hieved in human patients receiving Kyntheum 210 mg every 2 weeks based on the area under the concentration curve (AUC). Serum concentrations in monkey infants and in foetal rabbits indicated considerable passage of brodalumab from the mother to the foetus at the end of pregnancy.
Incynomolgus monkeys, after weekly subcutaneous dosing of brodalumab at dose levels up to 90 mg/kg for 6 months, brodalumab-related effects were limited to injection site reactions and mucocutaneous inflammation that was consistent with pharmacologic modulation of host surveillance to commensal microflora. There were no effects on peripheral blood immunophenotyping and the T-cell dependent antibody response assay. In a local tolerance test in rabbits, moderate to severe edema was observed after subcutaneous injection of a formulation containing brodalumab at the clinical concentration of 140 mg/ml.
6. Pharmaceutical particulars
6.1 List of excipients
Proline
Glutamate
Polysorbate 20
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
4 years
6.4 Special precautions for storage
Store in a refrigerator (2°C-8°C).
Do not freeze.
Keep the pre-filled syringe in the outer carton in order to protect from light.
Kyntheum may be stored at room temperature (up to 25°C) once, in the outer carton, for a maximum single period of 14 days. Once Kyntheum has been removed from the refrigerator and has reached room temperature (up to 25°C) it must either be used within 14 days or discarded.
6.5 Nature and contents of container
1.5 ml solution in a type I glass pre-filled syringe with stainless steel 27G x ½” needle, covered with an elastomeric needle cap.
Kyntheum is available in unit packs containing 2 pre-filled syringes and in multipacks containing 6 (3 packs of 2) pre-filled syringes.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
Kyntheum is a sterile solution for injection in pre-filled syringe. Each pre-filled syringe is for single use only. The 'Instructions for Use' should be consulted for detailed instructions on administration of Kyntheum.
To avoid discomfort at the site of injection, at least 30 minutes should be allowed for the pre-filled syringe to reach room temperature before injecting. The pre-filled syringe should not be warmed in any other way. The pre-filled syringe should not be shaken. The grey needle cap on the pre-filled syringe should not be removed while allowing to reach room temperature.
Kyntheum should be visually inspected for particles and discoloration prior to administration. Kyntheum is a clear to slightly opalescent, colourless to slightly yellow solution, free from particles. This medicine should not be used if the solution is cloudy or discoloured or contains lumps, flakes, or particles.
The pre-filled syringe should not be used if it has been dropped on a hard surface.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorisation holder
LEO Pharma A/S
Industriparken 55
DK-2750 Ballerup
Denmark
8. Marketing authorisation number(s)
EU/1/16/1155/001
EU/1/16/1155/002
9. Date of first authorisation/renewal of the authorisation
Date of first authorisation: 17 July 2017
10. Date of revision of the text
12 September 2017
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