[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: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.
[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: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.
Taking ritonavir with certain other medications may cause serious or life-threatening side effects. Tell your doctor if you are taking any of the following medications: ergot medications such as dihydroergotamine (D.H.E. 45, Migranal), ergotamine (Ergomar, in Cafergot, in Migergot), ergonovine, and methylergonovine (Methergine); medications for irregular heartbeat such as amiodarone (Cordarone, Pacerone), bepridil (Vascor) (not available in the U.S.), flecainide (Tambocor), propafenone (Rhythmol), and quinidine; and sedatives or sleeping pills such as midazolam (Versed) and triazolam (Halcion). Your doctor will probably tell you not to take ritonavir if you are taking any of these medications.
Ritonavir is used with other medications to treat human immunodeficiency virus (HIV) infection. Ritonavir is in a class of antiviral medications called protease inhibitors. It works by slowing the spread of HIV infection in the body. Ritonavir does not cure HIV and may not decrease the number of HIV-related illnesses. Ritonavir does not prevent the spread of HIV to other people.
Ritonavir comes as a capsule, a tablet, and a solution (liquid) to take by mouth. It is usually taken twice a day with meals. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take ritonavir exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Your doctor will probably start you on a low dose of ritonavir and gradually increase your dose, not more often than once every 2 to 3 days. Follow these directions carefully.
Swallow ritonavir tablets whole. Do not split, chew, or crush them.
If you are taking the oral solution, use a dose measuring spoon, syringe, or cup to measure the correct amount of liquid needed for each dose. Do not use a regular household spoon. You may take the solution by itself, or you may improve the taste by mixing it with 8 ounces of chocolate milk or Ensure or Advera brand dietary supplements. If you mix the medication with once of these liquids, you must drink the mixture no longer than one hour after you mix it.
If your doctor tells you to stop taking ritonavir capsules and start taking the tablets instead, you may experience more side effects such as nausea, vomiting, stomach pain, and diarrhea shortly after you switch. These symptoms may improve as your body adjusts to the tablets.
Continue to take ritonavir even if you feel well. Do not stop taking ritonavir without talking to your doctor. If you miss doses, take less than the prescribed dose, or stop taking ritonavir, your condition may become more difficult to treat.
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
Unless your doctor tells otherwise, continue your normal diet.
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
drowsiness
diarrhea
gas
heartburn
change in ability to taste food
headache
numbness, burning, or tingling of the hands, feet, or area around the mouth
muscle or joint pain
blistering or peeling of the skin
rash
hives
swelling of the eyes, face, tongue, lips, or throat
tightening of the throat
difficulty breathing or swallowing
nausea
vomiting
stomach pain
excessive tiredness
lack of energy
loss of appetite
pain in the upper right part of the stomach
yellowing of the skin or eyes
dizziness
lightheadedness
loss of consciousness
irregular heartbeat
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/Safety/MedWatch] or by phone [1-800-332-1088].
Ritonavir may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store the tablets and solution at room temperature. Do not refrigerate the solution and do not let it get too hot or too cold. It is best to refrigerate ritonavir capsules, but you may also store them at room temperature for up to 30 days. 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 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.
It is especially important to get medical help right away if a child drinks more than the usual dose of the solution. The solution contains a large amount of alcohol that could be very harmful to a child.
numbness, burning, or tingling of the hands or feet
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to ritonavir.
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.
Last Revised - 03/15/2012
AHFS® Consumer Medication Information. © Copyright, 2012. 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.