Genvoya: Uses, Side Effects and Dosage

What is Genvoya used for?

Genvoya is used to treat HIV infection in adults and children who weigh at least 25 kg (55 lbs).

Genvoya is for people who do not have an HIV virus that is resistant to Genvoya. Genvoya has not been studied in children weighing less than 25 kg (55 lbs).

How does Genvoya work?

Genvoya lowers the amount of HIV in the blood (viral load).

HIV infection destroys CD4+ (T) cells. These cells are important to help the immune system fight infections. After a large number of T cells are destroyed, acquired immune deficiency syndrome (AIDS) develops.

Genvoya may help increase the count of CD4+ (T) cells. Lowering the amount of HIV in the blood and increasing the CD4+ (T) cells lower the chance of getting infections that happen when your immune system is weak.

Genvoya does not cure HIV infection or AIDS. The long-term effects of Genvoya are not known. People taking Genvoya may still get infections or other conditions that happen with HIV infection. Some of these conditions are pneumonia and Mycobacterium avium complex (MAC) infections. It is very important that you see your healthcare professional on a regular basis while taking Genvoya.

Genvoya has not been shown to reduce the risk of passing HIV to others through sexual contact or blood. Continue to practice safe sex. Use condoms to lower the chance of sexual

Serious Warnings and Precautions

• “Flare-ups” of Hepatitis B Virus infection, in which the disease suddenly returns in a worse way than before, can occur if you also have hepatitis B and stop taking Genvoya. Do not stop taking Genvoya without your healthcare professional’s advice. If you stop taking Genvoya, tell your healthcare professional immediately about any new, unusual or worsening symptoms that you notice after stopping treatment. After you stop taking Genvoya, your healthcare professional will still need to check your health and take blood tests to check your liver. Genvoya is not approved for the treatment of hepatitis B virus infection.

contact with body fluids such as semen, vaginal secretions, or blood. Do not re-use or share needles.

What are the ingredients in Genvoya?

Medicinal ingredients: elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide (as tenofovir alafenamide hemifumarate)

Non-medicinal ingredients: croscarmellose sodium, hydroxypropyl cellulose, indigo carmine aluminum lake, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, sodium lauryl sulfate, talc and titanium dioxide.

Genvoya comes in the following dosage forms:

Genvoya is available as green, capsule-shaped tablets. Each tablet contains 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine and 10 mg of tenofovir alafenamide (equivalent to 11.2 mg of tenofovir alafenamide hemifumarate).

Do not use Genvoya if:

• you are allergic to elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide or any of the other ingredients in Genvoya. (see What are the ingredients in Genvoya?)
• you are taking any medication listed below:

Drugs that must not be taken with Genvoya:

• alfuzosin hydrochloride (Xatral^®)
• apixaban (Eliquis^®), rivaroxaban (Xarelto^®)
• astemizole* (Hismanal^®) or terfenadine (Seldane^®)
• cisapride* (Prepulsid^®)
• carbamazepine (Tegretol^®)
• ergot-containing medicines: dihydroergotamine, ergonovine, ergotamine, methylergonovine, such as Migranal^®, D.H.E. 45^®*, Methergine^®*, Migergot^®*, Ergomar^®*, and others
• lomitapide (Juxtapid^™)
• lovastatin (Advicor^®, Altoprev^®*, Mevacor^®)
• lurasidone (Latuda^®)
• midazolam* (Versed^®), when taken by mouth
• phenobarbital
• phenytoin (Dilatin^®)
• pimozide (Orap^®)
• rifampin (Rifamate^®*, Rofact^®)
• salmeterol (Advair^®, Serevent^®)
• sildenafil (Revatio^®), when used for treating lung problems
• simvastatin (Simcor^®*, Vytorin^®*, Zocor^®)
• St. John’s wort (Hypericum perforatum) or products containing St. John’s wort
• triazolam (Halcion^®*)

*Not available in Canada

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Genvoya. Talk about any health conditions or problems you may have, including if you:

• Have hepatitis B virus (HBV) infection and take Genvoya. Your HBV infection may get worse (flare-up) and symptoms worsen if you stop taking Genvoya (see Serious Warnings and Precautions box and Serious Side Effects table).
• Have a history of pancreatitis (swelling of the pancreas). If you develop symptoms of pancreatitis, such as nausea, vomiting and severe pain in the abdomen and/or back, tell your healthcare professional.
• Have kidney problems. Kidney problems, including kidney failure, have occurred in patients taking tenofovir. If you have kidney problems and are taking Genvoya along with certain medicines such as non-steroidal anti-inflammatory drugs, your kidney problems could get worse.
• Have a history of bone fracture, bone loss or osteoporosis. Bone loss has happened in some people who took Genvoya.
• Have lactic acidosis (high levels of acid in the blood). See the Serious Side Effects table for symptoms and tell your healthcare professional right away if you get these symptoms.
• Have severe liver problems including enlarged or fatty liver. See the Serious Side Effects table for symptoms and tell your healthcare professional right away if you get these symptoms.

