SUMMARY

• Janssen does not recommend the use of TALVEY in a manner that is inconsistent with the approved labeling.
• The Prescribing Information should be the source document for administration procedures.

Dosage Forms and Strengths

• TALVEY injection for subcutaneous (SC) use is a sterile, preservative-free, colorless to light yellow solution supplied as:¹
  • 3 mg/1.5 mL (2 mg/mL) in a single-dose vial in a carton.
  • 40 mg/1 mL in a single-dose vial in a carton.

Preparation and Administration

• TALVEY is intended for SC injection by a healthcare provider only.¹ 
• Utilize the following tables to determine the dosage based on predetermined weight ranges from the patient’s actual body weight.¹
  • 0.01 mg/kg Dose: Injection Volumes using TALVEY 3 mg/1.5 mL (2 mg/mL) Vial
  • 0.06 mg/kg Dose: Injection Volumes using TALVEY 3 mg/1.5 mL (2 mg/mL) Vial
  • 0.4 mg/kg Dose: Injection Volumes using TALVEY 40 mg/mL Vial
  • 0.8 mg/kg Dose: Injection Volumes using TALVEY 40 mg/mL Vial
• See below for the Preparation and Administration of TALVEY.¹
• The use of 3 mg/1.5 mL (2 mg/mL) in a single-dose vial for treatment (maintenance) doses was not studied in clinical trials.
• Each injection volume should not exceed 2 mL. Divide doses requiring greater than 2 mL equally into multiple syringes.¹
• There is no systematically collected clinical data to assure proper TALVEY absorption at injection volumes that exceed those listed in the Prescribing Information.

PRODUCT LABELING

• Please refer to the following section of the TALVEY full Prescribing Information which is relevant to your inquiry: DOSAGE AND ADMINISTRATION.¹

TALVEY Recommended Dosage

• Administer pretreatment medications prior to each dose of TALVEY in the step-up dosing schedule.¹
• Administer TALVEY SC on a weekly or biweekly (every 2 weeks) dosing schedule according to the tables below. Continue treatment until disease progression or unacceptable toxicity.¹
• TALVEY Weekly Dosing Schedule¹

• TALVEY Biweekly (Every 2 Weeks) Dosing Schedule¹

Preparation and Administration

• TALVEY is intended for SC injection by a healthcare provider only.¹ 
• 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 immune effector cell-associated neurotoxicity syndrome (ICANS).¹
• TALVEY is a colorless to light yellow solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if the solution is discolored, cloudy, or if foreign particles are present.¹
• 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.¹
• Do not combine TALVEY vials of different concentrations to achieve treatment dose.¹
• Use aseptic technique to prepare and administer TALVEY.¹

Preparation of TALVEY

• Refer to the following reference tables for preparation of TALVEY and to determine the dosage based on predetermined weight ranges.¹
• Use the table: 0.01 mg/kg Dose: Injection Volumes Using TALVEY 3 mg/1.5 mL (2 mg/mL) Vial to determine total dose, injection volume, and number of vials required based on patient’s actual body weight.¹

• Use the table: 0.06 mg/kg Dose: Injection Volumes Using TALVEY 3 mg/1.5 mL (2 mg/mL) Vial to determine total dose, injection volume, and number of vials required based on patient’s actual body weight.¹

• Use the table: 0.4 mg/kg Dose: Injection Volumes Using TALVEY 40 mg/mL Vial to determine total dose, injection volume, and number of vials required based on patient’s actual body weight.¹

• Use the table 0.8 mg/kg Dose: Injection Volumes Using TALVEY 40 mg/mL Vial to determine total dose, injection volume and number of vials required based on patient’s actual body weight.¹

• 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.¹
• Once equilibrated, gently swirl the vial for approximately 10 seconds to mix. Do not shake.¹
• Withdraw the required injection volume of TALVEY from the vial(s) into an appropriately sized syringe using a transfer needle.¹
  • 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.¹
• Replace the transfer needle with an appropriately sized needle for injection.¹

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.¹
• Do not inject into tattoos or scars or areas where the skin is red, bruised, tender, hard or not intact.¹
• Any unused medicinal product or waste material should be disposed in accordance with local requirements.¹

Monitoring

• Due to the risk of CRS and neurologic toxicity, including ICANS, patients should be hospitalized for 48 hours after administration of all doses within the TALVEY step-up dosing schedule.¹ 

Storage

• The prepared syringes should be administered immediately.¹
• 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.¹
• Discard if stored for more than 24 hours refrigerated or more than 24 hours at room temperature.¹
• If stored in the refrigerator, allow the solution to come to room temperature before administration.¹

• A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File databases (and/or other resources, including internal/external databases) was conducted on 19 June 2024.