Cobicistat (koe-BIK-i-stat), Darunavir (dar-UE-na-vir)

Treats HIV infection. HIV causes AIDS. This medicine does not cure HIV or AIDS, but combinations of drugs may slow the progress of the disease.

Brand Name(s):

Prezcobix

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• It is best to take this medicine with food or milk.
• Do not stop using this medicine without checking first with your doctor. If you stop the medicine even briefly, the virus may become harder to treat. Contact your doctor or pharmacist when your supply is running low so you do not run out.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• You must avoid many other medicines while you are using darunavir/cobicistat. These medicines used together could cause serious health problems, including death. Do not use this medicine if you are also using alfuzosin, carbamazepine, cisapride, dronedarone, elbasvir/grazoprevir, ivabradine, lomitapide, lovastatin, lurasidone, naloxegol, oral midazolam, phenobarbital, phenytoin, pimozide, ranolazine, rifampin, sildenafil for pulmonary hypertension, simvastatin, St John's wort, triazolam, and ergot medicines (including dihydroergotamine, ergotamine, or methylergonovine).
• Do not use this medicine together with colchicine if you have kidney or liver disease.
• There are many drugs that can interact with this medicine. Make sure your doctor knows about all other medicines you are using, especially the following:
  • Artemether/lumefantrine, bosentan, buspirone, clarithromycin, cyclosporine, diazepam, estazolam, everolimus, fesoterodine, glecaprevir/pibrentasvir, irinotecan, lomitapide, maraviroc, omeprazole, rifabutin, rifapentine, sirolimus, solifenacin, tacrolimus, zolpidem
  • Birth control pill that contains drospirenone or ethinylestradiol
  • Blood pressure medicine (including amiodarone, amlodipine, bepridil, carvedilol, disopyramide, diltiazem, felodipine, flecainide, lidocaine, metoprolol, mexiletine, nicardipine, nifedipine, propafenone, quinidine, timolol, verapamil
  • Blood thinner (including apixaban, dabigatran, edoxaban, warfarin)
  • Medicine for heart rhythm problems (including amiodarone, digoxin, disopyramide, flecainide, lidocaine, mexiletine, propafenone, quinidine)
  • Medicine to lower cholesterol or triglycerides (including atorvastatin, fluvastatin, pravastatin, rosuvastatin)
  • Medicine to treat an infection (including clarithromycin, erythromycin, isavuconazole, itraconazole, ketoconazole, posaconazole, telithromycin, voriconazole)
  • Medicine to treat depression (including paroxetine, sertraline, TCAs, trazodone)
  • Medicine for erectile dysfunction (including avanafil, tadalafil, vardenafil)
  • Medicine to treat cancer (including dasatinib, nilotinib, vinblastine, vincristine)
  • Medicine to treat depression or mental health problems (including quetiapine, trazodone, SSRIs, TCAs)
  • Medicine to treat seizures (including clonazepam, eslicarbazepine, oxcarbazepine)
  • Narcotic pain medicine (including buprenorphine, buprenorphine/naloxone, fentanyl, methadone, oxycodone, tramadol)
  • Steroid medicine (including betamethasone, budesonide, ciclesonide, dexamethasone, fluticasone, methylprednisolone, mometasone, triamcinolone)
  Your doctor may recommend you to use other similar medicines or may change your dose if you are using these medicines together with darunavir/cobicistat.
• There are many other drugs that can affect how this medicine works. Ask your doctor before you use any other medicine.
• If you also take didanosine, take it 1 hour before or 2 hours after you take this medicine.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. Birth control pills may not work as well to prevent pregnancy when used with this medicine. Use another form of birth control (including condoms or spermicide) along with your pills.
• Do not breastfeed. You can spread HIV or AIDS to your baby through your breast milk.
• Tell your doctor if you have kidney disease, liver disease, diabetes, hemophilia, or an allergy to sulfa drugs.
• This medicine may cause the following problems:
  • Liver problems
  • Serious skin reactions
  • New or worsening kidney problems
  • High blood sugar levels, which could become permanent
  • Increased risk of bleeding
• Your immune system may get stronger when you start taking HIV medicines. This could cause a hidden infection in your body to become active. Tell your doctor right away if you notice any changes in your health.
• Always practice safe sex, even if your partner also has HIV. If you stop taking this medicine or do not take it as prescribed, you may spread HIV to others. Do not reuse or share needles, or other items, that may have blood or body fluids on them.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Change in how much or how often you urinate, lower back or side pain
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Increased hunger or thirst, weight loss
• Rash with fever, tiredness, joint or muscle pain

If you notice these less serious side effects, talk with your doctor:

• Weight gain around your neck, upper back, breast, or waist, moon-shaped face

If you notice other side effects that you think are caused by this medicine, tell your doctor

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