If you have HBV infection and you stop taking Genvoya, your healthcare professional will need to check your health often and do blood tests regularly for several months to check your HBV infection. Tell your healthcare professional about any new or unusual symptoms you may have after you stop taking Genvoya.

Other warnings you should know about:

If you are pregnant or plan to become pregnant:

It is not known if Genvoya can harm your unborn child. Your healthcare professional will decide if you should take Genvoya.

Pregnancy Registry: There is a pregnancy registry for women who take antiviral medicines during pregnancy. This registry collects information about your health and your baby’s health. If you become pregnant while taking Genvoya, talk with your healthcare professional about taking part in this registry.

If you are breast-feeding or plan to breast-feed:

Do not breast-feed if you have HIV because of the chance of passing the HIV virus to your baby. One of the medicinal ingredients of Genvoya, emtricitabine, can be passed to your baby in your breast milk and may cause harm to your baby. It is not known if the other medicinal ingredients can be passed to your baby in breast milk. If you are a woman who has or will have a baby, talk with your healthcare professional about the best way to feed your baby.

Blood Sugar and Fat Levels

Your blood sugar levels (glucose) or levels of fats (lipids) in your blood may increase with HIV treatment. Your healthcare professional may order blood tests for you.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

If you are taking Genvoya, you should not take:

• Antiplatelets such as clopidogrel (Plavix^®).
• Anticonvulsants such as oxcarbazepine
• Antipsychotics such as quetiapine (Seroquel^®)
• Any other medicines to treat HIV-1 infection.
• Any other medicines that contain elvitegravir (STRIBILD^®).
• Any other medicines that contain cobicistat (STRIBILD, Symtuza^®, TYBOST^®, Prezcobix^®).
• Any other medicines that contain tenofovir (ATRIPLA^®, BIKTARVY^®, COMPLERA^®, Delstrigo^®, DESCOVY^®, ODEFSEY^®, STRIBILD, Symtuza^®, TRUVADA^®, VEMLIDY^®, VIREAD^®).
• Any other medicines that contain emtricitabine or lamivudine (ATRIPLA, BIKTARVY, COMPLERA, Delstrigo, DESCOVY, Dovato^®, EMTRIVA^®, ODEFSEY, STRIBILD, Symtuza, TRUVADA; 3TC, Combivir^®, Heptovir^®, Kivexa^®, Triumeq^®, Trizivir^®).
• Any other medicines containing ritonavir (Norvir^®, Kaletra^®).
• Adefovir (HEPSERA^®).

Also tell your healthcare professional if you take:

• Any medications, antacids, vitamins, and supplements containing magnesium, aluminum, calcium, iron, or zinc. These include antacids (for stomach ulcers, heartburn, or acid reflux), mineral supplements and vitamins that contain calcium or iron, and ulcer healing medication (sucralfate). Take medications, antacids, vitamins, and supplements containing magnesium, aluminum, calcium, iron, or zinc at least 2 hours before or after you take Genvoya.
• Antidepressants such as trazodone and Selective Serotonin Reuptake Inhibitors (SSRIs)
• Antifungals such as ketoconazole (Nizoral^®), itraconazole (Sporanox^®) and voriconazole (Vfend^®)
• Antiarrhythmics such as amiodarone, digoxin, disopyramide, flecainide (Tambacor^®), systemic lidocaine, mexiletine, propafenone and quinidine
• Antibacterials such as clarithromycin (Biaxin^®) and telithromycin (Ketek^®)
• Anticonvulsants such as ethosuximide
• Antimycobacterials such as rifabutin (Mycobutin^®)
• Anticoagulants such as warfarin, dabigatran (Pradaxa^®), edoxaban (Lixiana^®)
• Antigout (colchicine)
• Antivirals such as elbasvir/grazoprevir (Zepatier^®)
• Beta-blockers such as metoprolol (Lopressor^®) and timolol
• Calcium channel blockers such as amlodipine (Norvasc^®), diltiazem (Cardizem^®), felodipine, nifedipine, and verapamil
• Corticosteroids such as betamethasone, budesonide, dexamethasone, fluticasone (Flonase^®), mometasone, and triamcinolone
• Endothelial receptor antagonists such as bosentan (Tracleer^®)
• Hormonal contraceptives such as norgestimate/ethinyl estradiol and drospirenone/ethinyl estradiol
• Immunosuppressants such as cyclosporine (Neoral^®), sirolimus (Rapamune^®) and tacrolimus (Prograf^®)
• Neuroleptics such as risperidone (Risperdal^®) and perphenazine (Trilafon^®)
• PDE-5 inhibitors such as sildenafil (Viagra^®), tadalafil (Cialis^®, Adcirca^®), and vardenafil (Levitra^®)
• Sedative/hypnotics such as diazepam (Valium^®), flurazepam and buspirone

