Agouroirl.
A Fflzar Company

VlRACEPT” A

(nelfinavir mesylate)
Tablets and Oral Powder_
Information for Patients
_ about VlRACEPT‘ (VI-ra-cept)
Generic Name: nelfinavir (net-FIN-na-veer) mesylate

For the Treatment of Human

Immunodeficiency lfirus (HIV) Infection

Please read this infonnation carefully before taking VIRACEPT. 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 VIRACEPT 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. ‘ '

WHAT IS VIRAOEPT AND HOW DOES IT WORK?

VIRACEPT is used in combination with other antiretroviral drugs in the
treatment of people with human immunodeficiency vinls (Hill) infection.
Infection with HN leads to the destruction of CD4T 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).

VIRACEFT works by blocking HN protease (a protein—cutling enzyme),
which is required for HN to multiply. VIRACEPT has been shown to
significantly reduce the amount of HIV in the blood. Altllotlgh VIRACEPT
is not a cure for HN orAlDS, VIRACEPT can help reduce your risk for

death and illness associated with HIV. Patients who to0kV|RACEFT also

had significant increases in the number of CD4 cell count.

VIRACITT is usually taken together with other antiretroviral drugs
such as Retrovir® (zidovudine, AZT), Epivir® (lamivudine, arc), or
Zerit® (stavudine, d4T). Taking VIRACEFT in combination with ottler
antiretroviral drugs reduces the amount of HN in the body (viral load)
and raises CD4 counts. —

VIRACEFI’ 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 VIRAOEPT CURE HW OR AIDS?

VIRACEPT is not a cure for HN infection or AIDS. People taking ,
VIRACEPT may still develop opportunistic infections or other conditions
associated with HNirrfection. Some of these conditions are pneumonia,
herpes virus infections, Mycobacterium avium complex (MAC)
infections, and Kaposi's sarcoma.

There is no proof tllatVlRACEPT can reduce the risk of transmitting HN
to others through sexual contact or blood contamination.

WHO SHOULD OR SHOULD NOT TAKE VIRAOEPT?

Together with your doctor, you need to decide whether VIRACEPT is
appropriate for°you. In making your decision, the following should be
considered:

Allergies: If you have had a serious allergic reaction to VIRACEPT,
you must not take VIHAGEPT. 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 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.

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 ifthey have HIV.

children: VIRACEPT is available for the treatment of children 2 through
13 years of age with HIV. There is a powder fonn ofVlRACEPT that can
be mixed with milk, baby fonnula, or foods like pudding. Instructions on
how to take VIRACEPT powder can be found in a later motion that
discusses how VIRACEPT Oral Powder should be prepared.

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
betore taking VIRACEPT.

Other medical problems: Certain medical problems may affect the
use ofVlRACEPT. 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 rlot 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 arrlourlt of fat in the
upper back and neck (“buffalo hump"), breast, and arolmd the trunk. Loss
of fat from the face, legs and arms may also happen. The cause and
long-tenn health effects of these conditions are not known atthis time.

CAN VIRAOEPT BE TAKEN WITH OTHER MEDIGATIONS?

VIRACEPT may interact with other drugs, including those you take
without a prescription. You must discuss with your doctor any dnlgs
that you are taking or are planning to take before you take VIRACEPT.

Drugs you should g take with VIRAOEPT:
llismanal® (astemizole, for allergies)
Propulsid® (cisapride, for heartburn)
Gordarone® (amiodarone, for irregular heartbeat)

Ouinidine (for irregular heartbeat), also known as
v ouinaglute®, cardloquin®, Ouinidex, and otflers

Ergot derivatives (calergot® and ottlers, for migrairle headache)
ltalcion® (triazolam) '
versed® (mldazolam)

Mevacor® (lovastatin, for cholesterol lowering)
Zocor® (simvastatln, for cholesterol lowering)

Taking the above drugs with VIRACEPT may cause serious and/or life-
ttlreatening adverse events.

Rifampin (for tuberculosis), also known as Rimactane®, Rifadln®,
Rifater®, or Rifamate®
This dnlg reduces blood levels ofV|RACEPT.

Dose reduction required if you take VIRACEPT with: Mycobutin®
(rifabutin, for MAC); you will need to take a lower dose of Mycobutin.

A change or therapy should be considered if you are taking
VIRAGEPT with:

Phenobarbital
Phenytoin (Dilantin® and others) .
Carbamazepine (Tegreto|® 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.

special considerations ,

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.

It is not recommended to take VIRACEPT with the choIesterol—lowering
drugs Mevacor® (lovastatin) or zocor® (simvastatin) because of possible
drug interactions. There is also an increased risk of drug interactions
between VIRACEPT and l.lpitor® (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 toV|RACEPT
or cross resistance to other antiretroviral drugs.

