t.
A g o u ro n
Pharm aceuticals, h e .
A
P f i z • r
C o m p a n y
VIRACEPT*
(nelfinavir mesylate)
Tablets and Oral Powder
Information for Patients
about VIRACEPT* (Vl-ra-cept)
Generic Name: nelfinavir (nel-RN-na-veer) mesylate
For the Treatment of Human
Immunodeficiency Virus (HIV) Infection
Please read this information carefully before taking V1RACEPT. Also, please
read this leaflet each time you renew the prescription, just in case anything
has changed. This is a summary and not a replacement for a careful
discussion with your doctor. You and your doctor should discuss V1RACEPT
when you start taking this medication and at regular checkups. You should
remain under a doctor’s care when taking VIRACEPT and should not change
or stop treatment without first talking with your doctor.
A lert Find out about medicines that should NOT be taken with
VIRACEPT. Please also read the section "MEDICINES YOU SHOULD NOT
TAKE WITH VIRACEPT” .
WHAT IS VIRACEPT AND HOW DOES IT WORK?
VIRACEPT is used in combination with other antiretroviral drugs in the
treatment of people with human immunodeficiency vim s (HIV) infection.
Infection with HIV leads to the destruction of CD4 T cells, which are important
to the immune system. After a large number of CD4 cells have been
destroyed, the infected person develops acquired immune deficiency
syndrome (AIDS).
VIRACEPT works by blocking HIV protease (a protein-cutting enzyme), which
is required for HIV to multiply. VIRACEPT has been shown to significantly
reduce the amount of HIV in the blood. Although VIRACEPT is not a cure
for HIV or AIDS, VIRACEPT can help reduce your risk for death and illness
associated with HIV. Patients who took VIRACEPT also had significant
increases in the number of CD4 cell count.
VIRACEPT should be taken together with other antiretroviral drugs such
as Retrovir® (zidovudine, AZT), Epivir® (lamivudtne, 3TC), or Zerit® (stavudine,
d4T). Taking VIRACEPT in combination with other antiretroviral drugs
reduces the amount of HIV in the body (viral load) and raises CD4 counts.
VIRACEPT may be taken by adults, adolescents, and children 2 years of age
or older. Studies in infants younger than 2 years of age are now taking place.
DOES VIRACEPT CURE HIV OR AIDS?
VIRACEPT is not a cure for HIV infection or AIDS. People taking VIRACEPT may
still develop opportunistic infections or other conditions associated with HIV
infection. Some of these conditions are pneumonia, herpes vims infections,
M ycobacterium avium complex (MAC) infections, and Kaposi's sarcoma.
There is no proof that VIRACEPT can reduce the risk of transmitting HIV to
others through sexual contact or blood contamination.
WHO SHOULD OR SHOULD NOT TAKE VIRACEPT?
Taking the above drugs with VIRACEPT may cause serious and/or life-
threatening adverse events.
Rifampin® (for tuberculosis), also known as Rimactane®, Rifadin®,
Rifater®, or Rifamate®
This drug reduces blood levels of VIRACEPT.
Dose reduction required if you take VIRACEPT with: Mycobutin®
(rifabutin, for MAC); you will need to take a lower dose of Mycobutin.
A change of therapy should be considered if you are taking
VIRACEPT with:
Phénobarbital
Phenytoin (Dilantin® and others)
Carbamazepine (Tegretol® and others)
These agents may reduce the amount of VIRACEPT in your blood and
make it less effective.
Oral contraceptives (“the pill”)
If you are taking the pill to prevent pregnancy, you should use a different
type of contraception since VIRACEPT may reduce the effectiveness of
oral contraceptives.
Dosing in adults (including children 14 years of age and older)
It is not recommended to take VIRACEPT with the cholesterol-lowering
drugs Mevacor® (lovastatin) or Zocor® (simvastatin) because of possible
drug interactions. There is also an increased risk of drug interactions
between VIRACEPT and Lipitor® (atorvastatin) and Baycol® (cerivastatin);
talk to your doctor before you take either of these cholesterol reducing
drugs with VIRACEPT.
