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[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?
Atazanavir is used in combination with other medications to treat HIV infection (human immunodeficiency virus). Atazanavir is in a class of medications called HIV protease inhibitors. It works by slowing the spread of HIV in the body. Atazanavir will not cure HIV and may not prevent you from developing HIV-related illnesses. Atazanavir will not prevent you from spreading HIV to other people.
HOW should this medicine be used?
Atazanavir comes as a capsule to take by mouth. It is usually taken once a day with a meal or snack. Take atazanavir at around the same time 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 atazanavir exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
You will take other medications for HIV while you are taking atazanavir. Your doctor will tell you whether these medications should be taken at the same time as atazanavir, or several hours before or after you take atazanavir. Follow this schedule carefully, and ask your doctor or pharmacist if you have questions about the times you should take your medications.
Swallow the capsules whole; do not split, chew, or open them.
Atazanavir helps to control HIV infection, but does not cure it. Continue to take atazanavir even if you feel well. Do not stop taking atazanavir without talking to your doctor. When your supply of atazanavir starts to run low, get more from your doctor or pharmacist. If you stop taking atazanavir or skip doses, your condition may become more difficult to treat.
Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.
Are there OTHER USES for this medicine?
Atazanavir is also sometimes used to prevent infection in healthcare workers or other people who were accidentally exposed to HIV. Talk to your doctor about the risks of using this medication for your condition.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
Before taking atazanavir,
- tell your doctor and pharmacist if you are allergic to atazanavir or any other medications.
- tell your doctor if you are taking any of following medications or herbal products: cisapride (Propulsid) (not available in the US); ergot alkaloids such as dihydroergotamine (Migranal, D.H.E. 45), ergonovine (Ergotrate), ergotamine (Cafergot, Ercaf, others), or methylergonovine (Methergine); indinavir (Crixivan); irinotecan (Camptosar); lovastatin (Mevacor); midazolam (Versed) by mouth; pimozide (Orap); rifampin (Rimactane, Rifadin, in Rifater, in Rifamate,); simvastatin (Zocor); St. John's wort; and triazolam (Halcion). Your doctor will probably tell you not to take atazanavir.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, herbal products, 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); antidepressants ('mood elevators') such as amitriptyline (Elavil, others ),desipramine (Norpramin), doxepin (Adapin, Sinequan), imipramine (Tofranil), protriptyline (Vivactil), and trimipramine (Surmontil); certain antifungals such as itraconazole (Sporanox), ketoconazole (Nizoral), and voriconazole (Vfend); beta blockers such as labetalol (Normodyne), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal); calcium channel blockers such as bepridil (Vascor) (not available in the US), diltiazem (Cardizem, Covera, Dilacor, Tiazac, others), felodipine (Plendil), nicardipine (Cardene), nifedipine (Adalat, Procardia), and verapamil (Calan, Isoptin, Verelan); carbamazepine (Tegretol); certain cholesterol-lowering medications (statins) such as atorvastatin (Lipitor, in Caduet), and rosuvastatin (Crestor); clarithromycin (Biaxin, Prevpac); digoxin (Lanoxin, Digitek); fluticasone (Advair, Flonase, Flovent); medications for erectile dysfunction such as sildenafil (Viagra), tadalafil (Cialis), or vardenafil (Levitra); medications for irregular heartbeat such as amiodarone (Cordarone, Pacerone), lidocaine (Xylocaine), and quinidine; medications that suppress the immune system such as cyclosporine (Neoral, Sandimmune),sirolimus (Rapamune), and tacrolimus (Prograf); other medications for HIV or AIDS including efavirenz (Sustiva), nevirapine (Viramune), saquinavir (Invirase),and tenofovir (Viread, in Atripla, in Truvada); paclitaxel (Taxol);repaglinide (Prandin); rifabutin (Mycobutin); and trazodone. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with atazanavir, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
- If you are taking antacids, didanosine delayed-release capsules (Videx EC), or any other buffered medication such as buffered aspirin (Bufferin), take atazanavir 2 hours before or 1 hour after you take the medication. Ask your doctor or pharmacist if you are not sure if any of the medications you are taking are buffered.
