Stribild: Uses, Side Effects and Dosage

What is Stribild used for?

Stribild contains 4 medicines, elvitegravir, cobicistat, emtricitabine (EMTRIVA^®) and tenofovir DF (VIREAD^®), combined in one single tablet regimen.

Serious Warnings and Precautions

Stribild is used as a complete regimen to treat people with HIV infection. Stribild is for adults age 18 and older. Stribild is for people who do not have an HIV virus that is resistant to Stribild. Stribild has not been studied in children under age 18 or adults over age 65.

How does Stribild work?

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

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

Stribild may help increase the count of CD4+ (T) white blood cells that help fight off other infections. Lowering the amount of HIV in the blood and increasing the CD4+ (T) lowers the chance of getting infections that happen when your immune system is weak (opportunistic infections).

Stribild does not cure HIV infection or AIDS. The long-term effects of Stribild are not known at this time. People taking Stribild may still get opportunistic infections or other conditions that happen with HIV infection. Opportunistic infections are infections that develop because the immune system is weak. Some of these conditions are pneumonia, herpes virus infections, and Mycobacterium avium complex (MAC) infections. It is very important that you see your healthcare professional regularly while taking Stribild.

Stribild has not been shown to reduce the risk of passing HIV to others through sexual contact or blood contamination. Continue to practice safe sex. Use latex or polyurethane condoms to lower the chance of sexual contact with any body fluids such as semen, vaginal secretions, or blood. Do not re-use or share needles.

Together with your healthcare professional you need to decide whether Stribild is right for you.

What are the ingredients in Stribild?

Medicinal ingredients: elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate (tenofovir DF)

Non-medicinal ingredients: croscarmellose sodium, hydroxypropyl cellulose, indigo carmine FD&C Blue #2 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, sodium lauryl sulfate, talc, titanium dioxide and yellow iron oxide.

Stribild comes in the following dosage forms:

Stribild is available as tablets. Each tablet contains 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate (which is equivalent to 245 mg of tenofovir disoproxil), as active ingredients. The tablets are green, modified capsule-shaped, film-coated, debossed with “GSI” on one side and 1 on the other side.

Do not use Stribild if:

• you are allergic to Stribild or any of its ingredients. The medicinal ingredients are elvitegravir, cobicistat, emtricitabine and tenofovir DF (see: What are the ingredients in

  • Stribild).
• you are taking any medication that is listed below:

Drugs that must not be taken with Stribild:

• alfuzosin hydrochloride (Xatral^®)
• apixaban (Eliquis^®), rivaroxaban (Xarelto^®)
• astemizole* (Hismanal^®) or terfenadine (Seldane^®)
• cisapride* (Prepulsid^®)
• carbamazepine (Carbatrol^®, Epitol^®, Equetro^®, 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 (Luminal^®)
• phenytoin (Dilatin^®, Phenytek^®)
• 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 Stribild. Talk about any health conditions or problems you may have, including if you:

• Have or are at risk for bone disease or bone related problems. If you notice bone pain, or suffer a bone fracture, or other bone problem, consult your healthcare professional. If you have bone problems, you may wish to discuss calcium and/or vitamin D supplementation with your healthcare professional. The effect of supplementation with calcium and/or vitamin D is unknown.
• Have advanced HIV infection (AIDS) and have an infection, you may develop symptoms of infection and inflammation or worsening of the symptoms of an existing infection once treatment with Stribild is started. These symptoms may indicate that your body’s improved immune system is fighting infection. If you notice signs of inflammation or infection, tell your healthcare professional at once.
• Have liver problems (including hepatitis B or C virus infection)
• Have kidney problems
• Have pancreatitis (inflammation of the pancreas)
• Have other medical conditions

Other warnings you should know about:

Driving and Operating Machinery:

You may experience dizziness, trouble concentrating, or drowsiness while taking STRIBILD. If you experience these effects, you should avoid driving or operating machinery.

If you are pregnant or plan to become pregnant:

It is not known if Stribild can harm your unborn child.

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 Stribild, 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. Two of the components of Stribild, emtricitabine and tenofovir DF, can be passed to your baby in your breast milk and may cause harm to your baby. 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.

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

The following may interact with Stribild:

If you are taking Stribild, you should not take:

• Antiplatelets such as clopidogrel (Plavix^®)
• Do not take Stribild if you are on other medications that may affect your kidneys and have not discussed this with your healthcare professional.
• Any other medicines to treat HIV infection.
• Medicines that contain the same active components, elvitegravir (GENVOYA^® ), cobicistat (GENVOYA , Prezcobix^®, Symtuza^® or TYBOST^®), emtricitabine or tenofovir DF (ATRIPLA^®, BIKTARVY^®, COMPLERA, Delstrigo^®, DESCOVY^®, EMTRIVA^®, GENVOYA, ODEFSEY^®, Symtuza, TRUVADA^®, or VIREAD^®)
• Medicines that contain lamivudine (Combivir^®, 3TC^®, Delstrigo, Dovato^®, Heptovir^®, Kivexa^®, Triumeq^® or Trizivir^®)
• Medicines that contain tenofovir alafenamide (DESCOVY, GENVOYA, ODEFSEY, or VEMLIDY^®)
• ritonavir (Kaletra^®, Norvir^®)
• adefovir (HEPSERA^®)
• ledipasvir/sofosbuvir (HARVONI^®)

