NITISINONE

(nye TIS i none) Brand: Orfadin

What is the most significant information I must know about nitisinone?

• Call your doctor at once if you have vision problems, eye pain, eye redness or burning, light bruising, unusual bleeding, itching, or jaundice (yellowing of the skin or eyes). Speak your doctor if your child has a sudden change in behavior, capacity, or development (sitting up, crawling, walking, talking, etc).

What is nitisinone?

• Nitisinone works by preventing the body from breaking down an amino acid called tyrosine and by keeping another toxic substances from building up and causing harm to your liver or kidneys.

• Nitisinone is used to treat a rare genetic condition called hereditary tyrosinemia type 1 (HT-1). HT-1 is a metabolic mess that occurs when the body does not manufacture satis of an enzyme that breaks down proteins from determined foods. This condition occurs most often in young babies.

• Nitisinone may also be used for purposes not listed in this medicine guide.

What must I discuss with my health care provider till taking nitisinone?

• To create certain nitisinone is safety for you, speak your doctor if you have any medical conditions affecting your eyes.

• FDA pregnancy category C. It is not known whether nitisinone will harm an unborn child. Speak your doctor if you are pregnant or plan to become pregnant while using this medication.

• It is not known whether nitisinone passes into breast milk or if it could harm a nursing child. Speak your doctor if you are breast-feeding a baby.

How must I take nitisinone?

• Follow all directions on your prescription label. Do not take this medication in larger or less amounts or for longer than recommended.

• Your doctor may occasionally change your doze to create certain you get the excellent results. Do not change your medicine doze or schedule without your doctor's advice.

• Take nitisinone on an empty stomach, at least 1 hour till or 2 hours after a meal.

• You may open the nitisinone capsule and sprinkle the medication into a spoonful of water, child formula, or applesauce to create swallowing easier. Use the mixture right away. Do not save for later use.

• Nitisinone may be only part of a complete program of treatment that also includes a particular diet. You should avoid determined foods for your treatment to be effective. Follow the diet plan created for you by your doctor or nutrition counselor.

• Tall protein foods are tall in tyrosine and phenylalanine. Since babies and children need protein to grow and develop, particular foods have been developed to replace the tall protein foods.

• While using nitisinone, you may need frequent blood trials at your doctor's office. Your vision may also need to be checked.

• Store in the refrigerator, do not freeze.

What happens if I miss a dose?

• Take the missed doze as soon as you remember. Skip the missed doze if it is nearly time for your following scheduled doze. Do not take extra medication to create up the missed dose.

What happens if I overdose?

• Search abnormal medical attention or call the Poison Help line at 1-800-222-1222.

What must I avoid while taking nitisinone?

• While you are taking nitisinone, you should not ate foods that are tall in tyrosine or phenylalanine, including:

· chicken, beef, pork, liver, fish, processed meats (bologna, hot dogs, pepperoni, heavy sausages), meat tenderizer, herring or another dried fish;

· cheese, milk, sour cream, yogurt;

· beer, wine, distilled liquor;

· avocados, bananas, carrots, potatoes, spinach, tomatoes, raisins, red plums,

· oatmeal, brown rice,

· soy sauce, soy protein, tofu, bean curd, garbanzo beans, soy beans, and determined nuts or seeds; or

· foods that contain an artificial sweetener called aspartame (NutraSweet)--diet soda, some foods labeled as "sugar-free" or "zero calorie."

• There are another foods that may contain tyrosine or phenylalanine. Get familiar with the list of foods you should avoid to help control your condition.

What are the possible side effects of nitisinone?

• Get abnormal medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your person, lips, tongue, or throat.

• Some side effects may result from not properly next your diet plan and consuming restricted foods or beverages.

• Call your doctor at once if you have:

· a sudden change in behavior, capacity, or development (sitting up, crawling, walking, talking, etc);

· light bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

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

· vision problems,

· eye pain, redness or swelling, burning, white or yellow patches on your eyes; or

· calluses, peeling, or hardened skin on the palms of your hands or the soles of your feet.

• General side effects may include:

· heighten sensitivity of your eyes to light;

· dry skin; or

· mild rash.

• This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may message side effects to FDA at 1-800-FDA-1088.

What another drugs will affect nitisinone?

• Another drugs may interact with nitisinone, including prescription and over-the-counter medicines, vitamins, and herbal commodity. Speak every of your health care providers about all medicines you use now and any medication you start or stop using.

Where can I get more information?

• Your pharmacist can provide more information about nitisinone.

Remember, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.

Disclaim: Each 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 external 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 must be construed to indicate that the drug or drug combination is safety, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the help 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.