Hepatitis B virus infection should not be treated with darunavir, cobicistat, emtricitabine, or tenofovir (HBV; an ongoing liver infection). If you have HBV or believe you might have it, let your doctor know. Before beginning and throughout your treatment with darunavir, cobicistat, emtricitabine, and tenofovir, your physician may perform tests to determine whether you have HBV. Your condition could abruptly get worse if you stop taking darunavir, cobicistat, emtricitabine, and tenofovir if you have HBV. Once you stop using this medicine, your doctor will check on you frequently to see if your HBV has gotten worse while also ordering lab testing.

Keep all of your appointments with your physician and the lab. To monitor your body’s reaction to darunavir, cobicistat, emtricitabine, and tenofovir, your doctor will prescribe specific tests both before and during your therapy.

The dangers of using darunavir, cobicistat, emtricitabine, and tenofovir should be discussed with your doctor.

When no other HIV medications have been used to treat the human immunodeficiency virus (HIV) infection in adults or children weighing at least 88 pounds (40 kg), the combination of darunavir, cobicistat, emtricitabine, and tenofovir is used. It may also be used to replace the current HIV medication therapy in some patients already taking HIV medications. The antiviral drug class includes drugs including darunavir, cobicistat, emtricitabine, and tenofovir. Emtricitabine, tenofovir, and darunavir all act by lowering the level of HIV in the blood. Darunavir is kept in the body for a longer period of time thanks to cobicistat, which increases the medication’s effectiveness. The combination of darunavir, cobicistat, emtricitabine, and tenofovir won’t be able to treat HIV, but it may lower your risk of getting AIDS and other HIV-related conditions including serious infections or cancer. The risk of spreading the HIV virus to others may be reduced by taking these medications, engaging in safer sexual behaviour, and changing other aspects of one’s lifestyle.

Darunavir, cobicistat, emtricitabine, and tenofovir are all available as oral tablets. Once a day, it is often taken with food. At about the same time each day, take darunavir, cobicistat, emtricitabine, and tenofovir. Ask your doctor or chemist to explain any instructions on your prescription label that you are unsure about following. Follow the directions on the label for darunavir, cobicistat, emtricitabine, and tenofovir. Never take it in larger or less amounts or more frequently than directed by your doctor.

You can cut the tablets in half using a tablet-cutter if you have problems eating them whole. Take the divided tablets as soon as you’ve done so. Do not keep them for a later time.

Darunavir, cobicistat, emtricitabine, and tenofovir are used in combination to control HIV infection but not to treat it. Even if you feel good, keep taking darunavir, cobicistat, emtricitabine, and tenofovir. Without consulting your doctor, do not discontinue taking darunavir, cobicistat, emtricitabine, or tenofovir.

For a copy of the manufacturer’s information for the patient, ask your chemist or doctor.

Ask your doctor or chemist for more details if you believe this drug should be used for something else.