Taking St. John’s wort (hypericum perforatum), an herbal product sold as
a dietary supplement, or products containing St. John’s wort with VIRACEPT
is not recommended. Talk with your doctor if you are taking or are planning
to take St. John’s wort. Taking St. John's wort may decrease VIRACEPT levels
and lead to increased viral load and possible resistance to VIRACEPT or
cross resistance to other antiretroviral drugs.
Other medical problems: Certain medical problems may affect the use
of VIRACEPT. Some people taking protease inhibitors have developed new
or more serious diabetes or high blood sugar Some people with hemophilia
have had increased bleeding. It is not known whether the protease inhibitors
caused these problems. Be sure to tell your doctor if you have hemophilia
types A and B, diabetes mellitus, or an increase in thirst and/or frequent
urination.
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 hum p”), breast, and around the trunk. Loss of fat
from the face, legs and arms may also happen The cause and long-term
health effects of these conditions are not known at this time.
Number of
Number of
Level Teaspoons-)
Tablets
7 to <8.5
15.5 to <18.5
4
1
—
HOW SHOULD VIRACEPT BE TAKEN WITH OTHER ANTI-HIV DRUGS?
8.5 to <10.5
18.5 to <23
5
1 1/4
—
Taking VIRACEPT together with other anti-HIV drugs increases their ability
to fight the virus. It also reduces the opportunity for resistant viroses to grow.
Based on your history of taking other anti-HIV medicine, your doctor will
direct you on how to take VIRACEPT and other anti-HIV medicines. These
drugs should be taken in a certain order or at specific times. This will
depend on how many times a day each medicine should be taken. It will
also depend on whether it should bé taken with or without food.
10.5 to <12
23 to <26.5
6
1 1/2
—
12 to <14
26.5 to <31
7
1 3/4
—
14 to <16
31 to <35
8
2
—
16 to <18
35 to <39.5
9
21/4
—
18 to <23
39.5 to <50.5
10
21/2
2
*23
*50.5
15
3 3/4
3
In measuring oral powder, the scoop or teaspoon should be level.
Retrovir (zidovudine, AZT)
* 1 level scoop contains 50 mg of VIRACEPT. Use only the scoop provided
with your VIRACEPT bottle.
Epivir (lamivudine, 3TC)
Zerit (stavudine, d4T)
Nonnudeoside reverse transcriptase inhibitors (NNRTIs):
When VIRACEPT is taken together with:
Viramune® (nevirapine)
The amount of VIRACEPT in your blood is unchanged. A dose adjustment
is not needed when VIRACEPT is used with Viramune.
Sustiva™ (efavirenz)
The amount of VIRACEPT in your blood may be increased. A dose adjustment
is not needed when VIRACEPT is used with Sustiva.
Mevacor® (lovastatin, for cholesterol lowering)
Zocor® (simvastatin, for cholesterol lowering)
How should VIRACEPT Oral Powder be prepared?
The oral powder may be mixed with a small amount of water, milk,
formula, soy formula, soy milk, dietary supplements, or dairy foods such
as pudding or ice cream. Once mixed, the entire amount must be taken to
obtain the full dose.
Do not mix the powder with any acidic food or juice, such as orange or
grapefruit juice, apple juice, or apple sauce, because this may create a
bitter taste.
Once the powder is mixed, it may be stored at room temperature or
refrigerated for up to 6 hours. Do not heat the mixed dose once it has
been prepared.
Other NNRTIs
Do not add water to bottles of oral powder.
VIRACEPT powder is supplied with a scoop for measuring. For help in
determining the exact dose of powder for your child, please ask your
doctor, nurse, or pharmacist.
