SIMPONI 50 MG / 0.5 ML 1 PRE-FILLED PEN ( XX )

** Simponi® (Golimumab) 50 mg/0.5 ml Solution for injection in pre-filled pen (SmartJect®). 1 x pre-filled pen of 0.5 ml.

** Subcutaneous (S.C.) use.

** Each pre-filled pen contains:
50 mg golimumab.

** Therapeutic indications:
– Rheumatoid Arthritis (RA):
SIMPONI, in combination with methotrexate (MTX), is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis.
– Psoriatic Arthritis (PsA):
SIMPONI, alone or in combination with methotrexate (MTX), is indicated for the treatment of adult patients with active psoriatic arthritis.
– Ankylosing Spondylitis (AS):
SIMPONI is indicated for the treatment of adult patients with active ankylosing spondylitis.
– Ulcerative Colitis (UC):
SIMPONI is indicated in adult patients with moderately to severely active ulcerative colitis who have demonstrated corticosteroid dependence or who have had an inadequate response to or failed to tolerate oral aminosalicylates, oral corticosteroids, azathioprine (AZA), or 6-mercaptopurine (6-MP) for:
. inducing and maintaining clinical response
. improving endoscopic appearance of the mucosa during induction
. inducing clinical remission
. achieving and sustaining clinical remission in induction responders

** Pharmacotherapeutic group:
Immunosuppressants, tumour necrosis factor alpha (TNF-alpha) inhibitors, ATC code: L04AB06

** Mechanism of action:
Golimumab is a human monoclonal antibody that forms high affinity, stable complexes with both the soluble and transmembrane bioactive forms of human TNF-alpha, which prevents the binding of TNF-alpha to its receptors.

** Dosage:
The SIMPONI dose regimen is 50 mg administered by subcutaneous injection once a month.

** Contraindications:
– Hypersensitivity to the active substance or to any of the excipients.
– Active tuberculosis (TB) or other severe infections such as sepsis, and opportunistic infections:
SIMPONI® (golimumab) is a prescription medicine. SIMPONI® can lower your ability to fight infections. There are reports of serious infections caused by bacteria, fungi, or viruses that have spread throughout the body, including tuberculosis (TB) and histoplasmosis. Some of these infections have been fatal. Your doctor will test you for TB before starting SIMPONI® and will monitor you for signs of TB during treatment. Tell your doctor if you have been in close contact with people with TB. Tell your doctor if you have been in a region (such as the Ohio and Mississippi River Valleys and the Southwest) where certain fungal infections like histoplasmosis or coccidioidomycosis are common.
– Moderate or severe heart failure (NYHA class III/IV).

** WARNING: SERIOUS INFECTIONS AND MALIGNANCY
– Serious infections leading to hospitalization or death including tuberculosis (TB), bacterial sepsis, invasive fungal (such as histoplasmosis), and other opportunistic infections have occurred in patients receiving SIMPONI
– Discontinue SIMPONI if a patient develops a serious infection or sepsis
– Perform test for latent TB; if positive, start treatment for TB prior to starting SIMPONI
– Monitor all patients for active TB during treatment, even if initial latent TB test is negative
– Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which SIMPONI is a member

** Prescription only.

** Do not shake.

** The needle cover contains dry natural rubber (a derivative of latex).

** Allow the pre-filled pen to sit at room temperature outside the carton 30 minutes before use. Read the insert for further information.

** Store in a refrigerator (2-8 degrees C). Do not freeze. Keep the pre-filled pen in the outer carton in order to protect from light.
Keep out of the reach and sight of children.

** Janssen

Manufactured by:
Baxter Pharmaceutical Solutions LLC,
927 S Curry Pike, Bloomington, IN 47403, USA

Packaged and released by:
Cilag AG, Hochstrasse 201, 8205, Schaffhausen, Switzerlnad