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 Stribild.
• Analeptics such as modafinil
• Antidepressants such as amitriptyline, bupropion, desipramine, imipramine, nortriptyline, paroxetine and trazodone
• Antifungals such as ketoconazole (Nizoral^®), itraconazole (Sporanox^®) and voriconazole (Vfend^®)
• Antiarrhythmics such as amiodarone, digoxin, disopyramide, flecainide (Tambocor^®), lidocaine, mexiletine, propafenone and quinidine
• Antibacterials such as clarithromycin (Biaxin^®) and telithromycin (Ketek^®)
• Antimycobacterials such as rifabutin (Mycobutin^®) and rifapentine
• Anticoagulants such as warfarin, dabigatran (Pradaxa^®), edoxaban (Lixiana^®)
• Anticonvulsants such as oxcarbazepine, clonazepam and ethosuximide
• Antigout (colchicine)
• Antipsychotics such as quetiapine (Seroquel^®)
• Beta-blockers such as metoprolol (Lopressor^®) and timolol
• Calcium channel blockers such as amlodipine (Norvasc^®), diltiazem (Cardizem^®), felodipine, nifedipine and verapamil
• Cholesterol lowering agents such as atorvastatin (Lipitor^®)
• 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 clorazepate, diazepam (Valium^®), flurazepam and buspirone
• Sofosbuvir/velpatasvir (EPCLUSA^®)
• Sofosbuvir/velpatasvir/voxilaprevir (VOSEVI^®)

How to take Stribild:

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

Take Stribild every day exactly as your healthcare professional prescribed it, exactly as written on the label. Set up a dosing schedule and follow it carefully.

When your Stribild 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 Stribild is not taken regularly, as prescribed, the virus may develop resistance to Stribild and become harder to treat.

Only take medicine that has been prescribed specifically for you. Do not give Stribild to others or take medicine prescribed for someone else. Do not use if seal over bottle opening is broken or missing.

Usual dose:

• The usual dose of Stribild is one tablet orally (by mouth) once a day, preferably at the same time each day. Swallow with plenty of water.

• Take Stribild with food. Taking Stribild with food helps get the right amount of medicine in your body.

Overdose:

Missed Dose:

It is important that you do not miss any doses. If you miss a dose of Stribild and it is less than 12 hours from the time you usually take Stribild, then take the dose. If more than 12 hours have passed from the time you usually take Stribild, then wait until the next scheduled daily dose. Do not take more than 1 dose of Stribild 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 Stribild?

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

The common side effects of Stribild are:

• Diarrhea
• Nausea
• Headache

Additional side effects may include:

• Depression
• Vomiting
• Tiredness
• Stomach pain
• Upset stomach
• Gas
• Dizziness
• Trouble sleeping
• Abnormal dreams
• Rash

Other common side effects reported for EMTRIVA and VIREAD are:

• Allergic reaction (including skin rash, redness, irritation, swelling of the face, lips, tongue or throat)
• Pancreatitis (inflammation of the pancreas)
• Shortness of breath
• Skin discoloration (small spots or freckles)
• Sinusitis (inflammation of the sinuses)
• Nasopharyngitis (inflammation of the nasal cavity and throat area)
• Somnolence (feeling sleepy)
• Upper respiratory tract infection
• Back pain
• Weakness
• Pain

Changes in body fat have been seen in some patients taking antiretroviral therapy. These changes may include increased amounts of fat in the upper back and neck (“buffalo hump”), breast, and around the trunk. Loss of fat from the legs, arms and face may also happen. The cause and long-term health effects of these conditions are not known at this time.

Changes in your immune system (Immune Reconstitution Inflammatory Syndrome) can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time, or you could develop an autoimmune disease in which your immune system reacts against your own body (eg, Graves’ disease (which affects the thyroid gland), Guillain-Barré syndrome (which affects the nervous system) or polymyositis (which affects the muscles) and it may develop at any time, sometimes months later after the start of HIV therapy). Sometimes symptoms can be severe, so if you develop high temperature (fever), joint or muscle pain, redness, rash, swelling or fatigue, or any new symptoms, contact your healthcare professional right away.

Serious side effects and what to do about them

Serious side effects and what to do about them

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, tell your healthcare professional.

Reporting Side Effects

Storage:

• Keep Stribild and all other medications out of reach and sight of children.
• Stribild should be stored at 15-30°C (59-86°F). It should remain stable until the expiration date printed on the label.
• Do not keep your medicine in places that are too hot or cold.
• Do not keep medicine that is out of date or that you no longer need. If you throw any medicines away, make sure that children will not find them.
• Keep Stribild in its original container and keep the container tightly closed.

If you want more information about Stribild:

• 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 July 26, 2021

Gilead Sciences, Inc.

Foster City, CA 94404

USA

Gilead Sciences Canada, Inc.

Mississauga, ON

L5N 2W3

ATRIPLA^®, BIKTARVY^®, COMPLERA^®, DESCOVY^®, EMTRIVA^®, EPCLUSA^®, GENVOYA^®, HARVONI^®, HEPSERA^®, ODEFSEY^®, STRIBILD^®, TRUVADA^®, TYBOST^®, VEMLIDY^®, VIREAD^®, and VOSEVI^® 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. All rights reserved.

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