How does this medication work? What will it do for me?

Saquinavir is used usually in combination with ritonavir (another anti-HIV medication) and other anti-HIV (antiretroviral) medications to treat the infection caused by the human immunodeficiency virus (HIV), the virus responsible for acquired immune deficiency syndrome (AIDS). Saquinavir belongs to a class of medications called protease inhibitors. Saquinavir blocks the action of protease (pronounced "pro-tee-ace"), an enzyme that is needed by HIV to multiply.

This medication does not cure AIDS and does not prevent it from being spread to others. It does slow further growth or reproduction of HIV when used in combination with other medications, and it seems to slow down the destruction of the immune system. This may help to delay the development of problems that are related to AIDS or HIV disease.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?


Each hard gelatin, light brown and green capsule, imprinted with "Roche" and "0245" on opaque shells, contains 200 mg of saquinavir, present as saquinavir mesylate. Nonmedicinal ingredients: lactose, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, and talc; capsule shell: gelatin, indigotine, iron oxide, and titanium dioxide.


Each light orange to greyish- or brownish-orange, oval cylindrical, biconvex film-coated tablet, with "ROCHE" and "SQV 500" imprinted on the tablet face, contains 500 mg of saquinavir, present as saquinavir mesylate. Nonmedicinal ingredients: croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, and povidone K30; film-coat: hypromellose, iron oxide red, iron oxide yellow, talc, titanium dioxide, and triacetin.

How should I use this medication?

For people 16 years and older, the recommended dose of saquinavir is 1,000 mg taken twice a day with food (anytime within 2 hours after a meal or large snack). Saquinavir should be swallowed whole with a full glass of water or other non-alcoholic drink. Saquinavir should be taken at the same time as ritonavir.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is very important that this medication be taken on a regular basis as prescribed. The doses should be spaced as close to every 12 hours as possible. If you miss a dose, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. Do not stop taking this medication without telling your doctor. If you miss many doses in a row, talk to your doctor about how to resume dosing.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take saquinavir if you:

  • are allergic to saquinavir or any ingredients of the medication
  • have a history of problems with the electrical activity of the heart known as QT prolongation
  • have a history of problems with electrolyte imbalances (especially low potassium levels in the blood)
  • have severe liver problems
  • are taking any of the following medications:
  • alfuzosin
  • antiarrthymia medications (e.g., amiodarone, flecainide, procainamide, propafenone, quinidine, sotalol, lidocaine)
  • astemizole
  • cisapride
  • ergot derivatives
  • midazolam
  • pimozide
  • rifabutin
  • rifampin
  • sildenafil
  • "statin" medications (e.g., lovastatin, simvastatin)
  • terfenadine
  • trazodone
  • triazolam

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • diarrhea
  • drowsiness
  • dry or itchy skin
  • headache
  • mouth ulcers
  • tiredness
  • weakness

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • abdominal pain
  • burning or prickling sensation
  • changes in body fat
  • confusion
  • dehydration
  • dizziness
  • fainting
  • fruity mouth odour
  • heart rhythm changes, sensation of abnormal heartbeats
  • increased hunger
  • increased thirst
  • increased urination
  • lightheadedness
  • loss of appetite
  • nausea
  • seizures
  • skin rash
  • tingling or numbness
  • unusual tiredness
  • vomiting
  • weight loss

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Abnormal heart rhythm: Saquinavir may cause a problem with the electrical activity of the heart known as QT prolongation, which can affect the heart's rhythm. While you are taking this medication, your doctor will monitor your heart rhythm regularly with a test called an electrocardiogram (ECG). You should not take this medication if your ECG already shows that you have QT prolongation or if you are taking a medication that can cause QT prolongation.

Cholesterol: This medication may increase cholesterol or triglyceride (another type of body fat) levels. Your doctor will regularly monitor your cholesterol levels while you are taking saquinavir.

Diabetes: Antiretroviral medications such as saquinavir may increase blood sugar levels. If you have diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is required.

Fat redistribution: This medication may change how fat is distributed on your body. With long-term use, fat may accumulate on the stomach, back, and breasts and be reduced on the arm, legs, and face. Notify your doctor if you start developing any changes in your body's appearance.

Foods: Fatty foods and grapefruit juice increase the body's absorption of saquinavir.

Hemophilia: People with hemophilia may have an increased risk of bleeding while taking this medication. If you have hemophilia, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Immune reconstitution syndrome: This medication may cause immune reconstitution syndrome, where signs and symptoms of inflammation from previous infections appear. These symptoms occur soon after starting anti-HIV medications and can vary. They are thought to occur as a result of the immune system improving and being able to fight infections that have been present without symptoms, such as pneumonia, herpes, or tuberculosis. Report any new symptoms to your doctor immediately.

Liver function: Saquinavir can cause serious liver problems. If you are taking saquinavir, your doctor may request that you have regular liver function tests. People with impaired liver function should not take saquinavir.

Other medications: Saquinavir may interact with a number of medications, which may mean a change in how you take this medication (See "What medications can interact with this medication?"). Tell your doctor of all medications that you are taking. Certain medications should not be taken with saquinavir at all (see "Who should NOT take this medication?"). Saquinavir should never be used on its own and should always be used in combination with ritonavir and other HIV medications.

Pregnancy: The medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if saquinavir passes into breast milk. Because HIV can be transmitted by breast milk, breast-feeding is not recommended for women who are HIV-positive.

Children: The safety and effectiveness of using this medication have not been established for children younger than 16 years of age.

What other drugs could interact with this medication?

There may be an interaction between saquinavir and any of the following:

  • alfuzosin
  • almotriptan
  • antiarrthymia medications (e.g., amiodarone, flecainide, procainamide, propafenone, quinidine, sotalol, lidocaine)
  • aripiprazole
  • astemizole
  • boceprevir
  • bosentan
  • calcium channel blocking agents (e.g., diltiazem, felodipine, amlodipine, verapamil, flunarizine)
  • carbamazepine
  • cisapride
  • clarithromcyin
  • colchicine
  • corticosteroids for the nose (e.g., fluticasone, mometasone)
  • cyclosporine
  • darunavir
  • delavirdine
  • dexamethasone
  • digoxin
  • dihydroergotamine
  • dronedarone
  • efavirenz
  • eplerenone
  • erythromcyin
  • everolimus
  • fentanyl
  • fesoterodine
  • fluconazole
  • garlic capsules/supplements
  • indinavir
  • itraconazole
  • ketoconazole
  • lapatinib
  • maraviroc
  • methysergide
  • miconazole
  • midazolam
  • nelfinavir
  • nevirapine
  • nilotinib
  • phenobarbital
  • phenytoin
  • pimozide
  • rifabutin
  • rifampin
  • ritonavir
  • rivaroxaban
  • salmeterol
  • St. John's wort
  • sildenafil
  • silodosin
  • "statin" medications (e.g., atorvastatin, lovastatin, simvastatin)
  • tacrolimus
  • tadalafil
  • terfenadine
  • trazodone
  • triazolam
  • vardenafil

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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