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saquinavir

Generic Name: saquinavir (sa KWIN a veer)
Brand Name: Invirase, Fortovase

What is saquinavir?

Saquinavir is an antiviral medication that 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 purposes not listed in this medication guide.

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

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

You should not take this medication if you are allergic to saquinavir or ritonavir (Norvir, Kaletra).

Before you take saquinavir, 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.

Life-threatening side effects may occur if you take saquinavir with alfuzosin (Uroxatral), amiodarone (Cordarone, Pacerone), cisapride (Propulsid), dofetilide (Tikosyn), flecainide (Tambocor), lidocaine, lovastatin (Mevacor, Altoprev, Advicor), midazolam (Versed), pimozide (Orap), propafenone (Rythmol), quinidine (Quin-G), rifampin (Rifater, Rifadin, Rifamate), sildenafil (Revatio, for treating pulmonary arterial hypertension), simvastatin (Zocor, Simcor, Vytorin, Juvisync), trazodone (Desyrel), triazolam (Halcion), or an ergot medicine such as Ergomar, Cafergot, Ergotrate, Migranal, or Methergine.

Slideshow: Flashback: FDA Drug Approvals 2013

Many other drugs can interact with saquinavir. Tell your doctor about all medications you use. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

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.

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

You should not take this medication if you are allergic to saquinavir or ritonavir (Norvir, Kaletra).

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

  • amiodarone (Cordarone, Pacerone);

  • cisapride (Propulsid);

  • flecainide (Tambocor);

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

  • midazolam (Versed) or triazolam (Halcion);

  • pimozide (Orap);

  • propafenone (Rythmol);

  • quinidine (Quin-G);

  • rifampin (Rifater, Rifadin, Rifamate); or

  • an ergot medicine such as ergotamine (Ergomar, Cafergot), dihydroergotamine (D.H.E. 45, Migranal Nasal Spray), ergonovine (Ergotrate), or methylergonovine (Methergine).

To make sure you can safely take saquinavir, tell your doctor if you have any of these other conditions:

  • liver disease;

  • heart disease, heart rhythm disorder, or a history of Long QT syndrome;

  • diabetes;

  • hemophilia; or

  • high cholesterol or triglycerides.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby, but 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.

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.

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.

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 exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. 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.

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

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

To be sure saquinavir is helping your condition, your blood will need to be tested often. Your liver function may also need to be tested. Visit your doctor regularly.

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 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.

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 saquinavir?

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.

Saquinavir 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 a serious side effect such as:

  • increased thirst or urination, excessive hunger, fruity breath odor;

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

  • fever, chills, body aches, flu symptoms, mouth and throat ulcers;

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

  • rapid heart rate, increased sweating, tremors in your hands, anxiety, feeling irritable, sleep problems (insomnia);

  • diarrhea, unexplained weight loss, menstrual changes, impotence, loss of interest in sex;

  • swelling in your neck or throat (enlarged thyroid);

  • muscle weakness, tired feeling, trouble speaking or swallowing, joint or muscle pain, feeling short of breath;

  • weakness or prickly feeling in your fingers or toes;

  • problems with walking, breathing, speech, swallowing, or eye movement; or

  • severe lower back pain, loss of bladder or bowel control.

Less serious side effects may include:

  • mild nausea, vomiting, 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)

Saquinavir dosing information

Usual Adult Dose for HIV Infection:

Saquinavir 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:
Saquinavir 1000 mg plus ritonavir 100 mg orally twice a day
-or-
Saquinavir 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.
-Saquinavir 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: Saquinavir 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 other drugs will affect saquinavir?

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

  • atorvastatin (Lipitor, Caduet);

  • digoxin (digitalis, Lanoxin);

  • dexamethasone (DexPak, Cortastat, Dexasone, Solurex) and other steroids;

  • fluticasone (Advair, Flonase, Flovent);

  • garlic or St. John's wort;

  • methadone (Diskets, Dolophine, Methadose);

  • omeprazole (Prilosec);

  • an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), levofloxacin (Levaquin), and others;

  • antifungal medication such as itraconazole (Sporanox) or ketoconazole (Nizoral);

  • any other HIV/AIDS medication;

  • a blood thinner such as warfarin (Coumadin, Jantoven);

  • an antidepressant such as amitriptyline (Elavil, Etrafon), desipramine (Norpramin), or imipramine (Janimine, Tofranil);

  • drugs that weaken the immune system, such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), or tacrolimus (Prograf); or

  • heart or blood pressure medication such as amlodipine (Caduet, Lotrel, Norvasc), diltiazem (Cartia, Cardizem), felodipine (Plendil), isradipine (Dynacirc), nicardipine (Cardene), nifedipine (Nifedical, Procardia), nimodipine (Nimotop), nisoldipine (Sular), or verapamil (Calan, Covera, Isoptin, Verelan);

  • heart rhythm medication such as disopyramide (Norpace), ibutilide (Corvert), procainamide (Pronestyl), or sotalol (Betapace);

  • medicines to treat erectile dysfunction, such as sildenafil (Viagra), tadalafil (Cialis), or vardenafil (Levitra);

  • a sedative such as alprazolam (Xanax), clorazepate (Tranxene), diazepam (Valium), or flurazepam (Dalmane); or

  • seizure medications such as carbamazepine (Carbatrol, Tegretol), phenobarbital (Luminal, Solfoton), or phenytoin (Dilantin).

This list is not complete and there are many other drugs that can interact with saquinavir. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any 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.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 11.01. Revision Date: 2012-04-13, 5:25:37 PM.

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