Orfadin (Nitisinone Oral Suspension)

• It is used to treat hereditary tyrosinemia type 1 (HT-1).

• Tell all of your health care providers that you take Orfadin. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Have your urine checked as you have been told by your doctor.
• Have an eye exam as you have been told by your doctor.
• Nitisinone must be used with a special diet that is low in tyrosine and phenylalanine.
• Follow the diet plan that your doctor told you about.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Use Orfadin as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• To gain the most benefit, do not miss doses.
• Keep taking this medicine as you have been told by your doctor or other health care provider, even if you feel well.
• If the adapter has not been put in the bottle when you get it, follow how to prepare the bottle as you have been told or read the package insert.
• Take with or without food.
• Shake well before use.
• Measure liquid doses carefully. Use the measuring device that comes with Orfadin. If there is none, ask the pharmacist for a device to measure this medicine.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Upset stomach.
• Loose stools (diarrhea).

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.