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


This Medication Guide has been approved by the U.S. Food and Drug Administration.Revised: September 2020
Medication Guide
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.
What is the most important information I should know about INVIRASE?
  • INVIRASE must be taken along with ritonavir.
  • INVIRASE taken along with ritonavir should not be taken with cobicistat.
INVIRASE may cause serious side effects including:
  • Interactions with other medicines. It is important to know the medicines that should not be taken with INVIRASE. See the section "What should I tell my healthcare provider before taking INVIRASE?"
  • Changes in your heart rhythm and the electrical activity of your heart. These changes may be seen on an EKG (electrocardiogram) and can lead to serious heart problems. Your risk for these problems may be higher if you:
    • have a history of abnormal heart rhythm, including Congenital Long QT Syndrome, or other types of heart disease.
    • take other medicines that can affect your heart rhythm during treatment with INVIRASE.
    Tell your healthcare provider right away if you have any of these symptoms during treatment with 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 medicine used with ritonavir and other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1) in people over 16 years of age.
HIV is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).
In children under 16 years of age, INVIRASE doses that are both effective and safe could not be determined.

Do not take INVIRASE with ritonavir if you have the following conditions:

  • a condition called Congenital Long QT Syndrome.
  • complete AV (atrioventricular) heart block and you do not have a pacemaker, or you are at risk for complete AV heart block.
  • low potassium or low magnesium in your blood.
  • you have had a severe allergic reaction to saquinavir, saquinavir mesylate or any of the ingredients in INVIRASE. See the end of this Medication Guide for a complete list of ingredients in INVIRASE.
  • severe liver problems.
  • you have taken a medicine that contains rilpivirine within the last 2 weeks.
Talk to your healthcare provider before taking INVIRASE if you have any of the conditions listed above.
Taking INVIRASE with certain medicines can cause serious problems or life-threatening reactions.
Do not take INVIRASE with ritonavir if you take any of the following medicines:
  • alfuzosin
  • amiodarone
  • atazanavir
  • bepridil
  • clarithromycin
  • clozapine
  • dasatinib
  • dofetilide
  • disopyramide
  • Ergot containing medicines, including:
    • dihydroergotamine
    • ergonovine, ergonovine and methylergonovine
    • ergotamine
  • erythromycin
  • flecainide
  • halofantrine
  • haloperidol
  • lidocaine
  • lovastatin
  • lurasidone
  • midazolam
  • pentamidine
  • Phenothiazine containing medicines,
    • chlorpromazine
    • mesoridazine
    • thioridazine
  • pimozide
  • propafenone
  • quinidine
  • quinine
  • rifampin
  • rilpivirine
  • sertindole
  • sildenafil
  • simvastatin
  • sunitinib
  • tacrolimus
  • trazodone
  • triazolam
  • ziprasidone
Talk to your healthcare provider before taking any medicines listed above during treatment with INVIRASE and ritonavir. Though not complete, this is a list of medicines that should not be taken when INVIRASE is taken with ritonavir.
Before taking INVIRASE, tell your healthcare provider about all of your medical conditions, including if you:
  • have any heart problems, including a condition called Congenital Long QT Syndrome.
  • have diabetes.
  • have liver problems, including Hepatitis B or Hepatitis C.
  • a history of alcoholism.
  • have hemophilia.
  • are pregnant or plan to become pregnant. It is not known if INVIRASE will harm your unborn baby.
    Pregnancy Registry: There is a pregnancy registry for women who take antiretroviral medicines during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.
  • are breastfeeding or plan to breastfeed. Do not breastfeed if you take INVIRASE.
    • You should not breastfeed if you have HIV-1 because of the risk of passing HIV to your baby.
    • It is not known if INVIRASE passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby.
Tell your healthcare provider about all the medicines you take, including prescriptions and over-the-counter medicines, vitamins and herbal supplements.
INVIRASE may affect the way other medicines work, and other medicines may affect how INVIRASE works.
  • You can ask your healthcare provider or pharmacist for a list of medicines that interact with INVIRASE.
Do not start taking a new medicine without talking with your healthcare provider. Your healthcare provider can tell you if it is safe to take INVIRASE with other medicines.
How should I take INVIRASE?
  • Take INVIRASE exactly as your healthcare provider tells you.
  • Do not change your dose of INVIRASE or stop treatment without first talking with your healthcare provider.
  • Stay under the care of your healthcare provider during treatment with INVIRASE.
  • Take INVIRASE and ritonavir at the same time.
  • Take INVIRASE and ritonavir 2 times each day.
  • Take INVIRASE and ritonavir within 2 hours after a meal.
  • Do not miss a dose of INVIRASE. It is very important to take your medicine every day. If you skip doses or take less than the prescribed dose, the medicine will not work as well, and the virus may become harder to treat.
  • If you miss a dose of INVIRASE, you should take the next dose as soon as possible. Do not double your dose.
  • If you take too much INVIRASE, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the possible side effects of INVIRASE?
INVIRASE can cause serious side effects.

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

  • Diabetes and high blood sugar. Some people who take protease inhibitors including INVIRASE get new or more serious diabetes, or high blood sugar. Tell your healthcare provider if you notice an increase in thirst or urinate more often than normal during treatment with INVIRASE.
  • Liver problems. People with liver problems such as Hepatitis B or C, cirrhosis or have a history of alcoholism may have worsening liver problems. Tell your healthcare provider right away if you have any of these signs and symptoms of liver problems:
  • loss of appetite
  • yellowing of your skin or whites of your eyes (jaundice)
  • dark-colored urine
  • pale colored stools (bowel movements)
  • itchy skin
  • stomach area (abdominal) pain
  • Increased bleeding in people with hemophilia. Some people with hemophilia have increased bleeding with protease inhibitors including INVIRASE.
  • Increase in certain fat (cholesterol and triglycerides) levels in your blood. Your healthcare provider will check your blood for high levels of cholesterol and triglycerides before you start INVIRASE and during treatment with INVIRASE.
  • Changes in body fat can happen in people who take HIV-1 medicine. These changes may include increased amount of fat in the upper back and neck ("buffalo hump"), breasts, and around the middle of your body (trunk). Loss of fat from the legs, arms and face may also happen. The exact cause and long-term health effects of these conditions are not known.
Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider if you start having new or worse symptoms of infection after starting your HIV-1 medicine. The most common side effects of INVIRASE include:
  • nausea
  • vomiting
  • diarrhea
  • stomach area (abdominal) pain
  • tiredness
  • pneumonia
  • changes in body fat
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?
  • Store INVIRASE at room temperature between 68°F to 77°F (20°C to 25°C).
  • Keep INVIRASE in a tightly closed container.
Keep INVIRASE and all medicine out of the reach of children.
General information about the safe and effective use of 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. You can ask your pharmacist or healthcare provider for information about INVIRASE that is written for health professionals.
Active ingredient: saquinavir mesylate
Inactive ingredients:
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.
INVIRASE is a registered trademark of Hoffmann-La Roche Inc.
Distributed by: Genentech, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080-4990
© 2020 Genentech, Inc. All rights reserved.
For more information, go to or call 1-877-436-3683.

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

Revised: 6/2021
Genentech, Inc.