[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.
Tipranavir (taken with ritonavir [Norvir]) may cause bleeding in the brain. This condition may be life-threatening. Tell your doctor if you have recently had surgery or if you have recently been injured in any way. Also tell your doctor if you have a bleeding disorder such as hemophilia (condition in which the blood does not clot normally). Tell your doctor and pharmacist if you are taking any of the following medications: anticoagulants ('blood thinners') such as warfarin (Coumadin), aspirin or products containing aspirin, cilostazol (Pletal), clopidogrel (Plavix), or ticlopidine (Ticlid). You should also tell your doctor and pharmacist if you are taking vitamin E, other than the amount contained in a regular daily multivitamin. If you need to get emergency medical treatment for any reason, be sure to tell all of the doctors who treat you that you are taking tipranavir. Call your doctor immediately if you experience unusual bruising or bleeding during your treatment with tipranavir.
Tipranavir (taken with ritonavir [Norvir]) may cause liver damage that may be life-threatening. Tell your doctor if you have or have ever had hepatitis (swelling of the liver caused by a virus) or any other liver disease or if you drink or have drunk alcohol. If you experience any of the following symptoms, stop taking tipranavir and call your doctor immediately: tiredness; weakness; flu-like symptoms; loss of appetite; nausea; vomiting; pain, ache, swelling, or sensitivity on your right side below your ribs; yellowing of the skin or eyes; dark (tea-colored) urine; or pale bowel movements.
Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body's response to tipranavir.
Talk to your doctor about the risks of taking tipranavir.
Tipranavir is used with ritonavir (Norvir) and at least 2 other medications to treat human immunodeficiency virus (HIV). Tipranavir is in a class of medications called protease inhibitors. It works by slowing the spread of HIV in the body. Tipranavir does not cure HIV infection and may not prevent you from developing HIV-related illnesses. Tipranavir does not prevent you from spreading HIV to other people.
Tipranavir comes as a capsule and an oral solution (liquid) to take by mouth. It is taken with ritonavir, usually twice a day, with or without food. Take tipranavir and ritonavir 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 tipranavir exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Do not take tipranavir without ritonavir.
Swallow the capsules whole; do not chew them. If you are unable to swallow the capsules, tell your doctor or pharmacist.
Tipranavir helps to control HIV infection but does not cure it. Continue to take tipranavir even if you feel well. Do not stop taking tipranavir without talking to your doctor. If you stop taking tipranavir or skip doses, your condition may become more difficult to treat. When your supply of tipranavir starts to run low, get more from your doctor or pharmacist.
Ask your doctor or pharmacist for a copy of the manufacturer's information for the patient. Read this information carefully and ask your doctor or pharmacist if you have any questions.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medicine.
Take the missed dose together with ritonavir 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.
extreme thirst
frequent urination
extreme hunger
weakness
blurred vision
dry mouth
nausea and vomiting
shortness of breath
breath that smells fruity
decreased consciousness
diarrhea
vomiting
weight loss
headache
fever, chills, cough, or other signs of infection
rash
redness, blistering, or peeling of skin
itching
throat tightness
difficulty breathing or swallowing
muscle or joint pain or stiffness
Tipranavir 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 unopened bottles of tipranavir capsules in the refrigerator. Store opened bottles of tipranavir capsules at room temperature, and away from excess heat and moisture (not in the bathroom). Store tipranavir solution at room temperature. Do not refrigerate or freeze tipranavir solution. Mark the date you open the bottle of tipranavir on the label; if the medication is not used within 60 days, throw the remaining medication away. 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.
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.