Genvoya

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.

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.

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This product may also be used to reduce the risk of getting HIV infection after contact with the virus. Consult your doctor for more details.

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.

Emtricitabine and tenofovir alafenamide pass into breast milk. It is unknown if elvitegravir or cobicistat pass into breast milk. Because breast milk may transmit HIV, consult your doctor before breastfeeding.

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.

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.

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 keep 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.

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 1-800-222-1222. Canada residents can call 1-844-764-7669.

Store in the 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.