ELVITEGRAVIR/COBICISTAT/EMTRICITABINE/TENOFOVIR ALAFENAMIDE - ORAL

ELVITEGRAVIR/COBICISTAT/EMTRICITABINE/TENOFOVIR ALAFENAMIDE - ORAL

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)

COMMON BRAND NAME(S): Genvoya

GENERIC NAME(S): elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide

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, do all of the following: (1) continue to take all HIV medications exactly as prescribed by your doctor, (2) always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity, and (3) 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.


How to use ELVITEGRAVIR/COBICISTAT/EMTRICITABINE/TENOFOVIR ALAFENAMIDE - ORAL

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. If you take antacids, take the antacids at least 2 hours before or 2 hours after this medication. 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.

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 your doctor has prescribed this medication because he or she 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 trouble breathing/swallowing/moving your eyes, drooping face, paralysis, trouble speaking). 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.

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). During pregnancy, this medication should be used only when clearly needed. Treatment can lower the risk of passing HIV infection to your baby, and this medication may be part of that treatment. Discuss the risks and benefits with your doctor. 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.

Interactions

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 boceprevir, rifamycins (such as rifabutin, 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 always use an effective barrier method (latex or polyurethane condoms/dental dams) during all 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.

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.

Images

GENVOYA TABLET

color
green
shape
oblong
imprint
GSI, 510

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Faq for ELVITEGRAVIR/COBICISTAT/EMTRICITABINE/TENOFOVIR ALAFENAMIDE - ORAL

- Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide is used to treat HIV infection. It belongs to a class of drugs called antiretrovirals and helps to prevent the virus from multiplying in the body.

- Take this medication exactly as prescribed by your doctor. Usually, it is taken once a day with food. It is important to take it consistently to maintain effective levels in your body.

- The common side effects may include nausea, diarrhea, headache, tiredness, or trouble sleeping. However, if these side effects persist or worsen, contact your doctor promptly.

- It is generally advised to avoid excessive alcohol consumption while taking this medication. Alcohol can increase the risk of liver toxicity and decrease the effectiveness of the medication.

- Yes, this medication can interact with other drugs, such as certain antibiotics, antifungals, anticonvulsants, and other HIV medications. Inform your doctor about all the medications you are currently taking to avoid potential interactions.

- The duration of treatment will be determined by your doctor based on your individual circumstances. It is typically a long-term therapy, and stopping it without medical advice can lead to a resurgence of the HIV infection.

- No, this medication does not cure HIV but helps to control the virus and prevent it from multiplying. It is important to continue taking it as prescribed, even if you feel well, to maintain its effectiveness in managing your HIV infection.


Warning

WARNING: If you have hepatitis B infection, your hepatitis symptoms may get worse or become very serious if you stop taking this medication. Talk with your doctor before stopping this medication. Your doctor will monitor liver tests for several months after you stop elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide. Tell your doctor right away if you have symptoms of worsening liver problems.


Disclaimer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.