Darunavir, Cobicistat, Emtricitabine, And Tenofovir Alafenamide (Oral Route) Description and Brand Names

Description and Brand Names

Drug information provided by: Merative, Micromedex®

US Brand Name

Symtuza

Descriptions

Darunavir, cobicistat, emtricitabine, and tenofovir alafenamide 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 patients who have yet not received any medicine for HIV infection.

Darunavir, cobicistat, emtricitabine, and tenofovir alafenamide 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.

This product is available in the following dosage forms:

Tablet

Before Using

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.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of darunavir, cobicistat, emtricitabine, and tenofovir alafenamide combination in children weighing at least 40 kilograms (kg). Safety and efficacy have not been established in children weighing less than 40 kg.

Geriatric

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

Breastfeeding

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.

Drug Interactions

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
Astemizole
Bromocriptine
Carbamazepine
Cisapride
Colchicine
Conivaptan
Crizotinib
Dihydroergotamine
Domperidone
Doxorubicin
Doxorubicin Hydrochloride Liposome
Dronedarone
Drospirenone
Elbasvir
Eletriptan
Eliglustat
Eplerenone
Ergoloid Mesylates
Ergonovine
Ergotamine
Finerenone
Fosphenytoin
Gepirone
Grazoprevir
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
Terfenadine
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
Acebutolol
Acecainide
Aceclofenac
Acemetacin
Acyclovir
Adagrasib
Adenosine
Ado-Trastuzumab Emtansine
Afatinib
Ajmaline
Alfentanil
Alprazolam
Amikacin
Amikacin Liposome
Amineptine
Amiodarone
Amitriptyline
Amitriptylinoxide
Amlodipine
Amobarbital
Amoxapine
Amphetamine
Amprenavir
Amtolmetin Guacil
Apalutamide
Apixaban
Aprepitant
Aprindine
Aprobarbital
Aranidipine
Aripiprazole
Artemether
Asciminib
Aspirin
Atazanavir
Atenolol
Atogepant
Atorvastatin
Avacopan
Avanafil
Avapritinib
Bedaquiline
Benzhydrocodone
Benzphetamine
Berotralstat
Betamethasone
Betaxolol
Betrixaban
Bisoprolol
Boceprevir
Bosentan
Bosutinib
Bretylium
Brigatinib
Bromfenac
Budesonide
Bufexamac
Buprenorphine
Buspirone
Butabarbital
Butalbital
Cabazitaxel
Cabotegravir
Cabozantinib
Calcifediol
Capivasertib
Capmatinib
Capreomycin
Cariprazine
Carteolol
Carvedilol
Celecoxib
Celiprolol
Ceritinib
Choline Salicylate
Ciclesonide
Cidofovir
Cilnidipine
Cilostazol
Citalopram
Clarithromycin
Clevidipine
Clomipramine
Clonazepam
Clonixin
Clopidogrel
Clozapine
Cobicistat
Cobimetinib
Codeine
Conivaptan
Copanlisib
Crizotinib
Cyclophosphamide
Cyclosporine
Dabigatran Etexilate
Dabrafenib
Daclatasvir
Daridorexant
Darolutamide
Dasabuvir
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
Doxorubicin
Doxorubicin Hydrochloride Liposome
Dronedarone
Drospirenone
Droxicam
Duvelisib
Edoxaban
Efavirenz
Elacestrant
Elagolix
Elbasvir
Elexacaftor
Eltrombopag
Elvitegravir
Enasidenib
Encainide
Encorafenib
Entrectinib
Erdafitinib
Erlotinib
Erythromycin
Escitalopram
Eslicarbazepine Acetate
Esmolol
Estazolam
Estetrol
Estradiol
Eszopiclone
Ethinyl Estradiol
Ethynodiol
Etodolac
Etofenamate
Etonogestrel
Etoricoxib
Etravirine
Everolimus
Fedratinib
Felbinac
Felodipine
Fenoprofen
Fentanyl
Fepradinol
Feprazone
Fesoterodine
Fexinidazole
Finerenone
Flecainide
Flibanserin
Floctafenine
Fluconazole
Flufenamic Acid
Fluoxetine
Flurbiprofen
Fluticasone
Fluvastatin
Fluvoxamine
Fosamprenavir
Fosaprepitant
Fosnetupitant
Futibatinib
Ganciclovir
Gentamicin
Gepirone