- tell your doctor if you are taking a medication for indigestion, heartburn, or ulcers such as cimetidine (Tagamet), esomeprazole (Nexium), famotidine (Pepcid), lansoprazole (Prevacid), nizatidine (Axid), omeprazole (Prilosec), pantoprazole (Protonix), rabeprazole (Aciphex), or ranitidine (Zantac). Your doctor may tell you not to take the medication or to take a lower dose of the medication. If you are to continue taking the medication, your doctor will tell you how much time you should allow between taking the medication and taking atazanavir.
- tell your doctor if you have or have ever had an irregular heartbeat, diabetes or high blood sugar, hemophilia (a condition in which the blood does not clot normally) or any other bleeding disorder, hepatitis (a viral infection of the liver) or any other liver disease, kidney or heart disease.
- tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking atazanavir, call your doctor. You should not breast-feed if you are infected with HIV and are taking atazanavir.
- you should know that atazanavir may decrease the effectiveness of hormonal contraceptives (birth control pills, patches, rings, implants, and injections). Talk to your doctor about methods of birth control that will work for you while you are taking atazanavir.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking atazanavir.
- you should know that you may experience hyperglycemia (increases in your blood sugar) while you are taking this medication, even if you do not already have diabetes. Tell your doctor immediately if you have any of the following symptoms while you are taking atazanavir: extreme thirst, frequent urination, extreme hunger, blurred vision, or weakness. It is very important to call your doctor as soon as you have any of these symptoms, because high blood sugar that is not treated can cause a serious condition called ketoacidosis. Ketoacidosis may become life-threatening if it is not treated at an early stage. Symptoms of ketoacidosis include: dry mouth, nausea and vomiting, shortness of breath, breath that smells fruity, and decreased consciousness.
- you should know that while you are taking atazanavir your body fat may increase or move to different areas of your body such as the back of your neck and upper shoulders ('buffalo hump'), stomach, and breasts. You may lose fat from your arms, legs, face, and buttocks. Talk to your doctor if you notice any of these changes in your body fat.
- you should know that while you are taking medications to treat HIV infection, your immune system may get stronger and begin to fight other infections that were already in your body, such as pneumonia, herpes virus, tuberculosis, hepatitis, or a fungal infection. If you have new or worsening symptoms after starting treatment with atazanavir, be sure to tell your doctor.
What SPECIAL DIETARY instructions should I follow?
Talk to your doctor about eating grapefruit or drinking grapefruit juice while taking this medicine.
What should I do IF I FORGET to take a dose?
Take the missed dose as soon as you remember it. However, if you are scheduled to take your next dose within the next 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?
Atazanavir may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- stomach pain
- difficulty falling asleep or staying asleep
- muscle pain
- numbness, burning, pain, or tingling of hands or feet
Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:
- irregular heartbeat
- yellowing of skin or eyes
- pain in your back or side
- pain or burning with urination
- blood in urine
If you develop a rash or changes in the appearance of your skin along with any of the following symptoms, stop taking atazanavir and call your doctor immediately:
- shortness of breath
- general ill feeling or 'flu-like' symptoms
- muscle or joint aches
- red or swollen eyes
- mouth sores
- swelling of your face or neck
- yellowing of the skin or eyes
- loss of appetite
- dark-colored urine
- decreased urination
- light-colored bowel movements
Atazanavir may cause other side effects. Call your doctor if you have any unusual problems while you are 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 Web Site] or by phone [1-800-332-1088].
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 and pets. 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.
Symptoms of overdose may include:
- yellowing of skin or eyes
What OTHER INFORMATION should I know?
Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to atazanavir.
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.
Please be aware that this information is provided to supplement the care provided by your physician. It is neither intended nor implied to be a substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with any questions you may have regarding a medical condition.
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