invirase

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

Invirase is used together with Norvir (ritonavir) to treat HIV, which causes acquired immunodeficiency syndrome (AIDS).

Neither Invirase nor ritonavir will not cure HIV or AIDS.

Important information

Invirase must be taken together with another medicine called ritonavir (Norvir).

Before you take Invirase, tell your doctor if you have liver disease, diabetes; hemophilia, or high cholesterol, heart disease, heart rhythm disorder, or a history of Long QT syndrome.

Many drugs can interact with saquinavir, and some drugs should not be used together. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Invirase.

Life-threatening side effects may occur if you take Invirase with: alfuzosin, amiodarone, cisapride, dofetilide, flecainide, lidocaine, lovastatin, midazolam, pimozide, propafenone, quinidine, rifampin, sildenafil (Revatio, for treating pulmonary arterial hypertension), simvastatin, trazodone, triazolam, or an ergot medicine such as Ergomar, Cafergot, Ergotrate, Migranal, or Methergine.

HIV/AIDS is usually treated with a combination of drugs. Use all medications as directed by your doctor. Do not change your doses or medication schedule without your doctor"s advice. Every person with HIV or AIDS should remain under the care of a doctor.

Taking this medication will not prevent you from passing HIV to other people. Avoid having unprotected sex or sharing razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Before taking this medicine

You should not take Invirase if you are allergic to saquinavir or ritonavir (Norvir, Kaletra), or if you have:

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

• personal or family history of long QT syndrome;

• severe liver disease; or

• low levels of potassium or magnesium in your blood.

Life-threatening side effects may occur if you take Invirase with:

• alfuzosin;

• cisapride;

• pimozide;

• oral midazolam, or triazolam;

• rifampin;

• cholesterol medication - lovastatin (Mevacor, Altoprev, Advicor) or simvastatin (Zocor, Simcor, Vytorin);

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

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

To make sure Invirase is safe for you, tell your doctor if you have:

• heart disease;

• liver disease (including hepatitis B or C);

• a bleeding or blood clotting disorder such as hemophilia;

• diabetes; or

• high cholesterol or triglycerides.

Tell your doctor if you are pregnant or plan to become pregnant. HIV can be passed to your baby if you are not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of Invirase on the baby.

Invirase can make birth control pills less effective. Ask your doctor about using non hormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy.

Women with HIV or AIDS should not breast-feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Invirase is not approved for use by anyone younger than 16 years old.

How should I take Invirase?

Take Invirase exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Invirase 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.

To make swallowing easier, you may open the Invirase capsule and sprinkle the medicine into 1 tablespoon of jam or sugar syrup (use sorbitol if you are diabetic). Stir the mixture for about a minute and allow it to reach room temperature. Swallow the mixture right away without chewing. Do not save the mixture for later use.

While using Invirase, you may need frequent blood tests.

Use Invirase 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 drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor"s advice. Every person with HIV or AIDS should 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.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Try not to miss any of your doses. Skipping doses may increase the risk of your virus becoming resistant to antiviral medicine.

Invirase dosing information

Usual Adult Dose for HIV Infection:

Invirase 1000 mg plus ritonavir 100 mg orally twice a day

Comments:
-No additional ritonavir is recommended when saquinavir is administered with lopinavir 400 mg-ritonavir 100 mg twice a day.
-Unboosted saquinavir is not recommended by the manufacturer or the DHHS Panel on Clinical Practices for Treatment of HIV Infection due to low bioavailability.

Usual Adult Dose for Nonoccupational Exposure:

(Not approved by FDA)

Centers for Disease Control and Prevention recommendations:
Invirase 1000 mg plus ritonavir 100 mg orally twice a day
-or-
Invirase 400 mg plus ritonavir 400 mg orally twice a day

Duration: 28 days

Comments:
-Prophylaxis should be initiated as soon as possible, within 72 hours of exposure.
-Invirase plus ritonavir plus 2 NRTIs is one of the alternative regimens recommended for nonoccupational postexposure HIV prophylaxis.

Usual Pediatric Dose for HIV Infection:

16 years or older: Invirase 1000 mg plus ritonavir 100 mg orally twice a day

Comments:
-No additional ritonavir is recommended when saquinavir is administered with lopinavir 400 mg-ritonavir 100 mg twice a day.
-Unboosted saquinavir is not recommended by the manufacturer or the DHHS Panel on Clinical Practices for Treatment of HIV Infection due to low bioavailability.

What happens if I overdose?

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

What should I avoid while taking Invirase?

Taking this medicine will not prevent you from passing HIV to other people. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Invirase side effects

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

Invirase may increase your risk of certain infections or autoimmune disorders by changing the way your immune system works. Symptoms may occur weeks or months after you start treatment with Invirase. Tell your doctor if you have:

• signs of a new infection - fever, night sweats, swollen glands, mouth sores, diarrhea, stomach pain, weight loss;

• chest pain (especially when you breathe), dry cough, wheezing, feeling short of breath;

• cold sores, sores on your genital or anal area;

• rapid heart rate, feeling anxious or irritable, weakness or prickly feeling, problems with balance or eye movement;

• trouble speaking or swallowing, severe lower back pain, loss of bladder or bowel control; or

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

Call your doctor at once if you have:

• any type of infection, skin infection, or open sores;

• cough with yellow or green mucus, stabbing chest pain, wheezing, feeling short of breath;

• high blood sugar - increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss; or

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

Common Invirase side effects 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.

See also: Side effects (in more detail)

What other drugs will affect Invirase?

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

• colchicine;

• dexamethasone;

• fluticasone (Flonase, Advair);

• fusidic acid;

• methadone;

• omeprazole (Prilosec);

• sildenafil (Viagra) and other erectile dysfunction medicines;

• tadalafil (Adcirca) to treat pulmonary arterial hypertension;

• warfarin (Coumadin, Jantoven);

• an antibiotic or antifungal medicine;

• an herbal supplement, especially garlic or St. John"s wort;

• any other antiviral medicines to treat hepatitis or HIV;

• cholesterol medication;

• heart or blood pressure medication;

• medicine to prevent organ transplant rejection;

• a sedative such as Valium, or other medicines to treat anxiety or mental illness; or

• seizure medicine.

This list is not complete and many other drugs can interact with saquinavir. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you. Not all possible interactions are listed in this medication guide.