Human immunodeficiency virus (HIV) infection is treated with the drug combination of darunavir and cobicistat in patients who weigh at least 88 lb in adults and children (40 kg). Protease inhibitors, which include darunavir, are a group of drugs. HIV levels in the blood are lowered as a result of its action. Pharmacokinetic boosters are a group of drugs that includes cobicistat. In order for darunavir to have a stronger impact, it increases its body-wide concentration. Darunavir does not treat HIV, but it may lessen your risk of getting cancer, severe infections, and AIDS, which are all conditions linked to HIV. 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.

The oral tablet form of darunavir with cobicistat is available. Typically, it is taken once daily with food. Every day, take cobicistat and darunavir about the same time. Ask your doctor or chemist to explain any instructions on your prescription label that you do not understand, and carefully follow their instructions. Just as prescribed, use cobicistat and darunavir. Never take it in quantities or frequencies other than those recommended by your doctor.

HIV is not cured but is controlled by darunavir and cobicistat. HIV infection cannot be treated with darunavir and cobicistat alone; they must always be administered as a whole regimen. In order for the meds to continue to function to manage the infection, it is crucial that you take all of the prescription drugs your doctor has prescribed to treat your HIV infection at the same time. Even if you feel well, keep taking cobicistat and darunavir. Without consulting your doctor, don’t stop taking cobicistat with darunavir.

For a copy of the manufacturer’s information for the patient, ask your chemist or doctor. If you have any questions, make sure you carefully read this information and ask your doctor or chemist.

