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CRIXIVAN ®
(indinavir sulfate) Capsules

CRIXIVAN
(KRIK-sih-van) for HIV (Human Immunodeficiency Virus) Infection Generic name: indinavir (in-DIH-nuh-veer) sulfate

ALERT: Find out about medicines that should NOT be taken with CRIXIVAN . Please also read the section “MEDICINES YOU SHOULD NOT TAKE WITH CRIXIVAN”.

Please read this information before you start taking CRIXIVAN. Also, read the leaflet each time you renew your prescription, just in case anything has changed. Remember, this leaflet does not take the place of careful discussions with your doctor. You and your doctor should discuss CRIXIVAN when you start taking your medication and at regular checkups. You should remain under a doctor's care when using CRIXIVAN and should not change or stop treatment without first talking with your doctor.

What is CRIXIVAN?

CRIXIVAN is an oral capsule used for the treatment of HIV (Human Immunodeficiency Virus). HIV is the virus that causes AIDS (acquired immune deficiency syndrome). CRIXIVAN is a type of HIV drug called a protease (PRO-tee-ase) inhibitor.

How does CRIXIVAN work?

CRIXIVAN is a protease inhibitor that fights HIV. CRIXIVAN can help reduce your chances of getting illnesses associated with HIV. CRIXIVAN can also help lower the amount of HIV in your body (called “viral load”) and raise your CD4 (T) cell count. CRIXIVAN may not have these effects in all patients.

CRIXIVAN is usually prescribed with other anti-HIV drugs such as ZDV (also called AZT), 3TC, ddI, ddC, or d4T. CRIXIVAN works differently from these other anti-HIV drugs. Talk with your doctor about how you should take CRIXIVAN.

How should I take CRIXIVAN?

There are six important things you must do to help you benefit from CRIXIVAN:

1. Take CRIXIVAN capsules every day as prescribed by your doctor. Continue taking CRIXIVAN unless your doctor tells you to stop. Take the exact amount of CRIXIVAN that your doctor tells you to take, right from the very start. To help make sure you will benefit from CRIXIVAN, you must not skip doses or take “drug holidays”. If you don't take CRIXIVAN as prescribed, the activity of CRIXIVAN may be reduced (due to resistance).
2. Take CRIXIVAN capsules every 8 hours around the clock, every day. It may be easier to remember to take CRIXIVAN if you take it at the same time every day. If you have questions about when to take CRIXIVAN, your doctor or health care provider can help you decide what schedule works for you.
3. If you miss a dose by more than 2 hours, wait and then take the next dose at the regularly scheduled time. However, if you miss a dose by less than 2 hours, take your missed dose immediately. Then take your next dose at the regularly scheduled time. Do not take more or less than your prescribed dose of CRIXIVAN at any one time.
4. Take CRIXIVAN with water. You can also take CRIXIVAN with other beverages such as skim or non-fat milk, juice, coffee, or tea.
5. Ideally, take each dose of CRIXIVAN without food but with water at least one hour before or two hours after a meal. Or you can take CRIXIVAN with a light meal. Examples of light meals include:
   dry toast with jelly, juice, and coffee (with skim or non-fat milk and sugar if you want)
   cornflakes with skim or non-fat milk and sugar Do not take CRIXIVAN at the same time as any meals that are high in calories, fat, and protein (for example — a bacon and egg breakfast). When taken at the same time as CRIXIVAN, these foods can interfere with CRIXIVAN being absorbed into your bloodstream and may lessen its effect.
6. It is critical to drink plenty of fluids while taking CRIXIVAN. Adults should drink at least six 8ounce glasses of liquids (preferably water) throughout the day, every day. Your health care provider will give you further instructions on the amount of fluid that you should drink. CRIXIVAN can cause kidney stones. Having enough fluids in your body should help reduce the chances of forming a kidney stone. Call your doctor or other health care provider if you develop kidney pains (middle to lower stomach or back pain) or blood in the urine.

Does CRIXIVAN cure HIV or AIDS?

CRIXIVAN does not cure HIV infection or AIDS and you may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. You should remain under the care of a doctor when using CRIXIVAN.

Avoid doing things that can spread HIV-1 infection.

