DECEMBER 24, 1999 • HOUSTON VOICE
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 CRIXfVAN?
CRIXIVAN is an oral capsule used for the treatment of HIV (Human Immunodeficiency Virus).
HIV is the virus that causes AIOS (acquired immune deficiency syndrome). CRIXIVAN is a type ot 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.
CRDOVAN is usually prescribed with other anti-HIV drugs such as ZDV (also called AZT), 3TC. ddl, ddC. or
d4T. CRIXIVAN works differently from these other anti-HIV drugs. Talk with your doctor about how you
should take CRIXIVAN.
CRIXfVAN has been studied in adults. The safety and effectiveness of CRIXIVAN in children and adolescents
have not been established.
How should I take CRIXIVAN?
There are six important things you must do to help you benefit from CRIXIVAN:
1 Take CRIXNAN capsules every day as prescribed by your doctor. Continue taking CRIXIVAN unless your
doctor tells you to stop. Take the exact amount ot CRMVAN that your docftxteis you to tate
start. To help make sure you will benefit trom CRIXIVAN, you must not skip doses or take "drug holidays".
If you don't take CRWVAN as prescribed, the activity of CRKfVAN 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 sjom or pon-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 fight meals include.
dry toast with jelly, juice, and coffee (with skjm or non-fat milk and sugar if you want)
com flakes with sJsjm or non-fat milk and sugar
Do not take CRIXIVAN at the same bme as any meals that are high in calories, fat. and protein
xample — a bacon and egg breakfast), when taken at the same time as CRIXIVAN. these roods
—fere with CRIXIVAN being absorbed into your bloodstream and may lessen its effect.
6. It is critical that you drink at least six 8-ounce glasses ot liquids (preferably water) throughout
the day, every day. 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 is not a cure for HIV or AIDS. People taking CRIXIVAN may still develop infections or other conditions
associated with HIV. Because of this, it is very important for you to remain under the care of a doctor.
Although CRIXIVAN is not a cure for HIV or AIDS, CRIXIVAN can help reduce your chances of getting illnesses,
including death, associated with HIV. CRIXIVAN may not have these effects in all patients.
Does CRIXIVAN reduce We risk of passing HIV to others ?
CRIXIVAN has not been shown to reduce the nsk ol passing HIV to others through sexual contact or blood
Who should not take CRIXIVAN?
Do not take CRfXJVAN 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 it;
■ 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 breast-feeding. You should stop breast -feeding if you are taking CRIXIVAN.
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.
■ 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.
Can CRIXIVAN be taken with other medications?"
Drugs you should not take with CRIXIVAN:
SELDANE* (terfenadine) HISMANAL'1 (astemizole)
VERSED* (midazolam) HALClON* (triazolam)
PROPULSID* (cisapride) Ergot medications (e.g., Wigraine* and Cafergot*)
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 rifampin, known as RIFADIN*. RIFAMATE", RIFATER",
Drugs you can take with CRIXIVAN include:
RETROVIR' (zidovudine, ZDV also called AZT)
ZERD* (stavudine. d4T)
V1DEX" (didanosine, ddl) -
MYCOBUTIN* (rifabutin) -
EPMR" (lamwudine, 3TC)
ORTHO-NOVUM 1/35* (oral contraceptive)
- If you take CRIXIVAN with V1DEX*, take them at least one hour apart.
- If you take CRIXIVAN with MYCOBUTIN", your doctor may adjust both the dose
of MYCOBUTIN and the dose of CRIXIVAN.
MZORAL" (ketoconazote) — If you take CRIXIVAN with NIZORAL'1, your doctor may adjust the dose of CRIXIVAN.
SPORftNOX" fttraconazole)—If you take CRMVAN with SPORANOX". your doctor may adjust the dose of CRIXIVAN
SUSTTVA"" (efavirenz)—If you take CRIXIVAN with SUSTTVA", your doctor may adjust the dose of CRIXIVAN.
Talk to your doctor about any medications you are taking.
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 atone 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. Drinking at
least six 8-ounce glasses of liquid (preferably water) each day should help reduce the chances of
forming a kidney stone. Cdll your dxtor or other health care provider if you develop kidney pains (middle
to lower stomach or back pain) or blood m the unne.
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 protease inhibitors. These changes may
include increased amount of fat in the upper back and neck ("buffalo hump"), breast, and around the
oss of fat from the legs and arms may also happen. The cause and long term health effects of
these conditions are not known at
Increases in bilirubin (one laboratory test of liver function) have been reported in approximately 10% of
patients. Usually, this linding 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,
Hank pain, feeling unwell, nausea, diarrhea, vomiting, acid regurgitation, loss of appetite, dry mouth,
back pain, headache, trouble sleeping, dizziness, tasle changes, rash, upper respiratory infection,
dry skin, and sore throat.
Swollen kidneys due to blocked urine flow occurred rarely.
Other side effects reported since CRIXIVAN has been marketed include:
allergic reactions; severe skin reactions; yellowing of the skin and/or eyes;
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 unne;
painful urination; and numbness of the mouth.
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?
m Keep CRIXIVAN capsules m the bottle they came in and at room
temperature (59°- 86°F).
■ Keep CRIXIVAN capsules dry by leaving the small desiccant "pillow"
in the bottle. Keep the bottle closed.
This medication was prescribed for your particular condition. Do not use it tor any other condition or give it to anybody else. Keep CRIXIVAN and all medicines
out of me reach of children. It you suspect that more than the prescribed dose ot this medicine has been taken, contact your local poison control center
or emergency room immediately.
This leaflet provides a summary of information about CRDOVAN It you nave any questions or concerns about either CWXrVAN or mv, la* to you doctor
led Issued June 1999