Source: European Medicines Agency (EU) Revision Year: 2026 Publisher: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
Rybrevant 1 600 mg solution for injection.
Rybrevant 2 240 mg solution for injection.
Rybrevant 2 400 mg solution for injection.
Rybrevant 3 520 mg solution for injection.
| Pharmaceutical Form |
|---|
|
Solution for injection. The solution is colourless to pale yellow. |
Rybrevant 1 600 mg solution for injection:
One mL of solution for injection contains 160 mg amivantamab.
One 10 mL vial of solution for injection contains 1 600 mg of amivantamab.
Rybrevant 2 240 mg solution for injection:
One mL of solution for injection contains 160 mg amivantamab.
One 14 mL vial of solution for injection contains 2 240 mg of amivantamab.
Rybrevant 2 400 mg solution for injection:
One mL of solution for injection contains 160 mg amivantamab.
One 15 mL vial of solution for injection contains 2 400 mg of amivantamab.
Rybrevant 3 520 mg solution for injection:
One mL of solution for injection contains 160 mg amivantamab.
One 22 mL vial of solution for injection contains 3 520 mg of amivantamab.
Amivantamab is a fully-human Immunoglobulin G1 (IgG1)-based bispecific antibody directed against the epidermal growth factor (EGF) and mesenchymal-epidermal transition (MET) receptors, produced by a mammalian cell line (Chinese Hamster Ovary [CHO]) using recombinant DNA technology.
Excipient with known effect:
One mL of solution contains 0.6 mg of polysorbate 80.
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
Amivantamab is a low-fucose, fully-human IgG1-based EGFR-MET bispecific antibody with immune cell-directing activity that targets tumours with activating EGFR Exon 20 insertion mutations. Amivantamab binds to the extracellular domains of EGFR and MET. Amivantamab disrupts EGFR and MET signalling functions through blocking ligand binding and enhancing degradation of EGFR and MET, thereby preventing tumour growth and progression. |
| List of Excipients |
|---|
|
Recombinant human hyaluronidase (rHuPH20) |
10 mL solution in a Type 1 glass vial with an elastomeric closure and an aluminium seal with a flip-off cap containing 1 600 mg amivantamab. Pack size of 1 vial.
14 mL solution in a Type 1 glass vial with an elastomeric closure and an aluminium seal with a flip-off cap containing 2 240 mg amivantamab. Pack size of 1 vial.
15 mL solution in a Type 1 glass vial with an elastomeric closure and an aluminium seal with a flip-off cap containing 2 400 mg amivantamab. Pack size of 1 vial.
22 mL solution in a Type 1 glass vial with an elastomeric closure and an aluminium seal with a flip-off cap containing 3 520 mg amivantamab. Pack size of 1 vial.
Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
EU/1/21/1594/002
EU/1/21/1594/003
EU/1/21/1594/004
EU/1/21/1594/005
Date of first authorisation: 09 December 2021
Date of latest renewal: 11 September 2023
| Drug | Countries | |
|---|---|---|
| RYBREVANT | Austria, Estonia, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Poland, Romania, United Kingdom, United States |
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