Gestodene
Gilteritinib
Glasdegib
Glecaprevir
Grazoprevir
Haloperidol
Horsetail
Hydrocodone
Hydrocortisone
Hydroquinidine
Hydroxyamphetamine
Ibrexafungerp
Ibrutinib
Ibuprofen
Ibutilide
Idelalisib
Ifosfamide
Iloperidone
Imipramine
Indecainide
Indinavir
Indomethacin
Infigratinib
Irinotecan
Irinotecan Liposome
Isavuconazole
Isradipine
Istradefylline
Itraconazole
Ivacaftor
Ivosidenib
Ixabepilone
Kanamycin
Ketoconazole
Ketoprofen
Ketorolac
Labetalol
Lapatinib
Larotrectinib
Lefamulin
Leflunomide
Lemborexant
Lenacapavir
Leniolisib
Lercanidipine
Levobunolol
Levoketoconazole
Levomilnacipran
Levonorgestrel
Lidocaine
Lisdexamfetamine
Lofepramine
Lopinavir
Lorlatinib
Lornoxicam
Lovotibeglogene Autotemcel
Loxoprofen
Lumacaftor
Lumateperone
Lumefantrine
Lumiracoxib
Lurbinectedin
Macitentan
Manidipine
Mavacamten
Meclofenamate
Medroxyprogesterone
Mefenamic Acid
Melitracen
Meloxicam
Meperidine
Mephobarbital
Mestranol
Methadone
Methamphetamine
Methohexital
Methotrexate
Methylprednisolone
Metipranolol
Metoprolol
Mexiletine
Midostaurin
Mifepristone
Mirtazapine
Mirvetuximab Soravtansine-gynx
Mitapivat
Mobocertinib
Modafinil
Momelotinib
Mometasone
Moricizine
Morniflumate
Morphine
Morphine Sulfate Liposome
Nabumetone
Nadolol
Nafcillin
Naproxen
Nebivolol
Nelfinavir
Neomycin
Nepafenac
Neratinib
Netilmicin
Netupitant
Nevirapine
Nicardipine
Nifedipine
Niflumic Acid
Nilotinib
Nimesulide
Nimesulide Beta Cyclodextrin
Nimodipine
Nirogacestat
Nisoldipine
Nitrendipine
Nomegestrol
Norelgestromin
Norethindrone
Norgestimate
Norgestrel
Nortriptyline
Olanzapine
Olaparib
Oliceridine
Olutasidenib
Omaveloxolone
Ombitasvir
Omeprazole
Ondansetron
Opipramol
Orlistat
Osilodrostat
Oxaprozin
Oxcarbazepine
Oxprenolol
Oxycodone
Oxyphenbutazone
Pacritinib
Palbociclib
Palovarotene
Panobinostat
Parecoxib
Paritaprevir
Paromomycin
Paroxetine
Pemigatinib
Penbutolol
Pentazocine
Pentobarbital
Perphenazine
Pexidartinib
Phenylbutazone
Pibrentasvir
Piketoprofen
Pimavanserin
Pindolol
Piperaquine
Piroxicam
Pirtobrutinib
Pitavastatin
Pixantrone
Plazomicin
Ponatinib
Prajmaline
Pralsetinib
Pranoprofen
Pravastatin
Prednisone
Procainamide
Proglumetacin
Propafenone
Propranolol
Propyphenazone
Proquazone
Protriptyline
Quetiapine
Quinidine
Quizartinib
Ranolazine
Reboxetine
Regorafenib
Relugolix
Repotrectinib
Retapamulin
Ribociclib
Rifabutin
Rifapentine
Rimegepant
Risperidone
Ritlecitinib
Ritonavir
Rivaroxaban
Rofecoxib
Roflumilast
Rosuvastatin
Ruxolitinib
Salicylic Acid
Salmeterol
Salsalate
Saquinavir
Secobarbital
Segesterone
Selpercatinib
Selumetinib
Sertraline
Simeprevir
Sirolimus
Sirolimus Protein-Bound
Sodium Salicylate
Sonidegib
Sotalol
Sparsentan
Sparteine
Spectinomycin
Streptomycin
Sufentanil
Sulindac
Sunitinib
Suvorexant
Tacrolimus
Tadalafil
Tafamidis
Tamoxifen
Tamsulosin
Tazemetostat
Tedisamil
Telaprevir
Telithromycin
Temsirolimus
Tenofovir Alafenamide
Tenoxicam
Teriflunomide
Tezacaftor
Thiopental
Thioridazine
Thiotepa
Tianeptine
Tiaprofenic Acid
Ticagrelor
Timolol
Tipranavir
Tobramycin
Tocainide
Tolfenamic Acid
Tolmetin
Topotecan
Toremifene
Trabectedin
Tramadol
Trazodone
Triamcinolone
Trimipramine
Trofinetide
Ulipristal
Upadacitinib
Valacyclovir
Valbenazine
Valdecoxib
Valganciclovir
Vamorolone
Vardenafil
Vemurafenib
Venlafaxine
Verapamil
Vernakalant
Vilanterol
Vilazodone
Vinblastine
Vincristine
Vincristine Sulfate Liposome
Vinflunine
Vorapaxar
Voriconazole
Vortioxetine
Warfarin
Zaleplon
Zanubrutinib
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
Cobicistat
Darunavir
Indinavir
Nelfinavir
Tenofovir Disoproxil Fumarate

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.

