Adalimumab 40 mg solution for injection in pre-filled syringe

What Adalimumab 40 mg is used for:

• Adalimumab is used to treat
• 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

Do not use Adalimumab:

• If you are allergic to adalimumab or any of the other ingredients of this medicine.
• If you have active tuberculosis or other severe infections. 
• If you have moderate or severe heart failure. 

Warnings and precautions:

• Allergic reactions:
• If you get allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or rash do not inject more Adalimumab and contact your doctor immediately since, in rare cases, these reactions can be life threatening.
• Infections:
• If you have an infection, including long-term infection or an infection in one part of the body (for example, leg ulcer) consult your doctor before starting Adalimumab. If you are unsure, contact your doctor.
• Children and adolescents:
• Vaccinations: if possible children should be up to date with all vaccinations before using Adalimumab.

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 Adalimumab 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 physical activity or upon lying down or swelling of the feet
• signs of infection such as fever, feeling sick, wounds, dental problems, burning on urination
• feeling weak or tired
• coughing
• tingling
• numbness
• double vision
• persistent fever, bruising, bleeding, paleness

Other medicines and Adalimumab: 

• You should not take Adalimumab with medicines containing the following active substances due to increased risk of serious infection:
• anakinra
• abatacept

How to use Adalimumab:

• Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or
• axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
• Adults : 40 mg every other week
• Polyarticular juvenile idiopathic arthritis
• Children, adolescents and adults : from 2 years of age ≥ 30 kg  : 40 mg every other week

• Children and adolescents from 2 years of age 10 kg to < 30 kg 20 mg every other week
• Plaque psoriasis
• Adults : First dose of 80 mg (two 40 mg injections in one day), followed by 40 mg every other week starting one week after the first dose.
• Children and adolescents from 4 to 17 years of age ≥ 30 kg  : First dose of 40 mg, followed by 40 mg one week later.
• Children and adolescents from 4 to 17 years of age 15 kg to < 30 kg : First dose of 20 mg, followed by 20 mg one week later.
• Crohn’s disease
• Children, adolescents and adults from 6 years of age ≥ 40 kg  : First dose of 80 mg (two 40 mg injections in one day), followed by 40 mg two weeks later.
• Children and adolescents from 6 to 17 years of age < 40 kg : First dose of 40 mg, followed by 20 mg two weeks later.
• Ulcerative colitis
• Adults : First dose of 160 mg (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by 80 mg (two 40 mg injections in one day) two weeks later.
• Adalimumab is administered by injection under the skin (by subcutaneous injection).

How to store Adalimumab:

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the label/blister/carton after EXP.
• Store in a refrigerator (20C – 80C). Do not freeze.
• Keep the pre-filled syringe in the outer carton in order to protect from light.