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What is saquinavir?

Saquinavir is an antiviral medication. It is in a group of drugs called protease (PRO-tee-ayz) inhibitors. Saquinavir prevents human immunodeficiency virus (HIV) cells from multiplying in your body.

Saquinavir is used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). Saquinavir is not a cure for HIV or AIDS.

Saquinavir may also be used for other purposes not listed in this medication guide.

Precautions

Instructions

Side Effects

Interactions

Precautions

Do not take this medication if you are allergic to saquinavir.

Do not take saquinavir with any of the following medications. They can cause life-threatening side effects if you use them while you are taking saquinavir:

• amiodarone (Cordarone, Pacerone);
• astemizole (Hismanal);
• bepridil (Vascor);
• cisapride (Propulsid);
• flecainide (Tambocor);
• midazolam (Versed) or triazolam (Halcion);
• pimozide (Orap);
• propafenone (Rythmol);
• quinidine (Cardioquin, Quinidex, Quinaglute);
• terfenadine (Seldane); or
• or ergot medicines such as ergotamine (Ergomar, Cafergot), dihydroergotamine (D.H.E. 45, Migranal Nasal Spray), ergonovine (Ergotrate), or methylergonovine (Methergine).

Before taking saquinavir, tell your doctor if you are allergic to any drugs, or if you have:

• liver disease;
• diabetes;
• a bleeding disorder (hemophilia); or
• high cholesterol or triglycerides.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take saquinavir.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby, but HIV can be passed to the baby if the mother is not properly treated during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Take all of your HIV medicines as directed to control your infection while you are pregnant.

Your name may need to be listed on an antiviral pregnancy registry when you start using this medication.

Saquinavir can make birth control pills less effective. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking saquinavir.

You should not breast-feed while you are using saquinavir. Women with HIV or AIDS should not breast-feed at all. Even if your baby is born without HIV, you may still pass the virus to the baby in your breast milk.

Do not give this medication to a child younger than 16 years old without the advice of a doctor.

If you also take didanosine, take it 2 hour before or after you take saquinavir.

Taking saquinavir will not prevent you from passing HIV to other people through unprotected sex or sharing of needles. Talk with your doctor about safe methods of preventing HIV transmission during sex, such as using a condom and spermicide. Sharing drug or medicine needles is never safe, even for a healthy person.

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Instructions

Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of a saquinavir overdose are not known.

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

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Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking saquinavir and call your doctor at once if you have any of these serious side effects:

• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
• increased urination or extreme thirst;
• easy bruising or bleeding;
• signs of a new infection, such as fever or chills, cough, or flu symptoms; or
• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

• mild nausea, vomiting, diarrhea, stomach pain;
• numbness or tingling, especially around your mouth;
• muscle pain;
• headache, mood changes; or
• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

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Interactions

Many drugs can interact with saquinavir. Below is just a partial list. Tell your doctor if you are using:

• digoxin (digitalis, Lanoxin);
• fluticasone (Advair, Flonase, Flovent);
• garlic or St. John's wort;
• antibiotics such as clarithromycin (Biaxin), itraconazole (Sporanox), ketoconazole (Nizoral), or rifampin (Rifadin, Rimactane, Rifater);
• antidepressants such as amitriptyline (Elavil, Etrafon), imipramine (Janimine, Tofranil), trazodone (Desyrel), and others;
• a blood thinner such as warfarin (Coumadin);
• a calcium channel blocker such as amlodipine (Caduet, Lotrel, Norvasc), diltiazem (Tiazac, Cartia, Dilacor), felodipine (Plendil), nifedipine (Procardia, Adalat), or verapamil (Calan, Covera, Isoptin, Verelan);
• cholesterol-lowering medicine such as atorvastatin (Lipitor), lovastatin (Mevacor, Altocor), or simvastatin (Zocor);
• drugs that weaken the immune system, such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), or tacrolimus (Prograf);
• other HIV /AIDS medicine such as darunavir (Prezista), lopinavir/ritonavir (Kaletra), or tipranavir (Aptivus);
• insulin or diabetes medication you take by mouth;
• medicines to treat erectile dysfunction, such as sildenafil (Viagra), tadalafil (Cialis), or vardenafil (Levitra); or
• seizure medications such as carbamazepine (Carbatrol, Tegretol), phenobarbital (Luminal, Solfoton), or phenytoin (Dilantin).

This list is not complete and there may be other medicines that can interact with saquinavir. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

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