HOW SHOULD VIRAOEPT BE TAKEN WITH OTHER ANT I-HW DRUGS?

Taking VIHACEPT together with other anti-HN drllgs 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-HN medicine, your doctor
will direct you on how to take VIRACEPT and other anti-HN 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 be taken with or without food.

Nucleoside analogues: No dnlg interaction problems were seen when
VIRACEPT was given with:

FIetrovir® (zidovudine, AZT)
Epivir® (lamivudine, 3Tc®)
zerit® (stavudine, d4T)
~VICIeX® (didanosine, ddl)

If you are taking both lfidex (ddl) and VIRACEPT:

lfidex should be taken witflout food, on an empty stomach. Therefore,
you should take VIRACEPT with food one hour after or more than two
hours before you take Videx.

' Nonnucleoside reverse transcriptase inhibitors (NNltTIs):

When VIRACEPT is taken together with:\firamune® (nevirapine) The
amount of VIRACEPT in your blood may be reduced. Studies are now
taking place to team about the safety of combining VIRACEPT with
lfiramune. . _

Systiva"" (efavirenz)

The amount of VIRACEPT in your blood may be increased. A dose
adjustment is not needed when VIRACEPT is used with Sustiva.

‘Other NNRTIS

VIRACEPT has not been studied with other NNRTls.

Other protease inhibitors:

When VIRACEPT is taken together with:

Crixivan® (indinavir)

The amount of botll drugs in your blood may be increased. Currently, there

are no safety and efficacy data available from the use of this combination.
Norvir® (ritonavir)

The amount ofVlRACEFT 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 VIRAOEPT?

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 dianhea 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

' hadfourormoreIoosestooIsaday.lnmostcases,diarmeacanbeoormolIed

using antidiarrheal medicines, such as Imodium® A-D (loperamide) and
others, which are available without a prescription.

Other side effects that occurred in 2% or more oftpatients receiving
VIBACEPT include nausea, gas and rash.

There were other side effects noted in clinical studies that occurred in
less than 2% of patients receiving VlRACEPT. However, these side effects
may have been due to other drugs that patients were taking or to the
illness itself. Except for diarrllea, 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.

HOW SHOULD I TAKE VIRAOEPT?

VIRACEPT is available only with your 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.

Take VIIIACEPT 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. ‘

Only take medicine that has been prescribed specifically for you. Do not
give VIRACEFT to others or take medicine prescribed for someone else.

The dosing ofVlRACEPT may be different for you than for other patients.

Y Follow the directions froln your doctor, exactly as written on the

label. The amount ofVlRACEPT in the blood should remain somewhat
consistent over time. Missing doses will cause the concentration of
VIRACEPT to decrease; therefore, you should rlot miss any doses.
However, if you miss a dose, you should take the dose as soon as
possible and then take your next scheduled dose and future doses

as originally scheduled.

Dosing in adults (including children 14 years of age and older)
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.

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
times daily with a meal or light snack. This can be administered either in
tablet form or, in chiIdren.unable to take tablets, as VIRACEPT Oral Powder.

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. , '

Pediatric 0038 to lie Mntrdsterod Three Times Daily
Bodv Weilllll lllnberot Illlmbor of tlurnberof
Kg Lb LeveISeoops" level Teaspoonst Tablets

7 to <8.5 15,510 <18.5 4 1 —
8.5 to <10.5 18.5 to <23 5 1 1/4 —
10.5 to <12 23 to <26.5 6 1 1/2 —
12 to <14 26.5 to <31 7 1 3/4 —
» 14to<16 31to<35 8 2 I -—
16 to <18 35 to <39.5 9 2 1/4 ——

V 18 to <23 39.5 to <50.5 10 2 1/2 2

223 250.5 15 3 3/4 3

In measuring oral powder, the scoop or teaspoon should be level.

* 1 level scoop contains 50 mg of VIRACEPT. Use only the scoop
provided with your VIRACEPT bottle.

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. « I

How should VIBAGEPT 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. I
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.»

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.

VIRACEPT Oral Powder contains aspartame, a low-calorie sweetener,
and therefore should not be taken by children with phenylketonuria (PKIJ).

HOW SHOULD VIRAOEPT BE STORED?

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 You can also call 1.888.VlRACEPT

(1 .888.847.2237) toll free.

Call 1..VIRAOEPT

VIRACEFT and Agouron are registered trademarks of Agouron
Phannaceuticals, Inc. .

Copyright ©2000, Agouron Pharmaceuticals, Inc. All rights reserved.

¥
Agotron.

hc.

A PHZII Complny

Agouron Pharmaceuticals Inc.
La Jolla, California, 92037, USA

L203-0000 PPI Rev.O5/18/O0