Like most medications, Kyntheum® can cause side effects, although not everybody experiences them. If you get any side effects talk to your doctor, nurse or pharmacist

Do not use Kyntheum® if:

You are allergic to brodalumab or any of the other ingredients of this medicine (listed in the patient information leaflet enclosed in your Kyntheum® box)
You have active Crohn’s disease
You have an infection which your doctor thinks is important (for example, active tuberculosis)

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before using Kyntheum:

if you have a history of Crohn’s disease
If you have ever had or are having suicidal thoughts or actions, depression, anxiety, or mood problems
If you have an infection now or often get infections
If you have a long-term (chronic) infection
If you have tuberculosis (TB), have had a positive TB test, or have been in close contact with someone with TB.
You may be treated with another medicine for TB before you begin treatment with Kyntheum
If you have recently received or are scheduled to receive a vaccination
You should not be given certain types of vaccines (called ‘live vaccines’) while being treated with Kyntheum
If you have used Kyntheum during the last three months of your pregnancy, you should talk to your doctor before vaccinating your baby
If you are receiving any other treatment for psoriasis, such as another immunosuppressant or phototherapy with ultraviolet (UV) light.

After starting Kyntheum, tell your doctor, pharmacist or nurse immediately:

if you have been told by your doctor that you have developed Crohn’s disease
If you feel depressed, anxious, or have thoughts of suicide, or have unusual mood changes
If you have an infection or have any signs of infection
If you have been told you have tuberculosis

You can also report side effects directly here.

Reporting of Suspected Adverse Reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via:

IE

HPRA Pharmacovigilance, Earlsfort Terrace, Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, Website: www.hpra.ie, e-mail: medsafety@hpra.ie Adverse events should also be reported to Drug Safety at LEO Pharma by calling +353 1 4908924 or e-mail medical-info.ie@leo-pharma.com

UK

Reporting forms and information can be found at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Adverse events should also be reported to Drug Safety at LEO Pharma by calling +44 (0)1844 347333 or e-mail medical-info.uk@leo-pharma.com

MAT-23315
Date of preparation: February 2019

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