Brand Name(s):

  • Crixivan®


[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: Web Siteand Web Site.

WHY is this medicine prescribed?

Indinavir is used to treat human immunodeficiency virus infection (HIV) in adults. It belongs to a class of drugs called protease inhibitors, which slow the spread of HIV infection in the body. It is usually taken with other antiviral medications. Indinavir is not a cure and may not decrease the number of HIV-related illnesses. Indinavir does not prevent the spread of HIV to other people.

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Indinavir comes as a capsule to take by mouth. It is usually taken every 8 hours (three times a day). Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take indinavir exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Continue to take indinavir even if you feel well. Do not stop taking indinavir without talking to your doctor.

Are there OTHER USES for this medicine?

Indinavir is also used sometimes in combination with zidovudine (Retrovir, AZT) and lamivudine (Epivir) to treat health-care workers and other individuals exposed to HIV infection after accidental contact with HIV-contaminated blood, tissues, or other body fluids. Talk to your doctor about the possible risks of using this drug for your condition.

What SPECIAL PRECAUTIONS should I follow?

Before taking indinavir,

  • tell your doctor and pharmacist if you are allergic to indinavir or any other drugs.
  • tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially astemizole (Hismanal), atorvastatin (Lipitor), cerivastatin (Baycol), cisapride (Propulsid), clarithromycin (Biaxin), delavirdine (Rescriptor), dexamethasone (Decadron), efavirenz (Sustiva), fluconazole (Diflucan), isoniazid (INH), itraconazole (Sporanox), ketoconazole (Nizoral), lovastatin (Mevacor), medications for seizures, midazolam (Versed), oral contraceptives, quinidine, rifabutin (Mycobutin), rifampin (Rifadin), sildenafil (Viagra), simvastatin (Zocor), terfenadine (Seldane), and triazolam (Halcion).
  • tell your doctor what vitamins and herbal products you are taking, especially St. John's wort.
  • if you are taking didanosine, take it at least one hour before or after indinavir.
  • tell your doctor if you have or have ever had hemophilia or kidney or liver disease or a history of alcohol abuse.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking indinavir, call your doctor.
  • tell your doctor if you drink alcohol.

What SPECIAL DIETARY instructions should I follow?

Take indinavir on an empty stomach, 1 hour before meals or 2 hours after meals, with plenty of fluids (an 8-ounce [240-milliliter] glass of water). However, if indinavir upsets your stomach, it may be taken with a light meal, such as dry toast or cornflakes with skim milk. Do not take with grapefruit juice. If you are also taking didanosine (DDI), take 1 hour apart on an empty stomach.

Drink at least 48 ounces (1.5 liters), which is approximately six 8-ounce (240-milliliter) glasses, of water or other liquids every 24 hours.

What should I do IF I FORGET to take a dose?

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.

What SIDE EFFECTS can this medicine cause?

Indinavir may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • headache
  • stomach pain
  • change in the distribution of body fat

If you experience any of the following symptoms, call your doctor immediately:

  • rash
  • back pain
  • pain in the side of your body
  • blood in urine
  • muscle pain
  • upset stomach
  • excessive tiredness
  • unusual bleeding or bruising
  • loss of appetite
  • pain in the upper right part of your stomach
  • flu-like symptoms
  • dark yellow or brown urine
  • yellowing of the skin or eyes
  • paleness

Indinavir may increase the sugar level in your blood. If you experience any of the following symptoms, call your doctor immediately:

  • frequent urination
  • increased thirst
  • weakness
  • dizziness
  • headache

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 Web Site] or by phone [1-800-332-1088].

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. A desiccant (drying agent) is included with your capsules; keep this in your medicine bottle at all times. 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.

What should I do in case of OVERDOSE?

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.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to indinavir.

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.

AHFS® Consumer Medication Information. © Copyright, 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.

Selected Revisions: March 15, 2012.