Talquetamab

The median time to onset of CRS was 27 (range: 0.1 to 167) hours from the last dose, and the median duration was 17 (range: 0 to 622) hours. Clinical signs and symptoms of CRS include but are not limited to pyrexia, hypotension, chills, hypoxia, headache, and tachycardia. Potentially life-threatening complications of CRS may include cardiac dysfunction, acute respiratory distress syndrome, neurologic toxicity, renal and/or hepatic failure, and disseminated intravascular coagulation (DIC).

Preparation and Administration Administer TALVEY via subcutaneous injection by a healthcare provider. TALVEY should be administered by a healthcare provider with adequate medical personnel and appropriate medical equipment to manage severe reactions, including CRS and neurologic toxicity, including ICANS [see Warnings and Precautions (5.1 , 5.2) ] .

TALVEY 3 mg/1.5 mL (2 mg/mL) vial and TALVEY 40 mg/mL vial are supplied as ready-to-use solution for injection that do not need dilution prior to administration. Do not combine TALVEY vials of different concentrations to achieve treatment dose. Use aseptic technique to prepare and administer TALVEY. Preparation Refer to the following reference tables for the preparation of TALVEY.

Use Table 9 to determine total dose, injection volume, and number of vials required based on patient's actual body weight for the 0.01 mg/kg dose using TALVEY 3 mg/1.5 mL (2 mg/mL) vial. [See table below.] mg/kg Dose: Injection Volumes using TALVEY 3 mg/1.5 mL (2 mg/mL) Vial Body Weight (kg) Total Dose (mg) Volume of Injection (mL) Number of Vials (1 vial = 1.5 mL) 0.01 mg/kg Dose 35 to 39 0.38 0.19 1 40 to 45 0.42 0.21 1 46 to 55 0.5 0.25 1 56 to 65 0.6 0.3 1 66 to 75 0.7 0.35 1 76 to 85 0.8 0.4 1 86 to 95 0.9 0.45 1 96 to 105 1 0.5 1 106 to 115 1.1 0.55 1 116 to 125 1.2 0.6 1 126 to 135 1.3 0.65 1 136 to 145 1.4 0.7 1 146 to 155 1.5 0.75 1 156 to 160 1.6 0.8 1 Use Table 10 to determine total dose, injection volume, and number of vials required based on patient's actual body weight for the 0.06 mg/kg dose using TALVEY 3 mg/1.5 mL (2 mg/mL) vial. [See table below.] 0 to 45 2.6 1.3 1 46 to 55 3 1.5 1 56 to 65 3.6 1.8 2 66 to 75 4.2 2.1 2 76 to 85 4.8 2.4 2 86 to 95 5.4 2.7 2 96 to 105 6 3 2 106 to 115 6.6 3.3 3 116 to 125 7.2 3.6 3 126 to 135 7.8 3.9 3 136 to 145 8.4 4.2 3 146 to 155 9 4.5 3 156 to 160 9.6 4.8 4 Use Table 11 to determine total dose, injection volume, and number of vials required based on patient's actual body weight for the 0.4 mg/kg dose using TALVEY 40 mg/mL vial. [See table below.] 0 0.5 1 56 to 65 24 0.6 1 66 to 75 28 0.7 1 76 to 85 32 0.8 1 86 to 95 36 0.9 1 96 to 105 40 1 1 106 to 115 44 1.1 2 116 to 125 48 1.2 2 126 to 135 52 1.3 2 136 to 145 56 1.4 2 146 to 155 60 1.5 2 156 to 160 64 1.6 2 Use Table 12 to determine total dose, injection volume, and number of vials required based on patient's actual body weight for the 0.8 mg/kg dose using TALVEY 40 mg/mL vial. [See table below.] 0 mg/mL Vial Body Weight (kg) Total Dose (mg) Volume of Injection (mL) Number of Vials (1 vial = 1 mL) 0.8 mg/kg Dose 35 to 39 29.6 0.74 1 40 to 45 34 0.85 1 46 to 55 40 1 1 56 to 65 48 1.2 2 66 to 75 56 1.4 2 76 to 85 64 1.6 2 86 to 95 72 1.8 2 96 to 105 80 2 2 106 to 115 88 2.2 3 116 to 125 96 2.4 3 126 to 135 104 2.6 3 136 to 145 112 2.8 3 146 to 155 120 3 3 156 to 160 128 3.2 4 Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Check that the TALVEY solution for injection is colorless to light yellow. Do not use if the solution is discolored, cloudy, or if foreign particles are present. Remove the appropriate strength TALVEY vial(s) from refrigerated storage [2°C to 8°C (36°F to 46°F)] and equilibrate to ambient temperature [15°C to 30°C (59°F to 86°F)] for at least 15 minutes.

Do not warm TALVEY in any other way. Once equilibrated, gently swirl the vial for approximately 10 seconds to mix. Do not shake. Withdraw the required injection volume of TALVEY from the vial(s) into an appropriately sized syringe using a transfer needle. Each injection volume should not exceed 2 mL. Divide doses requiring greater than 2 mL equally into multiple syringes.

TALVEY is compatible with stainless steel injection needles and polypropylene or polycarbonate syringe material. Replace the transfer needle with an appropriately sized needle for injection. Administration Inject the required volume of TALVEY into the subcutaneous tissue of the abdomen (preferred injection site). Alternatively, TALVEY may be injected into the subcutaneous tissue at other sites (e.g., thigh).

If multiple injections are required, TALVEY injections should be at least 2 cm apart. Do not inject into tattoos or scars or areas where the skin is red, bruised, tender, hard or not intact. Any unused medicinal product or waste material should be disposed in accordance with local requirements. Storage The prepared syringes should be administered immediately.

If immediate administration is not possible, store the TALVEY solution refrigerated at 2°C to 8°C (36°F to 46°F) for up to 24 hours followed by at room temperature of 15°C to 30°C (59°F to 86°F) for up to 24 hours. Discard if stored for more than 24 hours refrigerated or more than 24 hours at room temperature. If stored in the refrigerator, allow the solution to come to room temperature before administration.