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Crixivan (indinavir)
Full US Prescribing Information
Patient Product Information

Patient Information
What is Crixivan

What are the side effects?
Medicines you should not take with Crixivan
Medicines you can take with Crixivan
Taking Crixivan with foods?
www.merck.com (www.crixivan web site is no longer available)


What is Crixivan?

CRIXIVAN is a protease (PRO-tee-ase) inhibitor used in combination with other anti-HIV drugs for the treatment of 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 not a cure for HIV or AIDS
Does not reduce your chances of transmitting HIV to others
Should be taken only in combination with other drugs for HIV infection


Taking Crixivan with foods?

For some HIV medicines to work, you have to take them with food. Others must be taken on an empty stomach. If you’re on CRIXIVAN, you can take it with a light meal or on an empty stomach, whichever is easier for you. The rest of the day, when you’re not taking your CRIXIVAN, you can eat whatever you want.

If you are going to eat a big meal around your dose of CRIXIVAN, remember that CRIXIVAN works best when you take it 1 hour before eating a big meal or 2 hours after eating a big meal.

That’s because foods high in calories, fat, or protein get in the way of CRIXIVAN, meaning it may not get into your bloodstream and get to work. You can still eat things like bacon and eggs for breakfast, or a pizza or burger now and then for lunch or dinner. Just make sure you take CRIXIVAN 1 hour before or 2 hours after that kind of meal.

You can even eat a little something with your dose of CRIXIVAN. Just make it light. Meals like plain spaghetti with tomato sauce, or a corn tortilla with steamed rice and salsa. Or snacks like pretzels and soda, plain popcorn, or fat-free pudding.

You have more to choose from, too! Check out the food list made up especially for people who want to eat a light meal when taking CRIXIVAN. Ask your healthcare provider about this food list.



What Are the Side Effects?

Possible Side Effects


Do not take CRIXIVAN® (indinavir sulfate) if you have had a serious allergic reaction to CRIXIVAN or any of its components.

Some patients treated with CRIXIVAN developed kidney stones. For some, this leads to more severe kidney problems, including kidney failure, inflammation of the kidneys, or kidney infection, which sometimes spreads to the blood. Drinking at least six 8-ounce glasses of liquid (preferably water) each day should help reduce the chance of forming a kidney stone.

Also, some patients experienced rapid breakdown of red blood cells (hemolytic anemia), which in some cases was severe or resulted in death; some had liver problems, including liver failure and death.

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.

There have been reports of increased bleeding in patients with hemophilia A and B.

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 effects of these conditions are not known at this time.

Increases in bilirubin (one laboratory test of liver function) have occurred in approximately 14% of patients, and, on rare occasions, a patient 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.

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; 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.



Medicines you should not take with Crixivan

Cordarone® (amiodarone)
Ergot medications (eg, Wigraine®, Cafergot®, D.H.E. 45, Migranal®, Ergotrate®, Methergine®)
Halcion® (triazolam)
Hismanal® (astemizole)
Mevacor® (lovastatin)
Orap® (pimozide)
Propulsid® (cisapride)
Reyataz™ (atazanavir)
Rifadin®, Rifamate®, Rifater®, Rimactane® (rifampin)
Versed® (midazolam)
Zocor® (simvastatin)




Medicines you can take with Crixivan

Bactrim®/Septra® (trimethoprim/sulfamethoxazole)
Biaxin® (clarithromycin)
Crestor® (rosuvastatin)
Diflucan® (fluconazole)
Epivir® (lamivudine, 3TC)
Isoniazid® (INH)
Lipitor® (atorvastatin) *
Methadone
Mycobutin® (rifabutin) *
Nizoral® (ketoconazole) *
Ortho-Novum 1/35® (oral contraceptive)
Rescriptor® (delavirdine)*
Retrovir® (zidovudine)
Sporanox® (itraconazole) *
Sustiva® (efavirenz) *
Tagamet® (cimetidine)
Videx® (didanosine) *
Zerit® (stavudine, d4T)