Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| Sotorasib | Lumykras | "4.2 Posology and method of administration , 4.5. Interactions with other medicinal products" | Interaction with omeprazole and Breast cancer resistance protein (BCRP) substrate | Dec,2023 |
| Asciminib | Scemblix | 4.5. Interactions with other medicinal products | Interaction with OATP1B and BCRP substrates, rosuvastatin and atorvastatin | Nov,2023 |
| Zanubrutinib | Itrazol | "4.3 Contraindications , 4.5. Interactions with other medicinal products" | "4.3 Contraindications 4.5. Interactions with other medicinal products" "Co-administration of Cytochrome (CYP3A4) substrates is contraindicated with ITRAZOL " | Nov,2023 |
| Warfarin Sodium | Coufatex | 4.5. Interactions with other medicinal products | Interactions with Ibrutinib. | Nov,2023 |
| Warfarin Sodium | Coufatex | 4.5. Interactions with other medicinal products | Interactions with Ibrutinib. | Nov,2023 |
| Dabigatran Etexilate Mesylate | Pradaxa | 4.8. Undesirable effects | Anticoagulant-related nephropathy in patients with predisposing risk factors | May,2024 |