INVIRASE- saquinavir mesylate capsule 
INVIRASE- saquinavir mesylate tablet, film coated 
Genentech, Inc.

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Medication Guide

INVIRASE® (in-ver-ase)

(saquinavir mesylate)

Capsules and Tablets

Read this Medication Guide before you start taking INVIRASE and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. You and your healthcare provider should talk about your treatment with INVIRASE before you start taking it and at regular checkups. You should stay under a healthcare provider's care when taking INVIRASE.

Also read the Medication Guide for ritonavir (Norvir).

What is the most important information I should know about INVIRASE?

INVIRASE may cause serious side effects including:

Tell your healthcare provider right away if you have any of these symptoms while taking INVIRASE:

See the section below "What are the possible side effects of INVIRASE?" for more information about serious side effects.

What is INVIRASE?

INVIRASE is a prescription anti-HIV medicine used in people over 16 years of age. HIV-1 is the virus that causes AIDS (Acquired Immune Deficiency Syndrome). INVIRASE is a type of HIV-1 medicine called a protease inhibitor. INVIRASE is used with ritonavir and other anti-HIV medicines to treat people with human immunodeficiency virus (HIV-1) infection.

When used with other HIV-1 medicines, INVIRASE may help to reduce the amount of HIV-1 in your blood (called "viral load"). INVIRASE may also help to increase the number of white blood cells called CD4 (T) cell which help fight off other infections. Reducing the amount of HIV-1 and increasing the CD4 (T) cell count may improve your immune system. This may reduce your risk of death or infections (opportunistic infections) that can happen when your immune system is weak.

In children, INVIRASE doses that are both effective and safe could not be determined.

INVIRASE does not cure HIV-1 infection or AIDS. People taking INVIRASE may develop infections or other conditions associated with HIV-1 infection, including opportunistic infections (for example, pneumonia and herpes virus infections).

Avoid doing things that can spread HIV-1 infection to others:

Who should not take INVIRASE?

Do not take INVIRASE if you take any of the following medicines or have the following conditions:

Talk to your healthcare provider before taking INVIRASE if you have any of the conditions listed above.

Taking INVIRASE with certain other medicines can cause serious problems or life threatening reactions.

Do not take INVIRASE/ritonavir (Norvir) if you take any of the following medicines:

Talk to your healthcare provider before taking INVIRASE if you take any of the medications listed above.

What should I tell my healthcare provider before taking INVIRASE?

INVIRASE may not be right for you. Before you take INVIRASE, tell your healthcare provider if you:

Tell your healthcare provider about all the medicines you take, including prescriptions and non-prescriptions medicines, vitamins and herbal supplements. INVIRASE may affect the way other medicines work, and other medicines may affect how INVIRASE works. Do not start taking a new medicine without talking with your healthcare provider or pharmacist. Your healthcare provider can tell you if it is safe to take INVIRASE with other medicines.

Especially tell your healthcare provider if you take:

Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take INVIRASE?

What are the possible side effects of INVIRASE?

INVIRASE can cause serious side effects.

Common side effects of INVIRASE include:

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of INVIRASE. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may also report side effects to Genentech at 1-800-835-2555.

How should I store INVIRASE?

Keep INVIRASE and all medicine out of the reach of children.

General information about INVIRASE

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use INVIRASE for a condition for which it was not prescribed. Do not give INVIRASE to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about INVIRASE. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about INVIRASE that is written for health professionals.

For more information, go to http://www.gene.com/gene/products/information/invirase or call 1-877-436-3683.

What are the ingredients in INVIRASE?

Active ingredient: saquinavir mesylate

Inactive ingredients:

200 mg Capsule: lactose, microcrystalline cellulose, povidone K30, sodium starch glycolate, talc, and magnesium stearate.

Capsule shell: gelatin and water with the following dye systems: red iron oxide, yellow iron oxide, black iron oxide, FD&C Blue #2, and titanium dioxide.

500 mg Tablet: lactose, microcrystalline cellulose, povidone K30, croscarmellose sodium, and magnesium stearate.

Film coat: hypromellose, titanium dioxide, talc, iron oxide yellow, iron oxide red, and triacetin.

The brands listed are trademarks of their respective owners and are not trademarks of Roche Laboratories, Inc. The makers of these brands are not affiliated with and do not endorse Roche Laboratories, Inc. or its products.

INVIRASE is a registered trademark of Hoffmann-La Roche Inc.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Capsules Manufactured by:

Roche Farma, S.A., Leganes, Spain

Tablets Manufactured by:

Roche Farma, S.A., Leganes, Spain

Distributed by:

Genentech USA, Inc.
A Member of the Roche Group
1 DNA Way
South San Francisco, CA 94080-4990

IET_318959_PI_2012_04_K1
IEC_318959_PI_2012_04_K2
IET_318959_MG_2012_04_K1
IEC_318959_MG_2012_04_K2

Revised: November 2012

© 2012 Genentech, Inc. All rights reserved.

Representative sample of labeling (see the HOW SUPPLIED section for complete listing):

Revised: 11/2012
 
Genentech, Inc.