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What is darunavir?

Darunavir is an antiviral medication in a group of HIV medicines called protease (PRO-tee-ayz) inhibitors. Darunavir prevents human immunodeficiency virus (HIV) cells from multiplying in your body.

Darunavir is used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). Darunavir is not a cure for HIV or AIDS.

Darunavir may also be used for other purposes not listed in this medication guide.

Precautions

Instructions

Side Effects

Interactions

Precautions

You should not take this medication if you are allergic to darunavir.

Some drugs can cause life-threatening side effects if you use them while you are taking darunavir. Do not take darunavir with:

• astemizole (Hismanal) or terfenadine (Seldane);
• cisapride (Propulsid);
• pimozide (Orap);
• lovastatin (Mevacor) or simvastatin (Zocor);
• rifampin (Rifadin, Rimactane, Rifater);
• triazolam (Halcion) or oral midazolam (Versed);
• St. John's wort; or
• ergot medicines such as ergotamine (Ergomar, Cafergot), dihydroergotamine (D.H.E. 45, Migranal Nasal Spray), ergonovine (Ergotrate), or methylergonovine (Methergine).

If you have certain conditions, you may need a dose adjustment or special tests to safely take this medication. Before taking darunavir, tell your doctor if you are allergic to sulfa drugs, or if you have:

• liver disease (especially hepatitis or cirrhosis);
• diabetes;
• a bleeding disorder such as hemophilia; or
• high cholesterol or triglycerides.

FDA pregnancy category C. It is not known whether darunavir is harmful to an unborn baby. HIV can be passed to the baby if the mother is not properly treated during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Take all of your HIV medicines as directed to control your infection while you are pregnant.

Your name may need to be listed on an antiviral pregnancy registry when you start using this medication.

Taking darunavir together with birth control pills can make the darunavir less effective. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking darunavir.

You should not breast-feed while you are using darunavir. Women with HIV or AIDS should not breast-feed at all. Even if your baby is born without HIV, you may still pass the virus to the baby in your breast milk.

If you also take didanosine, take it 1 hour before or 2 hours after you take darunavir.

Avoid having unprotected sex or sharing needles, razors, or toothbrushes. Taking this medication will not prevent you from passing HIV to other people. Talk with your doctor about safe methods of preventing HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

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Instructions

Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of a darunavir overdose are unknown.

Take the missed dose of darunavir and ritonavir as soon as you remember and take your next dose at the regularly scheduled time.

If you take darunavir 800 milligrams once daily and you are more than 12 hours late in taking your medications, skip the missed dose and take the next regularly scheduled dose. Do not take extra medicine to make up the missed dose.

If you take darunavir 600 milligrams twice daily and you are more than 6 hours late in taking your medications, skip the missed dose and take the next regularly scheduled dose.

Always take darunavir and ritonavir together. Do not take extra medicine to make up the missed dose.

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Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking darunavir and call your doctor at once if you have any of these serious side effects:

• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
• the first sign of any skin rash, no matter how mild;
• increased urination or extreme thirst;
• signs of a new infection, such as fever or chills, cough, flu symptoms, easy bruising or bleeding;
• severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate; or
• nausea, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

• diarrhea, bloating, upset stomach, mild stomach pain;
• muscle pain;
• weakness;
• headache; or
• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Interactions

Many drugs can interact with darunavir. Below is just a partial list. Tell your doctor if you are using:

• methadone (Methadose, Dolophine, Diskets);
• risperidone (Risperdal) or thioridazine (Mellaril);
• an antibiotic such as clarithromycin (Biaxin), rifabutin (Mycobutin), or rifampin (Rifadin, Rimactane, Rifater);
• an antifungal medication such as itraconazole (Sporanox), ketoconazole (Nizoral), or voriconazole (Vfend);
• an antidepressant such as desipramine (Norpramin), paroxetine (Paxil), sertraline (Zoloft), trazodone (Desyrel), and others;
• beta-blockers such as metoprolol (Lopressor, Toprol) or timolol (Blocadren, Betimol, Cosopt, Timoptic);
• a blood thinner such as warfarin (Coumadin);
• a calcium channel blocker such as felodipine (Plendil), nicardipine (Cardene), nifedipine (Procardia, Adalat), or verapamil (Calan, Covera, Isoptin, Verelan);
• cholesterol-lowering medicine such as atorvastatin (Lipitor) pravastatin (Pravachol), rosuvastatin (Crestor);
• drugs that weaken the immune system, such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), or tacrolimus (Prograf);
• a heart rhythm medication such as amiodarone (Cordarone), digoxin (digitalis, Lanoxin), flecainide (Tambocor), lidocaine, propafenone (Rythmol), or quinidine (Quinaglute, Quinidex);
• insulin or diabetes medication you take by mouth;
• medicines to treat erectile dysfunction, such as sildenafil (Viagra), tadalafil (Cialis), or vardenafil (Levitra);
• other HIV /AIDS medicine such as efavirenz (Sustiva), lopinavir/ritonavir (Kaletra), or saquinavir (Invirase, Fortovase);
• seizure medications such as carbamazepine (Carbatrol, Tegretol), phenobarbital (Luminal, Solfoton), or phenytoin (Dilantin); or
• a steroid medication such as dexamethasone (Decadron, Hexadrol) or fluticasone (Advair, Flonase, Flovent).

This list is not complete and there are many other medicines that can interact with darunavir. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

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