stop growth hormone. But there is an alternative

Previously it was untraceable, now it disappears completely. The drug Norditropin NordiFlex 15 mg/1.5 ml injectable solution, based on somatropin, will be definitively discontinued from February 22, 2024. This was stated by the Italian Medicines Agency in a note, which alerts patients suffering from stature deficit due to Noonan Syndrome. AIFA, however, specifies that «the ceased marketing in question is not related to any defect in the quality of the medicines or to safety problems». Let’s see together what will happen and what to do if you are following a therapy based on Norditropin NordiFlex 15 mg/1.5 ml solution for injection.

What happen

Starting from April 2023, a shortage of the medicine Norditropin NordiFlex 15 mg/1.5 ml solution for injection was declared, but now the Italian Medicines Agency informs that «the marketing of the medicine, in all authorized packaging, will be definitively interrupted» . This was communicated by the national regulatory body in an update released in agreement with Novo Nordisk SpA. Specifically, it was communicated that the drug, consisting of 1 pre-filled multi-dose glass pen of 1.5 ml, is definitively discontinued from marketing as of 22 February 2024. Norditropin NordiFlex 5 mg/1.5 ml solution for injection will presumably remain in quota distribution until 15 April 2024. Subsequently, periods of total shortage and quota distribution will alternate until definitive marketing ceases, during 2025.

What to do if you use this medicine

The note specifies that «healthcare professionals are invited to ensure that patients using Norditropin NordiFlex 15 mg/1.5 ml and Norditropin NordiFlex 5mg/1.5 ml are informed of this problem and to safely transfer patients to a alternative growth hormone therapy at their discretion, based on their clinical judgment and any relevant local regulations and/or institutional and professional guidance. Doctors are advised not to start new patients on Norditropin NordiFlex therapy.”

The news

Considering that Norditropin Nordiflex is the only somatropin-based medicine authorized in Italy for the treatment of patients suffering from height deficit due to Noonan Syndrome, AIFA has included the somatropin medicine for this indication in the list established pursuant to the Law n. 648/96). Therefore, somatropin can be prescribed, entirely at the expense of the National Health Service, for the treatment of height deficit due to Noonan Syndrome according to the criteria established by AIFA note 39. The prescription of the medicine must be authorized by the regional centres.

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