Other protease inhibitors:
When VIRACEPT is taken together with:
Crixivan® (indinavir)
VIRACEPT Oral Powder contains aspartame, a low-calorie sweetener, and
therefore should not be taken by children with phenylketonuria (PKU).
The amount of both drugs in your blood may be increased. Currently, there
are no safety and efficacy data available from the use of this combination.
HOW SHOULD VIRACEPT BE STORED?
Norvir™ (ritonavir)
The amount of VIRACEPT in your blood may be increased. Currently, there
are no safety and efficacy data available from the use of this combination.
Invirase® (saquinavir)
The amount of saquinavir in your blood may be increased. Currently, there
are no safety and efficacy data available from the use of this combination.
WHAT ARE THE SIDE EFFECTS OF VIRACEPT?
There were other side effects noted in clinical studies that occurred in
less than 2% of patients receiving VIRACEPT. However, these side effects
may have been due to other drugs that patients were taking or to the
illness itself. Except for diarrhea, there were not many differences in side
effects in patients who took VIRACEPT along with other drugs compared
with those who took only the other drugs. For a complete list of side
effects, ask your doctor, nurse, or pharmacist.
Halcion® (triazolam)
1 1 level teaspoon contains 200 mg of VIRACEPT. Note: A measuring
teaspoon used for dispensing medication should be used for
measuring VIRACEPT Oral Powder. Ask your pharmacist to make sure you
have a medication dispensing teaspoon.
VIRACEPT has not been studied with other NNRTIs.
Ergot derivatives (Cafergot® and others, for migraine headache)
Versed® (midazolam)
Body Weight
Nucleoside analogues: No drug interaction problems were seen when
VIRACEPT was given with:
Other side effects that occurred in 2% or more of patients receiving
VIRACEPT include nausea, gas and rash.
Propulsid® (cisapride, for heartburn)
Pediatric Dose to Be Adm inistered Three Times Daily
Number of
Quinidine (for irregular heartbeat), also known as Quinaglute®,
Cardioquin®, Quinidex®, and others
Medicines you should not take with VIRACEPT:
Dose instructions will be provided by the child’s doctor. The dose will be
given three times daily using the measuring scoop provided, a measuring
teaspoon, or one or more tablets depending on the weight and age of the
child. The amount of oral powder or tablets to be given to a child is
described in the chart below.
Level Scoops*
Cordarone® (amiodarone, for irregular heartbeat)
VIRACEPT may interact with other drugs, including those you take without
a prescription. You must discuss with your doctor any drugs that you are
taking or are planning to take before you take VIRACEPT.
The VIRACEPT dose in children depends on their weight. The recommended
dose is 20 to 30 mg/kg (or 9 to 14 mg/pound) per dose, taken three times
daily with a meal or light snack. This can be administered either in tablet
form or, in children unable to take tablets, as VIRACEPT Oral Powder.
Lb
Like all medicines, VIRACEPT can cause side effects. Most of the side
effects experienced with VIRACEPT have been mild to moderate. Diarrhea
is the most common side effect in people taking VIRACEPT, and most
adult patients had at least mild diarrhea at some point during treatment.
In clinical studies, about 15-20% of patients receiving VIRACEPT 750 mg
(three tablets) three times daily or 1250 mg (five tablets) two times daily
had four or more loose stools a day. In most cases, diarrhea can be controlled
using antidiarrheal medicines, such as Imodium® A-D (loperamide) and
others, which are available without a prescription.
CAN VIRACEPT BE TAKEN WITH OTHER MEDICATIONS?
Dosing in children 2 to 13 years of age
K«
If you are taking both Videx (ddl) and VIRACEPT:
Videx should be taken without food, on an empty stomach. Therefore, you
should take VIRACEPT with food one hour after or more than two hours
before you take Videx.
If you have liver disease: VIRACEPT has not been studied in people with
liver disease. If you have liver disease, you should tell your doctor before
taking VIRACEPT.
