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|Invirase

SAQUINAVIR (Systemic)

Some commonly used brand names are:

In the U.S.—

• Fortovase
• Invirase

In Canada—

• Fortovase
• Invirase

Category

• Antiviral, systemic

Description

Saquinavir (sa-KWIN-a-veer) is used, usually in combination with other HIV medicines including ritonavir (e.g., Norvir), 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)
• Tablets (U.S.)
• Soft gelatin capsules (U.S., Canada)

Before Using This Medicine

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:

• Amiodarone (e.g., Cordarone) or
• Bepridil (e.g., Vascor) or
• Flecainide (e.g., Tambocor) or
• Propafenone (e.g., Rythmol) or
• Quinidine (e.g., Quinidex)—Do not take any of these medicines with saquinavir.

• 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
• Pimozide (e.g., Orap) or
• Rifampin (e.g., Rifadin) or
• Terfenadine (e.g., Seldane) or
• Triazolam (e.g., Halcion)—Do not take any of these medicines with saquinavir.

• Calcium channel blocking agents (bepridil [e.g., Vascor], diltiazem [e.g., Cardizem], felodipine [e.g., Plendil], isradipine [e.g., DynaCirc], nicardipine [e.g., Cardene], nifedipine [e.g., Procardia], nimodipine [e.g., Nimotop], verapamil [e.g., Calan])—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
• Nevirapine (e.g., Viramune) or
• Phenobarbital (e.g., Luminal) or
• Phenytoin (e.g., Dilantin) or
• Rifabutin (e.g., Mycobutin)—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

• Efavirenz (e.g., Sustiva)—Can cause both medicines to not work as well.

• Erectile dysfunction drugs (sildenafil [e.g., Viagra], tadalafil [e.g., Cialis], vardenafil [e.g., Levitra])—Dose adjustments will need to be made when taken together with saquinavir

• Ethinyl estradiol-containing birth control pills except progestin only or “mini pills” (e.g., Nor-QD, Micronor, Ovrette)—May need to use a different kind of birth control pill when taking saquinavir

• Garlic capsules—Do not take garlic capsules while you are taking this medicine

• Methadone (e.g., Dolophine)—Methadone dose may need to be increased while you are taking saquinavir

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:

• Alcoholism or
• Cirrhosis of the liver or
• Hepatitis B or
• Hepatitis C—May cause liver problems to become worse

• Diabetes mellitus (sugar diabetes) or
• High blood sugar—May make these conditions worse.

• Hemophilia—Possible increased risk of bleeding

• Kidney disease, severe—Caution should be used

• 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. If liver disease is severe, do not take saquinavir.

Proper Use of This Medicine

It is important that this medicine be taken with food in order to work properly. Take saquinavir 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.

Take only the brand name of this medicine that the doctor has prescribed for you. Do not switch from one brand name to another unless your doctor tells you to. Different brands may not contain the same amount of medicine.

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 and tablets [brand name Invirase ]):
  • For treatment of HIV infection:
    • Adults—1000 milligrams (mg) two times a day, in combination with ritonavir (e.g., Norvir).
    • Children up to 16 years of age—Use and dose must be determined by your doctor.

  Note:

  Invirase must be used in combination with ritonavir (e.g., Norvir). Your doctor will tell you the dose of ritonavir that you should take.

• For oral dosage form (soft gelatin capsules [brand name Fortovase ]):
  • For treatment of HIV infection:
    • Adults—1200 mg three times a day, alone or 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 While Using This Medicine

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.

This medicine may decrease the effects of some oral contraceptives (birth control pills). To avoid unwanted pregnancy, it is a good idea to use some additional contraceptive measures while being treated with saquinavir. .

Saquinavir does not decrease the risk of transmitting the HIV infection to others through sexual contact or by contamination through blood. HIV may be acquired from or spread to others through infected body fluids, including blood, vaginal fluid, or semen. If you are infected, it is best to avoid any sexual activity involving an exchange of body fluids with other people. If you do have sex, always wear (or have your partner wear) a condom (“rubber”). Only use condoms made of latex, and use them every time you have vaginal, anal, or oral sex . The use of a spermicide (such as nonoxynol-9) may also help prevent the spread of HIV if it is not irritating to the vagina, rectum, or mouth. Spermicides have been shown to kill HIV in lab tests. Do not use oil-based jelly, cold cream, baby oil, or shortening as a lubricant—these products can cause the condom to break. Lubricants without oil, such as K-Y Jelly , are recommended. Women may wish to carry their own condoms. Birth control pills and diaphragms will help protect against pregnancy, but they will not prevent someone from giving or getting the AIDS virus. If you inject drugs, get help to stop. Do not share needles or equipment with anyone. In some cities, more than half of the drug users are infected, and sharing even 1 needle or syringe can spread the virus. If you have any questions about this, check with your health care professional.

Side Effects of This Medicine

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.

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:

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Developed: 08/05/1998
Revised: 11/15/2005

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