MedlinePlus Drug Information: Darunavir

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Other drug names:	A B C D E F G H I J K L M N O P Q R S T U V W X Y Z 0-9

Darunavir

(da roon' a veer)

Contents of this page:
Why is this medication prescribed? How should this medicine be used? Other uses for this medicine What special precautions should I follow? What special dietary instructions should I follow? What should I do if I forget a dose?	What side effects can this medication cause? What storage conditions are needed for this medicine? In case of emergency/overdose What other information should I know? Brand names Other names

IMPORTANT WARNING: Return to top

[Posted 03/12/2008] FDA and Tibotec Therapeutics notified healthcare professionals of changes to the WARNINGS section of the prescribing information for darunavir (Prezista) tablets regarding the risk of hepatotoxicity. In clinical trials and postmarketing experience, drug induced hepatitis has been reported in patients receiving combination therapy with darunavir/ritonavir. Appropriate laboratory testing should be conducted prior to initiating therapy with darunavir/ritonavir and patients should be monitored during treatment. Increased AST/ALT monitoring should be considered in patients with underlying chronic hepatitis, cirrhosis, or in patients who have pretreatment elevations of transaminases, especially during the first several months of darunavir/ritonavir treatment. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Prezista, http://www.fda.gov/medwatch/safety/2008/prezista_DHCP.pdf and http://www.fda.gov/cder/foi/label/2008/021976s003s004lbl.pdf.

Why is this medication prescribed? Return to top

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Darunavir is used with ritonavir (Norvir) and other medications to treat human immunodeficiency virus (HIV) in people who have already been treated for HIV. Darunavir is in a class of medications called protease inhibitors. It works by slowing the spread of HIV in the body. Darunavir does not cure HIV infection and may not prevent you from developing HIV-related illnesses. Darunavir does not prevent you from spreading HIV to other people.

How should this medicine be used? Return to top

Darunavir comes as a tablet to take by mouth. It is usually taken with food and with ritonavir twice a day. Take darunavir at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take darunavir exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Do not take darunavir without ritonavir.

Swallow the tablets whole with a drink such as water or milk. Do not chew the tablets.

Darunavir controls HIV but does not cure it. Continue to take darunavir even if you feel well. Do not stop taking darunavir without talking to your doctor. If you stop taking darunavir or skip doses, your condition may become more difficult to treat. When your supply of darunavir starts to run low, get more from your doctor or pharmacist.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Other uses for this medicine Return to top

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow? Return to top

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Before taking darunavir,

tell your doctor and pharmacist if you are allergic to darunavir, ritonavir, sulfa medications, or any other medications. Ask your pharmacist if you are unsure if a medication you are allergic to is a sulfa medication.
tell your doctor if you are taking any of the following medications: astemizole (Hismanal) (not available in the U.S.); cisapride (Propulsid); ergot-type medications such as dihydroergotamine (D.H.E. 45, Migranal), ergonovine (Ergotrate), ergotamine (Bellergal-S, Cafergot, Ergomar, Wigraine), and methylergonovine (Methergine); midazolam (Versed); pimozide (Orap); terfenadine (Seldane) (not available in the U.S.); or triazolam (Halcion). Your doctor will probably tell you not to take darunavir
tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin); antifungals such as itraconazole (Sporanox), ketoconazole (Nizoral), and voriconazole (Vfend); calcium-channel blockers such as felodipine (in Lexxel, Plendil), nicardipine (Cardene), and nifedipine (Adalat, Procardia); cholesterol-lowering medications (statins) such as atorvastatin (in Caduet, Lipitor), lovastatin (Mevacor), pravastatin (Pravachol), and simvastatin (Zocor); dexamethasone (Decadron, Dexone); fluticasone (in Advair, Flonase, Flovent); certain phosphodiesterase inhibitors (PDE-5 inhibitors)such as sildenafil (Revatio, Viagra), tadalafil (Cialis), and vardenafil (Levitra); other medications for HIV including efavirenz (Sustiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), and saquinavir (Invirase); medications for irregular heartbeat including amiodarone (Cordarone, Pacerone), bepridil (Vascor) (no longer available in the U.S.), and quinidine; certain medications for seizures such as carbamazepine (Equetro, Carbatrol, Tegretol), phenobarbital, and phenytoin (Dilantin, Phenytek); certain medications that suppress the immune system such as cyclosporine (Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Prograf); methadone (Dolophine, Methadose); rifabutin (Mycobutin); rifampin (Rimactane, Rifadin);certain selective serotonin reuptake inhibitors (SSRIs) such as paroxetine (Paxil) and sertraline (Zoloft); and trazodone. Many other medications may also interact with darunavir, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
if you are taking didanosine (Videx), take it 1 hour before or 2 hours after you take darunavir.
tell your doctor what herbal products you are taking, especially St. John's wort.
tell your doctor if you have or have ever had diabetes or high blood sugar; hemophilia (bleeding disorder in which the blood does not clot properly); hepatitis (swelling of the liver caused by a virus) or any other liver disease; or an infection that does not go away or that comes and goes such as cytomegalovirus (CMV; a viral infection that may cause symptoms in patients with weak immune systems), mycobacterium avium complex disease (MAC; a bacterial infection that may cause serious symptoms in people with AIDS), pneumonia, or tuberculosis (TB; a type of lung infection).
tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking darunavir, call your doctor. Do not breastfeed if you are infected with HIV or are taking darunavir.
you should know that darunavir may decrease the effectiveness of hormonal contraceptives (birth control pills, patches, rings, injections, or implants). Talk to your doctor about other ways to prevent pregnancy while you are taking this medication.
you should know that your body fat may increase or move to different areas of your body such as your breasts, upper back, neck, chest, and stomach area. Loss of fat from the legs, arms, and face can also happen.

What special dietary instructions should I follow? Return to top

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medicine.

What should I do if I forget a dose? Return to top

If you miss a dose by less than 6 hours, take the missed dose as soon as you remember it and then take the next dose at the scheduled time. However, if you miss a dose by more than 6 hours, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can this medication cause? Return to top

Darunavir may cause hyperglycemia (high blood sugar). Call your doctor if you have any of the following symptoms of hyperglycemia:

extreme thirst
frequent urination
extreme hunger
weakness
blurred vision

If high blood sugar is not treated, a serious, life-threatening condition called diabetic ketoacidosis could develop. Call your doctor immediately if you have any of these symptoms:

dry mouth
nausea and vomiting
shortness of breath
breath that smells fruity
decreased consciousness

Darunavir may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

headache
diarrhea
nausea
stomach pain
constipation

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

rash
blisters
fever
swelling, tenderness, redness, or other signs of infection

Darunavir may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/index.html] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine? Return to top

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose Return to top

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What other information should I know? Return to top

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Brand names Return to top

Prezista®

Other names Return to top

TMC-114

Last Revised - 06/01/2007
Last Reviewed - 06/01/2007

American Society of Health-System Pharmacists, Inc. Disclaimer