What is the most important information I should know about saquinavir?

Do not take saquinavir with amiodarone (Cordarone, Pacerone), bepridil (Vascor), flecainide (Tambocor), propafenone (Rythmol), rifampin (Rifadin, Rimactane, Rifater), (Quinaglute, Quinidex), astemizole (Hismanal), terfenadine (Seldane), cisapride (Propulsid), pimozide (Orap), midazolam (Versed), triazolam (Halcion), or an ergot medicine such as Ergomar, Cafergot, Wigraine, D.H.E. 45, Migranal, Methergine.

There are many 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.

HIV/AIDS is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Do not change your doses or medication schedule without advice from your doctor. Every person with HIV or AIDS should remain under the care of a doctor.

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.

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.

What should I discuss with my healthcare provider before taking saquinavir?

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.

How should I take saquinavir?

Take saquinavir exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Take each dose with a full glass (8 ounces) of water.

Saquinavir should be taken together with another medication called ritonavir (Norvir).

Take saquinavir and ritonavir with food or within 2 hours after eating a full meal.

It is important to use saquinavir regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

HIV/AIDS is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Be sure to read the medication guide or patient instructions provided with each of your medications. Do not change your doses or medication schedule without advice from your doctor. Every person with HIV or AIDS should remain under the care of a doctor.

To be sure saquinavir is helping your condition, your blood will need to be tested on a regular basis. Your liver function may also need to be tested. Do not miss any scheduled appointments.

Store saquinavir at room temperature away from moisture and heat.

What happens if I miss a dose?

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.

What happens if I overdose?

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

What should I avoid while taking saquinavir?

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.

What are the possible side effects of saquinavir?

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.

What other drugs will affect saquinavir?

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.

Where can I get more information?

Your pharmacist can provide more information about saquinavir.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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Copyright 1996-2003 Cerner Multum, Inc. Version: 8.03. Revision date: 01/03/2008.