Pediatric Indication for Tresiba
December 16, 2016 - The U.S. FDA approved an expanded indication for Tresiba® (insulin degludec), manufactured by Novo Nordisk. Tresiba now can be used to improve glycemic (blood sugar) control for teens and children as young as one year of age. It was already approved for patients with either type 1 or type 2 diabetes. It is a basal (long-acting) insulin that is injected once daily. Tresiba is available in both 100 units/mL (U-100) and 200 units/mL (U-200) FlexTouch® insulin pen delivery devices. Each disposable pen is prefilled with 3mL of Tresiba. Doses up to 80 units (of U-100) or 160 units (U-200) may be given in one injection. However, it should not be used for patients whose doses are 5 units or less. A new pen needle should be used for each injection and each insulin pen should be used by only one person, even after the needles are changed.
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 regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular 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.