Nitisinone

Nitisinone is used for:

Treating hereditary tyrosinemia type 1 (HT-1), a genetic metabolism disorder. Nitisinone is used in combination with dietary restriction of tyrosine and phenylalanine.

Nitisinone is a 4-hydroxyphenylpyruvate dioxygenase inhibitor. It works by blocking the breakdown of tyrosine. This helps to reduce the amount of toxic byproducts in the body produced by the breakdown of tyrosine.

Do NOT use Nitisinone if:

• you are allergic to any ingredient in Nitisinone

Contact your doctor or health care provider right away if any of these apply to you.

Before using Nitisinone :

Some medical conditions may interact with Nitisinone . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have any other metabolism disorders (eg, porphyria)

Some MEDICINES MAY INTERACT with Nitisinone . However, no specific interactions with Nitisinone are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Nitisinone may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Nitisinone :

Use Nitisinone as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Nitisinone on an empty stomach at least 1 hour before eating.
• If you have difficulty swallowing the capsule, it may be opened and the contents sprinkled into a small amount of water, formula, or applesauce immediately before use. Do not store the mixture for use at a later time.
• If you miss a dose of Nitisinone , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

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

Important safety information:

• It is important to follow the dietary plan provided by your doctor in order to avoid the risk of serious side effects from Nitisinone .
• Diabetes patients - Nitisinone may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.
• LAB TESTS, including platelet and white blood cell counts, vision tests, liver function tests, and blood phosphate or tyrosine levels, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• PREGNANCY and BREAST-FEEDING: It is unknown if Nitisinone can cause harm to the fetus. If you think you may be pregnant, discuss with your doctor the benefits and risks of using Nitisinone during pregnancy. It is unknown if Nitisinone is excreted in breast milk. If you are or will be breast-feeding while you are using Nitisinone , check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Nitisinone :

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with this product. Seek medical attention right away if any of these SEVERE side effects occur:

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include eye problems (eg, redness, swelling, burning, vision changes, light sensitivity, pain); skin lesions.

Store Nitisinone in the refrigerator between 36 and 46 degrees F (2 and 8 degrees C). Keep Nitisinone out of the reach of children and away from pets.

General information:

• If you have any questions about Nitisinone , please talk with your doctor, pharmacist, or other health care provider.
• Nitisinone is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Nitisinone . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.