• Do not share needles or other injection equipment.
• Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades.
• Do not have any kind of sex without protection. Always practice safe sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood.

Who should not take CRIXIVAN?

Do not take CRIXIVAN if you have had a serious allergic reaction to CRIXIVAN or any of its components.

What other medical problems or conditions should I discuss with my doctor?

Talk to your doctor if:

• You are pregnant or if you become pregnant while you are taking CRIXIVAN. We do not yet know how CRIXIVAN affects pregnant women or their developing babies.
• You are breastfeeding. Do not breastfeed. We do not know if CRIXIVAN can be passed to your baby in your breast milk and whether it could harm your baby. Also, mothers with HIV-1 should not breastfeed because HIV-1 can be passed to the baby in the breast milk.

Also talk to your doctor if you have:

• Problems with your liver, especially if you have mild or moderate liver disease caused by cirrhosis
• Problems with your kidneys
• Diabetes
• Hemophilia
• High cholesterol and you are taking cholesterol-lowering medicines called “statins”

Tell your doctor about any medicines you are taking or plan to take, including non-prescription medicines, herbal products including St. John's wort (Hypericum perforatum), or dietary supplements.

Can CRIXIVAN be taken with other medications?

MEDICINES YOU SHOULD NOT TAKE WITH CRIXIVAN

Taking CRIXIVAN with the above medications could result in serious or life-threatening problems (such as irregular heartbeat or excessive sleepiness).

In addition, you should not take CRIXIVAN with the following:

Rifampin, known as RIFADIN®, RIFAMATE®, RIFATER®, or RIMACTANE®.

There is also an increased risk of drug interactions between CRIXIVAN and LIPITOR® (atorvastatin) and CRESTOR® (rosuvastatin); talk to your doctor before you take any of these cholesterol-reducing drugs with CRIXIVAN.

Taking CRIXIVAN with REYATAZ® (atazanavir) is not recommended because they can both sometimes cause increased levels of bilirubin in the blood.

Taking CRIXIVAN with St. John's wort (Hypericum perforatum), an herbal product sold as a dietary supplement, or products containing St. John's wort is not recommended. Taking St. John's wort has been shown to decrease CRIXIVAN levels and may lead to increased viral load and possible resistance to CRIXIVAN or cross resistance to other antiretroviral drugs.

Before you take VIAGRA® (sildenafil), CIALIS® (tadalafil), or LEVITRA® (vardenafil) with CRIXIVAN, talk to your doctor about possible drug interactions and side effects. If you take any of these medicines together with CRIXIVAN, you may be at increased risk of side effects such as low blood pressure, visual changes, and penile erection lasting more than 4 hours, which have been associated with sildenafil, tadalafil, and vardenafil. If an erection lasts longer than 4 hours, you should seek immediate medical assistance to avoid permanent damage to your penis. Your doctor can explain these symptoms to you.

MEDICINES YOU CAN TAKE WITH CRIXIVAN

VIDEX® (didanosine, ddI) — If you take CRIXIVAN with VIDEX, take them at least one hour apart.

MYCOBUTIN® (rifabutin) — If you take CRIXIVAN with MYCOBUTIN, your doctor may adjust both the dose of MYCOBUTIN and the dose of CRIXIVAN. NIZORAL® (ketoconazole) — If you take CRIXIVAN with NIZORAL, your doctor may adjust the dose of CRIXIVAN.

RESCRIPTOR® (delavirdine) — If you take CRIXIVAN with RESCRIPTOR, your doctor may adjust the dose of CRIXIVAN.

SPORANOX® (itraconazole) — If you take CRIXIVAN with SPORANOX, your doctor may adjust the dose of CRIXIVAN.

SUSTIVA™ (efavirenz) — If you take CRIXIVAN with SUSTIVA, check with your doctor.

Intravenous VERSED® (midazolam) — If you take CRIXIVAN with Intravenous VERSED®, your doctor may adjust the dose of VERSED®.

Talk to your doctor about any medications you are taking.

Calcium Channel Blockers: Tell your doctor if you are taking calcium channel blockers (e.g., amlodipine, felodipine).

Antiarrhythmics: Tell your doctor if you are taking antiarrhythmics (e.g., quinidine). Anticonvulsants: Tell your doctor if you are taking anticonvulsants (e.g., phenobarbital, phenytoin, or carbamazepine).

