New Dosing Schedule Approved for Orfadin
September 1, 2017 – The U.S. FDA has approved a new dosing schedule for Orfadin® (nitisinone), manufactured by Sobi, to treat hereditary tyrosinemia type 1 (HT-1). HT-1 is a genetic condition that prevents affected individuals from producing adequate amounts of an enzyme necessary to break down tyrosine, an amino acid, in the body. Orfadin is used in conjunction with dietary restrictions to prevent excessive accumulation of tyrosine. Under the new dosing schedule, patients who are at least five years old and have been stable for a minimum of four weeks on the previously recommended twice-daily dosing schedule of Orfadin may now take the total daily dose once per day.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.