[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.
The combination of lopinavir and ritonavir is used with other antiviral medications to treat human immunodeficiency virus (HIV). Lopinavir and ritonavir are in a class of medications called protease inhibitors. They work by slowing the spread of HIV in the body. When lopinavir and ritonavir are taken together, ritonavir also helps to increase the amount of lopinavir in the body so that the medication will have a greater effect. Lopinavir and ritonavir will not cure HIV and may not decrease the number of HIV-related illnesses. Lopinavir and ritonavir do not prevent the spread of HIV to other people.
The combination of lopinavir and ritonavir comes as a tablet and a solution (liquid) to take by mouth. It is usually taken twice a day, but may be taken once a day by certain adults. The solution must be taken with food. The tablets may be taken with or without food. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take lopinavir and ritonavir exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Swallow the tablets whole; do not split, chew, or crush them.
If you are using the solution, shake it well before each use to mix the medication evenly. Use a dose-measuring spoon or cup to measure the correct amount of liquid for each dose, not a regular household spoon.
Continue to take lopinavir and ritonavir even if you feel well. Do not stop taking lopinavir and ritonavir without talking to your doctor. If you miss doses, take less than the prescribed amount, or stop taking lopinavir and 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 you 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.
weakness
diarrhea
gas
heartburn
weight loss
headache
difficulty falling asleep or staying asleep
muscle pain
numbness, burning, or tingling in the hands or feet
nausea
vomiting
stomach pain
extreme tiredness
loss of appetite
pain in the upper right part of the stomach
yellowing of the skin or eyes
itchy skin
dizziness
lightheadedness
fainting
irregular heartbeat
blisters
rash
Lopinavir and ritonavir 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/Safety/MedWatch] or by phone [1-800-332-1088].
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store the tablets at room temperature and protect them from excess moisture. It is best to keep the tablets in the container they came in; if you must take them out of the container, you should use them within 2 weeks. You may keep the oral solution in the refrigerator until the expiration date printed on the label, or you may store it at room temperature for up to 2 months. 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 and other ingredients that could be very harmful to a child.
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to lopinavir and 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.