Darunavir, Oral

What are other names for this medicine?

Type of medicine: protease inhibitor (anti-HIV)

Generic and brand names: darunavir, oral; Prezista

What is this medicine used for?

This medicine is taken by mouth to treat HIV-1 infection. It is usually taken with other medicines.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• an allergic reaction to any medicine
• diabetes
• hemophilia or bleeding problems
• high cholesterol or high triglycerides
• kidney problems
• liver disease

Taking this medicine with certain other medicines may be life-threatening. Tell your provider about ALL of the medicines you take, especially antihistamines, antibiotics, sedatives, and medicines for prostate problems, migraines, mental disorders, or heart rhythm problems.

Males: If you take sildenafil (Viagra), tadalafil (Cialis), or vardenafil (Levitra) while you are taking this medicine, you may be at increased risk of side effects such as low blood pressure, vision changes or priapism (prolonged and painful erections).

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. Do not breast-feed while taking this medicine.

Birth control pills may be less effective while you are taking this medicine. Talk to your healthcare provider if you need birth control.

How do I take it?

Take this medicine exactly as your healthcare provider prescribes. Do not change your dosage on your own. Do not stop taking this medicine without your healthcare provider's approval. If you are not sure of how much and how often to take this medicine, ask your healthcare provider or pharmacist to explain.

Take this medicine with other medicines your healthcare provider prescribes. Follow your healthcare provider's instructions exactly.

Take this medicine with food. Do not chew, break, or crush the tablets. Swallow the tablets whole with a full glass of water or milk. Take this medicine at the same time that you take ritonavir.

Do not miss any doses. If you miss a dose and realize it in less than 6 hours, take your missed dose immediately. Then take your next dose at the regularly scheduled time. If you miss a dose by more than 6 hours, wait and take the next dose at the regularly scheduled time. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What should I watch out for?

This medicine is not a cure for HIV infection. You may continue to get illnesses associated with advanced HIV infection, including other infections. There is no evidence that this medicine will reduce the risk of spreading HIV through sexual contact or blood contamination.

You will need to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests.

If you need emergency care, surgery, or dental work, tell the healthcare provider or dentist you are taking this medicine.

Do not give this medicine to other people, even if they have the same symptoms you have.

Your body fat may change as a result of taking this medicine. Your legs and arms may be thin but your chest, belly, back and face may have more fat. Discuss this with your healthcare provider.

Diabetics: Your dosage of insulin or medicines taken by mouth for diabetes may need to be changed. If you are controlling your diabetes with diet and exercise, you may need to start taking medicine. Talk to your healthcare provider about this.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider about any side effects that continue or get worse.

Serious (report these to your healthcare provider right away): Nausea, vomiting, and abdominal pain; bleeding; severe weakness; severe skin rash, blistering, or peeling; diarrhea; yellowing of eyes or skin; leg pain; tingling or numbness in the hands, feet, or mouth; pounding heartbeat; increased thirst and urination.

