AMGEVITA (ADALIMUMAB) 40 MG/0.8ML 2 PEN

1. What AMGEVITA is and what it is used for

AMGEVITA contains the active substance adalimumab.

AMGEVITA is intended for the treatment of the inflammatory diseases described below:

Rheumatoid arthritis

Polyarticular juvenile idiopathic arthritis

Enthesitis-related arthritis

Ankylosing spondylitis

Axial spondyloarthritis without radiographic evidence of ankylosing spondylitis

Psoriatic arthritis

Plaque psoriasis

Hidradenitis suppurativa

Crohn’s disease

Ulcerative colitis

Non-infectious uveitis

The active ingredient in AMGEVITA, adalimumab, is a human monoclonal antibody. Monoclonal antibodies are proteins that attach to a specific target.

2. What you need to know before you use AMGEVITA

Do not use AMGEVITA:

if you are allergic to adalimumab or any of the other ingredients of this medicine.

if you have a severe infection, including active tuberculosis. It is important that you tell your doctor if you have symptoms of infections, e.g. fever, wounds, feeling tired, or dental problems.

if you have moderate or severe heart failure. It is important to tell your doctor if you have had or have a serious heart condition.

3. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects are mild to moderate. However, some may be serious and require treatment. Side effects may occur at least up to 4 months after the last AMGEVITA injection.

Tell your doctor immediately if you notice any of the following

severe rash, hives or other signs of allergic reaction;

swollen face, hands, feet;

trouble breathing, swallowing;

shortness of breath with exertion or upon lying down or swelling of the feet.

Tell your doctor as soon as possible if you notice any of the following

signs of infection such as fever, feeling sick, wounds, dental problems, burning on urination;

feeling weak or tired;

coughing;

tingling;

numbness;

double vision;

arm or leg weakness;

a bump or open sore that doesn't heal;

signs and symptoms suggestive of blood disorders such as persistent fever, bruising, bleeding, and paleness.

The symptoms described above can be signs of the below-listed side effects, which have been observed with adalimumab.