Invirase is an antiviral medicine that prevents human immunodeficiency virus (HIV) from multiplying in your body.

Invirase is used together with ritonavir to treat HIV, the virus that can cause acquired immunodeficiency syndrome (AIDS).

Invirase is not a cure for HIV or AIDS.

You should not take Invirase if you have certain serious heart problems, severe liver disease, low blood levels of potassium or magnesium, or if you have taken rilpivirine in the past 2 weeks.

Invirase must be taken together with another medicine called ritonavir.

Many drugs can interact with saquinavir, and some drugs should not be used together. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Invirase.

Invirase can cause serious heart rhythm problems. Call your doctor at once if you have fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness.

Taking this medication will not prevent you from passing HIV to other people. Avoid having unprotected sex or sharing razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Take Invirase exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Invirase must be taken together with ritonavir and it should not be used alone.

Take your medicine with food or within 2 hours after eating a full meal. Take the medicine at the same times each day.

You will need frequent medical tests.

Use all HIV medications as directed and read all medication guides you receive. Do not change your dose or stop using a medicine without your doctor's advice. Every person with HIV should remain under the care of a doctor.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Usual Adult Dose for HIV Infection:

Standard dose: Invirase 1000 mg plus ritonavir 100 mg orally twice a day

Therapy-naive patients (starting therapy with Invirase/ritonavir):
-The first 7 days: Invirase 500 mg plus ritonavir 100 mg orally twice a day
-After 7 days: Invirase 1000 mg plus ritonavir 100 mg orally twice a day

Patients switching immediately (no washout period) from another ritonavir-containing regimen or from a NNRTI-based regimen (excluding delavirdine, rilpivirine): Invirase 1000 mg plus ritonavir 100 mg orally twice a day

Patients switching from a regimen containing delavirdine:
-The first 7 days: Invirase 500 mg plus ritonavir 100 mg orally twice a day
-After 7 days: Invirase 1000 mg plus ritonavir 100 mg orally twice a day

Usual Adult Dose for Nonoccupational Exposure:

US CDC Recommendations: Invirase 1000 mg plus ritonavir 100 mg orally twice a day
Duration of therapy: 28 days

Comments:
-Only with expert consultation, as part of an alternative regimen for use as nonoccupational postexposure prophylaxis of HIV infection
-Prophylaxis should be started as soon as possible, within 72 hours of exposure.
-Current guidelines should be consulted for additional information.

Usual Adult Dose for Occupational Exposure:

US Public Health Service Working Group Recommendations: Invirase 1000 mg plus ritonavir 100 mg orally twice a day
Duration of therapy: 28 days, if tolerated

Comments:
-Only with expert consultation, as part of an alternative regimen for use as HIV postexposure prophylaxis
-Prophylaxis should be started as soon as possible, preferably within hours after exposure.
-The optimal duration of prophylaxis is unknown and may differ based on institution protocol.
-Current guidelines should be consulted for additional information.

Usual Pediatric Dose for HIV Infection:

16 years or older:
Standard dose: Invirase 1000 mg plus ritonavir 100 mg orally twice a day

Therapy-naive patients (starting therapy with Invirase/ritonavir):
-The first 7 days: Invirase 500 mg plus ritonavir 100 mg orally twice a day
-After 7 days: Invirase 1000 mg plus ritonavir 100 mg orally twice a day

Patients switching immediately (no washout period) from another ritonavir-containing regimen or from a NNRTI-based regimen (excluding delavirdine, rilpivirine): Invirase 1000 mg plus ritonavir 100 mg orally twice a day

Patients switching from a regimen containing delavirdine:
-The first 7 days: Invirase 500 mg plus ritonavir 100 mg orally twice a day
-After 7 days: Invirase 1000 mg plus ritonavir 100 mg orally twice a day

Comments:
-Doses that are both reliably effective and safe (i.e., below levels of concern for QT and PR interval prolongation) could not be established for pediatric patients younger than 16 years.

You should not take Invirase if you are allergic to saquinavir, or if you have:

• a serious heart condition called "AV block" (unless you have a pacemaker);

• long QT syndrome (in you or a family member);

• severe liver disease;

• low levels of potassium or magnesium in your blood;

• if you also take medicine that contains cobicistat; or

• if you have taken rilpivirine in the past 2 weeks.

Life-threatening side effects may occur if you take Invirase and ritonavir with certain other medicines. Your doctor may change your treatment plan if you also use:

• other HIV medicines - atazanavir, rilpivirine;

• alfuzosin;

• oral midazolam, or triazolam;

• sildenafil (Revatio, for treating pulmonary arterial hypertension);

• tacrolimus;

• antidepressant or anti-psychotic medicine - chlorpromazine, clozapine, haloperidol, lurasidone, mesoridazine, pimozide, thioridazine, trazodone, ziprasidone;

• cancer medicine - dasatinib, sunitinib;

• certain anti-infective medicines - clarithromycin, dapsone, erythromycin, halofantrine, pentamidine, rifampin;

• cholesterol medication - lovastatin, simvastatin;

• ergot medicine - dihydroergotamine, ergotamine, ergonovine, methylergonovine; or

• heart rhythm medicine - amiodarone, disopyramide, dofetilide, flecainide, lidocaine, propafenone, or quinidine.

To make sure Invirase is safe for you, tell your doctor if you have ever had:

• heart disease;

• liver disease (including hepatitis B or C);

• hemophilia (a bleeding disorder);

• cirrhosis, alcoholism;

• diabetes; or

• hereditary galactose intolerance, severe lactase deficiency, or glucose-galactose malabsorption.

To prevent HIV in a newborn baby, use all medications to control your infection during pregnancy. Your name may be listed on an antiviral pregnancy registry.

Invirase can make birth control pills less effective. Ask your doctor about other birth control options such as an injection, implant, skin patch, vaginal ring, condom, diaphragm, cervical cap, or contraceptive sponge.

Women with HIV should not breastfeed. The virus can pass to your baby in your breast milk.

Invirase is not approved for use by anyone younger than 16 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely. Skipping doses may increase the risk of your virus becoming resistant to antiviral medicine.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Using this medicine may not prevent your disease from spreading. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Get emergency medical help if you have signs of an allergic reaction to Invirase: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• heart rhythm problems - fast or pounding heartbeats, fluttering in your chest, shortness of breath, sudden dizziness (like you might pass out);

• high blood sugar - increased thirst, increased urination, dry mouth, fruity breath odor; or

• liver problems - upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Saquinavir affects your immune system, which may cause certain side effects (even weeks or months after you've taken this medicine). Tell your doctor if you have:

• signs of a new infection - fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;

• trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or

• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Common Invirase side effects may include:

• nausea, vomiting, diarrhea, stomach pain;

• tired feeling; or

• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Many drugs can interact with saquinavir, and some drugs should not be used at the same time. Tell your doctor about all your current medicines and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.