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


Medication Guide

INVIRASE® (in-ver-ase)
(saquinavir mesylate)

INVIRASE® (in-ver-ase)
(saquinavir mesylate)

Important: Ask your healthcare provider or pharmacist about medicines that should not be taken with INVIRASE. For more information, see the section "Who should not take INVIRASE?"

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:

  • dizziness
  • lightheadedness
  • fainting
  • sensation of abnormal heartbeats

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


INVIRASE is a prescription HIV-1 (Human Immunodeficiency Virus) medicine used with ritonavir and other antiretroviral medicines to treat HIV-1 in people over 16 years of age.

HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).

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

When used with other antiretroviral medicines to treat HIV-1, INVIRASE may help:

Reducing the amount of HIV-1 and increasing the CD4+ (T) cells in your blood may help improve your immune system. This may reduce your risk of death or getting infections that can happen when your immune system is weak (opportunistic infections.)

INVIRASE does not cure HIV infection or AIDS. You must stay on continuous HIV therapy to control HIV infection and decrease HIV-related illnesses.

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

Ask your healthcare provider if you have any questions about how to prevent passing HIV-1 to other people.

Who should not take INVIRASE?

Do not take INVIRASE if you 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 with ritonavir (NORVIR) if you take any of the following medicines:

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

What should I tell my healthcare provider before taking INVIRASE?

Before taking INVIRASE, tell your healthcare provider about all of your medical conditions, including if you:

Tell your healthcare provider about all the medicines you take, including prescriptions and over-the-counter medicines, vitamins and herbal supplements. Tell your healthcare provider if you take St. John's wort.

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.

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:

  • nausea
  • vomiting
  • diarrhea
  • stomach area (abdominal) pain
  • tiredness
  • pneumonia
  • changes in body fat

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 1-888-835-2555.

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 condition 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 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.

Capsules Manufactured by: Roche Farma, S.A., Leganes, Spain
Tablets Manufactured by: Roche Farma, S.A., Leganes, Spain
© 2016 Genentech, Inc. All rights reserved.

Distributed by:

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

This Medication Guide has been approved by the U.S. Food and Drug Administration.
Revised: September 2016

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

Revised: 9/2016
Genentech, Inc.