*Not marketed in Canada.

How to take Genvoya:

Stay under a healthcare professional’s care when taking Genvoya. Do not change your treatment or stop treatment without first talking with your healthcare professional.

When your Genvoya supply starts to run low, get more from your healthcare professional. This is very important because the amount of virus in your blood may increase if the medicine is stopped for even a short time. If Genvoya is not taken on a regular basis, as prescribed, the virus may develop resistance to Genvoya and become harder to treat.

Only take medicine that has been prescribed specifically for you.

Do not give Genvoya to others or take medicine prescribed for someone else.

Do not use if seal over bottle opening is broken or missing.

Usual dose: Adults and children weighing 25 kg or more:

• The usual dose of Genvoya is one tablet orally (by mouth) once a day. Try to take the tablet at the same time each day. Swallow with plenty of water.

• Genvoya must be taken with food.

  Adults on Dialysis:

  • If you are on dialysis, take your daily dose of Genvoya following dialysis.

Overdose:

Missed Dose:

It is important that you do not miss any doses. If you miss a dose of Genvoya and it is less than 18 hours from the time you usually take Genvoya, then take the dose. If more than 18 hours has passed from the time you usually take Genvoya, then wait until the next scheduled daily

dose. Do not take more than 1 dose of Genvoya in a day. Do not take 2 doses at the same time. Call your healthcare professional if you are not sure what to do.

What are possible side effects from using Genvoya?

These are not all the possible side effects you may feel when taking Genvoya. If you experience any side effects not listed here, tell your healthcare professional.

The common side effects of Genvoya are:

• Diarrhea
• Nausea
• Headache
• Tiredness

Additional side effects may include:

• Gas
• Swelling in the face, lips, tongue or throat (angioedema)
• Hives

Changes in your immune system (Immune Reconstitution Inflammatory Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time.

Autoimmune disorders (when the immune system attacks healthy body tissue), may also occur after you start taking medicines for HIV infection. Examples of this include: Graves’ disease (which affects the thyroid gland), Guillain-Barré syndrome (which affects the nervous system), polymyositis (which affects the muscles), or autoimmune hepatitis (which affects the liver). Autoimmune disorders may occur many months after the start of treatment. Look for any other symptoms such as:

• high temperature (fever), redness, rash or swelling.
• joint or muscle pain.
• numbness or weakness beginning in the hands and feet and moving up towards the trunk of the body.
• palpitations (chest pain) or rapid heart rate.

If you notice these or any symptoms of inflammation or infection, tell your healthcare professional immediately.

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting Side Effects

Storage:

• Genvoya should be stored below 30°C. It should remain stable until the expiration date printed on the label.
• Keep Genvoya in its original container and keep the container tightly closed.
• Keep out of reach and sight of children.

If you want more information about Genvoya:

• Talk to your healthcare professional.
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website (www.gilead.ca), or by calling 1-866-207-4267.

Last Revised August 6, 2021

Gilead Sciences, Inc.

Foster City, CA 94404

USA

Gilead Sciences Canada, Inc.

Mississauga, ON L5N 2W3

ATRIPLA^®, BIKTARVY^®, COMPLERA^®, DESCOVY^®, EMTRIVA^®, GENVOYA^®, HEPSERA^®, ODEFSEY^®, STRIBILD^®, TRUVADA^®, TYBOST^®, VEMLIDY^®, and VIREAD^® are trademarks of Gilead Sciences, Inc. or its related companies.

All other marks referenced herein are the property of their respective owners.

©2021 Gilead Sciences, Inc.

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