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Generic Name: saquinavir (sa-KWIN-a-veer)
Brand Name: Fortovase

Fortovase cannot be interchanged with saquinavir mesylate ( Invirase) capsules.

Fortovase is used for:

Treating HIV infection. Fortovase should be used with other antiretroviral agents.

Fortovase is a protease inhibitor. It works by blocking the growth of an enzyme (HIV protease) that the HIV virus needs to reproduce in the body.

Do NOT use Fortovase if:

  • you are allergic to any ingredient in Fortovase
  • you are currently taking alfuzosin, certain antihistamines (eg, astemizole, terfenadine), certain benzodiazepines (eg, midazolam, triazolam), certain cholesterol medicines (eg, simvastatin, lovastatin), cisapride, ergot derivatives (eg, ergotamine, ergonovine), erythromycin, medicines to treat an irregular heartbeat (eg, amiodarone, flecainide, propafenone, bepridil, quinidine), certain medicines used to treat migraine headaches (eg, sumatriptan, eletriptan), pimozide, rifampin, or St. John's wort
  • you have severe liver disease

Contact your doctor or health care provider right away if any of these apply to you.

Before using Fortovase:

Some medical conditions may interact with Fortovase. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, plan to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have cholesterol or lipid problems, diabetes or a family history of diabetes, hepatitis or other liver problems, severe kidney problems, or hemophilia

Some MEDICINES MAY INTERACT with Fortovase. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Many prescription and nonprescription medicines (eg, used for birth control, heart problems, high cholesterol, HIV infection, impotence, infections, mental or mood problems, migraine headaches, pain, seizures, and other conditions), and herbs found in multivitamin products, herbal teas, and dietary supplements (eg, garlic, St. John's wort, and others) may interact with Fortovase and may increase the risk of side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Fortovase may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Fortovase:

Use Fortovase as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take Fortovase with a meal or within 2 hours after a full meal or large snack.
  • If you are taking Fortovase with ritonavir, take the medications at the same time and within 2 hours after a meal, unless otherwise directed by your health care provider.
  • Fortovase comes with an additional patient leaflet. Read it carefully and reread it each time you get Fortovase refilled.
  • Taking Fortovase at the same time each day will help you to remember to take it.
  • Take Fortovase regularly to receive the most benefit from it.
  • Consult your doctor before including grapefruit or grapefruit juice in your diet.
  • Do not miss any doses. If you miss a dose of Fortovase, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Fortovase.

Important safety information:

  • Changes in body fat have occurred in some patients taking this type of HIV medicine. These changes may include increased amount of fat in the upper back and neck, breast, and around the trunk. Loss of fat from the legs, arms, and face may also happen. The cause and long-term effects of this are unknown.
  • When your medicine supply begins to run low, get more from your doctor or pharmacy as soon as possible. The virus may develop resistance to Fortovase if you stop taking it, even for a short period of time, and may become harder to treat.
  • Fortovase is not a cure for HIV. You may continue to develop infections and other complications while taking Fortovase. Remain under the care of your doctor while taking Fortovase. The long-term effects of taking Fortovase are unknown.
  • Fortovase offers no protection against the passing of HIV to others through sexual contact or blood contamination. Use barrier forms of contraception (eg, condoms) and do not share needles if you are infected with HIV.
  • Fortovase may increase triglyceride and lipid levels. The long-term chance of complications from these increased triglyceride and lipid levels, such as heart attack and stroke, are not known at this time.
  • Women infected with HIV should not breast-feed their infants because of the risk of passing the virus or Fortovase to their infants.
  • Hemophilia patients - Report all bleeding episodes to your doctor.
  • Diabetes patients - Fortovase may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.
  • Fortovase may cause dizziness or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Fortovase. Using Fortovase alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
  • LAB TESTS, including viral load, CD4 count, triglyceride levels, and liver function, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Fortovase with caution in the ELDERLY because they may be more sensitive to its effects.
  • Use Fortovase with extreme caution in CHILDREN younger than 16 years of age. Safety and effectiveness in this age group have not been confirmed.
  • If you are taking birth control pills, Fortovase may decrease the effectiveness of the pills. Use an additional form of birth control (eg, condoms) while you are taking Fortovase. .
  • PREGNANCY AND BREAST-FEEDING: If you plan to become pregnant, talk with your health care provider about the benefits and risk of using Fortovase during pregnancy. It is unknown if Fortovase is excreted in breast milk. Do not breast-feed while taking Fortovase.

Possible side effects of Fortovase:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Anxiety; blurred vision; bronchitis; change in sexual ability; constipation; diarrhea; dry lips/skin; gas; headache; heartburn; loss of appetite; nausea; night sweats; sleeplessness; stomach discomfort; taste change; tiredness; vomiting; warts; weight gain.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); back pain; bloody stools; body fat changes; chest pain; confusion; coughing up blood; dark urine; difficulty urinating; dizziness; excessive thirst, hunger, or urination; fast heartbeat; fever; flu-like symptoms; fruity breath odor; itching; loss of coordination; mental or mood changes; muscle pain; numbness or tingling; pneumonia; seizures; shortness of breath; slow onset of drowsiness; stomach pain or tenderness; tenderness or bleeding of gums; thoughts of hurting yourself; unusual vaginal discharge or odor; unusual weakness; white patches in mouth; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. 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 at .

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Fortovase:

Store Fortovase in the refrigerator between 36 and 46 degrees F (2 and 8 degrees C). Once brought to room temperature 77 degrees F (25 degrees C), capsules should be used within 3 months. Do not freeze. Keep the bottle tightly closed. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Fortovase out of the reach of children and away from pets.

General information:

  • If you have any questions about Fortovase, please talk with your doctor, pharmacist, or other health care provider.
  • Fortovase is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Fortovase. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: June 3, 2015

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.