European Security Information Issued

Summary of Drug Safety Updates (as of September 1, 2025)

This document summarizes recent drug safety ⁢updates⁤ from the National Agency for the Safety of Medicines and Health Products (ANSM)‍ and the Pharmacovigilance⁢ Risk Assessment Committee (PRAC).

1. Interactions⁣ between CRYSVITA (burosumab) and⁣ Tegretol oral suspension (carbamazepine)

* The ANSM is alerting healthcare professionals to potential interactions between CRYSVITA (burosumab) and Tegretol oral suspension (carbamazepine).
* Further information will ⁤be provided in letters from the concerned laboratories.

2. ⁣Caspofungine⁣ and Polyacrylonitrile Hemofiltration ⁤membranes

* Warning: Do not use polyacrylonitrile (PAN)-based membranes during continuous hemofiltration in critically ill patients receiving Caspofungine.
* ⁤ PAN membranes‍ can bind to Caspofungine, reducing its effectiveness and potentially worsening systemic fungal infections (with a risk⁣ of death in critical patients).
* Recommendations:

‍ * ⁣ check the type of hemofiltration membrane used ⁤ before and during Caspofungine treatment.
⁢ * Switch to a different membrane type or consider an alternative antifungal if PAN membranes are in use.

3. burosumab (Crysvita) and Risk of Severe Hypercalcemia

* Cases of severe hypercalcemia‍ have been reported in patients treated with ⁢Burosumab, especially those with tertiary hyperparathyroidism.
* Recommendations:

‍ * Do not administer⁤ Crysvita to patients with moderate to severe hypercalcemia (> 3 mmol/l) until the hypercalcemia is ⁣treated and resolved.
* Monitor serum calcium levels:
‍ ⁣ ⁢ * Before starting treatment.
* 1-2 weeks after initiation or dose adjustment.
* Every 6 months during treatment ⁢(every 3 months in children aged 1-2).
* Monitor parathyroid hormone‍ levels every 6 months (every 3 months in children aged 1-2).

Source: Information shared by the ANSM based on PRAC findings ⁣(as of September 1,2025). ⁤ Further details can be found at https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-1-4-september-2025 and https://www.vidal.fr/actualites/30995-caspofungine-en-reanimation-ne-pas-utiliser-de-membranes-derivees-du-polyacrylonitrile.html.