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Elvitegravir, cobicistat, emtricitabine, and tenofovir (Oral route)

Pronunciation:

el-vi-TEG-ra-vir, koe-BIK-i-stat, em-trye-SYE-ta-been, ten-OF-oh-vir dye-soe-PROX-il FUE-ma-rate

Brand Names:

  • Stribild

Dosage Forms:

  • Tablet

Warnings:

Oral route(Tablet)

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues in combination with other antiretrovirals. Not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy have not been established in patients coinfected with HBV and HIV-1. Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued emtricitabine or tenofovir disoproxil fumarate. Monitor hepatic function upon discontinuation of therapy in patients coinfected with HIV-1 and HBV .

Classifications:

Therapeutic—

Anti-Infective Agent

Pharmacologic—

Integrase Inhibitor

Uses of This Medicine:

Elvitegravir, cobicistat, emtricitabine, and tenofovir combination is used to treat human immunodeficiency virus (HIV) infection. HIV is the virus that causes acquired immune deficiency syndrome (AIDS). This medicine is usually given to adult patients who have yet not received any medicine for HIV infection.

Elvitegravir, cobicistat, emtricitabine, and tenofovir combination will not cure or prevent HIV infection or AIDS. It helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay problems that are usually related to AIDS or HIV disease from occurring. This medicine will not keep you from spreading HIV to other people. People who receive this medicine may continue to have other problems usually related to AIDS or HIV disease.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of elvitegravir, cobicistat, emtricitabine, and tenofovir combination in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of elvitegravir, cobicistat, emtricitabine, and tenofovir combination in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution for patients receiving this medicine.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersBAnimal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Alfuzosin
  • Cisapride
  • Conivaptan
  • Crizotinib
  • Dabrafenib
  • Dihydroergotamine
  • Doxorubicin
  • Doxorubicin Hydrochloride Liposome
  • Dronedarone
  • Eplerenone
  • Ergonovine
  • Ergotamine
  • Everolimus
  • Fentanyl
  • Ibrutinib
  • Ivabradine
  • Lomitapide
  • Lovastatin
  • Lurasidone
  • Maraviroc
  • Methylergonovine
  • Midazolam
  • Pazopanib
  • Pimozide
  • Primidone
  • Quetiapine
  • Ranolazine
  • Rifampin
  • Riociguat
  • Romidepsin
  • Sildenafil
  • Simvastatin
  • St John's Wort
  • Tolvaptan
  • Trabectedin
  • Triazolam
  • Vemurafenib
  • Vilazodone
  • Vincristine
  • Vincristine Sulfate Liposome
  • Vinflunine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Ado-Trastuzumab Emtansine
  • Afatinib
  • Alprazolam
  • Aluminum Carbonate, Basic
  • Aluminum Hydroxide
  • Aluminum Phosphate
  • Amiodarone
  • Amobarbital
  • Apixaban
  • Aprepitant
  • Aprobarbital
  • Aripiprazole
  • Armodafinil
  • Artemether
  • Atazanavir
  • Atorvastatin
  • Bedaquiline
  • Bosentan
  • Bosutinib
  • Brentuximab Vedotin
  • Bromocriptine
  • Budesonide
  • Buprenorphine
  • Buspirone
  • Butabarbital
  • Butalbital
  • Cabazitaxel
  • Cabozantinib
  • Calcium Carbonate
  • Carbamazepine
  • Cilostazol
  • Citalopram
  • Clarithromycin
  • Clobazam
  • Clozapine
  • Crizotinib
  • Cyclosporine
  • Dabrafenib
  • Dasatinib
  • Delavirdine
  • Dexamethasone
  • Didanosine
  • Digoxin
  • Dihydroxyaluminum Aminoacetate
  • Dihydroxyaluminum Sodium Carbonate
  • Disopyramide
  • Docetaxel
  • Efavirenz
  • Eletriptan
  • Enzalutamide
  • Eslicarbazepine Acetate
  • Etravirine
  • Felodipine
  • Flecainide
  • Fluoxetine
  • Fluticasone
  • Fosaprepitant
  • Fosphenytoin
  • Haloperidol
  • Iloperidone
  • Imatinib
  • Itraconazole
  • Ketoconazole
  • Lapatinib
  • Levomilnacipran
  • Lidocaine
  • Lopinavir
  • Lumefantrine
  • Macitentan
  • Magaldrate
  • Magnesium Carbonate
  • Magnesium Hydroxide
  • Magnesium Oxide
  • Magnesium Trisilicate
  • Mephobarbital
  • Methohexital
  • Methotrexate
  • Mexiletine
  • Mifepristone
  • Mitotane
  • Modafinil
  • Nafcillin
  • Nevirapine
  • Nilotinib
  • Nisoldipine
  • Oxcarbazepine
  • Paclitaxel
  • Pentobarbital
  • Phenobarbital
  • Phenytoin
  • Pioglitazone
  • Piperaquine
  • Pixantrone
  • Pomalidomide
  • Ponatinib
  • Prednisone
  • Primidone
  • Propafenone
  • Quinidine
  • Regorafenib
  • Retapamulin
  • Rifabutin
  • Rifapentine
  • Ritonavir
  • Rivaroxaban
  • Rufinamide
  • Salmeterol
  • Saxagliptin
  • Secobarbital
  • Simeprevir
  • Sirolimus
  • Sodium Bicarbonate
  • Sunitinib
  • Tadalafil
  • Tamoxifen
  • Tamsulosin
  • Telaprevir
  • Telithromycin
  • Temsirolimus
  • Thiopental
  • Ticagrelor
  • Topiramate
  • Tramadol
  • Trazodone
  • Vardenafil
  • Vemurafenib
  • Verapamil
  • Vilanterol
  • Vilazodone
  • Voriconazole
  • Warfarin
  • Zolpidem

