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):

Prezista

When This Medicine Should Not Be Used:

How to Use This Medicine:

Liquid, Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Darunavir is used with other medicines to treat HIV infection. Take all of the medicines your doctor has prescribed at the right time of day and in the correct order. Do not stop using your medicine unless your doctor tells you to.
• It is best to take this medicine with food or milk.
• Tablet: Swallow whole with water or milk. Do not crush, break, or chew the tablet.
• Oral liquid: Measure the oral liquid medicine with a marked measuring spoon, oral syringe, or medicine cup. Shake the bottle well before each use.
• Do not stop using this medicine without checking first with your doctor. If you stop the medicine even for a short time, 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. Keep the oral liquid in its original container. Do not refrigerate or freeze it.

Drugs and Foods to Avoid:

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

• Do not use this medicine if you are also using alfuzosin, dihydroergotamine, dronedarone, elbasvir/grazoprevir, ergotamine, ivabradine, lomitapide, lovastatin, lurasidone, methylergonovine, naloxegol, oral midazolam, pimozide, ranolazine, rifampin, sildenafil, simvastatin, St John's wort, or triazolam.
• 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, salmeterol, sirolimus, solifenacin, tacrolimus, zolpidem
  • Birth control pill that contains drospirenone, ethinyl estradiol, or norethindrone
  • Blood pressure medicine (including amlodipine, bepridil, carvedilol, diltiazem, felodipine, metoprolol, nicardipine, nifedipine, timolol, verapamil
  • Blood thinner (including apixaban, clopidogrel, dabigatran, edoxaban, prasugrel, rivaroxaban, ticagrelor, warfarin)
  • Medicine for erectile dysfunction (including avanafil, tadalafil, vardenafil)
  • Medicine for heart rhythm problems (including amiodarone, digoxin, disopyramide, flecainide, lidocaine, mexiletine, propafenone, quinidine)
  • Medicine to lower cholesterol or triglycerides (including atorvastatin, pravastatin, rosuvastatin)
  • Medicine to treat an infection (isavuconazole, itraconazole, ketoconazole, posaconazole, voriconazole)
  • 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 using other similar medicines or may change your dose if you are using these medicines together with darunavir/cobicistat or darunavir/ritonavir.
• Many other drugs can interact with darunavir. Make sure your doctor knows about all other medicines you are using.
• If you also use didanosine, take it at least 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 liver disease (including hepatitis or cirrhosis), diabetes, or hemophilia. Tell your doctor if you are allergic to sulfa drugs.
• This medicine may cause the following problems:
  • Liver problems
  • Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis
  • 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
• Dark urine or pale stools, loss of appetite, stomach pain, yellow skin or eyes
• Increased hunger or thirst, change in how much or how often you urinate, unusual weight loss
• Unusual bleeding, bruising, or weakness

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

• Diarrhea, stomach pain
• Headache
• Weight gain around your neck, upper back, breast, or waist

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