[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.
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.
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.
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.
Talk to your doctor about eating grapefruit or drinking grapefruit juice while taking this medicine.
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.
nausea
vomiting
stomach pain
diarrhea
headache
depression
fever
difficulty falling asleep or staying asleep
muscle pain
rash
numbness, burning, pain, or tingling of hands or feet
irregular heartbeat
dizziness
lightheadedness
yellowing of skin or eyes
pain in your back or side
pain or burning with urination
blood in urine
shortness of breath
general ill feeling or 'flu-like' symptoms
fever
muscle or joint aches
red or swollen eyes
blisters
mouth sores
swelling of your face or neck
yellowing of the skin or eyes
vomiting
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 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 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.
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.
yellowing of skin or eyes
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.
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.