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You found out you’ve got the virus called HIV. You know because you got yourself tested. And you're taking the important step of getting treatment.
One of the medicines used to treat HIV is CRIXIVAN® (indinavir sulfate). It’s a strong medicine that helps keep HIV under control for a long time when used with other medicines. Sometimes the virus makes it easy for you to get other illnesses. CRIXIVAN can help you lower your chances of getting sick from these types of infections. But it may not have these effects for everybody.
HIV makes lots of copies of itself every day. Your body fights back with lots of good “helper” cells called CD4 or T cells. But if there’s too much HIV in your blood, you have what’s called a high VIRAL LOAD.
CRIXIVAN, in combination with your other HIV medicines, works by stopping the virus from making copies of itself. It helps lower your viral load. And it helps your body make more CD4 cells to help you fight your infections.
ALERT: Find out about medicines that should NOT be taken with CRIXIVAN. Please also read the table “MEDICINES YOU SHOULD NOT TAKE WITH CRIXIVAN.” Talk to your doctor about any medications you are taking.
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:
Take CRIXIVAN capsules every day as prescribed by your doctor.
You can take CRIXIVAN on an empty stomach or with a light meal or snack. Ideally, take each dose of CRIXIVAN without food but with water at least 1 hour before or 2 hours after a meal. With CRIXIVAN and other HIV medications, it is important NOT to skip a dose, take an extra dose, or take a “drug holiday.”
It is critical to drink plenty of fluids while taking CRIXIVAN.
Important Information About CRIXIVAN
Do not take CRIXIVAN if you have had a serious allergic reaction to CRIXIVAN or any of its components.
Talk to your doctor if:
Discuss all medications you are taking or plan to take with your doctor, including nonprescription medicines, herbal products, or dietary supplements. Taking CRIXIVAN with any products containing St. John’s wort, an herbal supplement, is not recommended because it 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.
If you take Viagra® (sildenafil), Cialis® (tadalafil), or Levitra® (vardenafil) with CRIXIVAN, you may be at increased risk of side effects of these medications, such as low blood pressure, visual changes, and penile erection lasting more than 4 hours. If an erection lasts longer than 4 hours, you should seek immediate medical assistance to avoid permanent damage to your penis.
| MEDICINES YOU SHOULD NOT TAKE WITH CRIXIVAN, SOME OF WHICH COULD RESULT IN SERIOUS AND/OR LIFE-THREATENING PROBLEMS |
| 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) |
*May require special instruction from your doctor, including dose modification.
Tell your doctor if you are taking calcium channel blockers (eg, amlodipine, felodipine), antiarrhythmics (eg, quinidine), anticonvulsants (eg, carbamazepine, phenobarbital, phenytoin), or steroids (eg, dexamethasone).
Possible Side Effects
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.
For additional information about CRIXIVAN, please read the Patient Product Information.
The physician Prescribing Information is also available.