Proper Use

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.

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.

Take this medicine with food.

If you cannot swallow the tablet whole, you may cut it into two using a tablet cutter. Take both halves of the tablet right away.

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 weighing at least 40 kilograms (kg)—1 tablet once a day with food. Each tablet contains 800 milligrams (mg) of darunavir, 150 mg of cobicistat, 200 mg of emtricitabine, and 10 mg of tenofovir alafenamide.
  - Children weighing less than 40 kilograms—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.

Precautions

It is very important that your doctor check your progress at regular visits, especially during the first few weeks that you take this medicine, to make sure this medicine is working properly. Blood and urine tests may be needed to check for any unwanted effects.

This medicine should not be used together with alfuzosin (Uroxatral®), carbamazepine (Tegretol®), dronedarone (Multaq®), elbasvir/grazoprevir (Zepatier®), ivabradine (Corlaonor®), lomitapide (Juxtapid®), lovastatin (Mevacor®), lurasidone (Latuda®), midazolam (Versed®), naloxegol (Movantik®, Moventig®), phenobarbital (Luminal®), phenytoin (Dilantin®), pimozide (Orap®), ranolazine (Ranexa®), rifampin (Rifadin®, Rimactane®), sildenafil (Revatio®), simvastatin (Zocor®), St. John's wort, triazolam (Halcion®), or ergot medicines (eg, dihydroergotamine, ergotamine, methylergonovine, Cafergot®, Ergomar®, Wigraine®). Do not use this medicine together with colchicine (Colcrys®) if you have kidney or liver disease.

Using this medicine while you are pregnant can harm your unborn baby. Birth control pills may not work as well to prevent pregnancy when used with this medicine. Use another form of birth control (eg, condoms, spermicide) along with your pills to keep from getting pregnant during treatment with this medicine. If you think you have become pregnant while using this medicine, tell your doctor right away.

Serious skin reactions (eg, Stevens-Johnson syndrome) can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions, often with a purple center, skin rash, sore throat, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness.

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 (eg, Graves' disease, polymyositis, and Guillain-Barré syndrome) may also occur.

A decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.

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 nausea, vomiting, decreased appetite, muscle cramping or pain, stomach pain, unusual tiredness or weakness, trouble breathing, or yellow skin or eyes.

This medicine may increase blood sugar levels. Check with your doctor if you notice a change in the results of your blood or urine sugar tests.

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.

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 (eg, St John's wort) or vitamin supplements.

Side Effects

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

Rash

Less Common

Blistering, peeling, or loosening of the skin
bloating
blurred vision
chills
constipation
cough
dark urine
diarrhea
dry mouth
fast heartbeat
fever
flushed, dry skin
fruit-like breath odor
general tiredness and weakness
heavy jaw feeling
increased hunger
increased thirst
increased urination
indigestion
itching
joint or muscle pain
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
light-colored stools
loosening of a tooth
loss of appetite
loss of consciousness
nausea
pain, swelling, or numbness in the mouth or jaw
pains in the stomach, side, or abdomen, possibly radiating to the back
red skin lesions, often with a purple center
red, irritated eyes
sore throat
sores, ulcers, or white spots in the mouth or on the lips
stomachache
sweating
trouble breathing
unexplained weight loss
unusual tiredness or weakness
upper right abdominal or stomach pain
vomiting
yellow eyes or skin

Incidence not known

Lower back pain
muscle cramps, spasms, or stiffness
pain or burning while urinating
sudden decrease in amount of urine

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:

Less common

Abnormal dreams
belching
difficulty in moving
excess air or gas in the stomach or bowels
headache
heartburn
passing gas
redistribution or accumulation of body fat
stomach discomfort, upset, or pain
swelling of the breasts or breast soreness in both females and males
swollen joints
weight loss

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.

Portions of this document last updated: April 01, 2024

Original article: https://www.mayoclinic.org/drugs-supplements/darunavir-cobicistat-emtricitabine-and-tenofovir-alafenamide-oral-route/description/drg-20443835

Darunavir, Cobicistat, Emtricitabine, And Tenofovir Alafenamide (Oral Route)