Saquinavir (patient information)

IMPORTANT WARNING:

Roche Pharmaceuticals has announced that Fortovase® brand saquinavir capsules will no longer be available in the United States by February 15, 2006. This action is not based on any known safety problems with Fortovase, but is being taken because Fortovase is not widely used. If you are taking Fortovase, talk to your doctor about switching to another treatment.

Invirase® brand hard gelatin capsules and tablets and Fortovase® brand soft gelatin capsules all contain saquinavir, but can not be substituted for one another.Invirase must be taken with another medication called ritonavir (Norvir), which is called "boosted" therapy. Fortovase may be taken without ritonavir, but it must be taken more often and at a different dose than Invirase. Do not take Fortovase and Invirase at the same time. Take only the brand of saquinavir that was prescribed by your doctor and do not switch to the other brand of saquinavir unless your doctor tells you that you should. Each time you have your prescription filled, look at the brand name printed on your prescription label and at the tablets or capsules inside your bottle to be sure that you have received the right medication. Ask your doctor if you have not yet started taking saquinavir and don't know how your tablets or capsules should look.

Why is this medication prescribed

Saquinavir is used in combination with other medications to treat human immunodeficiency virus (HIV) infection in patients with or without acquired immunodeficiency syndrome (AIDS). Saquinavir is in a class of antiviral medications called protease inhibitors. It works by slowing the spread of HIV in the body. Saquinavir does not cure HIV and may not prevent you from developing HIV-related illnesses.Saquinavir does not prevent the spread of HIV to other people.

How should this medicine be used

Saquinavir comes as a hard gelatin capsule (Invirase), a tablet (Invirase), and a soft gelatin capsule (Fortovase) to take by mouth. The hard gelatin capsule and tablet are usually taken with ritonavir (Norvir) two times a day with a meal or up to 2 hours after a full meal. The soft gelatin capsule is usually taken three times a day with a meal or up to 2 hours after a meal. Take saquinavir at around the same times every day. It may be easier to remember to take saquinavir if you take it with meals. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take saquinavir exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Continue to take saquinavir even if you feel well. Do not stop taking saquinavir without talking to your doctor. If you miss doses, take less than the prescribed dose or stop taking saquinavir, your condition may become more difficult to treat.

Other uses for this medicine

Saquinavir soft gelatin capsules are also used to help prevent infection in health care workers or other people who were accidentally exposed to HIV. Talk to your doctor about the possible risks of using this medication for your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow

Before taking saquinavir:

• tell your doctor and pharmacist if you are allergic to saquinavir, any other medications, or any of the ingredients in saquinavir. Ask your pharmacist for a list of the ingredients.
• do not take astemizole (Hismanal) (no longer available in the United States); cisapride (Propulsid) (no longer available in the United States);ergot medications such as dihydroergotamine (Migranal), ergoloid mesylates (Germinal, Hydergine), ergonovine (Ergotrate), ergotamine (Cafergot, Wigraine), methylergonovine (Methergine), and methysergide (Sansert);medications for irregular heartbeat such as amiodarone (Cordarone, Pacerone), bepridil (not available in the United States), flecainide (Tambocor), propafenone (Rhythmol), or quinidine (Quinidex); midazolam (Versed); pimozide (Orap); rifampin (Rifadin, Rimactane, in Rifamate); terfenadine (Seldane) (no longer available in the United States);or triazolam (Halcion)while taking saquinavir.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin); antifungals such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), and voriconazole (Vfend); aprepitant (Emend); benzodiazepines such as alprazolam (Xanax), clorazepate (ClorazeCaps, Tranxene, others), diazepam (Valium), and flurazepam (Dalmane);buspirone (BuSpar); calcium channel blockers such as amlodipine (Norvasc), diltiazem (Cardizem, Dilacor, Tiazac, others), felodipine (Plendil), isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Adalat, Procardia), nimodipine (Nimotop), nisoldipine (Sular), and verapamil (Calan, Covera, Isoptin, Verelan); cholesterol-lowering medications (statins) such as atorvastatin (Lipitor), lovastatin (Advicor, Altocor, Mevacor), and simvastatin (Zocor); chlorpheniramine (antihistamine in over-the-counter cough and cold medications); cimetidine (Tagamet); clarithromycin (Biaxin, in Prevpac); clindamycin (Cleocin);dapsone (Avlosulfon); dexamethasone (Decadron, Dexone);disopyramide (Norpace); erythromycin (E.E.S., E-Mycin, Erythrocin); fentanyl (Duragesic); fluoxetine (Prozac, Sarafem); fluvoxamine (Luvox); griseofulvin (Fulvicin, Grifulvin, Gris-PEG); haloperidol (Haldol); hormonal contraceptives (birth control pills, rings, and patches); immunosuppressants such as cyclosporine (Neoral, Sandimmune), tacrolimus (Protopic), or rapamycin (sirolimus, Rapamune); insulin or oral medications for diabetes; isoniazid (INH, Nydrazid); medications to treat erectile dysfunction such as sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra); medications to treat HIV or AIDS including atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva), indinavir (Crixivan), lopinavir (in Kaletra), nelfinavir (Viracept), nevirapine (Viramune), or ritonavir (Norvir, in Kaletra); medications to treat seizures such as carbamazepine (Carbatrol, Epitol, Tegretol), phenytoin (Dilantin, Phenytek), and phenobarbital (Luminal, Solfoton); methadone (Dolophine, Methadose); nefazodone;phenylbutazone (Azolid, Butazolidin, others) (no longer available in the United States);propranolol (Inderal, in Inderide); quinine; ranitidine (Zantac);rifabutin (Mycobutin); sertraline (Zoloft);tamoxifen (Nolvadex); trazodone; tricyclic antidepressants including amitriptyline (in Limbitrol), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Sinequan), imipramine (Tofranil), others; troleandomycin (TAO); vincristine; and zafirlukast (Accolate) . Other medications may interact with saquinavir, so be sure to tell your doctor and pharmacist about all the medications you are taking, even those that do not appear on this list. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor what herbal products you are taking or plan to take, especially St. John's wort and garlic capsules.
• tell your doctor if you drink or have ever drunk large amounts of alcohol, if you have ever taken any form of saquinavir in the past, and if you or anyone in your family has or has ever had diabetes. Also tell your doctor if you have or have ever had high cholesterol or triglycerides (fats in the blood); hemophilia (a bleeding disorder); or heart, kidney, or liver disease.
• tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking saquinavir, call your doctor . You should not breastfeed if you are infected with HIV or are taking saquinavir.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking saquinavir.
• you should be aware that your body fat may increase or move to different areas of your body, such as your upper back, neck ("buffalo hump"), breasts, and around your stomach. You may notice a loss of body fat from your face, legs, and arms.

What special dietary instructions should I follow

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medication.

What should I do if I forget a dose

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Side effects

Mild side effects

Saquinavir may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• stomach pain
• upset stomach
• vomiting
• heartburn
• gas or bloating
• constipation
• change in the way food tastes
• increased appetite
• sores in mouth
• headache
• weakness
• tiredness
• dizziness
• anxiety
• depression
• difficulty falling asleep or staying asleep
• runny nose
• pain, burning, numbness, or tingling in the hands or feet
• warts
• muscle or back pain
• changes in sex drive

Severe side effects

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• rash
• itching
• chest pain
• shortness of breath
• flu-like symptoms
• fever
• yellowing of the skin or eyes
• extreme tiredness
• lack of energy
• loss of appetite
• pain in the upper right part of the stomach
• cough

Saquinavir may increase the sugar level in your blood. If you experience any of the following symptoms, call your doctor immediately:

• thirst
• dry mouth
• tiredness
• flushing
• dry lips or skin
• frequent urination
• loss of appetite
• trouble breathing or fast breathing
• upset stomach
• vomiting
• fruity breath
• loss of consciousness

Saquinavir may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/report.htm] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

• throat pain

What other information should I know

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before and during treatment to check your body's response to saquinavir.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Brand names

• Invirase®
• Fortovase®