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Atazanavir
  • Boceprevir
  • Darunavir
  • Fosamprenavir
  • Indinavir
  • Lopinavir
  • Nelfinavir
  • Ritonavir
  • Saquinavir
  • Telaprevir
  • Tipranavir

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Bone problems (eg, fracture, osteomalacia), history of or
  • Fanconi syndrome (kidney disease), history of or
  • Hepatitis B infection, history of or
  • Kidney failure, history of—Use with caution. May make these conditions worse.
  • Kidney disease, moderate to severe or
  • Liver disease, severe—Use is not recommended in patients with these conditions.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Read it again each time you refill your prescription in case there is new information. You should talk to your doctor if you have any questions.

This medicine should be taken with food.

Do not change the dose or stop using this medicine without checking first with your doctor. When your supply of this medicine is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of this medicine.

If you are taking aluminum or magnesium-containing antacids (such as Maalox®, Mylanta®, Tums®), do not take them at the same time that you take this medicine. It is best to take these medicines at least 2 hours before or after taking Stribild®. These medicines may keep Stribild® from working properly.

Elvitegravir, cobicistat, emtricitabine, and tenofovir contains a fixed amount of medicine in each tablet.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For treatment of HIV infection:
      • Adults—One tablet once a day with food. Each tablet contains 150 milligrams (mg) of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and 300 mg of tenofovir.
      • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Do not use this medicine if the seal on the bottle is broken or missing. Keep the bottle tightly closed. Keep the medicine in the original bottle that you were given at the pharmacy.

Precautions While Using This Medicine:

Your doctor will want to check your progress at regular visits, especially during the first few weeks that you take this medicine. Blood and urine tests may be needed to check for any unwanted effects.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or non-prescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

The medicines in this combination tablet are also available as Atripla®, Complera®, Emtriva®, Truvada®, or Viread®. Do not take the elvitegravir, cobicistat, emtricitabine, and tenofovir combination with any of these medicines.

This medicine should not be used together with adefovir (Hepsera®), alfuzosin (Uroxatral®), cisapride (Propulsid®), lamivudine (Combivir®, Epivir®, Epivir-HBV®, Epzicom®, Trizivir®), lovastatin (Mevacor®), midazolam (Versed®), pimozide (Orap®), rifampin (Rifadin®, Rimactane®), ritonavir (Kaletra®, Norvir®), sildenafil (Revatio®), simvastatin (Zocor®), triazolam (Halcion®), St John's wort, ergotamine medicines (such as dihydroergotamine, ergotamine, methylergonovine, Cafergot®, Ergomar®, Wigraine®), certain other antiviral medications (acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir), aminoglycoside antibiotics, or high-dose or multiple NSAID pain medicines.

Two rare but serious reactions to this medicine are lactic acidosis (too much acid in the blood) and liver toxicity. These reactions are more common if you are female, obese, or have been taking anti-HIV medicines for a long time. Call your doctor right away if you have abdominal or stomach pain, nausea, vomiting, decreased appetite, muscle cramping or pain, unusual tiredness or weakness, trouble breathing, or yellow skin or eyes.

This medicine may also increase your risk of developing fractures (broken bones). Ask your doctor about this if you have any concerns.

This medicine does not decrease the risk of transmitting the HIV infection to others through sexual contact or by contaminated blood. Make sure you understand and practice safe sex, even if your partner also has HIV. Avoid sharing needles with anyone.

This medicine may cause you to have excess body fat. Tell your doctor if you notice changes in your body shape, such as an increased amount of fat in the upper back and neck, or around the chest and stomach area. You might also lose fat from the legs, arms, and face.

Your immune system may get stronger when you start taking HIV medicines. Tell your doctor right away if you notice any changes in your health. Sometimes the immune system will start to fight infections that were hidden in your body, such as pneumonia, herpes, or tuberculosis. Autoimmune disorders (such as Graves' disease, polymyositis, and Guillain-Barré syndrome) may also occur.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
Cloudy urine
Incidence not known
Abdominal or stomach pain
bloody urine
bone fractures
bone pain
change in urination
convulsions
cough
decreased appetite
difficulty swallowing
dizziness
dry mouth
fast or irregular heartbeat
fever
general feeling of discomfort
increased thirst
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
light-colored stools
lower back or side pain
mood changes
muscle pain or stiffness
nausea, vomiting or diarrhea
numbness or tingling in the hands, feet, or lips
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
skin rash, hives, or itching
sleepiness
swelling of the face, fingers, or lower legs
tightness in the chest
trouble breathing
unusual tiredness or weakness
weight gain
yellow eyes and skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
Abnormal dreams
headache
Less common
Bloated
full feeling
passing gas
trouble sleeping
unusual drowsiness
Incidence not known
Chills
constipation
indigestion
lack or loss of strength
pains in the stomach, side, or abdomen, possibly radiating to the back

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.


Last Updated: 4/4/2014

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