains the prescription medicines elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide.

It is not known if GENVOYA is safe and effective in children who weigh less than 55 pounds (25 kg).

Do Not Take Genvoya If You Also Take A Medicine That Contains: 

  • alfuzosin hydrochloride
  • carbamazepine
  • cisapride
  • ergot-containing medicines, including:
    • dihydroergotamine mesylate
    • ergotamine tartrate
    • methylergonovine maleate
  • lomitapide
  • lovastatin
  • lurasidone
  • midazolam, when taken by mouth
  • phenobarbital
  • phenytoin
  • pimozide
  • rifampin
  • sildenafil, when used for treating the lung problem, pulmonary arterial hypertension
  • simvastatin
  • triazolam
  • St. John's wort (Hypericum perforatum)or a product that contains St. John's wort.

Before Taking Genvoya, Tell Your Healthcare Provider About All Of Your Medical Conditions, Including If You: 

  • have liver problems, including hepatitis B infection
  • have kidney problems
  • are pregnant or plan to become pregnant.
    • It is not known if GENVOYA can harm your unborn baby.
    • GENVOYA should not be used during pregnancy because you may not have enough GENVOYA in your body during pregnancy.
    • Tell your healthcare provider if you become pregnant during treatment with GENVOYA. Your healthcare provider may prescribe different medicines if you become pregnant while taking GENVOYA.

    Pregnancy Registry: There is a pregnancy registry for women who take antiretroviral 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 breast milk.

    Talk with your healthcare provider about the best way to feed your baby during treatment with GENVOYA.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

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 other medicines.

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.
  • Take GENVOYA 1 time each day with food.
  • If you are on dialysis, take your daily dose of GENVOYA following dialysis.
  • Do not change your dose or stop taking GENVOYA without first talking with your healthcare provider. Stay under a healthcare provider's care during treatment with GENVOYA.
  • If you need to take a medicine for indigestion (antacid) that contains aluminum hydroxide, magnesium hydroxide, or calcium carbonate during treatment with GENVOYA, take it at least 2 hours before or after you take GENVOYA.
  • Do not miss a dose of GENVOYA.
  • 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.
  • If you take too much GENVOYA, call your healthcare provider or go to the nearest hospital emergency room right away.

Genvoya May Cause Serious Side Effects, Including: 

    • Store GENVOYA below 86 F (30 C).
    • Keep GENVOYA in its original container.
    • Keep the container tightly closed.

    Keep GENVOYA and all medicines out of reach of children.

    General information about the safe and effective use of GENVOYA.

    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.

    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.

Active Ingredients: 

elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide

Inactive Ingredients: 

croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, silicon dioxide, and sodium lauryl sulfate. The tablets are film-coated with a coating material containing FD&C Blue No. 2/indigo carmine aluminum lake, iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.

Manufactured and distributed by: Gilead Sciences, Inc. Foster City, CA 94404

GENVOYA is a trademark of Gilead Sciences, Inc., or its related companies.

2018 Gilead Sciences, Inc. All rights reserved.

207561-GS-012

DRUG: Genvoya

GENERIC: elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-0568-0

COLOR: green

SHAPE: OVAL

SCORE: No score

SIZE: 19 mm

IMPRINT: GSI;510

PACKAGING: 30 in 1 BLISTER PACK

Active Ingredient(s): 

  • cobicistat 150mg in 1
  • emtricitabine 200mg in 1
  • elvitegravir 150mg in 1
  • tenofovir alafenamide fumarate 10mg in 1

Inactive Ingredient(s): 

  • FERRIC OXIDE YELLOW
  • POLYETHYLENE GLYCOL, UNSPECIFIED
  • TITANIUM DIOXIDE
  • FD&C BLUE NO. 2
  • POLYVINYL ALCOHOL, UNSPECIFIED
  • TALC
  • LACTOSE MONOHYDRATE
  • HYDROXYPROPYL CELLULOSE (1600000 WAMW)
  • MAGNESIUM STEARATE
  • MICROCRYSTALLINE CELLULOSE
  • CROSCARMELLOSE SODIUM
  • SODIUM LAURYL SULFATE
  • WATER

Remedy_Label

GENVOYA
elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70518-0568(NDC:61958-1901)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ELVITEGRAVIR(UNII: 4GDQ854U53) (ELVITEGRAVIR - UNII:4GDQ854U53)ELVITEGRAVIR150 mg
COBICISTAT(UNII: LW2E03M5PG) (COBICISTAT - UNII:LW2E03M5PG)COBICISTAT150 mg
EMTRICITABINE(UNII: G70B4ETF4S) (EMTRICITABINE - UNII:G70B4ETF4S)EMTRICITABINE200 mg
TENOFOVIR ALAFENAMIDE FUMARATE(UNII: FWF6Q91TZO) (TENOFOVIR ANHYDROUS - UNII:W4HFE001U5)TENOFOVIR ALAFENAMIDE10 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
WATER(UNII: 059QF0KO0R)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
TALC(UNII: 7SEV7J4R1U)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
ColorgreenScoreno score
ShapeOVAL (capsule-shaped)Size19mm
FlavorImprint CodeGSI;510
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70518-0568-030 in 1 BLISTER PACK; Type 0: Not a Combination Product06/06/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20756106/06/2017
Labeler -REMEDYREPACK INC. (829572556)

Revised: 12/2018document Id: 

7e53a8f9-1ac5-2777-e053-2a91aa0a9187Set id: a22331e0-b0ea-47fa-a073-c60d175e652bVersion: 5Effective Time: 20181231REMEDYREPACK INC.



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