The dosing of VIRACEPT may be different for you than for other patients.
Follow the directions from your doctor, exactly as written on the label.
The amount of VIRACEPT in the blood should remain somewhat consistent
over time. Missing doses will cause the concentration of VIRACEPT to
decrease; therefore, you should not m iss any doses. However, if you
m iss a dose, you should take the dose as soon as possible and then take
your next scheduled dose and future doses as originally scheduled.
The recommended adult dose of VIRACEPT is 1250 mg (five tablets) taken
two times a day or 750 mg (three tablets) taken three times a day. Each
dose should be taken with a meal or light snack.
Videx® (didanosine, ddl)
Children: VIRACEPT is available for the treatment of children 2 through 13
years of age with HIV. There is a powder form of VIRACEPT that can be mixed
with milk, baby formula, or foods like pudding. Instructions on how to take
VIRACEPT powder can be found in a later section that discusses how
VIRACEPT Oral Powder should be prepared.
Only take medicine that has been prescribed specifically for you. Do not
give VIRACEPT to others or take medicine prescribed for someone else.
Before you take Viagra® (sildenafil) with VIRACEPT, talk to your doctor
about possible drug interactions and side effects. If you take Viagra and
VIRACEPT together, you may be at increased risk of side effects of Viagra
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. Your doctor can explain these symptoms to you.
Allergies: If you have had a serious allergic reaction to VIRACEPT, you
must not take VIRACEPT. You should also inform your doctor, nurse, or
pharmacist of any known allergies to substances such as other medicines,
foods, preservatives, or dyes.
If you are breast-feeding: You should discuss with your doctor the best way
to feed your baby. You should be aware that if your baby does not already
have HIV, there is a chance that it can be transmitted through breast-feeding.
Women should not breast-feed if they have HIV.
Take VIRACEPT exactly as directed by your doctor. Do not increase or
decrease any dose or the number of doses per day. Also, take this medicine
for the exact period of time that your doctor has instructed. Do not stop
taking VIRACEPT without first consulting with your doctor, even if
you are feeling better.
Special considerations
Together with your doctor, you need to decide whether VIRACEPT is appropriate
for you. In making your decision, the following should be considered:
If you are pregnant: The effects of VIRACEPT on pregnant women or their
unborn babies are not known. If you are pregnant or plan to become
pregnant, you should tell your doctor before taking VIRACEPT.
HOW SHOULD I TAKE VIRACEPT?
VIRACEPT is available only with y o u doctor’s prescription Your doctor may
prescribe the light blue VIRACEPT Tablets either as 1250 mg (five tablets)
taken two times a day or as 750 mg (three tablets) taken three times a day.
VIRACEPT should always be taken with a meal or a light snack. VIRACEPT
tablets are film-coated to help make the tablets easier to swallow.
Keep VIRACEPT and all other medicines out of the reach of children. Keep
bottle closed and store at room temperature (between 59°F and 86°F)
away from sources of moisture such as a sink or other damp place. Heat
and moisture may reduce the effectiveness of VIRACEPT.
Do not keep medicine that is out of date or that you no longer need. Be
sure that if you throw any medicine away, it is out of the reach of children.
Discuss all questions about your health with your doctor. If you have
questions about VIRACEPT or any other medication you are taking, ask
your doctor, nurse, or pharmacist. Ybu can also call 1 888.VIRACEPT
(1 888 847.2237) toll free.
Call 1.888. VIRACEPT
VIRACEPT and Agouron are registered trademarks of Agouron
Pharmaceuticals, Inc.
Copyright ©2001, Agouron Pharmaceuticals, Inc. All rights reserved.
Agouron«
Pharmaceuticals, he.
A
Pfizer
Company
Agouron Pharmaceuticals Inc.
La Jolla, California, 92037, USA
1-V01171-BG
L203-0001 PPI
Rev 01/25/01