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Agouron
Pharm aceuticate, h e.
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P fiz e 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-FIN-na-veer) mesylate
For the Treatment of Human
Immunodeficiency Virus (HIV) Infection
Please read this information 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. Ybu 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 VIRACEPT AND HOW DOES IT WORK?
VIRACEPT is used in combination with other antiretroviral drugs in the
treatment of people with human immunodeficiency virus (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 is usually taken together with other antiretroviral drugs
such as R etro vir® (zidovudine, AZT), Epivir® (lamivudine, 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,
Mycobacterium 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?
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 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 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 if they have HIV.
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.
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.
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 hump”), 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.
CAN VIRACEPT BE TAKEN WITH OTHER MEDICATIONS?
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
Drugs you should not take with VIRACEPT:
Hismanal® (astemizole, for allergies)
Propulsid® (cisapride, for heartburn)
Cordarone® (amiodarone, for irregular heartbeat)
Quinidine (for irregular heartbeat), also known as
Quinaglute®, Cardioquin®, Quinidex, and others
Ergot derivatives (Cafergot® and others, for migraine headache)
Halcion® (triazolam)
Versed® (midazolam)
Mevacor® (lovastatin, for cholesterol lowering)
Zocor® (simvastatin, for cholesterol lowering)
HOW SHOULD I 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:
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 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.
Phénobarbital
Phenytoin (Dilantin® and others)
Only take medicine that has been prescribed specifically for you. Do not
give VIRACEPT to others or take medicine prescribed for someone else.
The dosing of VIRACEPT may be different for you than for other patients.
Follow the directions from your doctor, exactly as w ritten 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 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.
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.
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 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® (cenvastatin);
talk to your doctor before you take either of these cholesterol reducing
drugs with VIRACEPT.
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 children 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
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.
HOW SHOULD VIRACEPT BE TAKEN WITH OTHER ANTI-HIV DRUGS?
Taking VIRACEPT together with 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 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 be taken with or without food.
Nucleoside analogues: No drug interaction problems were seen when
VIRACEPT was given with:
Retrovir® (zidovudine, AZT)
Epivir® (lamivudine, 3TC®)
Zerit® (stavudine, d4T)
Videx® (didanosine, ddl)
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.
Nonnucleoside reverse transcriptase inhibitors (NNRTIs):
When VIRACEPT is taken together wittrViramune® (nevirapine) The amount
of VIRACEPT in your blood may be reduced. Studies are now taking place to
learn about the safety of combining VIRACEPT 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.
Other NNRTIs
VIRACEPT has not been studied with other NNRTIs.
Other rrotease inhibitors:
When VIRACEPT is taken together with:
Crixivan® (indinavir)
Pädiatrie Dose to Be Administered Three Times Daily
Body Weight
Number of
Number of
Number of
Kg
Lb
Level Scoops*
Level Teaspoonst
Tablets
7 to < 8 .5
15.5 to < 1 8 .5
4
1
—
8 .5 to < 1 0 .5
18.5 to < 2 3
5
1 1 /4
—
10.5 to < 1 2
23 to < 2 6 .5
6
1 1 /2
—
12 to < 1 4
26 .5 to <31
7
1 3/4
14 to < 1 6
31 to < 3 5
8
2
—
16 to < 1 8
35 to < 3 9 .5
9
2 1/4
—
18 to < 2 3
3 9 .5 to < 5 0 .5
10
2 1/2
2
>23
> 5 0 .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.
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.
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.
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.
Norvir® (ritonavir)
VIRACEPT Oral Powder contains aspartame, a low-calorie sweetener, and
therefore should not be taken by children with phenylketonuria (PKU).
HOW SHOULD VIRACEPT BE STORED?
•
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?
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.
Other side effects that occurred in 2% or more of patients receiving
VIRACEPT include nausea, gas and rash.
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.
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.
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.VIRACEPT
(1.888.847.2237) toll free.
Call 1.888. VIRACEPT
VIRACEPT and Agouron are registered trademarks of Agouron
Pharmaceuticals, Inc.
Copyright ©2000, Agouron Pharmaceuticals, Inc. All rights reserved.
f t
Agouron
rTiaiTnaceiiiJcais, nc.
A
Pfizer
Com pany
Agouron Pharmaceuticals Inc.
La Jolla, California, 92037, USA
L203-0000 PPI
Rev. 05/18/00
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