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nitisinone - oral, Orfadin (cont.)

HOW TO USE: Take this medication by mouth on an empty stomach at least 1 hour before a meal, usually twice daily, or as directed by your doctor.For children who are unable to swallow capsules, the capsules may be opened and the contents mixed in a small amount of water, formula, or applesauce immediately before use. Make sure the child swallows the entire dose.The dosage is based on weight, medical condition, and response to treatment. The manufacturer recommends that patients should not take more than 2 milligrams per kilogram a day.Take this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.It is very important that patients taking this medication follow a special diet low in protein, tyrosine, and phenylalanine. Consult your doctor, pharmacist, or dietician for more details. (See also Drug Interactions and Precautions sections.)Nitisinone can increase tyrosine levels and cause eye problems. Patients should have an eye test (slit-lamp examination) before using this medication so that later the doctor can see whether there have been changes. (See also Side Effects and Precautions sections.)

SIDE EFFECTS: Remember that the doctor has prescribed this medication because he or she has judged that the benefit is greater than the risk of side effects. Many people using this medication do not have serious side effects.This medication may rarely cause a low number of blood cells such as white cells and platelets. This effect can decrease your body's ability to fight an infection or cause easy bruising/bleeding. Tell your doctor immediately if you develop any of the following unlikely symptoms: signs of infection (such as fever, chills, persistent sore throat), easy bruising/bleeding.Your condition and this medication can cause liver problems. Tell the doctor immediately if any of these symptoms of liver problems occur: severe stomach/abdominal pain, persistent nausea or vomiting, yellowing eyes/skin, dark urine.Your condition and this medication can cause high levels of tyrosine in the blood. Therefore, it is very important to follow the low protein/low tyrosine diet recommended by your doctor. See also Precautions section. Too much tyrosine may cause skin, eye, or brain problems. Tell the doctor immediately if any of these symptoms occur: eye redness/itching/discharge, vision changes, eye pain, eye sensitivity (especially to light), dry/itchy skin, sores on palms of hands/soles of feet, developmental delays (such as holding head up, rolling over, crawling).A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact the doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.



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