Product Details
Genvoya® Elvitegravir / Cobicistat / Emtricitabine / Tenofovir Alafenamide 150 mg - 150 mg - 200 mg - 10 mg Tablet Bottle 30 Tablets
Manufacturer: GILEAD SCIENCES
MFG#: 61958-1901-01
NDC: 61958-1901-01
PID: 304020
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Additional Information
| Product Name | Genvoya® Elvitegravir / Cobicistat / Emtricitabine / Tenofovir Alafenamide 150 Mg - 150 Mg - 200 Mg - 10 Mg Tablet Bottle 30 Tablets |
| Application | HIV Integrase Inhibitor |
| Generic Drug Name | Elvitegravir / Cobicistat / Emtricitabine / Tenofovir Alafenamide |
| Mechanism of Action | Elvitegravir inhibits integrase, Cobicistat enhances drug levels, Emtricitabine and Tenofovir inhibit reverse transcription |
| Dosage Form | Tablet |
| Strength | 150 mg Elvitegravir, 150 mg Cobicistat, 200 mg Emtricitabine, 10 mg Tenofovir Alafenamide |
| Dosing Frequency | Once daily with food |
| Common Side Effects | Diarrhea, headache, nausea, fatigue, upper respiratory tract infections |
| Serious Adverse Effects | Kidney dysfunction, liver toxicity, lactic acidosis, bone mineral density loss |
| Container Type | Bottle |
| Quantity | 30 Tablets |
| Indications | HIV-1 infection treatment in adults and pediatric patients (=35 kg) |
Description
Genvoya® is a fixed-dose combination tablet containing elvitegravir (150 mg), cobicistat (150 mg), emtricitabine (200 mg), and tenofovir alafenamide (10 mg). Genvoya® can be used as a complete regimen for treatment-naïve patients or as a replacement therapy for patients who are virologically suppressed on a stable antiretroviral (ARV) regimen for at least 6 months, with no history of treatment failure or resistance to any of the components.
Each tablet is green, capsule-shaped, and film-coated, with "GSI" debossed on one side and "510" on the other. Genvoya® works by combining the actions of four antiretroviral agents: elvitegravir inhibits the integrase enzyme, cobicistat acts as a pharmacokinetic enhancer to boost elvitegravir levels, while emtricitabine and tenofovir alafenamide are nucleoside reverse transcriptase inhibitors (NRTIs) that prevent viral replication.
The recommended dosage of Genvoya® is one tablet taken once daily with food. It is important to adhere to the prescribed regimen to maintain viral suppression and prevent the development of resistance. Regular monitoring of kidney function and liver enzymes is recommended, as adverse effects may occur.
Product Properties:
| Description | - |
|---|---|
| Description | - |
| DESI Drug Ind | - |
| DESI Drug Ind | - |
| DESI2 Drug Ind | - |
| DESI2 Drug Ind | NR |
| Drug Category | - |
| Drug Category | S |
| Drug Type Code | 1 |
| Drug Type Code | S |
| FDA Approval Date | 11/06/2015 |
| FDA Approval Date | 11/05/2015 |
| FDA Therap Equiv | TAB |
| FDA Therap Equiv | NR |
| HCPCS | - |
| HCPCS | - |
| Market Entry Date | - |
| Market Entry Date | 11/06/2015 |
| Medical Coverage | - |
| Medical Coverage | - |
| Termination Date | 1 |
| Termination Date | - |
| Unit | 30 |
| Unit | TAB |
| Units Per Pkg | 30 |
| Units Per Pkg | 11/05/2015 |
| Active Ingredients | 1321 emtricitabine 143491570; 14621 elvitegravir 697761981; 14623 cobicistat; 16564 tenofovir alafenamide fumarate |
| Active Ingredients | 1321 emtricitabine 143491570; 14621 elvitegravir 697761981; 14623 cobicistat; 16564 tenofovir alafenamide fumarate |
| AHFS Class | 8180820 HIV NUCLEOSIDE, NUCLEOTIDE RT INHIBITORS; 8180812 HIV INTEGRASE INHIBITOR ANTIRETROVIRALS |
| AHFS Class | 8180820 HIV NUCLEOSIDE, NUCLEOTIDE RT INHIBITORS; 8180812 HIV INTEGRASE INHIBITOR ANTIRETROVIRALS |
| DEA Class | NC |
| DEA Class | NC |
| Dose Form | TABLET |
| Dose Form | TABLET |
| Fine Line Class | 850085008510 All Rx Products |
| Fine Line Class | 850085008510 All Rx Products |
| Gen Code and Des | 75117 elviteg/cob/emtri/tenof alafen ORAL TABLET 150-200-10 |
| Gen Code and Des | 75117 elviteg/cob/emtri/tenof alafen ORAL TABLET 150-200-10 |
| Inactive Ingredients | 10138 blue dye; 2432 lactose 64044515 |
| Inactive Ingredients | 10138 blue dye; 2432 lactose 64044515 |
| OMP Family | - |
| OMP Family | - |
| Product Category | RX Pharmaceuticals |
| Product Category | RX Pharmaceuticals |
| Strength | 150/200MG |
| Strength | 150/200MG |
| Common Brand Name | COMMON BRAND NAME(S): Genvoya |
| Common Brand Name | COMMON BRAND NAME(S): Genvoya |
