VIATRIS-PRODUCT PROFILE

Indication

1) Rheumatoid Arthritis (RA):

·Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA.

2) Juvenile Idiopathic Arthritis (JIA):

·Reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 4 years of age and older.

3) Psoriatic Arthritis (PsA):

·Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA.

4) Ankylosing Spondylitis (AS):

·Reducing signs and symptoms in adult patients with active AS.

5) Adult Crohn’s Disease (adult CD):

·Reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy. Reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab products.

6) Ulcerative Colitis (UC):

·Inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine or 6-mercaptopurine

7) Plaque Psoriasis (PsO):

The treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.

Dose Administration

 The patient information leaflet contains a very clear diagrammatic guide on how to administer a dose from the PFP.

 Delivery of the dose commences when the patient places the orange base of the pen on their skin, and pushes down. At this time, the patient will hear the 1st loud click.

 The patient should continue to hold the pen against their skin until one, or all, of the following occur, which confirm delivery of the dose of adalimumab:

o the orange indicator fills the viewing window and stops moving o a 2nd loud click is heard

o ten seconds have passed.

 Once the PFP is removed from the skin, the needle will be automatically covered.

Storage

 Hulio®40 mg PFP should be stored in a refrigerator (2°C - 8°C). It should not be frozen.

 The PFP should be kept in the outer packaging in order to protect it from light.

 A single Hulio® 40 mg PFP may be stored at temperatures up to a maximum of 25°C for a period of up to 14 days.

The PFP must be protected from light, and discarded if not used within the 14-day period.

FKB327 binds specifically to TNF-alpha and blocks its interaction with the p55 and p75 cell surface TNF receptors. FKB327 also lyses surface TNF expressing cells in vitro in the presence of complement. TNF is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Elevated levels of TNF are found in the synovial fluid of patients with RA, JIA, PsA, and AS and play an important role in both the pathologic inflammation and the joint destruction that are hallmarks of these diseases. Increased levels of TNF are also found in psoriasis plaques.

FKB327 product is a sterile liquid solution with the following proposed presentations:

• Autoinjector (also referred to as a pre-filled pen (PFP) in this application)

Injection: 40 mg/0.8 mL in a single-dose prefilled autoinjector

• Prefilled syringe

Injection: 40 mg/0.8 mL in a single-dose prefilled plastic syringe Injection: 20 mg/0.4 mL in a single-dose prefilled plastic syringe

Each strength of FKB327 in prefilled syringes and in the pre-filled pen is the same as that of US- Humira. FKB327 also has the same dosage form and route of administration as that of US- Humira.

2015-2011

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2010-2001

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