darunavir

Generic Name: darunavir (da ROON a veer)Brand Names: Prezista

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.

What is the most important information I should know about darunavir?

Do not take darunavir with astemizole (Hismanal), cisapride (Propulsid), pimozide (Orap), lovastatin (Mevacor), simvastatin (Zocor), oral midazolam (Versed), triazolam (Halcion), rifampin (Rifadin, Rimactane, Rifater), St. John's wort, terfenadine (Seldane), or an ergot medicine such as Ergomar, Ergotrate, Cafergot, D.H.E. 45, Migranal, Methergine, and others. These drugs can cause life-threatening side effects if you use them while you are taking darunavir.

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.

HIV/AIDS is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Do not change your doses or medication schedule without advice from your doctor. Every person with HIV or AIDS should remain under the care of a doctor.

Avoid having unprotected sex or sharing needles, razors, or toothbrushes. Taking darunavir 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.

What should I discuss with my healthcare provider before taking darunavir?

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 any of these other conditions, you may need a dose adjustment or special tests to safely take darunavir:

• 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.

How should I take darunavir?

Take darunavir exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Darunavir must be taken together with another medication called ritonavir (Norvir).

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Take this medicine with a full glass (8 ounces) of water or milk. Darunavir and ritonavir is most effective when taken with food.

Swallow the darunavir tablet whole.

It is important to use darunavir regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Your liver function may also need to be tested., especially if you have hepatitis B or C. Do not miss any follow-up visits to your doctor.

HIV/AIDS is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Be sure to read the medication guide or patient instructions provided with each of your medications. Do not change your doses or medication schedule without advice from your doctor. Every person with HIV or AIDS should remain under the care of a doctor.

Store darunavir at room temperature away from moisture and heat.

See also: Darunavir dosage in more detail

What happens if I miss a dose?

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.

What happens if I overdose?

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

What should I avoid while taking darunavir?

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.

Darunavir 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.

Darunavir Dosing Information

Usual Adult Dose for HIV Infection:

Therapy-naive: Darunavir 800 mg plus ritonavir 100 mg orally once a day with foodTherapy-experienced: Darunavir 600 mg plus ritonavir 100 mg orally twice a day with food

Usual Pediatric Dose for HIV Infection:

6 to less than 18 years:20 to less than 30 kg: Darunavir 375 mg plus ritonavir 50 mg orally twice a day with food30 to less than 40 kg: Darunavir 450 mg plus ritonavir 60 mg orally twice a day with food40 kg or more: Darunavir 600 mg plus ritonavir 100 mg orally twice a day with food

What other drugs will affect darunavir?

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

• buprenorphine and naloxone (Suboxone);

• 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 diltiazem (Cartia, Cardizem), felodipine (Plendil), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others;

• 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.

Where can I get more information?

• Your pharmacist can provide more information about darunavir.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 2.09. Revision Date: 08/21/2009 1:30:00 PM.