Elvitegravir/ cobicistat/ emtricitabine/ tenofovir

Generic Name: elvitegravir/cobicistat/emtricitabine/tenofovir (EL-vi-TEG-ra-vir/koe-BIK-i-stat/EM-trye-SYE-ta-been/ten-OF-oh-vir)
Brand Name: Stribild

Severe and sometimes fatal lactic acidosis (a buildup of lactic acid in the blood) and liver problems have occurred with this type of medicine. The risk may be greater in women, patients who are very overweight, or patients who have been taking nucleoside medicines (eg, emtricitabine, tenofovir) for a long time.

Tell your doctor right away if you develop symptoms of lactic acidosis (eg, unusual weakness or tiredness; unusual muscle pain; fast or difficult breathing; stomach pain with nausea and vomiting; feeling cold, especially in the arms and legs; dizziness or light-headedness; fast or irregular heartbeat). Tell your doctor right away if you develop symptoms of liver problems (eg, yellowing of the skin or eyes, dark urine, pale stools, persistent loss of appetite, nausea, stomach pain).

Elvitegravir/cobicistat/emtricitabine/tenofovir has not been approved to treat hepatitis B virus (HBV) infection. The safety and effectiveness of elvitegravir/cobicistat/emtricitabine/tenofovir in patients who have both HBV and HIV infection have not been confirmed. Some patients with both HBV and HIV infection who took elvitegravir/cobicistat/emtricitabine/tenofovir experienced severe worsening of HBV infection after they stopped taking it. Patients who have both HBV and HIV infection need close medical follow-up to check for worsening liver problems for at least several months after they stop elvitegravir/cobicistat/emtricitabine/tenofovir. Keep all doctor and lab appointments. Do not stop taking elvitegravir/cobicistat/emtricitabine/tenofovir without checking with your doctor.


Elvitegravir/ cobicistat/ emtricitabine/ tenofovir is used for:

Treating HIV infection. Elvitegravir/cobicistat/emtricitabine/tenofovir is used alone (you do not need to take other medicines with it to treat HIV). It is not a cure for HIV or AIDS.

Elvitegravir/cobicistat/emtricitabine/tenofovir is a combination of antiviral medicines. It contains an integrase strand transfer inhibitor along with a medicine to strengthen its action and 2 reverse transcriptase inhibitors. It works by reducing the amount of HIV in the body by blocking its ability to multiply.

Do NOT use elvitegravir/ cobicistat/ emtricitabine/ tenofovir if:

  • you are allergic to any ingredient in elvitegravir/cobicistat/emtricitabine/tenofovir
  • you have moderate to severe kidney problems or severe liver problems
  • you are taking adefovir or ritonavir, medicine that contains lamivudine, or another medicine that contains emtricitabine or tenofovir
  • you are taking other medicine to treat HIV
  • you are taking alfuzosin, avanafil, boceprevir, cabazitaxel, cisapride, crizotinib, an ergot medicine (eg, dihydroergotamine), lovastatin, lurasidone, oral midazolam, pimozide, a rifamycin (eg, rifampin, rifapentine), salmeterol, silodosin, simvastatin, St. John's wort, tamsulosin, telaprevir, ticagrelor, triazolam, or vincristine liposome
  • you are taking sildenafil to treat pulmonary arterial hypertension (PAH)
  • you are taking or have recently taken a medicine that may harm your kidneys (eg, an aminoglycoside antibiotic [eg, gentamicin], amphotericin B, cyclosporine, a nonsteroidal anti-inflammatory drug [NSAID] [eg, ibuprofen], tacrolimus, vancomycin). Ask your doctor if you are not sure if any of your medicines might harm your kidneys

Contact your doctor or health care provider right away if any of these apply to you.

