Swissmedic Health Professional Communications

Spevigo Authorization Transfer to LEO, Delayed Leaflet

Swissmedic notifies healthcare professionals that the marketing authorization for Spevigo (spesolimabum, authorization no. 68625) was transferred from Boehringer Ingelheim (Schweiz) GmbH to LEO Pharmaceutical Products Sarath Ltd. effective 02.03.2026. To prevent supply disruption, packages with outdated package leaflets remain in circulation until the reprint is completed. These leaflets have not yet been updated with the latest approved safety information.

Kyprolis Visible Particles After Reconstitution - Safety Communication

Swissmedic issued a health professional communication regarding Kyprolis (carfilzomibum) 10 mg and 60 mg following routine stability monitoring that detected visible particles (transparent, colorless) in reconstituted samples. All distributed batches remain safe for use. The communication emphasizes strict adherence to visual inspection procedures per approved reconstitution instructions before administration.

Crysvita Severe Hypercalcemia Risk Communication

Swissmedic, in coordination with Kyowa Kirin, issued a Direct Healthcare Professional Communication (DHPC) warning of severe hypercalcemia risk associated with Crysvita (Burosumab). Cases of elevated serum calcium, including life-threatening hypercalcemia, have been reported, particularly in patients with tertiary hyperparathyroidism. The communication establishes contraindications for patients with moderate to severe hypercalcemia (>3.0 mmol/L) and provides updated monitoring protocols.

Swissmedic: Lisdexamfetamine Contraindication for Pheochromocytoma Patients

Swissmedic is updating the contraindications for lisdexamfetamine dimesylate to include patients with pheochromocytoma. This change aims to prevent potentially life-threatening increases in catecholamine levels. The product information for both healthcare professionals and patients will be amended to reflect this new contraindication.

Voxzogo (vosoritidum) Packaging Text Error Identified

Swissmedic has identified a packaging text error on Voxzogo (vosoritidum) outer packaging. The incorrect dosage information was printed on specific batches, and affected batches have been identified. The company has issued an information letter detailing the error and corrective actions.

Keppra (Levetiracetam) Syringe Change and Medication Error Risk

Swissmedic and UCB-Pharma AG are issuing a communication regarding a change in the application syringe for Keppra (Levetiracetam) oral solution. A new 5 ml syringe replaces the 3 ml syringe for children aged 6 months to 4 years, requiring healthcare professionals to inform caregivers about the change and proper dosing to prevent medication errors.

Cytosar (cytarabinum) Barcode Expiry Date Discrepancy Alert

Swissmedic has issued a Health Professional Communication regarding a barcode expiry date discrepancy for Cytosar (cytarabinum) 2g/20ml, batch CT32407B. The date encoded in the 2D barcode on the vial label is incorrect and does not match the legible expiry date printed on the vial.

Yttrium Citrate (90Y)-YMM-1 Failed Sterility Test

Swissmedic has issued a communication regarding Citrate d'Yttrium (90Y)-YMM-1, Suspension for Injection, batch Z008. The batch failed its sterility test after incubation. While no immediate patient danger is expected, affected patients require close monitoring.