KYNTHEUM
As listed in the register: KYNTHEUM 210 mg, solution injectable en seringue préremplie
210 mg · solution injectable
- Prescription only
- Active substance
- Brodalumab
- Made by
- LEO PHARMA A/S (DANEMARK)
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
Mediclarum has not yet retrieved and stored the official label for this product, so none of its text is shown here. Open the official leaflet
How it works
From the US prescribing label for the same active substance (Siliq). It describes the substance, not this exact product.
Brodalumab is a human monoclonal IgG2 antibody that selectively binds to human IL-17RA and inhibits its interactions with cytokines IL-17A, IL-17F, IL-17C, IL-17A/F heterodimer, and IL-25.
IL-17RA is a protein expressed on the cell surface and is a required component of receptor complexes utilized by multiple IL-17 family cytokines.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-05-28
Safety of the active substance
From the US prescribing label for the same active substance (Siliq). It describes the substance, not this exact product.
WARNING: SUICIDAL IDEATION AND BEHAVIOR Suicidal ideation and behavior, including completed suicides, have occurred in patients treated with SILIQ.
- SILIQ is contraindicated in patients with:.
- Crohn’s disease because SILIQ may cause worsening of disease [see Warnings and Precautions ( 5.7 )]..
- Clinically significant hypersensitivity to brodalumab or to any of the excipients in SILIQ or component of the container.
- Hypersensitivity reactions, including anaphylaxis, have been reported with postmarket use of SILIQ [see Warnings and Precautions ( 5.3 )]..
Most common adverse reactions (incidence ≥1%) were arthralgia, headache, fatigue, diarrhea, oropharyngeal pain, nausea, myalgia, injection site reactions, influenza, neutropenia, and tinea infections.
Quoted from the US prescribing label for the same active substance. Your own pack’s leaflet is the authority for your product. DailyMed
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
European UnionNo exact match for this strength and form
SpainNo exact match for this strength and form
CanadaNo exact match for this strength and form
Netherlands1 matching products
Details
| Made by | LEO PHARMA A/S (DANEMARK) |
|---|---|
| Active substance | Brodalumab |
| Strength | 210 mg |
| Form | solution injectable |
| Route | sous-cutanée |
| Dispensing (as stated by the register) | prescription réservée aux spécialistes et services MEDECINE INTERNE · prescription réservée aux spécialistes et services DERMATOLOGIE · liste I |
| Marketed | Yes, according to the register |
| Authorisation procedure | Procédure centralisée |
| EU number | EU/1/16/1155 |
| Name in the register | KYNTHEUM 210 mg, solution injectable en seringue préremplie |
| Packs | 2 seringues préremplies en verre de 1,5 ml |
| CIS | 65620419 |
| CIP13 | 3400930117286 |
Source: Base de données publique des médicaments · 2026-09-30 · not reviewed by a clinician
Source : Base de données publique des médicaments (ANSM / Ministère de la Santé), sous Licence Ouverte. Reuse terms: Licence Ouverte / Open Licence (Etalab).