[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.
Telaprevir is used along with two other medications (ribavirin [Copegus, Rebetol] and peginterferon alfa [Pegasys]) to treat chronic hepatitis C (an ongoing viral infection that damages the liver) in people who have not yet been treated for this condition or whose condition could not successfully be treated with ribavirin and peginterferon alfa alone. Telaprevir is in a class of medications called protease inhibitors. It works by decreasing the amount of hepatitis C virus (HCV) in the body. Telaprevir may not prevent the spread of hepatitis C to other people.
Telaprevir comes as a tablet to take by mouth. It is usually taken three times a day (every 7 to 9 hours). You must eat a meal or snack that contains about 20 grams of fat within 30 minutes before you take telaprevir. Ask your doctor for examples of foods that contain 20 grams of fat that you can eat when you take telaprevir. Do not take telaprevir without food. Take telaprevir 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 telaprevir exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Continue to take telaprevir even if you feel well. Telaprevir must be taken in combination with peginterferon alfa and ribavirin, usually for 12 weeks. Peginterferon alfa and ribavirin are usually continued after treatment with telaprevir is finished. Do not stop taking telaprevir, peginterferon alfa, or ribavirin, unless told to do so by your doctor.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with telaprevir and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.
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.
If you remember the missed dose within 4 hours of the time you were scheduled to take it, take the missed dose with a snack or meal (containing about 20 grams of fat) right away. However, if it is more than 4 hours since you were to take the dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
tiredness
nausea
vomiting
diarrhea
change in ability to taste
itching
hemorrhoids
discomfort, burning or itching around the anus
rash (with or without itching)
yellowing of the skin or eyes
blisters in the mouth or throat
red, swollen eyes
fever
swelling of the face
decreased urination
pale skin
dizziness
shortness of breath
weakness
Telaprevir 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 it at room temperature and away from excess heat and moisture (not in the bathroom). After a bottle of telaprevir is first opened, the medication must be used within 28 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.
nausea
diarrhea
vomiting
headache
loss of appetite
changes in taste
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to telaprevir.
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.