| Pharmacy Drug Brand Name: | Orfadin® |
| Active Ingredient(s): | nitisinone |
| Strength(s) / Dose(s): | 2 mg, 5 mg, and 10 mg |
| Delivery / Dosage Form(s): | Capsules |
| Company Manufacturer Name: | Swedish Orphan International, AB |
| Availability / Prescription: | Prescription only |
| Date Approved by FDA *: | January 18, 2002 |
* Approval by the FDA does not necessarily mean that this drug is available for consumers at this time.
What is Orfadin used for?
Orfadin is used to treat hereditary tyrosinemia type 1, a rare pediatric disease or damage causing progressive liver failure and liver cancer in young children. It is used along with a diet restricting the amino acids tyrosine and phenylalanine.
Special Warnings with Orfadin:
Patients and their parents or caregivers should tell their doctor right away about:
- any unexplained eye symptoms (eye pain or discomfort, redness, swelling or burning of the eyes)
- rash
- jaundice (yellowing of the skin and whites of the eyes, and dark color to the urine)
- excessive bleeding
What should I tell my health care (healthcare) provider?
- Tell your health care (healthcare) provider if you are trying to become pregnant, are already pregnant, or are breast-feeding.
- Tell your health care (healthcare) provider if you are allergic to nitisinone (Orfadin) or to any of the other ingredients in Orfadin.
- Tell your health care (healthcare) provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
What are some possible side effects of Orfadin? (This is not a comprehensive list of possible side effects assosciated with Orfadin. Your doctor or pharmacist can provide expert advice on the possible side effects of this drug.)
The most common side effects of Orfadin were related to high tyrosine levels due to patients not eating the right foods as well as rare cases of a decrease in platelet and white blood cell counts.