When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to saquinavir, or if you have heart rhythm problems (such as long QT syndrome).

How to Use This Medicine:
Capsule, Liquid Filled Capsule, Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• This medicine should always be taken together with ritonavir. Take all other medicines your doctor has prescribed at the right time. This will help your medicines work better.
• Take this medicine within 2 hours after a meal.
• Capsule: If you cannot swallow the capsule whole, you may open it and mix the contents with either 15 mL (about 1/2 ounce) of sugar syrup or sorbitol syrup or 3 teaspoons of jam. Stir for 30 to 60 seconds. Let the mixture come to room temperature. Eat the entire mixture to make sure you get the full dose.
• Do not stop using this medicine without first checking with your doctor. If you stop the medicine even briefly, the virus may become harder to treat. Contact your doctor or pharmacist when your supply of medicine is running low so you do not run out.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine if you also using any of the following:
  
  • Alfuzosin, atazanavir, cisapride, clozapine, dapsone, haloperidol, lovastatin, oral midazolam, pimozide, rifampin, sertindole, sildenafil, simvastatin, tacrolimus, trazodone, triazolam, ziprasidone
  • Medicine for heart rhythm problems (including amiodarone, bepridil, disopyramide, dofetilide, flecainide, lidocaine, propafenone, quinidine)
  • Medicine to treat an infection (including clarithromycin, erythromycin, halofantrine, pentamidine, quinine)
  • Phenothiazine medicine (including chlorpromazine, mesoridazine, thioridazine)
  • Ergot medicine (including dihydroergotamine, ergonovine, ergotamine, methylergonovine)
• Many other drugs can interact with saquinavir. Make sure your doctor knows about all other medicines you are using.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant, or if you have liver disease (including hepatitis), diabetes, high cholesterol, or hemophilia. Tell your doctor about all heart conditions you have, including heart failure or heart block. Also tell your doctor if you are lactose intolerant or drink alcohol.
• Do not breastfeed. You can spread HIV or AIDS to your baby through your breast milk.
• This medicine may cause the following problems:
  
  • Changes in heart rhythm, such as PR or QT prolongation
  • High cholesterol or triglycerides
  • High blood sugar levels, a problem that could become permanent
• Your immune system may get stronger when you start taking an HIV medicine. This could cause a hidden infection in your body to become active. Tell your doctor right away if you notice any changes in your health.
• This medicine will not keep you from giving HIV to others. Always practice safe sex, even if your partner also has HIV. Do not share needles or other items that may have blood or body fluids on them.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Fainting, dizziness, lightheadedness
• Fast, slow, or uneven heartbeat, chest pain
• Increased hunger or thirst, change in how much or how often you urinate, unusual weight loss
• Sudden and severe stomach pain, nausea, vomiting, fever

If you notice these less serious side effects, talk with your doctor:

• Diarrhea, nausea
• Weight gain around your neck, upper back, breast, or waist

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088