Pharmaceutical particulars : מידע רוקחי

6.     PHARMACEUTICAL PARTICULARS
6.1    List of excipients

Sucrose
Sodium acetate trihydrate
Polysorbate 20
Glacial acetic acid
EDTA disodium salt dihydrate
Water for injections

6.2    Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3    Shelf life

Unopened vial
The expiry date of the product is indicated on the packaging materials.
Prepared syringe
The prepared syringes should be administered immediately. If immediate administration is not possible, in-use storage times of the prepared syringe should be no longer than 20 hours at 2 °C - 8 °C or ambient temperature (15 °C – 30 °C). Discard after 20 hours if not used.

6.4    Special precautions for storage

Store in a refrigerator (2 °C - 8 °C).
Do not freeze.
Store in the original carton in order to protect from light.
6.5    Nature and contents of container

3 mL solution for injection in a Type 1 glass vial with an elastomeric closure, and aluminium seal with a flip-off button containing 30 mg of teclistamab (10 mg/mL).
Pack size of 1 vial.

1.7 mL solution for injection in a Type 1 glass vial with an elastomeric closure, and aluminium seal with a flip-off button containing 153 mg of teclistamab (90 mg/mL).
Pack size of 1 vial.

6.6     Special precautions for disposal and other handling

It is very important that the instructions for preparation and administration provided in this section 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 section 4.4).

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.
o     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.

Table 9:  Injection volumes of TECVAYLI (10 mg/mL) for Step-up dose 1 (0.06 mg/kg) Body weight     Total dose   Volume of injection Number of vials
(kg)          (mg)              (mL)             (1 vial=3 mL)
35-39           2.2               0.22                   1
40-44           2.5               0.25                   1
45-49           2.8               0.28                   1
50-59           3.3               0.33                   1
60-69           3.9               0.39                   1
Step-Up dose 1        70-79           4.5               0.45                   1 (0.06 mg/kg)         80-89           5.1               0.51                   1 90-99           5.7               0.57                   1
100-109          6.3               0.63                   1
110-119          6.9               0.69                   1
120-129          7.5               0.75                   1
130-139          8.1               0.81                   1
140-149          8.7               0.87                   1
150-160          9.3               0.93                   1
 o      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.

Table 10:  Injection volumes of TECVAYLI (10 mg/mL) for Step-up dose 2 (0.3 mg/kg) Body weight     Total dose   Volume of injection Number of vials
(kg)          (mg)              (mL)             (1 vial=3 mL)
35-39           11                1.1                    1
40-44           13                1.3                    1
45-49           14                1.4                    1
50-59           16                1.6                    1
60-69           19                1.9                    1
Step-up dose 2        70-79           22                2.2                    1 (0.3 mg/kg)          80-89           25                2.5                    1 90-99           28                2.8                    1
100-109          31                3.1                    2
110-119          34                3.4                    2
120-129          37                3.7                    2
130-139          40                4.0                    2
140-149          43                4.3                    2
150-160          47                4.7                    2
 o       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.

Table 11:  Injection volumes of TECVAYLI (90 mg/mL) for maintenance dose (1.5 mg/kg) Body weight     Total dose   Volume of injection Number of vials
(kg)          (mg)              (mL)           (1 vial=1.7 mL)
35-39            56               0.62                  1
40-44            63               0.70                  1
45-49            70               0.78                  1
50-59            82               0.91                  1
60-69            99               1.1                   1
Maintenance           70-79           108               1.2                   1 dose (1.5 mg/kg)       80-89           126               1.4                   1 90-99           144               1.6                   1
100-109          153               1.7                   1
110-119          171               1.9                   2
120-129          189               2.1                   2
130-139          198               2.2                   2
140-149          216               2.4                   2
150-160          234               2.6                   2

•       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.
o      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.
o      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.


7.     MANUFACTURER and REGISTRATION HOLDER

Manufacturer: Janseen Biologics B.V., Einsteinweg 101, 2333 CB Leiden, The Netherlands 
Registration Holder: J-C Health Care Ltd., Kibbutz Shefayim, 6099000, Israel