Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

D-Sorbitol
Sodium acetate trihydrate
Polysorbate 80
Acetic acid, glacial
Water for injection

6.2   Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products and/or diluents except those listed in section 6.6.

6.3   Shelf life

Unopened vial
The expiry date of the product is indicated on the packaging materials.

Tepkinly 4 mg/0.8 ml

Diluted epcoritamab
Chemical and physical in-use stability has been demonstrated for 24 hours at 2 °C to 8 °C including up to 12 hours at room temperature (20-25 °C).

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours at 2 °C to 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.

Minimise exposure to daylight. Allow epcoritamab solution to equilibrate to room temperature before administration. Discard unused epcoritamab solution beyond the allowable storage time.

Tepkinly 48 mg

Prepared epcoritamab (No dilution required)
Chemical and physical in-use stability has been demonstrated for 24 hours at 2 °C to 8 °C including up to 12 hours at room temperature (20-25 °C).

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours at 2 °C to 8 °C, unless preparation has taken place in controlled and validated aseptic conditions.

Minimise exposure to daylight. Allow epcoritamab solution to equilibrate to room temperature before administration. Discard unused epcoritamab solution beyond the allowable storage time.

6.4   Special precautions for storage

Store and transport refrigerated (2 °C to 8 °C).
Do not freeze.
Keep the vial in the outer carton in order to protect from light.
Tepkinly 4 mg/0.8 ml
For storage conditions after dilution of the medicinal product, see section 6.3.

Tepkinly 48 mg
For storage conditions after first opening of the medicinal product, see section 6.3.

6.5   Nature and contents of container

Tepkinly 4 mg/0.8 ml
Type I glass vial with a bromobutyl rubber stopper coated with fluoropolymer at the contact site and aluminium seal with a plastic light blue flip off cap, containing 4 mg per 0.8 ml concentrate for solution for injection.

Tepkinly 48 mg
Type I glass vial with a bromobutyl rubber stopper coated with fluoropolymer at the contact site and aluminium seal with a plastic orange flip off cap, containing 48 mg per 0.8 ml solution for injection.
Each carton contains one vial.

6.6   Special precautions for disposal and other handling

Epcoritamab must be prepared and administered by a healthcare provider as a subcutaneous injection.
Each vial of epcoritamab is intended for single use only.
Each vial contains an overfill that allows withdrawal of the labelled amount.

The administration of epcoritamab takes place over the course of 28-day cycles, following the dosing schedule in section 4.2.

Tepkinly 4 mg/0.8 ml

Epcoritamab should be inspected visually for particulate matter and discolouration prior to administration.
The concentrate should be a colourless to slightly yellow solution. Do not use if the solution is discoloured, or cloudy, or if foreign particles are present.


Preparation of epcoritamab
Epcoritamab has to be prepared using aseptic technique. Filtration of the diluted solution is not required.
Preparation instructions for 0.16 mg and 0.8 mg doses of epcoritamab
0.16 mg priming dose preparation instructions – 2 dilutions required Use an appropriately sized, syringe, vial, and needle for each transfer step.

1) Prepare epcoritamab vial a) Retrieve one 4 mg/0.8 ml epcoritamab vial with the light blue cap from the refrigerator.
b) Allow the vial to come to room temperature for no more than 1 hour.
c) Gently swirl the epcoritamab vial.
DO NOT vortex or vigorously shake the vial.

2) Perform first dilution a) Label an appropriately sized empty vial as “dilution A”.
b) Transfer 0.8 ml of epcoritamab into the dilution A vial.
c) Transfer 4.2 ml of sodium chloride 9 mg/ml (0.9%) sterile solution into the dilution A vial. The initial diluted solution contains 0.8 mg/ml of epcoritamab.
d) Gently swirl the dilution A vial for 30 – 45 seconds.

3) Perform second dilution a) Label an appropriately sized empty vial as “dilution B”.
b) Transfer 2 ml of solution from the dilution A vial into the dilution B vial. The dilution A vial is no longer needed and should be discarded.
c) Transfer 8 ml of sodium chloride 9 mg/ml (0.9%) sterile solution into the dilution B vial to make a final concentration of 0.16 mg/ml.
d) Gently swirl the dilution B vial for 30 – 45 seconds.

4) Withdraw dose

Withdraw 1 ml of the diluted epcoritamab from the dilution B vial into a syringe. The dilution B vial is no longer needed and should be discarded.

5) Label syringe
Label the syringe with the product name, dose strength (0.16 mg), date and the time of day. For storage of the diluted epcoritamab, see section 6.3.

6) Discard the vial and any unused portion of epcoritamab in accordance with local requirements.


0.8 mg intermediate dose preparation instructions – 1 dilution required Use an appropriately sized syringe, vial and needle for each transfer step.

1) Prepare epcoritamab vial a) Retrieve one 4 mg/0.8 ml epcoritamab vial with the light blue cap from the refrigerator.
b) Allow the vial to come to room temperature for no more than 1 hour.
c) Gently swirl the epcoritamab vial.
DO NOT vortex or vigorously shake the vial.

2) Perform dilution a) Label an appropriately sized empty vial as “dilution A”.
b) Transfer 0.8 ml of epcoritamab into the dilution A vial.
c) Transfer 4.2 ml of sodium chloride 9 mg/ml (0.9%) sterile solution into the dilution A vial to make a final concentration of 0.8 mg/ml.
d) Gently swirl the dilution A vial for 30 – 45 seconds.

3) Withdraw dose
Withdraw 1 ml of the diluted epcoritamab from the dilution A vial into a syringe. The dilution A vial is no longer needed and should be discarded.

4) Label syringe
Label the syringe with the product name, dose strength (0.8 mg), date and the time of day. For storage of the diluted epcoritamab, see section 6.3.

5) Discard the vial and any unused portion of epcoritamab in accordance with local requirements.



Tepkinly 48 mg
Epcoritamab should be inspected visually for particulate matter and discolouration prior to administration.
The solution for injection should be a colourless to slightly yellow solution. Do not use if the solution is discoloured, or cloudy, or if foreign particles are present.

48 mg full dose preparation instructions - No dilution required
Tepkinly 48 mg vial is supplied as ready-to-use solution that does not need dilution prior to administration.
Epcoritamab has to be prepared using aseptic technique. Filtration of the solution is not required.
1) Prepare epcoritamab vial a) Retrieve one 48 mg epcoritamab vial with the orange cap from the refrigerator.
b) Allow the vial to come to room temperature for no more than 1 hour.
c) Gently swirl the epcoritamab vial.
DO NOT vortex or vigorously shake the vial.

2) Withdraw dose
Withdraw 0.8 ml of epcoritamab into a syringe.

3) Label syringe
Label the syringe with the product name, dose strength (48 mg), date and the time of day. For storage of the prepared epcoritamab, see section 6.3.

4) Discard the vial and any unused portion of epcoritamab in accordance with local requirements.


Any unused medicinal product or waste material should be disposed of in accordance with local requirements.