Other: Loss of appetite, trouble sleeping, headache, runny nose or stuffy nose, change in sense of taste.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• antacids (take them at least 1 hour before or after doses of this medicine)
• antiarrhythmics such as amiodarone (Cordarone), flecainide (Tambocor), propafenone (Rythmol), mexiletine, dofetilide (Tikosyn), disopyramide (Norpace), quinidine (quinidine gluconate, quinidine sulfate), and lidocaine
• antibiotics such as azithromycin (Zithromax), clarithromycin (Biaxin), and erythromycin (EryC, Ery-Tab, E.E.S., Erythrocin)
• antidepressants such as bupropion (Wellbutrin, Wellbutrin SR, Zyban), fluoxetine (Prozac, Sarafem), sertraline (Zoloft), paroxetine (Paxil), venlafaxine (Effexor, Effexor XR), trazodone, and nefazodone
• antifungals such as fluconazole (Diflucan), itraconazole (Sporanox), posaconazole (Noxafil), voriconazole (VFEND), and ketoconazole (Nizoral)
• antipsychotic medicines such as clozapine (Clozaril), pimozide (Orap), perphenazine (Trilafon), risperidone (Risperdal), aripiprazole (Abilify), olanzapine (Zyprexa), and thioridazine
• antiseizure medicines such as carbamazepine (Tegretol), oxcarbazepine (Trileptal), fosphenytoin (Cerebyx), phenobarbital, clonazepam (Klonopin), ethosuximide (Zarontin), divalproex sodium (Depakote, Depakote ER), lamotrigine (Lamictal), and phenytoin (Dilantin)
• birth control pills or contraceptive patch (talk to your healthcare provider if you need birth control)
• blood thinners such as warfarin (Coumadin), clopidogrel (Plavix), ticlopidine (Ticlid), heparin, and aspirin
• calcium channel blockers such as felodipine (Plendil), nifedipine (Procardia, Procardia XL, Adalat CC), diltiazem (Cardizem, Cardizem CD, Cardizem LA, Cardizem SR, Cartia XT, Dilacor XR, Diltia XT, Taztia XT, Tiazac), nimodipine (Nimotop), verapamil (Calan, Calan SR, Covera-HS, Isoptin SR, Verelan, Verelan PM), amlodipine (Norvasc), nisoldipine (Sular), isradipine (DynaCirc, DynaCirc CR), and nicardipine (Cardene, Cardene SR)
• cholesterol-lowering medicines such as atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Mevacor), pravastatin (Pravachol), and simvastatin (Zocor)
• colchicine
• corticosteroids such as dexamethasone (Decadron), hydrocortisone (Cortef), methylprednisolone (Medrol), and prednisone (Deltasone, Orasone)
• diabetes medicines such as insulin, glyburide (DiaBeta, Micronase), glipizide (Glucotrol), repaglinide (Prandin), tolbutamide, glimepiride (Amaryl), metformin (Glucophage), rosiglitazone (Avandia), nateglinide (Starlix), repaglinide (Prandin), exenatide (Byetta), miglitol (Glyset), and pioglitazone (Actos)
• didanosine (Videx, Videx EC) (take at least 2 hours before or after doses of this medicine)
• ergot medicines such as dihydroergotamine (D.H.E. 45, Migranal), ergotamine (Ergomar), ergonovine (Ergotrate), and methylergonovine (Methergine)
• immunosuppressants such as cyclosporine (Sandimmune, Neoral, Gengraf), tacrolimus (Prograf), and sirolimus (Rapamune)
• medicines to treat erectile dysfunction such as sildenafil (Viagra), tadalafil (Cialis), or vardenafil (Levitra)
• other medicines to treat HIV such as abacavir (Ziagen), amprenavir (Agenerase), fosamprenavir (Lexiva), efavirenz (Sustiva), delavirdine (Rescriptor), indinavir (Crixivan), nelfinavir mesylate (Viracept), ritonavir (Norvir), saquinavir (Invirase, Fortovase), tenofovir (Viread), lopinavir/ritonavir (Kaletra), nevirapine (Viramune), zidovudine (AZT), and atazanavir (Reyataz)
• medicines to treat over-active bladder such as alfuzosin (Uroxatral), darifenacin (Enablex), tolterodine (Detrol, Detrol LA) and solifenacin (Vesicare)
• natural remedies such as garlic, melatonin, red yeast rice, or St. John's Wort
• pain medicines such as meperidine (Demerol), methadone (Dolophine, Methadone Intensol, Methadose), piroxicam (Feldene), propoxyphene (Darvon), fentanyl (Duragesic), and tramadol (Ultram, Ultracet)
• rifabutin (Mycobutin)
• rifampin (Rifadin, Rimactane)
• sedatives such as alprazolam (Xanax), diazepam (Valium), lorazepam (Ativan), chlordiazepoxide (Librium), clorazepate (Tranxene), estazolam (ProSom), flurazepam (Dalmane), midazolam (Versed), zolpidem (Ambien), triazolam (Halcion), and eszopiclone (Lunesta)
• tricyclic antidepressants such as amitriptyline (Elavil), nortriptyline (Aventyl, Pamelor), imipramine (Tofranil), doxepin (Sinequan), desipramine (Norpramin), trimipramine (Surmontil), protriptyline (Vivactil), and maprotiline

The effects of this medicine may be increased if you take it with grapefruit juice. Discuss this with your healthcare provider.

Keep a list of all your medicines (prescription, nonprescription, supplements, natural remedies, and vitamins) with you. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.