Saquinavir is an antiviral medicine that prevents human immunodeficiency virus (HIV) from multiplying in your body.

Saquinavir is used together with ritonavir to treat HIV, the virus that can cause acquired immunodeficiency syndrome (AIDS). Neither saquinavir nor ritonavir will cure HIV or AIDS.

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

You should not take saquinavir if you have certain serious heart problems, severe liver disease, low blood levels of potassium or magnesium, or if you have taken rilpivirine in the past 2 weeks.

Saquinavir must be taken together with another medicine called ritonavir.

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together.

Saquinavir can cause serious heart rhythm problems. Call your doctor at once if you have fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness.

Saquinavir comes as a capsule and a tablet to take by mouth. It is usually taken at the same time as ritonavir (Norvir) two times a day within 2 hours after a full meal. It may be easier to remember to take saquinavir if you take it with meals. Take saquinavir at around the same times every day. 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.

Swallow the tablets whole; do not chew, or crush them.

If you are not able to swallow the capsule whole, you can take saquinavir by opening the capsule and mixing the contents with sugar syrup, sorbitol, or jam. To prepare each dose, add 3 teaspoons (15 mL) of sugar syrup, sorbitol, or jam to an empty container. Open the saquinavir capsule and add the contents to the container. Stir the mixture for 30 to 60 seconds. If you used cold syrup, sorbitol, or jam, wait for the mixture to come to room temperature before eating. Be sure to eat the entire mixture so that you receive the full dose.

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.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with saquinavir and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Saquinavir must be taken together with ritonavir and it should not be used alone.

Take your medicine with food or within 2 hours after eating a full meal. Take the medicine at the same times each day.

You will need frequent medical tests.

Use all HIV medications as directed. Do not change your dose or stop using a medicine without your doctor's advice. Remain under the care of a doctor.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

You should not take saquinavir if you are allergic to it, or if you have:

• a serious heart condition called "AV block" (unless you have a pacemaker);

• long QT syndrome (in you or a family member);

• severe liver disease;

• low levels of potassium or magnesium in your blood;

• if you also take medicine that contains cobicistat; or

• if you have taken rilpivirine in the past 2 weeks.

Life-threatening side effects may occur if you take saquinavir and ritonavir with certain other medicines. Your doctor may change your treatment plan if you also use:

• other HIV medicines--atazanavir, rilpivirine;

• alfuzosin;

• oral midazolam, or triazolam;

• sildenafil (Revatio, for treating pulmonary arterial hypertension);

• tacrolimus;

• antidepressant or anti-psychotic medicine--chlorpromazine, clozapine, haloperidol, lurasidone, mesoridazine, pimozide, thioridazine, trazodone, ziprasidone;

• cancer medicine--dasatinib, sunitinib;

• certain anti-infective medicines--clarithromycin, dapsone, erythromycin, halofantrine, pentamidine, rifampin;

• cholesterol medication--lovastatin, simvastatin;

• ergot medicine--dihydroergotamine, ergotamine, ergonovine, methylergonovine; or

• heart rhythm medicine--amiodarone, disopyramide, dofetilide, flecainide, lidocaine, propafenone, or quinidine.

Tell your doctor if you have ever had:

• heart disease;

• liver disease (including hepatitis B or C);

• hemophilia (a bleeding disorder);

• cirrhosis, alcoholism;

• diabetes; or

• hereditary galactose intolerance, severe lactase deficiency, or glucose-galactose malabsorption.

To prevent HIV in a newborn baby, use all medications to control your infection during pregnancy. Your name may be listed on an antiviral pregnancy registry.

Saquinavir can make birth control pills less effective. Ask your doctor about other birth control options such as an injection, implant, skin patch, vaginal ring, condom, diaphragm, cervical cap, or contraceptive sponge.

Women with HIV should not breastfeed. The virus can pass to your baby in your breast milk.

Not approved for use by anyone younger than 16 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely. Skipping doses may increase the risk of your virus becoming resistant to antiviral medicine.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

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

Using saquinavir will not prevent your disease from spreading. Do not have unprotected sex or share razors or toothbrushes. Ask your doctor how to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe.

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

Saquinavir may cause serious side effects. Call your doctor at once if you have:

• heart rhythm problems--fast or pounding heartbeats, fluttering in your chest, shortness of breath, sudden dizziness (like you might pass out);

• high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor; or

• liver problems--upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Saquinavir affects your immune system, which may cause certain side effects (even weeks or months after you've taken saquinavir). Tell your doctor if you have:

• signs of a new infection--fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;

• trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or

• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Common side effects of saquinavir may include:

• nausea, vomiting, diarrhea, stomach pain;

• tired feeling; 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. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Many drugs can affect saquinavir, and some drugs should not be used at the same time. Tell your doctor about all other medicines you use. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before and during your treatment to check your body's response to saquinavir. Your doctor may also order an electrocardiogram (ECG; test that measures the electrical activity in the heart) before and during your treatment.

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

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.