| Drug Interaction | DRUG INTERACTIONS: See also How To Use section. Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug are: adefovir, orlistat, other drugs that may affect the kidneys (including aminoglycosides such as amikacin/gentamicin). Do not take this medication with other HIV medications (such as ritonavir). Do not take this medication with other products that contain cobicistat, elvitegravir, emtricitabine, lamivudine, or tenofovir. This medication can slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include dronedarone, eletriptan, eplerenone, ergot alkaloids (such as ergotamine, dihydroergotamine), salmeterol, tolvaptan, rivaroxaban, certain alpha blockers (such as alfuzosin, tamsulosin), certain benzodiazepines (such as midazolam, triazolam), certain statins (such as lovastatin, simvastatin), certain drugs to treat erectile dysfunction-ED or pulmonary hypertension (such as avanafil, sildenafil), among others. Other medications can affect the removal of this medication from your body, which may affect how this medication works. Examples include mitotane, rifampin, St. John's wort, certain drugs used to treat seizures (such as carbamazepine, oxcarbazepine, phenobarbital, phenytoin, primidone), among others. This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. This medication may also increase the risk of some hormonal birth control side effects. Talk to your doctor about other reliable forms of birth control, and use an effective barrier method (latex or polyurethane condoms/dental dams) during sexual activity to decrease the risk of spreading HIV to others. Tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your hormonal birth control is not working well. |
| Drug Interaction | DRUG INTERACTIONS: See also How To Use section. Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug are: adefovir, orlistat, other drugs that may affect the kidneys (including aminoglycosides such as amikacin/gentamicin). Do not take this medication with other HIV medications (such as ritonavir). Do not take this medication with other products that contain cobicistat, elvitegravir, emtricitabine, lamivudine, or tenofovir. This medication can slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include dronedarone, eletriptan, eplerenone, ergot alkaloids (such as ergotamine, dihydroergotamine), salmeterol, tolvaptan, rivaroxaban, certain alpha blockers (such as alfuzosin, tamsulosin), certain benzodiazepines (such as midazolam, triazolam), certain statins (such as lovastatin, simvastatin), certain drugs to treat erectile dysfunction-ED or pulmonary hypertension (such as avanafil, sildenafil), among others. Other medications can affect the removal of this medication from your body, which may affect how this medication works. Examples include mitotane, rifampin, St. John's wort, certain drugs used to treat seizures (such as carbamazepine, oxcarbazepine, phenobarbital, phenytoin, primidone), among others. This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. This medication may also increase the risk of some hormonal birth control side effects. Talk to your doctor about other reliable forms of birth control, and use an effective barrier method (latex or polyurethane condoms/dental dams) during sexual activity to decrease the risk of spreading HIV to others. Tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your hormonal birth control is not working well. |
| Allocation Period | - |
| Allocation Period | - |
| Case Quantity | 96 |
| Case Quantity | 96 |
| Drug Form Pack Size | 30 |
| Drug Form Pack Size | 30 |
| Form | TABLET |
| Form | TABLET |
| Hazard Code | - |
| Hazard Code | - |
| Listed Chemical | - |
| Listed Chemical | - |
| NIOSH Code | - |
| NIOSH Code | - |
| Orange Book | ZC Pharmaceutical entity and labeler evaluated but no therapeutic equivalence rating given. Usually applies to single source drugs. |
| Orange Book | ZC Pharmaceutical entity and labeler evaluated but no therapeutic equivalence rating given. Usually applies to single source drugs. |
| Retail Pack Quantity | 1 |
| Retail Pack Quantity | 1 |
| Returnable Status | Returnable |
| Returnable Status | Returnable |
| Special Storage Cond | 00 None |
| Special Storage Cond | 00 None |
| Temp Zone | 20 Cool-Store Cont Temp |
| Temp Zone | 20 Cool-Store Cont Temp |
| Unit | EA |
| Unit | EA |
| Unit Size | 30 |
| Unit Size | 30 |
| How to Use | HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth with food as directed by your doctor, usually once daily. It is very important to continue taking this medication exactly as prescribed by your doctor. Do not skip any doses. Take this medication at least 2 hours before or 2 hours after taking other products that may make it work less well. Some examples include: sucralfate, antacids, and vitamins/minerals that contain magnesium, aluminum, calcium, iron, or zinc. For the best effect, take this medication at evenly spaced times. To help you remember, take this medication at the same time every day. Do not take more or less of this drug than prescribed or stop taking it even for a short time unless directed to do so by your doctor. Doing so may cause the amount of virus to increase, make the infection more difficult to treat (resistant), or worsen side effects. |
