Simponi

Company: MSD.
Legal category: Prescription. High Tech. Sports permitted.
Active ingredient: Golimumab 50mg/0.5ml.
Description: Solution for injection in pre-filled pen.
Presentation: Price available on request.
Indications: Treatment of moderate to severe, active rheumatoid arthritis in combination with methotrexate (MTX) when the response to disease-modifying anti-rheumatic drug (DMARD) therapy including MTX has been inadequate. Treatment of active and progressive psoriatic arthritis, alone or in combination with MTX, when the response to previous DMARD therapy has been inadequate. Treatment of severe, active ankylosing spondylitis in patients who have responded inadequately to conventional therapy.

Pharmacology: Golimumab is a human monoclonal antibody that forms high affinity, stable complexes with both the soluble and transmembrane bioactive forms of human TNF-α, which prevents the binding of TNF-α to its receptors.
Dosage: Adult: 50mg by subcutaneous injection once a month, on the same date each month. Response is usually achieved within 12 to 14 weeks (after 3-4 doses). Patients weighing >100kg, if inadequate response after 3-4 doses, may be increased to 100mg once a month; reconsider treatment if no benefit achieved after 3-4 additional doses of 100mg. Elderly: As per adults. Children: Under 18 years, not recommended.
Contraindications: Hypersensitivity to the active substance or to any of the excipients. Active tuberculosis (TB), severe infections (such as sepsis), opportunistic infections. Moderate or severe heart failure (NYHA class III/IV). Pregnancy (unless clearly necessary), lactation (for at least 6 months after treatment).
Special precautions: Monitor closely for infections including TB before, during and for up to 5 months after therapy; discontinue if a serious infection occurs. May occur: Reactivation of hepatitis B. Caution: Hepatitis B carriers, history of malignancy, elderly, hepatic impairment. Renal/ hepatic impairment: No data. Malignancies reported in children and adolescents treated with TNF-blockers. Increased risk for lymphoma and leukaemia. Severe persistent asthma, COPD, heavy smoking (increased risk of malignancies). Mild heart failure (NYHA class I/II); discontinue if new or worsening symptoms. Assess benefit/risk in patients with pre-existing or recent onset of demyelinating disorders, including multiple sclerosis. Surgery (monitor closely for infections). Discontinue if patient develops symptoms of lupus-like syndrome and is positive for antibodies against double-stranded DNA. Pancytopenia, leukopenia, neutropenia, aplastic anemia, thrombocytopenia, cytopenias including pancytopenia, have been reported; consider discontinuation. Women of childbearing potential must use adequate contraception to prevent pregnancy and continue its use for at least 6 months after the last treatment. Driving/using machines. Contains sorbitol, fructose. Packaging contains latex.
Drug interactions: Not recommended: Anakinra, abatacept, live vaccines.
Adverse drug reactions: Upper respiratory tract infections (nasopharyngitis, pharyngitis, laryngitis, rhinitis), bacterial infections (cellulitis), viral infections (influenza, herpes), bronchitis, sinusitis, superficial fungal infections, anaemia, allergic reactions (bronchospasm, hypersensitivity, urticaria), autoantibody positive, depression, insomnia, dizziness, paresthesia, headache, hypertension, GI upset, increased ALT/AST, alopecia, dermatitis, pruritus, rash, pyrexia, asthenia, injection site reactions, impaired healing, chest discomfort.
Full prescribing information and references available from Merck Sharp and Dohme Ireland (Human Health) Ltd. Telephone: (01) 2998700. Fax: (01) 2998701.