The Italian Medicines Agency has announced that the drug Norditropin NordiFlex 15 mg/1.5 ml solution for injection, based on somatropin, will be completely discontinued starting from February 22, 2024. This decision comes after a previous shortage of the medicine was declared in April 2023.
According to AIFA, the cessation of marketing is not due to any quality or safety issues with the medicine, but rather a decision made in agreement with the manufacturer Novo Nordisk SpA. The discontinuation will also affect the Norditropin NordiFlex 5 mg/1.5 ml solution for injection, with a staggered distribution until April 2025.
For patients who are currently using Norditropin NordiFlex 15 mg/1.5 ml or Norditropin NordiFlex 5mg/1.5 ml, healthcare professionals are advised to safely transition them to alternative growth hormone therapy based on their clinical judgment and local regulations. Additionally, doctors are cautioned against starting new patients on Norditropin NordiFlex therapy.
Norditropin NordiFlex is the only somatropin-based medicine authorized in Italy for treating patients with height deficits due to Noonan Syndrome. AIFA has included somatropin in the list of medicines that can be prescribed at the expense of the National Health Service for this indication, following specific criteria outlined in AIFA note 39.
Patients and healthcare providers are encouraged to stay informed about the discontinuation of Norditropin NordiFlex and to seek alternative treatment options as needed.