Darunavir

Brand Name(s):

• Prezista®

Other Name(s):

• TMC-114

IMPORTANT WARNING:

[Posted 3/1/2012]ISSUE:FDA notified healthcare professionals of updates to the prescribing information concerning interactions between protease inhibitors and certain statin drugs. Protease inhibitors and statins taken together may raise the blood levels of statins and increase the risk for muscle injury (myopathy). The most serious form of myopathy, called rhabdomyolysis, can damage the kidneys and lead to kidney failure, which can be fatal.

BACKGROUND:Statins are a class of prescription drugs used together with diet and exercise to reduce blood levels of low-density lipoprotein (LDL) cholesterol (''bad cholesterol''). HIV protease inhibitors are a class of prescription anti-viral drugs used to treat HIV. HCV protease inhibitors are a class of prescription anti-viral drugs used to treat hepatitis C infection.

RECOMMENDATION:Healthcare professionals should follow the recommendations in the prescribing information (drug labels) when prescribing HIV or HCV protease inhibitors with statins. See the FDA Drug Safety Communication for additional information, including a data summary. For more information visit the FDA website at: Web Siteand Web Site.

[Posted 02/09/2012]ISSUE:FDA notified healthcare professionals and patients that drug interactions between the hepatitis C virus (HCV) protease inhibitor boceprevir (Victrelis) and certain ritonavir-boosted human immunodeficiency virus (HIV) protease inhibitors (atazanavir, lopinavir, darunavir) can potentially reduce the effectiveness of these medicines when they are used together.

A drug interaction study showed that taking boceprevir (Victrelis) with ritonavir (Norvir) in combination with atazanavir (Reyataz) or darunavir (Prezista), or with Kaletra (lopinavir/ritonavir) reduced the blood levels of the HIV medicines and boceprevir in the body. FDA will be updating the boceprevir drug label to include information about these drug interactions.

BACKGROUND:Boceprevir is a hepatitis C virus (HCV) protease inhibitor used with the medicines peginterferon alfa and ribavirin to treat chronic (long-lasting) hepatitis C infection in adults. HIV protease inhibitors are a class of anti-viral drugs used to treat HIV infection. Ritonavir is an HIV protease inhibitor used to boost other HIV protease inhibitors, increasing their levels in the blood and making them more effective.

RECOMMENDATION:Patients should not stop taking any of their medicines without talking to their healthcare professional. Patients should contact their healthcare professional if they have any questions or concerns.

Healthcare professionals who have started patients infected with both chronic HCV and HIV on boceprevir and antiretroviral therapy containing a ritonavir-boosted protease inhibitor should closely monitor patients for HCV treatment response and for potential HCV and HIV virologic rebound. For more information visit the FDA website at: Web Siteand Web Site.

WHY is this medicine prescribed?

Darunavir is used with ritonavir (Norvir) and other medications to treat human immunodeficiency virus (HIV) in adults and children 6 years of age and older. 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?

Darunavir comes as a tablet to take by mouth. It is usually taken with food and with ritonavir once or twice a day. Take darunavir at around the same time(s) 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.

Are there OTHER USES for this medicine?

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

What SPECIAL PRECAUTIONS should I follow?

Before taking darunavir,

• tell your doctor and pharmacist if you are allergic to darunavir, ritonavir, sulfa medications, any other medications, or any of the ingredients in darunavir tablets. Ask your pharmacist for a list of the ingredients or 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: alfuzosin (Uroxatral); cisapride (Propulsid) (not available in the U.S.); ergot-type medications such as dihydroergotamine (D.H.E. 45, Migranal), ergonovine (Ergotrate), ergotamine (Bellergal-S, Cafergot, Ergomar, Wigraine), and methylergonovine (Methergine); lovastatin (in Advicor, Altoprev, Mevacor); midazolam (Versed); pimozide (Orap); rifampin (Rimactane, in Rifamate, in Rifater, Rifadin); sildenafil (Revatio); simvastatin (in Simcor, in Vytorin, Zocor); 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, Jantoven); antifungals such as itraconazole (Sporanox), ketoconazole (Nizoral), and voriconazole (Vfend); beta blockers such as metoprolol (Lopressor, Toprol XL) and timolol (Betimol, in Combigan, in Cosopt, Istalol, Timoptic); bosentan (Tracleer); buprenorphine (Buprenex, Butrans, in Suboxone, Subutex); 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), pravastatin (Pravachol), and rosuvastatin (Crestor); colchicine (Colcrys); desipramine (Norpramin); dexamethasone (Decadron, Dexpak); fluticasone (in Advair, Flonase, Flovent); other medications for HIV including indinavir (Crixivan), lopinavir/ritonavir (Kaletra), maraviroc (Selzentry), and saquinavir (Invirase); medications for irregular heartbeat including amiodarone (Cordarone, Pacerone), bepridil (Vascor) (not available in the U.S.), digoxin (Lanoxin), flecainide (Tambocor), propafenone (Rythmol), 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 (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Prograf); methadone (Dolophine, Methadose); certain phosphodiesterase inhibitors (PDE-5 inhibitors) used for erectile dysfunction such as sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra); rifabutin (Mycobutin); risperidone (Risperdal); salmeterol (in Advair, Serevent); certain selective serotonin reuptake inhibitors (SSRIs) such as paroxetine (Paxil) and sertraline (Zoloft); tadalafil (Adcirca); thioridazine; 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. You should not take St. John's wort during your treatment with darunavir.
• 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), cirrhosis (a disease which causes scarring of liver tissue), 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 breast-feed 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?

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

What should I do IF I FORGET to take a dose?

If you are taking darunavir once a day and you miss a dose by less than 12 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 12 hours, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

If you are taking darunavir twice a day and 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 medicine cause?

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

What should I know about STORAGE and DISPOSAL of this medication?

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.

What should I do in case of OVERDOSE?

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?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to be sure it is safe for you to take darunavir and to check your body's response to darunavir.

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.

AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: March 15, 2012.