Before taking darunavir, cobicistat, emtricitabine, and tenofovir,

• If you have an allergy to any of the substances in darunavir, cobicistat, emtricitabine, or tenofovir tablets, any other drugs, sulfa medications, or any of the above, inform your doctor and chemist right away. Get a list of the ingredients from your chemist.
• If you are taking any of the following medications, let your doctor know: colchicine (Colcyrs, Mitigare) in patients with renal or liver illness; alfuzosin (Uroxatral); carbamazepine (Carbatrol, Epitol, Tegretol, among others); cisapride (Propulsid) (not available in the United States); ergot medicines such as dihydroergotamine (D.H.E. 45, Migranal), ergotamine (Ergomar, in Cafergot, in Migergot), and methylergonovine (Methergine); dronedarone (Multaq); elbasvir and grazoprevir (Zepatier); midazolam used orally, naloxegol (Movantik), lomitapide (Juxtapid), lovastatin (Altoprev), lurasidone (Latuda), and phenobarbital; rifampin (Rifadin, Rimactane, in Rifamate, in Rifater), phenytoin (Dilantin, Phenytek), pimozide (Orap), ranolazine (Ranexa), sildenafil (only Revatio, brand used for lung disease); St. John’s wort; triazolam; or simvastatin (Simcor, Zocor, and Vytorin) (Halcion). If you are taking one or more of these drugs, your doctor will probably advise you not to take darunavir, cobicistat, emtricitabine, and tenofovir.
• Inform your doctor and chemist about any additional prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products you are now taking or intend to use. Incorporate any of the following: antibiotics known as aminoglycosides, such as gentamicin; acyclovir (Sitavig, Zovirax), cidofovir, ganciclovir (Cytovene, Valcyte), valacyclovir (Valtrex), and valganciclovir (Valcyte); antifungal medications such as isavuconazonium (Cresemba), itraconazole (Onmel, Sporanox), ketoconazole, and voriconazole (Vfend); medications such erythromycin (E.E.S., Eryc, Ery-Tab), telithromycin (no longer available in the US, Ketek), and clarithromycin (Biaxin, in PrevPac); aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn), apixaban (Eliquis), artemether, and lumefantrine (Coartem); benzodiazepines, including zolpidem (Ambien, Zolpmist), diazepam (Valium, Diastat), estazolam, flurazepam, and midazolam administered intravenously; beta blockers such as bosentan (Tracleer), metoprolol (Lopressor, Toprol-XL, in Dutoprol), and timolol; buprenorphine (Belbuca, Buprenex, and others); buprenorphine and naloxone (Bunavail, Suboxone); buspirone; calcium channel blockers such verapamil (Calan, Verelan, in Tarka), amlodipine (Norvasc), diltiazem (Cardizem, Diltzac, Tiazac, and others), felodipine, and nifedipine (Adalat CC, Afeditab CR, Procardia); atorvastatin (Lipitor, in Caduet), fluvastatin (Lescol), pitavastatin (Livalo), pravastatin (Pravachol), and rosuvastatin (Crestor) are examples of cholesterol-lowering drugs (statins); dasatinib (Sprycel) is a drug that lowers cholesterol; amitriptyline, desipramine (Norpramin), imipramine (Tofranil), nortriptyline (Pamelor), paroxetine (Brisdelle, Paxil, Pexeva), sertraline (Zoloft), and trazodone are examples of antidepressant drugs; fentanyl (Duragesic, Subsys), digoxin (Lanoxin), eslicarbazepine (Aptiom), everolimus (Afinitor, Zortress), fesoterodine (Toviaz), and irinotecan (Camptosar); amiodarone (Nexterone, Pacerone), disopyramide (Norpace), flecainide, lidocaine (Xylocaine), mexiletine, propafenone (Rythmol), and quinidine (in Nuedexta) are some examples of drugs for irregular heartbeat; methadone (Methadose), nilotinib (Tasigna), oral contraceptives (often known as “birth control pills”), immune system suppressing drugs such cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Prograf); phosphodiesterase (PDE5) inhibitors such avanafil (Stendra), oxycarbazepine (Trileptal), oxycodone (Xtampza, in Percodan), perphenazine, quetiapine (Seroquel), and avanafil (Stendra); rifabutin (Mycobutin); rifapentine (Priftin); risperidone (Risperdal); rivaroxaban (Xarelto); salmeterol (Serevent, in Advair); sildenafil (Viagra), tadalafil (Adcirca, Cialis), and vardenafil (Levitra, Staxyn); thioridazine; ticagrelor (Brilinta); tramadol (Conzip, Ultram); vinblastine; vincristine; warfarin; and simeprevir (Olysio; no longer available in the US). Other medications include solifenacin (Vesicare), simeprevir (Olysio; no longer available in the US), simeprevir, budesonide (Pulmicort) (Coumadin, Jantoven). Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects. Darunavir, cobicistat, emtricitabine, and tenofovir may interact with a variety of other drugs. As a result, it is important to inform your doctor about all the drugs you are taking, even ones that are not on this list.
• Inform your doctor if you have or have ever had any of the conditions listed in the IMPORTANT WARNING section, any infection that persists or flares up, such as TB (a lung infection) or CMV (a virus that can cause symptoms in people with weakened immune systems), diabetes, haemophilia (a condition where the blood does not clot normally), liver disease, or kidney disease.
• If you are pregnant or plan to become pregnant, let your doctor know. Call your doctor right away if you become pregnant while taking darunavir, cobicistat, emtricitabine, or tenofovir.
• If you are breastfeeding, let your doctor know. If you have HIV or are taking tenofovir, cobicistat, darunavir, or emtricitabine, you shouldn’t breastfeed.
• You need to be aware that your body fat may expand or shift to several regions, including your upper back, neck (the “buffalo hump”), breasts, and the area surrounding your abdomen. Your face, legs, and arms may show a reduction of body fat.
• You should be aware that while you use medications to treat your HIV infection, your immune system could become more powerful and start to combat other infections that were previously present in your body. You could become ill with those infections as a result of this. Tell your doctor right away if you experience any new or worsening symptoms while taking darunavir, cobicistat, emtricitabine, or tenofovir.

Keep eating normally unless your doctor instructs you otherwise.

If you miss a dosage, take it as soon as you recall. If the next dose is soon due, skip the missed one and carry on with your regular dosing plan. To make up for a missing dose, do not take a second one.

There may be negative effects from darunavir, cobicistat, emtricitabine, and tenofovir. If any of these symptoms are severe or do not go away, let your doctor know right once:

• Diarrhea
• Headache
• Digestive discomfort
• Gas

Some adverse effects may be severe. Call your doctor right away or seek emergency medical care if you encounter any of the signs or symptoms detailed in the sections titled “IMPORTANT WARNING” or “SPECIAL PRECAUTIONS”:

• Light-colored stools, right upper stomach pain, loss of appetite, nausea, vomiting, dark yellow or brown urine, yellow skin or eyes, or light-colored bowel movements
• Either more or less urination
• Weakness, discomfort in the muscles, shortness of breath, rapid breathing, stomach pain accompanied by nausea and vomiting, blue hands and feet, lightheadedness, vertigo, or a rapid or irregular heartbeat
• Infection symptoms such as a sore throat, fever, chills, cough, and others
• Severe rash or rash accompanied by at least one of the following symptoms: fever, aches in the muscles or joints, red or watery eyes, blisters or skin that is starting to peel off, mouth sores, or swelling of the face or neck

Further negative effects could be brought on by darunavir, cobicistat, emtricitabine, and tenofovir. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

Keep this medication tightly closed in the original container and out of the reach of children. Keep it away from excessive heat and moisture at room temperature (not in the bathroom). The desiccant (drying agent) pouches should not be taken out of the container.

Although many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning. http://www.upandaway.org

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your chemist or the garbage/recycling agency in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medications website at http://goo.gl/c4Rm4p for additional information.

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Moreover, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

Darunavir, cobicistat, emtricitabine, and tenofovir should always be available. Do not put off getting a refill on your prescription until you are out of medicine.

No one else should take your medication. Any queries you may have regarding prescription refills should be directed to your chemist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.