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)

Posttreatment Acute Exacerbation of Hepatitis BSevere acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued emtricitabine or tenofovir disoproxil fumarate, two of the components of elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate tablets. Hepatic function should be monitored closely in these patients. If appropriate, initiation of anti-hepatitis B therapy may be warranted .

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 children younger than 12 years of age or weighing less than 35 kilograms. 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.

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
Alprazolam
Bromocriptine
Carbamazepine
Cisapride
Colchicine
Conivaptan
Crizotinib
Dihydroergotamine
Doxorubicin
Doxorubicin Hydrochloride Liposome
Dronedarone
Drospirenone
Eletriptan
Eliglustat
Eplerenone
Ergoloid Mesylates
Ergonovine
Ergotamine
Finerenone
Fosphenytoin
Gepirone
Isavuconazonium Sulfate
Ivabradine
Levoketoconazole
Lisuride
Lomitapide
Lovastatin
Lurasidone
Maraviroc
Mavacamten
Metergoline
Methylergonovine
Methysergide
Midazolam
Naloxegol
Nicergoline
Pacritinib
Pazopanib
Phenobarbital
Phenytoin
Pimozide
Primidone
Ranolazine
Rifampin
Riociguat
Romidepsin
Sildenafil
Silodosin
Simvastatin
St John's Wort
Tolvaptan
Triazolam
Ubrogepant
Venetoclax
Voclosporin

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.

Abametapir
Acalabrutinib
Acecainide
Aceclofenac
Acemetacin
Acyclovir
Adagrasib
Adenosine
Ado-Trastuzumab Emtansine
Afatinib
Ajmaline
Alfentanil
Aluminum
Amikacin
Amikacin Liposome
Amineptine
Amiodarone
Amitriptylinoxide
Amoxapine
Amphetamine
Amprenavir
Amtolmetin Guacil
Apalutamide
Apixaban
Aprepitant
Aprindine
Aripiprazole
Aspirin
Atazanavir
Atogepant
Atorvastatin
Avacopan
Avanafil
Avapritinib
Bedaquiline
Benzhydrocodone
Benzphetamine
Berotralstat
Betamethasone
Betrixaban
Boceprevir
Bosentan
Bosutinib
Bretylium
Brigatinib
Bromfenac
Budesonide
Bufexamac
Buprenorphine
Buspirone
Cabazitaxel
Cabotegravir
Cabozantinib
Calcifediol
Calcium
Capreomycin
Cariprazine
Carvedilol
Celecoxib
Ceritinib
Choline Salicylate
Ciclesonide
Cidofovir
Cilostazol
Citalopram
Clarithromycin
Clomipramine
Clonixin
Clopidogrel
Clozapine
Cobicistat
Cobimetinib
Codeine
Copanlisib
Cyclophosphamide
Cyclosporine
Dabigatran Etexilate
Dabrafenib
Daclatasvir
Daridorexant
Dasatinib
Deflazacort
Delamanid
Delavirdine
Desipramine
Desogestrel
Dexamethasone
Dexibuprofen
Dexketoprofen
Dextroamphetamine
Diazepam
Dibenzepin
Diclofenac
Didanosine
Dienogest
Diflunisal
Digoxin
Dihydrocodeine
Diltiazem
Dipyrone
Disopyramide
Docetaxel
Dofetilide
Domperidone
Donepezil
Doxepin
Drospirenone
Droxicam
Duvelisib
Edoxaban
Efavirenz
Elacestrant
Elagolix
Elbasvir
Elexacaftor
Elvitegravir
Encainide
Encorafenib
Entrectinib
Erlotinib
Erythromycin
Escitalopram
Eslicarbazepine Acetate
Estazolam
Estradiol
Eszopiclone
Ethinyl Estradiol
Ethynodiol
Etodolac
Etofenamate
Etonogestrel
Etoricoxib
Etravirine
Everolimus
Fedratinib
Felbinac
Felodipine
Fenoprofen
Fentanyl
Fepradinol
Feprazone
Fesoterodine
Fexinidazole
Flecainide
Floctafenine
Fluconazole
Flufenamic Acid
Fluoxetine
Flurbiprofen
Fluticasone
Fluvastatin
Fluvoxamine
Fosamprenavir
Fosaprepitant
Fosnetupitant
Futibatinib
Ganciclovir
Gentamicin
Gestodene
Gilteritinib
Glasdegib
Grazoprevir
Haloperidol
Horsetail
Hydrocodone
Hydrocortisone
Hydroquinidine
Hydroxyamphetamine
Ibrexafungerp
Ibrutinib
Ibuprofen
Ibutilide
Idelalisib
Ifosfamide
Iloperidone
Imipramine
Indecainide
Indomethacin
Infigratinib
Irinotecan
Irinotecan Liposome
Iron
Isavuconazole
Istradefylline
Itraconazole
Ivacaftor
Ivosidenib
Ixabepilone
Kanamycin
Ketoconazole
Ketoprofen
Ketorolac
Lapatinib
Larotrectinib
Ledipasvir
Lefamulin
Lemborexant
Lenacapavir
Leniolisib
Lercanidipine
Levoketoconazole
Levomilnacipran
Levonorgestrel
Lidocaine
Lisdexamfetamine
Lofepramine
Lopinavir
Lorlatinib
Lornoxicam
Loxoprofen
Lumateperone
Lumiracoxib
Lurbinectedin
Macitentan
Magaldrate
Magnesium
Manidipine
Mavacamten
Meclofenamate
Medroxyprogesterone
Mefenamic Acid
Melitracen
Meloxicam
Meperidine
Mestranol
Methadone
Methamphetamine
Methylprednisolone
Metoprolol
Mexiletine
Midostaurin
Mifepristone
Mirtazapine
Mirvetuximab Soravtansine-gynx
Mitapivat
Mobocertinib
Mometasone
Moricizine
Morniflumate
Morphine
Morphine Sulfate Liposome
Nabumetone
Naproxen
Nebivolol
Neomycin
Nepafenac
Neratinib
Netilmicin
Netupitant
Nevirapine
Nifedipine
Niflumic Acid
Nilotinib
Nimesulide
Nimesulide Beta Cyclodextrin
Nimodipine
Nisoldipine
Nomegestrol
Norelgestromin
Norethindrone
Norgestimate
Norgestrel
Nortriptyline
Olanzapine
Olaparib
Omaveloxolone
Opipramol
Orlistat
Osilodrostat
Oxaprozin
Oxcarbazepine
Oxycodone
Oxyphenbutazone
Palbociclib
Palovarotene
Panobinostat
Parecoxib
Paromomycin
Paroxetine
Pemigatinib
Pentazocine
Perphenazine
Pexidartinib
Phenylbutazone
Piketoprofen
Pimavanserin
Piperaquine
Piroxicam
Pirtobrutinib
Pitavastatin
Pixantrone
Plazomicin
Ponatinib
Prajmaline
Pralsetinib
Pranoprofen
Pravastatin
Prednisone
Procainamide
Proglumetacin
Propafenone
Propyphenazone
Proquazone
Protriptyline
Quetiapine
Quinidine
Quizartinib
Reboxetine
Regorafenib
Relugolix
Retapamulin
Ribociclib
Rifabutin
Rifapentine
Rimegepant
Ritlecitinib
Ritonavir
Rivaroxaban
Rofecoxib
Rosuvastatin
Ruxolitinib
Salicylic Acid
Salmeterol
Salsalate
Saquinavir
Segesterone
Selpercatinib
Selumetinib
Sertraline
Simeprevir
Sirolimus
Sirolimus Protein-Bound
Sodium Salicylate
Sonidegib
Sparsentan
Sparteine
Spectinomycin
Streptomycin
Sucralfate
Sufentanil
Sulindac
Sunitinib
Suvorexant
Tacrolimus
Tadalafil
Tamsulosin
Tazemetostat
Tedisamil
Telithromycin
Temsirolimus
Tenofovir Alafenamide
Tenoxicam
Tezacaftor
Thiotepa
Tianeptine
Tiaprofenic Acid
Ticagrelor
Timolol
Tipranavir
Tobramycin
Tocainide
Tocilizumab
Tolfenamic Acid
Tolmetin
Topotecan
Toremifene
Trabectedin
Tramadol
Trazodone
Triamcinolone
Trimipramine
Ulipristal
Upadacitinib
Valacyclovir
Valbenazine
Valdecoxib
Valganciclovir
Vardenafil
Vemurafenib
Venlafaxine
Verapamil
Vernakalant
Vilanterol
Vilazodone
Vinblastine
Vincristine
Vincristine Sulfate Liposome
Vinflunine
Vorapaxar
Voriconazole
Vortioxetine
Warfarin
Zaleplon
Zanubrutinib
Zinc
Ziprasidone
Zolpidem
Zuranolone

