Darunavir (By mouth)

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or have diabetes, liver disease (including hepatitis B or C), or hemophilia. Tell your doctor if you are allergic to sulfa medicines (such as Bactrim® or Septra®).
• You should not breast feed if you have HIV or AIDS, because you may give the infection to your baby through your breast milk.
• Check with your doctor right away if you have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.
• This medicine may increase blood sugar levels. Tell your doctor if you have increased hunger or thirst, changes in how much you urinate, or unusual weight loss. Check with your doctor if you notice a change in the results of your blood or urine sugar tests.
• Your immune system may get stronger when you start taking HIV medicines. Tell your doctor right away if you notice any changes in your health. Sometimes the immune system will start to fight infections that were hidden in your body, such as pneumonia, herpes, or tuberculosis.
• Serious skin reactions can occur with this medicine. Check with your doctor right away if you have any of the following symptoms: blistering, peeling, or loosening of the skin; chills; cough; diarrhea; itching; fever; joint or muscle pain; sores, ulcers, or red skin lesions; skin rash; sore throat; or unusual tiredness or weakness.
• This medicine will not keep you from giving HIV to your partner during sex. Make sure you understand and practice safe sex, even if your partner also has HIV. Do not share needles with anyone.
• Birth control pills may not work as well while you use darunavir. Use an additional form of birth control with your pills to avoid pregnancy.
• This medicine may cause changes in your body fat. Tell your doctor if you notice changes in your body shape, such as more fat in your upper back and neck or around your chest and stomach area. You may also lose fat from your legs, arms, and face.
• Do not stop using this medicine unless your doctor tells you to do so.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments. Blood tests may be needed to check for side effects.

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, or red skin rash
• Change in how much or how often you urinate
• Chest pain
• Dark-colored urine or pale stools
• Fever, chills, cough, or sore throat
• Increased hunger or thirst
• Muscle or joint pain
• Nausea, vomiting, loss of appetite, or pain in your upper stomach
• Painful or difficult urination
• Unusual bleeding, bruising, tiredness, or weakness
• Yellowing of your skin or the whites of your eyes

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

• Diarrhea or stomach pain
• Mild headache
• Mild skin rash
• Weight gain around your neck, upper back, breast, face, 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

Introduction

Darunavir (dar-UE-na-vir)

Treats human immunodeficiency virus (HIV) infection. HIV causes acquired immune deficiency syndrome (AIDS). Darunavir does not cure HIV or AIDS, but it may slow the progress of the disease. It is used with ritonavir (Norvir®).

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 use darunavir. Tell your doctor if you use a medicine to treat seizures (such as carbamazepine, phenobarbital, phenytoin, Dilantin®, or Tegretol®) or a medicine to lower cholesterol (such as atorvastatin, pravastatin, rosuvastatin, Crestor®, Lipitor®, or Pravachol®). Make sure your doctor knows if you also use other medicines to treat HIV or AIDS such as atazanavir, didanosine, efavirenz, indinavir, lopinavir/ritonavir, maraviroc, saquinavir, Crixivan®, Invirase®, Kaletra®, Reyataz®, Selzentry®, Sustiva®, or Videx®.
• Tell your doctor if you use clarithromycin (Biaxin®), rifabutin (Mycobutin®), a medicine for heart rhythm problems (such as amiodarone, bepridil, digoxin, flecainide, lidocaine, propafenone, quinidine, Cardioquin®, Cordarone®, Lanoxin®, Rythmol®, Tambocor®, or Vascor®), a blood thinner (such as warfarin, Coumadin®), a medicine to treat a fungus infection (such as itraconazole, ketoconazole, voriconazole, Nizoral®, Sporanox®, or Vfend®), certain blood pressure medicines (such as felodipine, nicardipine, nifedipine, metoprolol, Adalat®, Cardene®, Lopressor®, or Plendil®), or medicine to treat glaucoma (such as timolol or Timoptic®).
• Make sure your doctor knows if you use bosentan (Tracleer®), buprenorphine (Buprex®, Suboxone®), colchicine (Colcrys®), cyclosporine (Gengraf®, Neoral®, Sandimmune®), methadone (Dolophine®), midazolam given by injection, risperidone (Risperdal®), salmeterol (Advair®, Serevent®), sildenafil (Viagra®), sirolimus (Rapamune®), tacrolimus (Prograf®), tadalafil (Cialis®), telaprevir (Incivek?), thioridazine (Mellaril®), vardenafil (Levitra®), a steroid medicine (such as dexamethasone, fluticasone, Decadron®, or Flonase®), or a medicine to treat depression (such as desipramine, paroxetine, sertraline, trazodone, Desyrel®, Norpramin®, Paxil®, or Zoloft®).

Brand Name(s)

Prezista

There may be other brand names for this medicine.

When This Medicine Should Not Be Used

You should not use this medicine if you have had an allergic reaction to darunavir or ritonavir. Do not use this medicine if you also use alfuzosin (Uroxatral®), cisapride (Propulsid®), lovastatin (Advicor®, Altoprev®, Mevacor®), oral midazolam (Versed®), pimozide (Orap®), rifampin (Rifadin®, Rifater®), sildenafil (Revatio®), simvastatin (Simcor®, Vytorin®, Zocor®), triazolam (Halcion®), ergot medicines (such as dihydroergotamine, ergonovine, ergotamine, methylergonovine, Cafergot®, D.H.E. 45®, Ergomar®, Ergostat®, Migranal®, or Wigraine®), or St John's wort. Do not give this medicine to children younger than 3 years of age.

How to Use This Medicine

Suspension, Tablet

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• This medicine should always be taken together with ritonavir (Norvir®).
• If you also use didanosine (Videx®), take it at least 1 hour before or 2 hours after taking this medicine and ritonavir.
• It is best to take this medicine with food or milk.
• Swallow the tablet whole with water or milk. Do not crush, break, or chew it.
• Measure the oral liquid medicine with a marked measuring spoon, oral syringe, or medicine cup. Shake the bottle well before each use.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

If a dose is missed:

• If you take this medicine once a day and you miss a dose, and it is more than 12 hours since your last dose, wait and take your next dose at the normal time. If you miss a dose, and it is less than 12 hours since your last dose, take it as soon as you can and take your next dose at the normal time. Do not use extra medicine to make up for a missed dose.
• If you take this medicine two times a day and you miss a dose, and it is more than 6 hours since your last dose, wait and take your next dose at the normal time. If you miss a dose, and it is less than 6 hours since your last dose, take it as soon as you can and take your next dose at the normal time. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine

• 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.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.