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Before using elvitegravir/ cobicistat/ emtricitabine/ tenofovir:

Some medical conditions may interact with elvitegravir/cobicistat/emtricitabine/tenofovir. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have kidney problems
  • if you have a history of lactic acidosis, or abnormal liver function tests or liver problems, including HBV infection
  • if you have osteoporosis (weak bones), a family history of osteoporosis, or other risk factors of osteoporosis (eg, smoking, poor nutrition); or if you have a history of bone problems (eg, fracture)
  • if you are very overweight

Some MEDICINES MAY INTERACT with elvitegravir/cobicistat/emtricitabine/tenofovir. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Many prescription and nonprescription medicines (eg, used for abortion, aches and pains, allergies, angina, asthma or other lung or breathing problems, birth control, blood thinning, cancer, cystic fibrosis, depression or other mental or mood problems, diabetes or high blood sugar, erectile dysfunction, gout, hepatitis, high blood pressure, high cholesterol, immune system suppression, infections, inflammation, intermittent claudication, irregular heartbeat or other heart problems, migraines, myelofibrosis, nausea and vomiting, pain, prostate problems, PAH, seizures, sleeping problems, stomach or bowel problems, Tourette syndrome), multivitamin products, and herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo, St. John's wort) because they may interact with elvitegravir/cobicistat/emtricitabine/tenofovir. Ask your doctor or pharmacist if you are unsure if any of your medicines might interact with elvitegravir/cobicistat/emtricitabine/tenofovir

This may not be a complete list of all interactions that may occur. Ask your health care provider if elvitegravir/cobicistat/emtricitabine/tenofovir may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use elvitegravir/ cobicistat/ emtricitabine/ tenofovir:

Use elvitegravir/cobicistat/emtricitabine/tenofovir as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with elvitegravir/cobicistat/emtricitabine/tenofovir. Talk to your pharmacist if you have questions about this information.
  • Take elvitegravir/cobicistat/emtricitabine/tenofovir by mouth with food.
  • Do not take an antacid that has aluminum, magnesium, or calcium in it within 2 hours before or after you take elvitegravir/cobicistat/emtricitabine/tenofovir.
  • Continue to take elvitegravir/cobicistat/emtricitabine/tenofovir even if you feel well. Do not miss any doses.
  • Do not suddenly stop taking elvitegravir/cobicistat/emtricitabine/tenofovir without checking with your doctor. This may cause the virus to become less sensitive to this or other medicines. Some conditions (eg, hepatitis B) could become worse if you suddenly stop taking elvitegravir/cobicistat/emtricitabine/tenofovir.
  • Taking elvitegravir/cobicistat/emtricitabine/tenofovir at the same time each day will help you remember to take it.
  • If you miss a dose of elvitegravir/cobicistat/emtricitabine/tenofovir, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use elvitegravir/cobicistat/emtricitabine/tenofovir.

Important safety information:

