Epcoritamab

Important Dosing Information Certain doses of EPKINLY require dilution prior to administration. There are 2 available methods to prepare diluted EPKINLY: Empty sterile vial method as described in subsection 2.7 [see Dosage and Administration ] , or Sterile syringe method as described in subsection 2.8 [see Dosage and Administration ] .

Preparation of 3 mg and 48 mg EPKINLY doses does not require dilution. [see Dosage and Administration ] . EPKINLY should only be administered by a qualified healthcare professional with appropriate medical support to manage severe reactions such as CRS and ICANS [see Warnings and Precautions (5.1 , 5.2) ] . Administer EPKINLY to well-hydrated patients.

Premedicate before each dose in Cycle 1 [see Dosage and Administration ] . Administer EPKINLY subcutaneously according to the recommended step-up dosage schedule to reduce the incidence and severity of CRS [see Dosage and Administration ] . Due to the risk of CRS and ICANS, monitor all patients for signs and symptoms [see Dosage and Administration ] .

Assess whether hospitalization or outpatient monitoring is appropriate based on comorbidities or other situational factors for the first 48 mg dosage of EPKINLY for patients with: DLBCL or high-grade B-cell lymphoma: on Cycle 1 Day 15 [see Dosage and Administration ]. FL: on Cycle 1 Day 22 [see Dosage and Administration ].

Recommended Pre- and Post-Administration Medications Administer pre- and post-administration medications as outlined in Table 6 to reduce the risk of CRS [see Warnings and Precautions ] . [See table below.]

Preparation of Diluted EPKINLY using the Vial Method Read this entire section carefully before preparation of EPKINLY. Certain doses of EPKINLY require dilution prior to administration. Follow the preparation instructions provided below, as improper preparation may lead to improper dose. This section describes preparation of diluted EPKINLY using empty sterile vial method.

For preparation using sterile syringe method, see subsection 2.8 [see Dosage and Administration ] . EPKINLY is prepared and administered by a healthcare provider as a subcutaneous injection. The administration of EPKINLY takes place over the course of 28-day cycles, following the step-up dosage schedule in Section 2.2. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Use aseptic technique to prepare EPKINLY. Filtration of the diluted solution is not required. 0.16 mg Dose Preparation Instructions ( 2 dilutions required ) – Empty Sterile Vial Method Use an appropriately sized syringe, vial, and needle for each transfer step. [See table below.] Discard the vial containing unused EPKINLY. 0.8 mg Dose Preparation Instructions ( 1 dilution required ) – Empty Sterile Vial Method Use an appropriately sized syringe, vial, and needle for each transfer step. [See table below.] Discard the vial containing unused EPKINLY.

Preparation of Diluted EPKINLY using the Syringe Method Read this entire section carefully before preparation of EPKINLY. Certain doses of EPKINLY require dilution prior to administration. Follow the preparation instructions provided below, as improper preparation may lead to improper dose. EPKINLY is prepared and administered by a healthcare provider as a subcutaneous injection.

The administration of EPKINLY takes place over the course of 28-day cycles, following the step-up dosage schedule in Section 2.2. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Use aseptic technique to prepare EPKINLY.

Filtration of the diluted solution is not required. 0.16 mg Dose Preparation Instructions ( 2 dilutions required ) – Sterile Syringe Method Use an appropriately sized syringe and needle for each transfer step. [See table below.] Discard the vial containing unused EPKINLY. 0.8 mg Dose Preparation Instructions ( 1 dilution required ) – Sterile Syringe Method Use an appropriately sized syringe and needle for each transfer step. [See table below.] Discard the vial containing unused EPKINLY.

Preparation of 3 mg and 48 mg EPKINLY Doses Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Use aseptic technique to prepare EPKINLY. 3 mg Dose Preparation Instructions (No dilution required) EPKINLY 3 mg dose is required for patients with FL only [see Dosage and Administration ] . [See table below.] Discard the vial containing unused EPKINLY. 48 mg Dose Preparation Instructions ( No dilution required ) EPKINLY 48 mg/0.8 mL vial is supplied as ready-to-use solution that does not need dilution prior to administration. [See table below.] Discard the vial containing unused EPKINLY.