| How to Use | HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth with food as directed by your doctor, usually once daily. It is very important to continue taking this medication exactly as prescribed by your doctor. Do not skip any doses. Take this medication at least 2 hours before or 2 hours after taking other products that may make it work less well. Some examples include: sucralfate, antacids, and vitamins/minerals that contain magnesium, aluminum, calcium, iron, or zinc. For the best effect, take this medication at evenly spaced times. To help you remember, take this medication at the same time every day. Do not take more or less of this drug than prescribed or stop taking it even for a short time unless directed to do so by your doctor. Doing so may cause the amount of virus to increase, make the infection more difficult to treat (resistant), or worsen side effects. |
| Missed Dose | MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up. |
| Missed Dose | MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up. |
| Notes | NOTES: Do not share this medication with others. Lab and/or medical tests (such as kidney/liver function, test for hepatitis B virus, viral load, T-cell counts, blood mineral levels, bone density tests, urine glucose/protein) should be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments. Consult your doctor for more details. |
| Notes | NOTES: Do not share this medication with others. Lab and/or medical tests (such as kidney/liver function, test for hepatitis B virus, viral load, T-cell counts, blood mineral levels, bone density tests, urine glucose/protein) should be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments. Consult your doctor for more details. |
| Overdose | OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. |
| Overdose | OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. |
| Phonetic Pronunciation | (EL-vi-TEG-ra-vir/koe-BIK-i-stat/EM-trye-SYE-ta-been/ ten-OF-oh-vir AL-a-FEN-a-mide) |
| Phonetic Pronunciation | (EL-vi-TEG-ra-vir/koe-BIK-i-stat/EM-trye-SYE-ta-been/ ten-OF-oh-vir AL-a-FEN-a-mide) |
| Precautions | PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to elvitegravir, cobicistat, emtricitabine, or tenofovir; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems (hepatitis B, hepatitis C, cirrhosis), alcohol use, bone problems (such as bone disease, bone loss/osteoporosis, weak/broken bones), kidney disease, pancreatitis. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). This medication is not recommended for use during pregnancy. It may not work well in a pregnant woman. If you become pregnant or think you may be pregnant, tell your doctor right away. Your doctor may change your HIV medications. It is unknown if elvitegravir, cobicistat, or tenofovir alafenamide pass into breast milk. Emtricitabine passes into breast milk. Because breast milk can transmit HIV, do not breast-feed. |
| Precautions | PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to elvitegravir, cobicistat, emtricitabine, or tenofovir; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems (hepatitis B, hepatitis C, cirrhosis), alcohol use, bone problems (such as bone disease, bone loss/osteoporosis, weak/broken bones), kidney disease, pancreatitis. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). This medication is not recommended for use during pregnancy. It may not work well in a pregnant woman. If you become pregnant or think you may be pregnant, tell your doctor right away. Your doctor may change your HIV medications. It is unknown if elvitegravir, cobicistat, or tenofovir alafenamide pass into breast milk. Emtricitabine passes into breast milk. Because breast milk can transmit HIV, do not breast-feed. |
| Side Effects | SIDE EFFECTS: Diarrhea, nausea, headache, or tiredness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. As your immune system gets stronger, it can begin to fight off infections you already had, possibly causing disease symptoms to come back. You could also have symptoms if your immune system becomes overactive. This reaction may happen at any time (soon after starting HIV treatment or many months later). Get medical help right away if you have any serious symptoms, including: unexplained weight loss, severe tiredness, muscle aches/weakness that doesn't go away, headaches that are severe or don't go away, joint pain, numbness/tingling of the hands/feet/arms/legs, vision changes, signs of infection (such as fever, chills, swollen lymph nodes, trouble breathing, cough, non-healing skin sores), signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter), signs of a certain nerve problem known as Guillain-Barre syndrome (such as unsteadiness, loss of coordination, trouble swallowing/speaking/chewing, trouble moving your eyes). Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as depression, anxiety), signs of kidney problems (such as change in the amount of urine, pink/bloody urine). Rarely, this medication can cause severe (sometimes fatal) liver and blood problems (lactic acidosis). Tell your doctor right away if you develop symptoms of liver problems (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine) or lactic acidosis (such as deep/rapid breathing, drowsiness, nausea/vomiting, unusual weakness). A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345. |
