Nitisinone, Oral

What are other names for this medicine?

Type of medicine: enzyme inhibitor

Generic and brand names: nitisinone, oral; Orfadin

What is this medicine used for?

This medicine is taken by mouth to treat tyrosinemia (a disease caused by too much tyrosine in the blood.) It is used along with a special diet.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• an allergic reaction to any medicine
• a bleeding disorder
• eye problems
• liver problems.

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Take this medicine at least 1 hour before meals. If you have trouble swallowing, the capsule may be opened and the powder sprinkled in a small amount of water or formula, or on soft food such as applesauce. Take the medicine right away after mixing it.

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What should I watch out for?

While taking this medicine, it is important to follow your provider's instructions about diet.

You will need to have lab tests regularly to see how this medicine affects you. Keep all appointments for these tests.

Your eyes may be more sensitive to light. Wear sunglasses when outdoors and avoid bright lights. Also, your healthcare provider may want you to have your eyes checked regularly while you are taking this medicine.

If you need emergency care, surgery, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Serious (report these to your healthcare provider right away): Unusual bruising or bleeding; unusual tiredness or weakness; hallucinations; trouble urinating; vomiting; confusion; redness, burning, or swelling of the eyes; vision problems; rash or scaly skin; yellowish eyes or skin; dark urine; light colored bowel movements.

Other: Dry mouth, drowsiness, headache, constipation, nausea, sensitivity to light, mild rash, dry skin, itching.

What products might interact with this medicine?

No significant drug interactions have been reported. It is very important to follow the diet prescribed by your healthcare provider.

Keep a list of all your medicines (prescription, nonprescription, supplements, natural remedies, and vitamins) with you. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine in the refrigerator. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.