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Drug Information

Drug Generic Name TOCILIZUMAB
Drug Class CYTOKINE MODULATORS
Chapter Musculoskeletal and Joint Diseases

Indications: Tocilizumab is licensed for use in patients with moderate to severe active rheumatoid arthritis when response to at least one disease-modifying antirheumatic drug or tumour necrosis factor inhibitor has been inadequate, or in those who are intolerant of these drugs. Tocilizumab can be used in juvenile idiopathic arthritis.

Cautions: predisposition to infection or history of recurrent or chronic infection; interrupt treatment if serious infection occurs; history of intestinal ulceration or diverticulitis; monitor hepatic transaminases every 4–8 weeks for first 6 months, then every 12 weeks; monitor neutrophil and platelet counts 4–8 weeks after starting treatment and then as indicated; low platelet or absolute neutrophil count (discontinue if absolute neutrophil count less than 0.5 × 109/litre or platelet count less than 50 × 103/microlitre); monitor lipid profile 4–8 weeks after starting treatment and then as indicated; monitor for demyelinating disorders tuberculosis: Patients should be evaluated for tuberculosis before treatment. Patients with latent tuberculosis should be treated with standard therapy before starting tocilizumab.

Contra-indications: severe active infection, do not initiate if absolute neutrophil count less than 2 × 109/litre.

Hepatic impairment manufacturer advises caution. Renal impairment manufacturer advises monitor renal function closely in moderate or severe impairment Pregnancy manufacturer advises avoid unless essential (toxicity in animal studies); effective contraception required during and for 3 months after treatment.

Breast-feeding manufacturer advises use only if potential benefit outweighs risk —no information available.

Side Effects: abdominal pain, mouth ulceration, gastritis, raised hepatic transaminases; dizziness, peripheral oedema, hypertension, hypercholesterolaemia; headache;

infection (including upper respiratory-tract infection);

antibody formation, hypersensitivity, leucopenia, neutropenia; rash, pruritus.

less commonly: gastric ulcer, gastro-intestinal perforation, hypertriglyceridaemia, hypothyroidism, nephrolithiasis, infusion related reactions, anaphylaxis, and thrombocytopenia also reported.

Dose: Rheumatoid arthritis, by intravenous infusion: adult over 18 years, 8 mg/kg (max. 800 mg) once every 4 weeks; for details of dose adjustment in patients with liver enzyme abnormalities, or low absolute neutrophil or platelet count.

Brand Name
  • RoActemra Concentrate for intravenous infusion, tocilizumab 20 mg/ml, 10 ml (200-mg) vial, 20 ml (400-mg) vial
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