Tecvayli Caution For Usage

Special precautions for disposal and other handling: It is very important that the instructions for preparation and administration provided as follows are strictly followed to minimise potential dosing errors with TECVAYLI 10 mg/mL and TECVAYLI 90 mg/mL vials.
TECVAYLI should be administered via subcutaneous injection only. Do not administer TECVAYLI intravenously.
TECVAYLI should be administered by a healthcare professional with adequately trained medical personnel and appropriate medical equipment to manage severe reactions, including cytokine release syndrome (see Precautions).
TECVAYLI 10 mg/mL and TECVAYLI 90 mg/mL vials are for single use only.
TECVAYLI vials of different concentrations should not be combined to achieve maintenance dose.
Aseptic technique should be used to prepare and administer TECVAYLI.
Any unused medicinal product or waste material should be disposed in accordance with local requirements.
Preparation of TECVAYLI: Verify the prescribed dose for each TECVAYLI injection. To minimise errors, use the following tables to prepare TECVAYLI injection.
Use Table 9 to determine the total dose, injection volume and number of vials required based on patient's actual body weight for Step-up dose 1 using TECVAYLI 10 mg/mL vial. (See Table 9.)

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Use Table 10 to determine the total dose, injection volume and number of vials required based on patient's actual body weight for Step-up dose 2 using TECVAYLI 10 mg/mL vial. (See Table 10.)

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Use Table 11 to determine the total dose, injection volume and number of vials required based on patient's actual body weight for the maintenance dose using TECVAYLI 90 mg/mL vial. (See Table 11.)

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Remove the appropriate TECVAYLI vial from refrigerated storage (2°C - 8°C) and equilibrate to ambient temperature (15°C - 30°C), as needed, for at least 15 minutes. Do not warm TECVAYLI 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 TECVAYLI from the vial(s) into an appropriately sized syringe using a transfer needle.
Each injection volume should not exceed 2.0 mL. Divide doses requiring greater than 2.0 mL equally into multiple syringes.
TECVAYLI is compatible with stainless steel injection needles and polypropylene and polycarbonate syringe material.
Replace the transfer needle with an appropriately sized needle for injection.
Visually inspect TECVAYLI for particulate matter and discolouration prior to administration. Do not use if the solution is discoloured, or cloudy, or if foreign particles are present.
TECVAYLI solution for injection is colourless to light yellow.
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 (e.g., thigh). If multiple injections are required, TECVAYLI 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.
Incompatibilities: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.