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.

Amlodipine
Aripiprazole Lauroxil
Atazanavir
Darunavir
Indinavir
Lopinavir
Nelfinavir
Nirmatrelvir
Ritonavir
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 antacids or laxatives containing aluminum, calcium, or magnesium, sucralfate, calcium or iron supplements, or buffered medicines, take them at least 2 hours before or after taking Stribild®. These medicines may keep Stribild® from working properly.

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 and children 12 years of age and older and weighs at least 35 kilograms (kg)—One tablet once a day.
  - Children younger than 12 years of age or weighs less than 35 kg—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 or your child's 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.

The medicines in this combination tablet are also available as Atripla®, Complera®, Descovy®, Emtriva®, Genvoya®, Odefsey®, Truvada®, Tybost®, Viread®, or Vitekta®. 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®), carbamazepine (Tegretol®), lamivudine (Combivir®, Epivir®, Epivir-HBV®, Epzicom®, Triumeq®, Trizivir®), lovastatin (Mevacor®), lurasidone (Latuda®), midazolam (Versed®), phenobarbital (Luminal®), phenytoin (Dilantin®), pimozide (Orap®), rifampin (Rifadin®, Rimactane®), ritonavir (Kaletra®, Norvir®), sildenafil (Revatio®), simvastatin (Zocor®), triazolam (Halcion®), St John's wort, ergotamine medicines (eg, dihydroergotamine, ergotamine, methylergonovine, Cafergot®, Ergomar®, Wigraine®), other antiviral medications (eg, 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 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 or your child 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.

Your immune system may get stronger when you start taking HIV medicines. Tell your doctor right away if you or your child 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 (eg, Graves' disease, polymyositis, autoimmune hepatitis, and Guillain-Barré syndrome) may also occur.

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

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: Bloody urine; bone fractures; bone pain; change in urination; chest tightness; chills; constipation; cough; dark-colored urine; decreased appetite; difficulty with swallowing; dizziness; dry mouth; fast or irregular heartbeat; fast, shallow breathing; fever; general feeling of discomfort; increased thirst; indigestion; large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs; light-colored stools; loss of appetite; lower back or side pain; mood changes; muscle pain, cramps, or stiffness; nausea, vomiting or diarrhea; numbness or tingling in the hands, feet, or lips; pains in the stomach, side, or abdomen, possibly radiating to the back; puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue; seizures; skin rash, hives, itching; sleepiness; stomach pain; swelling of the face, fingers, or lower legs; 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

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: 11/16/2023

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