Steroids: Tell your doctor if you are taking steroids (e.g., dexamethasone).

What are the possible side effects of CRIXIVAN?

Like all prescription drugs, CRIXIVAN can cause side effects. The following is not a complete list of side effects reported with CRIXIVAN when taken either alone or with other anti-HIV drugs. Do not rely on this leaflet alone for information about side effects. Your doctor can discuss with you a more complete list of side effects.

Some patients treated with CRIXIVAN developed kidney stones. In some of these patients this led to more severe kidney problems, including kidney failure or inflammation of the kidneys or kidney infection which sometimes spread to the blood. Drinking at least six 8-ounce glasses of liquids (preferably water) each day should help reduce the chances of forming a kidney stone ( see How should I take CRIXIVAN?). Call your doctor or other health care provider if you develop kidney pains (middle to lower stomach or back pain) or blood in the urine.

Some patients treated with CRIXIVAN have had rapid breakdown of red blood cells (hemolytic anemia) which in some cases was severe or resulted in death.

Some patients treated with CRIXIVAN have had liver problems including liver failure and death. Some patients had other illnesses or were taking other drugs. It is uncertain if CRIXIVAN caused these liver problems.

Diabetes and high blood sugar (hyperglycemia) have occurred in patients taking protease inhibitors. In some of these patients, this led to ketoacidosis, a serious condition caused by poorly controlled blood sugar. Some patients had diabetes before starting protease inhibitors, others did not. Some patients required adjustments to their diabetes medication. Others needed new diabetes medication.

In some patients with hemophilia, increased bleeding has been reported.

Severe muscle pain and weakness have occurred in patients taking protease inhibitors, including CRIXIVAN, together with some of the cholesterol-lowering medicines called “statins”. Call your doctor if you develop severe muscle pain or weakness.

Changes in body fat have been seen in some patients taking antiretroviral therapy. These changes may include increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the trunk. Loss of fat from the legs, arms and face may also happen. The cause and long term health effects of these conditions are not known at this time.

In some patients with advanced HIV infection (AIDS), signs and symptoms of inflammation from opportunistic infections may occur when combination antiretroviral treatment is started.

Clinical Studies

Increases in bilirubin (one laboratory test of liver function) have been reported in approximately 14% of patients. Usually, this finding has not been associated with liver problems. However, on rare occasions, a person may develop yellowing of the skin and/or eyes.

Side effects occurring in 2% or more of patients included: abdominal pain, fatigue or weakness, low red blood cell count, flank pain, painful urination, feeling unwell, nausea, upset stomach, diarrhea, vomiting, acid regurgitation, increased or decreased appetite, back pain, headache, dizziness, taste changes, rash, itchy skin, yellowing of the skin and/or eyes, upper respiratory infection, dry skin, and sore throat.

Swollen kidneys due to blocked urine flow occurred rarely.

Marketing Experience

Other side effects reported since CRIXIVAN has been marketed include: allergic reactions; severe skin reactions; yellowing of the skin and/or eyes; heart problems including heart attack; stroke; abdominal swelling; indigestion; inflammation of the kidneys; decreased kidney function; inflammation of the pancreas; joint pain; depression; itching; hives; change in skin color; hair loss; ingrown toenails with or without infection; crystals in the urine; painful urination; numbness of the mouth and increased cholesterol.

Tell your doctor promptly about these or any other unusual symptoms. If the condition persists or worsens, seek medical attention.

How should I store CRIXIVAN capsules?

• Keep CRIXIVAN capsules in the bottle they came in and at room temperature (59°-86°F).
• Keep CRIXIVAN capsules dry by leaving the small desiccant in the bottle. Keep the bottle closed.

This medication was prescribed for your particular condition. Do not use it for any other condition or give it to anybody else. Keep CRIXIVAN and all medicines out of the reach of children. If you suspect that more than the prescribed dose of this medicine has been taken, contact your local poison control center or emergency room immediately.

This leaflet provides a summary of information about CRIXIVAN. If you have any questions or concerns about either CRIXIVAN or HIV, talk to your doctor.

Last reviewed on RxList: 3/2/2012
This monograph has been modified to include the generic and brand name in many instances.