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FILGINASE (SUSTIVA) INDICATIONS

Filginase (efavirenz) is an antiviral medication that prevents human immunodeficiency virus (HIV) cells from multiplying in your body.
Filginase is used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). Efavirenz is not a cure for HIV or AIDS.
This medicine may also be used for other purposes not listed in this medication guide.

FILGINASE (SUSTIVA) INSTRUCTIONS

Take Filginase 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.

Take Filginase on an empty stomach at bedtime, unless your doctor tells you otherwise.

Filginase can cause side effects such as mood or behavior changes. These symptoms may improve the longer you take the medication. Taking Filginase at bedtime may also lessen these effects. Contact your doctor if you have more serious symptoms such as severe depression or thoughts of hurting yourself.

Take Filginase regularly to get the most benefit. Get your prescriptions refilled before you run out of medicine completely.

Do not take Filginase as your only HIV medication. HIV/AIDS is usually treated with a combination of different drugs. Your disease may become resistant to Filginase if you do not take it in combination with other HIV medicines your doctor has prescribed. 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.

To be sure Filginase is helping your condition and not causing harmful effects, your blood and liver function may need to be tested often. Visit your doctor regularly.

This medication can cause you to have a false positive drug-screening test. If you provide a urine sample for drug-screening, tell the laboratory staff that you are taking Filginase.

FILGINASE (SUSTIVA) STORAGE

Take this medicine as prescribed by your doctor.

Ask your health care provider any questions you may have about how to use it.

FILGINASE (SUSTIVA) STORAGE

Store at room temperature (77 degrees F/25 degrees C). Storage for brief periods at 59-86 degrees F (15-30 degrees C) is permitted.

FILGINASE (SUSTIVA) MORE INFO:



Active Ingredient: Efavirenz

Filginase may cause serious psychiatric symptoms including confusion, severe depression, suicidal thoughts, aggression, extreme fear, hallucinations, or unusual behavior. Contact your doctor at once if you have any of these side effects, even if you have had them before.

Do not use Filginase without telling your doctor if you are pregnant. It could harm the unborn baby. Use two forms of birth control, including a barrier form (such as a condom or diaphragm with spermicide gel) while you are taking Filginase, and for at least 12 weeks after your treatment ends. Tell your doctor if you become pregnant during treatment.

Do not take Filginase with cisapride (Propulsid), pimozide (Orap), midazolam (Versed), triazolam (Halcion), or ergot medicines such as dihydroergotamine (D.H.E. 45), ergonovine (Ergotrate), ergotamine (Ergomar, Cafergot, Wigraine), or methylergonovine (Methergine).

These drugs can cause life-threatening side effects if you use them while you are taking Filginase.

There are many other medicines that can interact with Filginase, or make it less effective. 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.

Taking Filginase will not prevent you from passing HIV to other people. Talk with your doctor about safe methods of preventing HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Before taking Filginase

Do not use Filginase if you are allergic to efavirenz, or if you are using any of the following drugs:

cisapride (Propulsid);

midazolam (Versed) or triazolam (Halcion);

pimozide (Orap); or

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

Using any of these medicines while you are taking Filginase can cause serious medical problems or death.

To make sure you can safely take Filginase, tell your doctor if you have any of these other conditions:
liver disease (including hepatitis B or C);


high cholesterol or triglycerides; or

if you have ever taken delavirdine (Rescriptor) or nevirapine (Viramune) and they were not effective in treating your condition.

FDA pregnancy category D. Do not use Filginase if you are pregnant. It could harm the unborn baby. Use two forms of birth control, including a barrier form (such as a condom or diaphragm with spermicide gel) while you are taking Filginase, and for at least 12 weeks after your treatment ends. Tell your doctor if you become pregnant during treatment. HIV can be passed to the baby if the mother is not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection while you are pregnant.

Filginase may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of Filginase.

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.

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

Filginase may cause serious psychiatric symptoms including confusion, severe depression, suicidal thoughts, aggression, extreme fear, hallucinations, or unusual behavior. Contact your doctor at once if you have any of these side effects, even if you have had them before.

Call your doctor at once if you have a serious side effect such as:

fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;

nausea, stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

fever, chills, body aches, flu symptoms; or any other signs of new infection.

Less serious Filginase side effects may include:


mild nausea, vomiting, or stomach pain, diarrhea or constipation;

cough;

blurred vision;

headache, tired feeling, dizziness, spinning sensation;

trouble concentrating, problems with balance or coordination;

muscle or joint pain;

sleep problems (insomnia), unusual dreams; 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.



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