SUMMARY

• Janssen cannot recommend any practices, procedures, or storage conditions that deviate from product labeling or are not approved by the regulatory agencies.
• The Prescribing Information should be the source document for administration procedures.

Dosage Forms and Strengths

• TECVAYLI injection for subcutaneous (SC) use is a sterile, preservative-free, clear to slightly opalescent, colorless to light yellow solution supplied as¹:
  • 30 mg/3 mL (10 mg/mL) in a single-dose vial in a carton for step-up doses.
  • 153 mg/1.7 mL (90 mg/mL) in a single-dose vial in a carton for treatment doses.

Preparation and Administration

• TECVAYLI is intended for subcutaneous use 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 weight¹
  • Step-up Dose 1 (0.06 mg/kg) Injection Volumes Using TECVAYLI 30 mg/3 mL (10 mg/mL) Vial
  • Step-up Dose 2 (0.3 mg/kg) Injection Volumes Using TECVAYLI 30 mg/3 mL (10 mg/mL) Vial
  • Treatment Dose (1.5 mg/kg) Injection Volumes Using TECVAYLI 153 mg/1.7 mL (90 mg/mL) Vial
• See Preparation of TECVAYLI and Administration of TECVAYLI below.¹
• The use of 30 mg/3 mL (10 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 TECVAYLI absorption at injection volumes that exceed those listed in the Prescribing Information. 

PRODUCT LABELING

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

Preparation and Administration

• TECVAYLI is intended for SC use by a healthcare provider only.¹
• TECVAYLI should be administered by a healthcare provider with adequate medical personnel and appropriate medical equipment to manage severe reactions, including cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS).¹
• TECVAYLI is a clear to slightly opalescent, 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, or cloudy, or if foreign particles are present.¹
• TECVAYLI 30 mg/3 mL (10 mg/mL) vial and TECVAYLI 153 mg/1.7 mL (90 mg/mL) vial are supplied as ready-to-use solution that do not need dilution prior to administration.¹
• Do not combine TECVAYLI vials of different concentrations to achieve treatment dose.¹
• Use aseptic technique to prepare and administer TECVAYLI.¹

Preparation of TECVAYLI

• Refer to the following reference tables for preparation of TECVAYLI.¹
• Refer to the tables below to determine the dosage based on predetermined weight ranges.¹
• Use the table below to determine total dose, injection volume and number of vials required based on patient’s actual body weight for Step-up Dose 1 (0.06 mg/kg) Injection Volumes Using TECVAYLI 30 mg/3mL (10 mg/mL) Vial.¹

• Use the table below to determine total dose, injection volume and number of vials required based on patient’s actual body weight for Step-up Dose 2 (0.3 mg/kg) Injection Volumes Using TECVAYLI 30 mg/3 mL (10 mg/mL) vial.¹

• Use the table below to determine total dose, injection volume and number of vials required based on patient’s actual body weight for the Treatment Dose (1.5 mg/kg) Injection Volumes Using TECVAYLI 153 mg/1.7 mL (90 mg/mL) vial.¹

• Remove the appropriate strength TECVAYLI vial from refrigerated storage (2°C to 8°C [36°F to 46°F]).¹
• Once removed from refrigerated storage, equilibrate TECVAYLI to ambient temperature (15°C to 30°C [59°F to 86°F]), for at least 15 minutes. Do not warm TECVAYLI 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 TECVAYLI 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.¹
• TECVAYLI 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 of TECVAYLI

• Inject the required volume of TECVAYLI into the subcutaneous tissue of the abdomen (preferred injection site). Alternatively, TECVAYLI may be injected into the subcutaneous tissue at other sites (eg, thigh). If multiple injections are required, TECVAYLI 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 product or waste material should be disposed in accordance with local requirements.¹

Storage

• If the prepared dosing syringe(s) of TECVAYLI is not used immediately, store syringe(s) at 2°C to 8°C (36°F to 46°F) or at ambient temperature 15°C to 30°C (59°F to 86°F) for a maximum of 20 hours. Discard syringe(s) after 20 hours, if not used.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 TECVAYLI step-up dosing schedule.¹

Literature Search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File databases (and/or other resources, including internal/external databases) was conducted on 12 December 2024.