Taking the above drugs w ith VIRACEPT may cause serious and/or life-
threatening adverse events.
A gouron.
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marmaceuucan,nc.
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P f i z • r C o m p a n y
VIRACEPT*
(netfinavir m esylate)
Tablets and Oral Powder
Information for Patients
about VMACEPT* (Vl-ra-cept)
Generic Name: netfinavir (nel-RN-na-veer) mesylate
For the Treatment of Human
Immunodeficiency Virus (HIV) Infection
Please read this inform ation carefully before taking VIRACEPT. Also, please
read this leaflet each tim e you renew the prescription, just in case anything
has changed This is a sum m ary and not a replacem ent for a careful
discussion with your doctor. You and your doctor should discu ss VIRACEPT
when you start taking this m edication and at regular checkups. You should
remain under a doctor’s care when taking VIRACEPT and should not change
or stop treatm ent without first talking with your doctor
Alert 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 com bination with other antiretroviral drugs in the
treatm ent of people with human im m unodeficiency virus (HIV) infection.
Infection with HIV leads to the destruction of C 0 4T cells, which are important
to the immune system . After a large number of CD4 ce lls have been
destroyed, the infected person develops acquired immune deficiency
syndrom e (AIDS).
VIRACEPT works by blocking HIV protease (a protein-cutting enzyme), which
is required tor HIV to m ultiply. 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® (lamivudine, 3TC), or Zerit® (stavudme,
d4T). Taking VIRACEPT in com bination 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 HfV 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 virus infections,
M ycobacterium avium com plex (MAC) infections, and Kaposi’s sarcom a.
There is no proof that VIRACEPT can reduce the risk of transm itting HIV to
others through sexual contact or blood contam ination.
WHO SHOULD OR SHOULD NOT TAKE VIRACEPT?
Together with your doctor, you need to decide whether V H A C B T is appropriate
for you. In m aking your decision, the follow ing should be considered:
Rifampin® (for tuberculosis), also known as Rimactane®. Rifadin®,
Rifater® , or Rifamate®
This drug reduces blood levels of VIRACEPT.
Dose reduction required it you take VIRACEPT with: Mycobutin®
(rifabutin, for MAC); you w ill need to take a low er dose of Mycobutin
A change of therapy should be considered if you are taking
VIRACEPT with:
Phénobarbital
Phenytoin (Dilantin® and others)
Carbam azepine (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.
VIRACEPT is available only with your doctor's prescnption. Your doctor may
prescribe the light blue VIRACEPT Tablets either as 125B mg (five tablets)
taken two tim es a day or as 750 mg (three tablets) taken three tim es a day.
VIRACEPT should alw ays be taken w ith a meal or a light snack. VIRACEPT
tablets are film -coated to help m ake the tablets easier to swallow.
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 m edicine
for the exact period of tim e that your doctor has instructed Do not stop
taking VIRACEPT without first consulting with your doctor, even if
you are feeling better.
Only take m edicine that has been prescribed specifically for you. Do not
give VIRACEPT to others or take m edicine prescribed for som eone else.
The dosing of VIRACEPT may be different for you than tor other patients.
Follow the directions from your doctor, exactly as written on the label.
The amount of VIRACEPT in the blood should rem ain som ewhat consistent
over time. M issing doses w ill cause the concentration of VIRACEPT to
decrease; therefore, you should not miss 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.
Special considerations
Dosing in adults (including children 14 years of age and older)
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 im m ediate m edical assistance to avoid permanent dam age to your
penis. Your doctor can explain these sym ptom s to you.
The recomm ended adult dose of VIRACEPT is 1250 mg (five tablets) taken
two tim es a day or 750 mg (three tablets) taken three tim es a day. Each
dose should be taken with a m eal or light snack.
It is not recommended to take VIRACEPT with the cholesterol-low ering
drugs Mevacor® (lovastatin) or Zocor® (sim vastatin) because of possible
drug interactions. There is also an increased risk of drug interactions
between VIRACEPT and Lipitoc® (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 S I 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.
Dosing in children 2 to 13 years of age
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 tim es
daily with a meal or light snack. This can be adm inistered either in tablet
form or, in children unable to take tablets, as VIRACEPT Oral Powder.
Dose instructions w ill be provided by the ch ild 's doctor. The dose w ill be
given three tim es daily using the m easuring scoop provided, a m easunng
teaspoon, or one or more tablets depending on the w eight and age of the
child. The am ount of oral powder or tablets to be given to a child is
described in the chart below.
P e d ia t r ic D o s e to B e A d m in is t e r e d T h r e e T i m e s D a i l y
N u m b e r of
N u m b e r of
N u m b e r of
Kg
Lb
Leve l Scoops’
Leve l Teaspoonsf
T a b le ts
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 w ith other anti-HIV drugs increases their ability
to fight the virus. It also reduces the opportunity for resistant viruses to grow.
Based on your history of taking other anti-HIV m edicine, your doc v w ill
direct you on how to take VIRACEPT and other anti-HIV m edicines. These
drugs should be taken in a certain order or at specific tim es This w ill
depend on how many tim es a day each m edicine should be taken. It w ill
also depend on whether it should be taken w ith 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
B o d y W e ig h t
Nucleoside analogues: No drug interacbon problem s were seen when
VIRACEPT w as given with:
In m easuring 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 (lam ivudine, 3TC)
Zerit (stavudme, d4T)
Videx® (didanosine, ddl)
Allergies: If you have had a serious allergic reaction to VIRACEPT, you
must not take VIRACEPT. You should also inform your doctor, nurse, or
pharm acist of any known allergies to substances such as other m edicines,
foods, preservatives, or dyes.