  • Elvitegravir/cobicistat/emtricitabine/tenofovir may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use elvitegravir/cobicistat/emtricitabine/tenofovir with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • You should be tested for HBV infection before you start to take elvitegravir/cobicistat/emtricitabine/tenofovir.
  • Keep a list of all the medicines that you take. Make a new list each time medicines are added or stopped. Find out about medicines that should not be taken while you are using elvitegravir/cobicistat/emtricitabine/tenofovir. Be sure that each of your health care providers knows all the medicines that you are taking.
  • Do not change your dose of elvitegravir/cobicistat/emtricitabine/tenofovir without checking with your doctor.
  • When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking elvitegravir/cobicistat/emtricitabine/tenofovir, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.
  • Tell your doctor or dentist that you take elvitegravir/cobicistat/emtricitabine/tenofovir before you receive any medical or dental care, emergency care, or surgery.
  • Elvitegravir/cobicistat/emtricitabine/tenofovir is not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor.
  • Elvitegravir/cobicistat/emtricitabine/tenofovir does not stop the spread of HIV to others through blood or sexual contact. Do not have any kind of sex without protection (eg, latex or polyurethane condoms) if you have HIV infection. Do not share needles, injection supplies, or items like toothbrushes or razors. Talk with your health care provider about ways to prevent the spread of HIV to others.
  • Elvitegravir/cobicistat/emtricitabine/tenofovir has not been approved for the treatment of HBV. If you have HBV and HIV, you will need close medical follow-up for several months after stopping treatment with elvitegravir/cobicistat/emtricitabine/tenofovir. Follow-up includes medical exams and blood tests to check for HBV infection that could be getting worse.
  • The risk of severe side effects (eg, lactic acidosis, severe liver problems) may be greater in women, patients who are very overweight (obese), and patients who have taken nucleoside medicines (eg, emtricitabine, tenofovir) for a long time. Talk with your doctor if you have questions about your risk for severe side effects from elvitegravir/cobicistat/emtricitabine/tenofovir.
  • Changes in body fat (eg, an increased amount of fat in the upper back, neck, breast, and trunk, and loss of fat from the legs, arms, and face) may occur in some patients taking elvitegravir/cobicistat/emtricitabine/tenofovir. The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor.
  • Elvitegravir/cobicistat/emtricitabine/tenofovir may improve immune system function. This may reveal hidden infections in some patients. Tell your doctor right away if you notice symptoms of infection (eg, fever, sore throat, weakness, cough, shortness of breath) after you start elvitegravir/cobicistat/emtricitabine/tenofovir.
  • Ask your doctor if you should take a calcium and vitamin D supplement while you are taking elvitegravir/cobicistat/emtricitabine/tenofovir.
  • Lab tests, including liver function, kidney function, and bone mineral density, may be performed while you use elvitegravir/cobicistat/emtricitabine/tenofovir. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Elvitegravir/cobicistat/emtricitabine/tenofovir should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using elvitegravir/cobicistat/emtricitabine/tenofovir while you are pregnant. Elvitegravir/cobicistat/emtricitabine/tenofovir is found in breast milk. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or elvitegravir/cobicistat/emtricitabine/tenofovir to the baby. Do not breast-feed while taking elvitegravir/cobicistat/emtricitabine/tenofovir.

Possible side effects of elvitegravir/ cobicistat/ emtricitabine/ tenofovir:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back pain; cough; darkened skin color on the palms of the hands or soles of the feet; diarrhea; dizziness; headache; indigestion; joint pain; mild stomach pain; nausea; nose or throat irritation; runny or stuffy nose; sinus pain or drainage; strange dreams; tiredness; trouble sleeping; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); bone pain; fever; mental or mood changes (eg, depression); muscle pain, weakness, or cramping; numbness, burning, pain, or tingling in the hands or feet; severe or persistent dizziness; severe stomach or back pain (with or without nausea or vomiting); shortness of breath; symptoms of kidney problems (eg, increased or decreased urination, increased thirst); symptoms of lactic acidosis (eg, unusual weakness or tiredness; unusual muscle pain; fast or difficult breathing; stomach pain with nausea and vomiting; feeling cold, especially in the arms and legs; dizziness or light-headedness; fast or irregular heartbeat); symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; persistent loss of appetite).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of elvitegravir/cobicistat/emtricitabine/tenofovir:

Store elvitegravir/cobicistat/emtricitabine/tenofovir at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store in the original container away from heat, moisture, and light. Do not store in the bathroom. Do not use if the seal on the bottle is broken or missing. Keep elvitegravir/cobicistat/emtricitabine/tenofovir out of the reach of children and away from pets.

General information:

  • If you have any questions about elvitegravir/cobicistat/emtricitabine/tenofovir, please talk with your doctor, pharmacist, or other health care provider.
  • Elvitegravir/cobicistat/emtricitabine/tenofovir is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take elvitegravir/cobicistat/emtricitabine/tenofovir or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about elvitegravir/cobicistat/emtricitabine/tenofovir. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to elvitegravir/cobicistat/emtricitabine/tenofovir. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using elvitegravir/cobicistat/emtricitabine/tenofovir.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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