| Side Effects | SIDE EFFECTS: Diarrhea, nausea, headache, or tiredness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. As your immune system gets stronger, it can begin to fight off infections you already had, possibly causing disease symptoms to come back. You could also have symptoms if your immune system becomes overactive. This reaction may happen at any time (soon after starting HIV treatment or many months later). Get medical help right away if you have any serious symptoms, including: unexplained weight loss, severe tiredness, muscle aches/weakness that doesn't go away, headaches that are severe or don't go away, joint pain, numbness/tingling of the hands/feet/arms/legs, vision changes, signs of infection (such as fever, chills, swollen lymph nodes, trouble breathing, cough, non-healing skin sores), signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter), signs of a certain nerve problem known as Guillain-Barre syndrome (such as unsteadiness, loss of coordination, trouble swallowing/speaking/chewing, trouble moving your eyes). Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as depression, anxiety), signs of kidney problems (such as change in the amount of urine, pink/bloody urine). Rarely, this medication can cause severe (sometimes fatal) liver and blood problems (lactic acidosis). Tell your doctor right away if you develop symptoms of liver problems (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine) or lactic acidosis (such as deep/rapid breathing, drowsiness, nausea/vomiting, unusual weakness). A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345. |
| Storage | STORAGE: Store in original container at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company. |
| Storage | STORAGE: Store in original container at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company. |
| Uses | USES: This product is used to help control HIV infection. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life. This product contains 4 different medications: elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide. Elvitegravir is known as an integrase inhibitor. Cobicistat helps elvitegravir work better. Emtricitabine is called a nucleoside reverse transcriptase inhibitor, while tenofovir alafenamide is called a nucleotide reverse transcriptase inhibitor; both kinds of drugs are often called NRTIs. Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide is not a cure for HIV infection. To decrease your risk of spreading HIV disease to others, continue to take all HIV medications exactly as prescribed by your doctor. Use an effective barrier method (latex or polyurethane condoms/dental dams) during sexual activity as directed by your doctor. Do not share personal items (such as needles/syringes, toothbrushes, and razors) that may have contacted blood or other body fluids. Consult your doctor or pharmacist for more details. |
| Uses | USES: This product is used to help control HIV infection. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life. This product contains 4 different medications: elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide. Elvitegravir is known as an integrase inhibitor. Cobicistat helps elvitegravir work better. Emtricitabine is called a nucleoside reverse transcriptase inhibitor, while tenofovir alafenamide is called a nucleotide reverse transcriptase inhibitor; both kinds of drugs are often called NRTIs. Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide is not a cure for HIV infection. To decrease your risk of spreading HIV disease to others, continue to take all HIV medications exactly as prescribed by your doctor. Use an effective barrier method (latex or polyurethane condoms/dental dams) during sexual activity as directed by your doctor. Do not share personal items (such as needles/syringes, toothbrushes, and razors) that may have contacted blood or other body fluids. Consult your doctor or pharmacist for more details. |
Frequently Asked Questions (FAQs)
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Genvoya® Elvitegravir / Cobicistat / Emtricitabine / Tenofovir Alafenamide 150 mg - 150 mg - 200 mg - 10 mg Tablet Bottle 30 Tablets is manufactured by GILEAD SCIENCES.
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