Saquinavir (Systemic)
   
Saquinavir (Systemic)
US Brand Names
• Fortovase
• Invirase
Canadian Brand Names
• Fortovase
• Invirase
Description
Saquinavir (sa-KWIN-a-veer) is used, usually in combination with other medicines, in the treatment of the infection caused by the human immunodeficiency virus (HIV). HIV is the virus that causes acquired immune deficiency syndrome (AIDS).
Saquinavir will not cure or prevent HIV infection or AIDS; however, it helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay the development of problems usually related to AIDS or HIV disease. Saquinavir will not keep you from spreading HIV to other people. People who receive this medicine may continue to have other problems usually related to AIDS or HIV disease.
This medicine is available only with your doctor's prescription, in the following dosage forms:
Oral
• Capsules (U.S., Canada)
• Soft gelatin capsules (U.S., Canada)
Special Considerations
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For saquinavir, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to saquinavir. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.
Pregnancy
Studies have not been done in humans. However, saquinavir has not been reported to cause birth defects or other problems in animal studies.
Breast-feeding
It is not known whether saquinavir passes into human breast milk. However, breast-feeding is usually not recommended in AIDS patients because of the risk of passing the AIDS virus on to the infant.
Children
There is no specific information comparing use of saquinavir in children with use in other age groups.
Older adults
Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. There is no specific information comparing use of saquinavir in the elderly with use in other age groups.
Other medicines
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking saquinavir, it is especially important that your health care professional know if you are taking any of the following:
• Astemizole (e.g., Hismanal) or
• Cisapride (e.g., Propulsid) or
• Ergot medicines (dihydroergotamine [e.g., D.H.E. 45], ergoloid mesylates [e.g., Hydergine], ergotamine [e.g., Ergotrate], methylergonovine [e.g., Methergine], methysergide [e.g., Sansert]) or
• Midazolam (e.g., Versed) or
• Terfenadine (e.g., Seldane) or
• Triazolam (e.g., Halcion)-There is a possibility that saquinavir may interfere with the removal of these medicines from the body, which could lead to serious side effects
• Calcium channel blocking agents (bepridil [e.g., Bepadin], diltiazem [e.g., Cardizem], felodipine [e.g., Plendil], flunarizine [e.g., Sibelium], isradipine [e.g., DynaCirc], nicardipine [e.g., Cardene], nifedipine [e.g., Procardia], nimodipine [e.g., Nimotop], verapamil [e.g., Calan]) or
• Quinidine (e.g., Quinidex)-There is a possibility that saquinavir may interfere with the removal of these medicines from the body, which could lead to increased side effects
• Carbamazepine (e.g., Tegretol) or
• Dexamethasone (e.g., Decadron) or
• Phenobarbital (e.g., Luminal) or
• Phenytoin (e.g., Dilantin) or
• Rifabutin (e.g., Mycobutin) or
• Rifampin (e.g., Rifadin)-These medicines may decrease the amount of saquinavir in the body
• Delavirdine (e.g., Rescriptor) or
• Nevirapine (e.g., Viramune) or
• Ritonavir (e.g., Norvir)-This medicine may increase the amount of saquinavir in the body, which could lead to increased side effects
Other medical problems
The presence of other medical problems may affect the use of saquinavir. Make sure you tell your doctor if you have any other medical problems, especially:
• Hemophilia-Possible increased risk of bleeding
• Liver disease-Effects of saquinavir may be increased because of slower removal of the medicine from the body; also saquinavir has been reported to cause unwanted effects on the liver
Administration
It is important that this medicine be taken with food in order to work properly. Take saquinavir with a meal or within 2 hours after a meal .
Take this medicine exactly as directed by your doctor . Do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not stop taking this medicine without checking with your doctor first.
Keep taking saquinavir for the full time of treatment , even if you begin to feel better.
This medicine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, it is best to take the doses at evenly spaced times, day and night . For example, if you are to take three doses a day, the doses should be spaced about 8 hours apart. If you need help in planning the best times to take your medicine, check with your health care professional.
Only take medicine that your doctor has prescribed specially for you. Do not share your medicine with others.
Dosing
The dose of saquinavir will be different for different patients. Follow your doctor's orders or the directions on the label . The following information includes only the average doses of saquinavir. If your dose is different, do not change it unless your doctor tells you to do so.
• For oral dosage form (capsules [brand name Invirase ]):
o For treatment of HIV infection:
§ Adults-600 milligrams (mg) three times a day, in combination with other medicines for HIV infection.
§ Children up to 16 years of age-Use and dose must be determined by your doctor.
• For oral dosage form (soft gelatin capsules [brand name Fortovase ]):
o For treatment of HIV infection:
§ Adults-1200 mg three times a day, in combination with other medicines for HIV infection.
§ Children up to 16 years of age-Use and dose must be determined by your doctor.
Missed dose
If you miss a dose of this medicine, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
To store this medicine:
• Keep out of the reach of children.
• Store away from heat and direct light.
• Store the soft gelatin capsule form ( Fortovase ) in the refrigerator. The Invirase capsules do not need to be refrigerated.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.
Precautions
Do not take any other medicines without checking with your doctor first . To do so may increase the chance of side effects from saquinavir or other medicines.
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects, especially increases in blood sugar.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
Rare
Burning or prickling sensation; confusion; dehydration; dry or itchy skin; fruity mouth odor; increased hunger; increased thirst; increased urination; nausea; skin rash; unusual tiredness; vomiting; weight loss.
Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:
Less common or rare
Abdominal pain; diarrhea; headache; mouth ulcers; weakness.
Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.
February 10, 2003 
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