AUSTRALIAN PI HUMIRA (ADALIMUMAB) SOLUTION FOR ...

1 HUMIRA PI Version 46 Clean Copy 29 October 2018 Page 1 of 88 AUSTRALIAN PI HUMIRA (ADALIMUMAB) SOLUTION FOR SUBCUTANEOUS INJECTION 1 NAME OF THE MEDICINE Adalimumab (rch) 2 qualitative AND quantitative COMPOSITION HUMIRA (adalimumab) is a recombinant human immunoglobulin (IgG1) monoclonal antibody containing only human peptide sequences. HUMIRA was created using phage display technology resulting in fully human heavy and light chain variable regions, which confer specificity to human tumour necrosis factor (TNF), and human IgG1 heavy chain and kappa light chain sequences.

2 HUMIRA binds with high affinity and specificity to soluble tumour necrosis factor (TNF-alpha) but not lymphotoxin (TNF-beta). Adalimumab is produced by recombinant DNA technology in a mammalian cell expression system. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. Adult presentations contain 80 mg adalimumab per mL (100 mg/mL), 40 mg adalimumab per mL (50 mg/mL) or 40 mg adalimumab per mL (100 mg/mL). Presentations for paediatric use only contain either 20 mg adalimumab per mL (50 mg/mL), 20 mg adalimumab per mL (100 mg/mL) or 10 mg adalimumab per mL (50 mg/mL).

3 For the full list of excipients, see Section List of Excipients. 3 PHARMACEUTICAL FORM HUMIRA is supplied as a sterile, preservative-free SOLUTION of adalimumab for subcutaneous administration. The SOLUTION of HUMIRA is clear and colourless and isotonic with a pH of The drug product is supplied as either a single-use pre-filled glass syringe, vial or as a single use, pre-filled pen ( HUMIRA Pen). Enclosed within the pen is a single-use, pre-filled glass syringe. HUMIRA PI Version 46 Clean Copy 29 October 2018 Page 2 of 88 4 CLINICAL PARTICULARS Therapeutic indications Rheumatoid Arthritis HUMIRA is indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis.

4 This includes the treatment of patients with recently diagnosed moderate to severely active disease who have not received methotrexate. HUMIRA can be used alone or in combination with methotrexate. Juvenile Idiopathic Arthritis Polyarticular Juvenile Idiopathic Arthritis HUMIRA in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (DMARDs).

5 HUMIRA can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Enthesitis-Related Arthritis HUMIRA is indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy. Psoriatic Arthritis HUMIRA is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderate to severely active psoriatic arthritis in adult patients where response to previous DMARDs has been inadequate.

6 Ankylosing Spondylitis HUMIRA is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis. Crohn s Disease in Adults and Children ( 6 years) HUMIRA is indicated for the treatment of moderate to severe Crohn s disease, to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients; who have had an inadequate response to conventional therapies or, who have lost response to or are intolerant to infliximab. HUMIRA PI Version 46 Clean Copy 29 October 2018 Page 3 of 88 Ulcerative colitis HUMIRA is indicated for the treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies.

7 Patients should show a clinical response within 8 weeks of treatment to continue treatment beyond that time. (see PHARMACODYNAMIC PROPERTIES-CLINICAL TRIALS). Psoriasis in Adults and Children HUMIRA is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. HUMIRA is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.

8 Hidradenitis Suppurativa in Adults and Adolescents (from 12 years of age) HUMIRA is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy. Uveitis HUMIRA is indicated for the treatment of non-infectious intermediate, posterior and pan-uveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.

9 Dose and method of administration HUMIRA is administered by subcutaneous injection. This product is for one dose in one patient only. HUMIRA is intended for use under the guidance and supervision of a physician. Patients may self-inject HUMIRA if their physician determines that it is appropriate and with medical follow-up, as necessary, after proper training in subcutaneous injection technique. Sites for self-injection include thigh or abdomen. Injection sites should be rotated. New injections should never be given into areas where the skin is tender, bruised, red or hard.

10 Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration, whenever SOLUTION and container permit. HUMIRA PI Version 46 Clean Copy 29 October 2018 Page 4 of 88 HUMIRA should not be mixed in the same syringe or vial with any other medicine. Any unused product or waste material should be disposed of in accordance with local requirements. HUMIRA contains no antimicrobial agent. Discard any residue. Rheumatoid Arthritis The recommended dose of HUMIRA for adult patients with rheumatoid arthritis is 40 mg administered fortnightly as a single dose.