If you are taking both Videx (ddl) and VIRACEPT:
Videx should be taken w ithout food, on an empty stom ach Therefore, you
should take VIRACEPT with food one hour after or more than two hours
before you take Videx.
If you are pregnant The effects of VIRACEPT on pregnant women or their
unborn babies are not known, tf you are pregnant or plan to become
pregnant, you should tell your doctor before taking VIRACEPT.
Nonnucleoside reverse transcriptase inhibitors (NNRTIs):
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.
HOW SHOULD I TAKE VIRACEPT?
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 w ith Viramune.
Sustiva™ (efavirenz)
1 1 level teaspoon contains 200 mg of VIRACEPT. Note: A measuring
teaspoon used for dispensing medication should be used for
m easuring VIRACEPT Oral Powder. A sk your pharm acist to m ake sure you
have a m edication dispensing teaspoon.
How should VIRACEPT Oral Powder be prepared?
The oral powder m ay be mixed with a sm all am ount of water, m ilk,
form ula, soy form ula, soy m ilk, dietary supplem ents, or dairy foods such
as pudding or ice cream . Once m ixed, the entire amount m ust be taken to
obtain the full dose.
Do not mix the pow der with any acidic food or juice, such as orange or
grapefruit juice, apple juice, or apple sauce, because this may create a
bitter taste
Children: VIRACEPT is available for the treatm ent of children 2 through 13
years of age with HIV There is a powder to rn of VIRACEPT that can be mixed
with m ilk, baby form ula, 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
The amount of VIRACEPT in your blood may be Increased . A dose adjustment
is not needed when VIRACEPT is used with Sustiva.
Once the powder is mixed, it may be stored at room tem perature or
refrigerated for up to 6 hours. Do not heat the mixed dose once it has
been prepared.
Other NNRTIs
Do not add w ater to bottles of oral powder
VIRACEPT has not been studied w ith other NNRTIs.
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.
inner protease innioftors.
VIRACEPT powder is supplied with a scoop for m easuring. For help in
determ ining the exact dose of powder for your child, please ask your
doctor, nurse, or pharm acist
Other medical problems: Certain m edical problem s 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 problem s. Be sure to tell your doctor if you have hem ophilia
types A and B, diabetes m ellitus, or an increase in thirst and/or frequent
urination.
Changes in body fat have been seen in som e patients taking protease
inhibitors. 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 face, legs and arm s may also happen. The cause and long-term
health effects of these conditions are not known at this time.
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 com bination.
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 com bination.
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 com bination
WHAT ARE THE SIDE EFFECTS OF VIRACEPT?
Cordarone® (amiodarone, for irregular heartbeat)
Like a ll m edicines, VIRACEPT can cause side effects. Most of the side
effects experienced with VIRACEPT have been m ild to m oderate Diarrhea
is the m ost common side effect in people taking VIRACEPT, and most
adult patients had at least m ild diarrhea at som e point during treatment.
In clin ica l studies, about 15-20% of patients receiving VIRACEPT 750 mg
(three tablets) three tim es daily or 1250 mg (five tablets) two tim es daily
had four or more loose stools a day. In most cases, dianhea can be controlled
using antidiarrheal m edicines, such as Imodium® A-D (loperamide) and
others, w hich are available without a prescription.
Quinidine (for irregular heartbeat), also known as Qumaglute®,
Cardioquin®. Quinidex®, and others
Other side effects that occurred in 2% or more of patients receiving
VIRACEPT include nausea, gas and rash
Ergot derivatives (Cafergot® and others, for m igraine headache)
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 com plete list of side
effects, ask your doctor, nurse, or pharm acist
CAN VIRACEPT BE TAKEN WITH OTHER MEDICATIONS?
VIRACEPT may interact with other drugs, including those you take without
a prescription. You m ust discuss with your doctor any drugs that you are
taking or are planning to take before you take VIRACEPT.
Medicines you should not take with VIRACEPT:
Propulsid® (cisapride, for heartburn)
Halcion® (triazolam)
Versed® (midazolam)
Mevacor® (lovastatin, for cholesterol lowering)
Zocor® (sim vastatin, for cholesterol lowering)
Keep VIRACEPT and all other m edicines out of the reach of children Keep
bottle closed and store at room tem perature (between 59°F and 86°F)
away from sources of m oisture such as a sink or other damp place Heat
and m oisture may reduce the effectiveness of VIRACEPT
Do not keep m edicine that is out of date or that you no longer need. Be
sure that if you throw any m edicine away, it is out of the reach of children.
D iscuss all questions about your health with your doctor. If you have
questions about VIRACEPT or any other m edication you are taking, ask
your doctor, nurse, or pharm acist. You can also call 1 888.VIRACEPT
(1 888 847.2237) toll free.
Call 1.888. VIRACEPT
VIRACEPT and Agouron are registered tradem arks of Agouron
Pharm aceuticals, Inc.
Copyright © 2001, Agouron Pharm aceuticals, Inc. A ll rights reserved
Agouron«
marmaceuocaB, nc.
A
Pfiz er
C o m p a n y
Agouron Pharm aceuticals Inc.
La Jolla, California, 92037, USA
1-V01171-BG
L203-0001 PPI
Rev. 01/25/01