On amending the instructions for medical use of medicinal products containing octreotide (octreotide)

Following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC), recommendations were issued on updating the package insert.

In order to minimize the risk of underdiagnosis and delayed treatment of concomitant exocrine pancreatic insufficiency (EPI), which often occurs in patients receiving octreotide (octreotide) for neuroendocrine tumors, PRAC provided the following recommendations.

All holders of registration certificates for medicinal products containing octreotide must within two months of the publication of the PRAC recommendation make changes to the instructions for medical use.

Changes to be included in the relevant sections of the package insert (new text underlined in bold).

“Special precautions for use” section

Pancreatic function:

Exocrine pancreatic insufficiency (EPI) has been observed in some patients receiving octreotide therapy for gastroenteropancreatic neuroendocrine tumors. Symptoms of EPI may include steatorrhea, loose stools, abdominal bloating, and weight loss. Screening and appropriate treatment of EPI in accordance with clinical guidelines should be considered in patients with symptoms.

The original text of this publication can be found at the following links:

• https://www.ema.europa.eu/en/documents/prac-recommendation/prac-recommendations-signals-adopted-5-8-july-2021-prac-meeting_en.pdf
• https://www.ema.europa.eu/en/documents/prac-recommendation/prac-recommendations-signals-adopted-5-8-july-2021-prac-meeting_en.pdf