DECEMBER 17, 1999 • HOUSTON VOICE
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. 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 VIRACEPT AND HOW DOES IT WORK?
VIRACEPT is used in the treatment of people with human immunodeficiency virus (HIV) infection.
Infection with HIV leads to the destruction of C04 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. You should
be aware, however, that the effect of VIRACEPT on HlV in the blood has not been correlated with long-
term hearth benefits. Patients who took VIRACEPT also had significant increases in their CD4 cell count.
VIRACEPT is usually taken together with other antiretroviral drugs such as Retrovir* (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. The long-term effects of VIRACEPT are not known at
this time. People taking VIRACEPT may still develop opportunistic infections or other conditions
associated with HIV infection. Some of these conditions are pneumonia, herpes virus infections,
Mycobacterium avium complex (MAC) infections, and Kaposi's sarcoma.
It is not known whether vlRACEPT will help you live longer or reduce the number of infections or other
illnesses that may occur.
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: It 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.
II you art 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
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
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:
• Seldane* (terfenadine, for allergies)
■ 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 (Cafergofand others, for migraine headache)
• Halcion* (triazolam)
• Versed* (midazolam)
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.
Doss 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 wilh:
• 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.
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, d4Tl
• 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 (NNRTls):
When VIRACEPT is taken together with:
• Viramune* (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.
• Other NNRTls
VIRACEPT has not been studied with other NNRTls.
Other protease inhibitors:
When VIRACEPT is taken together with:
• Crixivan* (indinavir)
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)
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. If used in combination with saquinavir hard
gelatin capsules at 600 mg three times daily, no dose adjustments are needed. 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 20% of patients receiving VIRACEPT 750 mg (three tablets) three 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 abdominal pain,
asthenia, nausea, flatulence, and rash.
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.
HOW SHOULD I TAKE VIRACEPT?
VIRACEPT is available only with your doctor's prescription. The light blue VIRACEPT Tablets should be
taken three times a day. VIRACEPT should always be taken with a meal or a light snack. You do not have
to take VIRACEPT exactly every 8 hours. Instead, you can take it at normal times when you are eating.
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
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 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 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 14years of age and older)
The recommended adult dose of VIRACEPT is 750 mg (three tablets) taken three times a day. Each
dose should be taken with a meal or light snack.
Dosing in children 2 through 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.
Pediatric Dose to Be Administered Three Times Dally
7 lo < 8.5
15.5 lo <18.5
8.5 10 <10.5
18.5 to <23
10.5 to <12
23 to <26.5
12 to <14
26.5 to <31
14 to <16
31 to <3S
16 to <18
35 to <39.5
18 to <23
39.5 to <50.5
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 ba 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, rt 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 ot
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 (PKU).
HOW SHOULD VIRACEPT 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 hearth 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.
The following are registered trademarks of their respective manufacturers: Retrovir, Epivir/Glaxo
Wellcome Oncology/HIV; Zent Videx/Bristol-Myers Squibb Oncology; Invirase. Versed/Roche Laboratories
Inc; Seldane. Rifadin. Rifamate, Rifater/Hoechst Marion Roussel; Hismanal Propu sid/Janssen
Pharmaceutica Inc; Halcion, Mycobutin/Pharmacia & Upjohn Co; Rimactane. Tegretoi/LibaGeneva
Pharmaceuticals; Viramune/Roxane Laboratories, Inc; Dilantin/Parke-Davis, Crixivan/Merck & Co, Inc;
Imodium A-D/McNeil Consumer Products Co; Cordarone/Wyefh-Ayerst Laboratories; Quinaglute/Berlex
Laboratories; Cardioqum/The Purdue Frederick Co; Quinidex/A.H. Robins Co. Inc; Cafergot/Novartis
Pharmaceuticals Corp. Norvir is a trademark of Abbott Laboratories.
CALL 1 MB VIRACEPT
VIRACEPT It i registered trademark of Agouron Pharmaceuticals. Inc.
Copyright C1999 Agouron Pharmaceuticals, Inc. All rights reserved.
la Jolla, California, 92037, USA