ZYNLONTA

批准信原文要点

This Prior Approval supplemental biologics application provides for updates to the US Prescribing Information to add new information relating to capillary leak syndrome and cutaneous callogenous vasculopathy. The following sections of the label have been updated: Section 2.3 Dosage Modifications and Delays; Section 5.1 Effusion and Edema, Including Capillary Leak Syndrome; Section 6.2 Postmarketing Experience; Section 17 Patient Counseling Information.

批准信原文要点

This Prior Approval supplemental biologics application provides for updates to the United States Prescribing Information to include: Addition of hepatotoxicity to Dosage and Administration (Section 2.3), Warnings and Precautions (Section 5.4), Adverse Reactions (Section 6.1), Patient Counseling Information (Section 17); Revisions to Use in Specific Populations (Subsection 8.6 Hepatic Impairment) and Clinical Pharmacology (Subsection 12.3 Pharmacokinetics); Corresponding changes to the Patient Package Insert.

批准信原文要点

These Prior Approval supplemental biologics applications provide for the following changes: S-004: Updates to Sections 8.3 and 17 of the US Prescribing Information (USPI) and Patient Package Insert (PPI) to specify the duration of contraception after the last dose of Zynlonta of 10 months for women of childbearing potential and 7 months for men with female partners of childbearing potential. S-005: Addition of cutaneous toxicity to Section 6.2, Post-Marketing Experience to the USPI.

批准信原文要点

These Prior Approval supplemental biologics applications provide for the following changes: S-004: Updates to Sections 8.3 and 17 of the US Prescribing Information (USPI) and Patient Package Insert (PPI) to specify the duration of contraception after the last dose of Zynlonta of 10 months for women of childbearing potential and 7 months for men with female partners of childbearing potential. S-005: Addition of cutaneous toxicity to Section 6.2, Post-Marketing Experience to the USPI.