Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir)

Stay under a doctor's care when taking STRIBILD. Do not change your treatment or stop treatment without first talking with your doctor.

Take STRIBILD every day exactly as your doctor prescribed it. Follow the directions from your doctor, 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 doctor or pharmacy. 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 adult 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:

In case of drug overdose, contact your healthcare practitioner (e.g. doctor), hospital emergency department or regional poison control centre, even if there are no symptoms.

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 has 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 doctor or pharmacist if you are not sure what to do.

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
• Serious kidney problems
• Rash
• Suicidal ideation (suicidal thoughts) and suicide attempt (in patients who have had depression or previous mental health problems). If you have these thoughts, contact your doctor.

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 (e.g. 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 doctor right away.

Tell your doctor if you have any side effect that bothers you or that does not go away.

• In animal studies, tenofovir DF, a component of STRIBILD, caused harm to the bones of animals. If you notice bone pain, suffer a bone fracture, or other bone problem, consult your doctor. If you have bone problems, you may wish to discuss calcium and/or vitamin D supplementation with your doctor. The effect of supplementation with calcium and/or vitamin D is unknown.

• Patients who experience dizziness, trouble concentrating or drowsiness should avoid driving or operating machinery.

• If you 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 doctor at once.

BEFORE you use STRIBILD (elvitegravir/cobicistat/emtricitabine/tenofovir DF) talk to your doctor or pharmacist:

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 doctor 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 doctor about the best way to feed your baby.

If you have other medical conditions: Let your doctor know if you have other medical conditions, especially liver problems (including hepatitis B or C virus) infection, kidney problems, or have or are at risk for bone disease or bone related problems or pancreatitis (inflammation of the pancreas).

If you are taking other medicines: Some medicines can interact when taken together, including prescription and non-prescription medicines, herbal products and dietary supplements.

Drugs that should not be taken with STRIBILD:

• alfuzosin hydrochloride (Xatral)
• astemizole (Hismanal) or terfenadine (Seldane)
• cisapride (Prepulsid)
• carbamazepine (Carbatrol, Epitol, Equetro, Tegretol)
• ergot-containing medicines: dihydroergotamine, ergonovine, ergotamine, methylergonovine, such as Cafergot, Migranal, D.H.E. 45, Ergotrate, Methergine, Migergot, Ergomar, and others.
• lovastatin (Advicor, Altoprev*, Mevacor)
• midazolam (Versed), when taken by mouth
• phenobarbital (Luminal)
• phenytoin (Dilatin, Phenytek)
• pimozide (Orap)
• rifampin (Rifadin, Rifamate, Rifater, 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)

If you are taking STRIBILD, you should not take:

• Do not take STRIBILD if you are on other medications that may affect your kidneys and have not discussed this with your doctor.
• Any other medicines to treat HIV infection.
• Other medicines that contain tenofovir (ATRIPLA, COMPLERA, VIREAD, TRUVADA).
• Other medicines that contain emtricitabine or lamivudine (Combivir, EMTRIVA, 3TC or Heptovir, Kivexa, Trizivir)
• ritonavir (Kaletra, Norvir)
• adefovir (HEPSERA)
• ledipasvir/sofosbuvir (HARVONI)

Also tell your doctor if you take:

• An antacid medicine that contains aluminum, magnesium hydroxide, or calcium carbonate. Take antacids at least 2 hours before or after you take STRIBILD.
• Antidepressants such as trazodone
• Antifungals such as ketaconazole (Nizoral), itraconazole (Sporanox) and voriconazole (Vfend)
• Antiarrhythmics such as amiodarone (Cordarone), flecainide (Tambacor) and quinidine (Neudexta)
• Antibacterials such as clarithromycin (Biaxin) and telithromycin (Ketek)
• Antimycobacterials such as rifabutin (Mycobutin)
• Anticoagulants such as warfarin (Coumadin)
• Antigout (colchicine)
• Antipsychotics such as quetiapine (Seroquel)
• Beta-blockers such as metoprolol (Lopresor) and timolol
• Calcium channel blockers such as amlodipine (Norvasc), diltiazem (Cardizem), and felodipine
• Corticosteroids systemic such as dexamethasone and fluticasone (Flonase)
• Endothelial receptor antagonists such as bosentan (Tracleer)
• Hormonal contraceptives such as norgestimate/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

These are not all the medicines that may cause problems if you take STRIBILD. Be sure to tell your doctor about all the medicines you take.

Keep a complete list of all the prescription and nonprescription medicines as well as any herbal medicines that you are taking, how much you take and how often you take them. Make a new list when medicines or herbal medicines are added or stopped, or if the dose changes. Give copies of this list to all your doctors and pharmacists every time you visit them or fill a prescription. This will give your doctor a complete picture of the medicines you use. Then he or she can decide the best approach for the situation.