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

Before taking darunavir and cobicistat,

• If you have any allergies to medications, including darunavir, cobicistat, sulfa drugs, other drugs, or any of the chemicals in darunavir and cobicistat tablets, let your doctor and chemist know right once. If you are unsure whether a drug you are allergic to is a sulfa drug or would want a list of the ingredients, ask your chemist.
• Inform your doctor if you are using any of the following drugs or natural remedies: Alfuzosin (Uroxatral), Dronedarone (Multaq), Elbasvir and Grazoprevir (Zepatier), ergot alkaloids such methylergonovine (Methergine), ergonovine, and ergotamine (Ergomar, in Cafergot, in Migergot); a few drugs used to treat high cholesterol, such as lomitapide (Juxtapid), lovastatin (Mevacor), and simvastatin (Zocor); lurasidone (Latuda); midazolam used orally; naloxegol (Movantik); rifampin (Rimactane, Rifadin, in Rifater, in Rifamate), pimozide (Orap), ranolazine (Ranexa), include phenobarbital, phenytoin, and carbamazepine (Carbatrol, Epitol, Equetro, Tegretol, Tegretol XR), as well as several drugs used to treat seizures; only the Revatio brand of sildenafil is used to treat pulmonary conditions, together with triazolam and St. John’s wort (Halcion). If you are taking any of these medications, your doctor generally won’t recommend that you take darunavir.
• Inform your doctor and chemist about any additional prescription and over-the-counter drugs, vitamins, herbal remedies, and dietary supplements you are now taking or intend to take. Incorporate any of the following: a few medicines, including erythromycin, telithromycin, and clarithromycin (Biaxin, Erythro, and Ketek); anticancer medications like vinblastine, vincristine, irinotecan (Camptosar), dasatinib (Sprycel), and nilotinib (Tasigna); a few anticoagulants (often referred to as “blood thinners”), including apixaban (Eliquis), betrixaban (Bevyxxa), dabigatran (Pradaxa), edoxaban (Savaysa), rivaroxaban (Xarelto), and warfarin (Coumadin, Jantoven); amitriptyline, desipramine (Norpramin), imipramine (Tofranil, Surmontil), nortriptyline (Avently, Pamelor), paroxetine (Paxil), sertraline (Zoloft), and trazodone are examples of antidepressants (sometimes known as “mood lifters”); a number of antifungal medications, including isavuconazonium sulphate (Cresemba), itraconazole (Onmel, Sporanox), ketoconazole (Extina, Nizoral, Xolegel), posaconazole (Noxafil), and voriconazole (Vfend); drug that prevents blood clots from forming, such as ticagrelor (Brilinta) and clopidogrel (Plavix); such as amiodarone (Cordarone), disopyramide (Norpace, Norpace CR), flecainide (Tambocor), lidocaine, mexiletine (Mexitil), propafenone (Rythmol, Rythmol SR), and quinidine; bosentan (Tracleer); beta blockers like carvedilol (Coreg), metoprolol (Lopressor), and timolol (Blocarden); artemether/lumefantrine (Coartem); calcium channel blockers such verapamil (Calan, Verelan, in Tarka, etc.), amlodipine (Norvasc), diltiazem (Cardizem, Cartia, Tiazac, etc.), felodipine (Plendil), and nifedipine (Adalat, Afeditab, Procardia); a few statins, or drugs that decrease cholesterol, include atorvastatin (Lipitor, in Caduet), fluvastatin (Lescol, Lescol XL), pravastatin (Pravachol), and rosuvastatin (Crestor); corticosteroids such methylprednisolone, mometasone (Asmanex HFA, Asmanex Twisthaler, Nasacort, in Dulera), ciclesonide (Alevsco), budesonide (Entocort EC), dexamethasone (Flovent, Flonase, in Advair, Breo Ellipta, Trelegy Ellipta), fluticasone; glecaprevir and pibrentasvir (Mavyret); drosperinone (in Beyaz, Gianvi, Loryna, Ocella, Safyral, Syeda, Yasmin, and Yaz); fesoterodine (in Toviaz); cyclosporine (Gengraf, Neoral, Sandimmune), everolimus (Afinitor, Zortress), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf) are immune system suppressing drugs; efavirenz (Sustiva, in Atripla), etravirine (Intelence), maraviroc (Selzentry), nevirapine (Viramune), and ritonavir (Norvir, in Kaletra, in Viekira Pak) are other drugs used to treat HIV infection; some painkillers such buprenorphine (Belbuca, Butrans, in Suboxone, Subutex), fentanyl (Actiq, Duragesic, Lazanda, Subsys), and methadone (Dolophine, Methadone), oxycodone (Dazidox, Endocodone, ETH-Oxydose, Oxaydo, Oxecta, Oxycontin, Oxyfast, OxyIR, Percolone, Roxicodone, Xtampza ER, in Combunox, Endocet, Endodan, Lynox), and tramadol (Conzip, Qdolo, Rybix ODT, Ryzolt, Ultram; a few phosphodiesterase inhibitors (PDE-5 inhibitors) used to treat erectile dysfunction, such as avanafil (Stendra), tadalafil (Cialis), and vardenafil (Levitra, Staxyn); quetiapine (Seroquel); rifabutin (Mycobutin); and risperidone (Risperdal); salmeterol (Serevent, included in Advair); a number of sedatives, including buspirone (Buspar), diazepam (Valium), estazolam (Eurodin, ProSom), and zolpidem (Ambien); a number of drugs used to treat seizures, including solifenacin, eslicarbazepine (Aptiom), clonazepam (Klonopin), and oxcarbazepine (Oxtellar XR, Trileptal) (Vesicare). The dosage of your drugs may need to be adjusted, and your health may need to be closely watched for any negative effects. Darunavir may interact with a variety of other drugs, so be careful to inform your doctor about all the drugs you are taking, even those not on this list.
• Darunavir and cobicistat should be taken two hours before or one hour after didanosine delayed-release capsules (Videx EC).
• Inform your physician if you currently have or previously had kidney disease, hepatitis or any other liver disease, diabetes or high blood sugar, haemophilia (a condition in which the blood does not clot normally), or any other bleeding disorder.
• Inform your doctor if you are expecting a child or if you intend to do so. Call your physician if you conceive while taking cobicistat and darunavir. If you have HIV and are on darunavir and cobicistat, you should not breastfeed.
• You should be aware that hormonal contraceptives may not work as well when using darunavir and cobicistat (birth control pills, patches, rings, implants, and injections). Discuss birth control options with your doctor to ensure that they will be effective for you while you are on cobicistat and darunavir.
• Inform the surgeon or dentist that you are taking cobicistat and darunavir if you are having surgery, including dental surgery.
• You should be aware that even if you do not currently have diabetes, you could develop hyperglycemia (increases in blood sugar) while taking this drug. If you have any of the following symptoms while taking darunavir with cobicistat: intense thirst, frequent urination, intense hunger, blurred vision, or weakness, call your doctor right once. Because untreated high blood sugar can result in the deadly disease known as ketoacidosis, it is crucial that you contact your doctor as soon as you experience any of these symptoms. If ketoacidosis is not treated at an early stage, it could turn fatal. Ketoacidosis symptoms include dry mouth, nausea, vomiting, shortness of breath, a fruity odour to the breath, and a loss of consciousness.
• You should be aware that when you take HIV medicine, your immune system could become stronger and start to fight other infections that were already present in your body. You might begin to exhibit signs of those infections as a result of this. Tell your doctor right once if you experience any new or worsening symptoms while receiving darunavir and cobicistat medication.
• You should be aware that your body fat can change or accumulate in several places, including your breasts, upper back, neck, chest, and abdomen. It is also possible to lose fat from the face, arms, and legs.

If you plan to consume grapefruits or grapefruit juice while taking this medication, consult your doctor.

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.

Cobicistat with darunavir may have negative side effects. If any of these symptoms are severe or do not go away, let your doctor know right once:

• Headache
• Diarrhea
• Vomiting
• Nausea
• Rash
• Abdomen ache

Some adverse effects may be severe. Call your doctor right away or seek emergency medical attention if you have any of the following symptoms:

• Yellowing of the eyes or skin (especially in newborn infants)
• Aches in the low back or abdomen
• Difficulty urinating
• Urinary blood
• Vomiting
• Reduced appetite
• Less urinations
• Urine with a dark colour
• Colored-light bowel motions

Stop taking darunavir and cobicistat, call your doctor right away, or seek emergency medical attention if any of the following symptoms appear together with a severe rash:

• Widespread malaise or symptoms resembling the flu
• Fever
• An aching muscle or joint
• Eye swelling or redness
• Flaking or blistering skin
• Oral sores
• Your face or neck swelling
• Sore, warm, or colourful bump on your body

Cobicistat with darunavir may also have other adverse effects. 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).

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.

Keep all of your appointments with your physician and the lab. To determine how well your body is responding to cobicistat and darunavir, your doctor may or may not prescribe certain lab tests.

Cobicistat and darunavir 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.