IntravenousRheumatoid arthritisAdult: As monotherapy or in combination w/ methotrexate or other non-biologic disease-modifying drugs (DMARDs): Initially, 4 mg/kg once every 4 wk, may be increased to a usual dose of 8 mg/kg once every 4 wk via infusion over 1 hr. Max: 800 mg. Do not initiate in patients w/ absolute neutrophil count (ANC) <2 x 109/L, platelet count <100 x 109/L, or ALT/AST >1.5 x ULN (upper limit of normal). Interrupt dosing if ANC 0.5-1 x 109/L, platelet count 50-100 x 109/L, or ALT/AST >3-5 ULN. Discontinue if ANC <0.5 x 109/L, platelet count <50 x 109/L, or ALT/AST >5 x ULN.
Child: ≥2 yr Systemic juvenile idiopathic arthritis: <30 kg: 12 mg/kg; ≥30 kg: 8 mg/kg. Doses are given once every 2 wk via infusion over 1 hr. Juvenile idiopathic polyarthritis: <30 kg: 10 mg/kg; ≥30 kg: 8 mg/kg. Doses are given once every 4 wk via infusion over 1 hr.
SubcutaneousRheumatoid arthritisAdult: As monotherapy or in combination w/ methotrexate or other non-biologic DMARDs: 162 mg once wkly. Do not initiate in patients w/ absolute neutrophil count (ANC) <2 x 109/L, platelet count <100 x 109/L, or ALT/AST >1.5 x ULN (upper limit of normal). Interrupt dosing if ANC 0.5-1 x 109/L, platelet count 50-100 x 109/L, or ALT/AST >3-5 ULN. Discontinue if ANC <0.5 x 109/L, platelet count <50 x 109/L, or ALT/AST >5 x ULN.
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IV infusion: Dilute w/ NaCl 0.45% or 0.9% to a final volume of 50 mL (for childn <30 kg) or 100 mL (for adult and childn ≥30 kg). Withdraw equal volume of NaCl 0.9% or 0.45% to the volume of drug required for dose then slowly add tocilizumab dose into infusion bag or bottle.
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Severe active infections (e.g. sepsis, abscess, hepatitis B, active TB). Concomitant use w/ other biologic DMARDs.
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Patient w/ history of recurrent or chronic infections, or conditions that may predispose to infections (e.g. diverticulitis, DM), pre-existing or recent CNS demyelinating disorders, and those at risk for GI perforation. Hepatic impairment or active hepatic disease. Childn. Pregnancy and lactation.
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Significant: GI perforation, elevated transaminases, hyperlipidaemia, neutropenia, thrombocytopenia, viral reactivation (e.g. hepatitis B virus, HZV), auto-immune effects, malignancies. Rarely, multiple sclerosis, chronic inflammatory demyelinating polyneuropathy.
Nervous: Headache, flu-like symptoms, dizziness.
CV: HTN, hypotension, peripheral oedema.
GI: Gastritis, mouth ulcers, diarrhoea, nausea, abdominal pain.
Resp: Nasopharyngitis, upper resp tract infection, bronchospasm.
Endocrine: Hypertryglyceridaemia, hypothryroidism.
Haematologic: Leucopenia.
Ophthalmologic: Conjunctivitis.
Others: Infusion-related (e.g. HTN, headache, rash, hypersensitivity) or SC inj site (e.g. haematoma, erythema, pain, pruritus) reactions.
Potentially Fatal: Serious infections (e.g. active TB, invasive fungal infections, bacterial, viral and other opportunistic infections, serious hypersensitivity reactions (e.g. anaphylaxis).
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This drug may cause dizziness, if affected, do not drive or operate machinery.
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Measure neutrophil and platelet counts, lipids, and LFTs before and regularly during treatment. Perform screening test for latent TB prior to therapy. Monitor signs and symptoms of CNS demyelinating disorders.
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Risk of secondary transmission of infection when given concurrently w/ live vaccines. May increase the metabolism of drugs that are metabolised by CYP enzymes.
Potentially Fatal: Increased risk of infection w/ other biologic DMARDs, including tumour necrosis factor (TNF) blocking agents (e.g. adalimumab, etanercept, infliximab), IL-1 receptor antagonists (e.g. anakinra), anti-CD20 monoclonal antibodies (e.g. rituximab), selective costimulation modulators (e.g. abatacept).
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Description: Tocilizumab, a recombinant humanised monoclonal antibody of the IgG1 subclass, inhibits the actions of interleukin-6 (sIL-6R and mIL- 6R), a pleiotropic pro-inflammatory cytokine that is involved in T-cell activation, induction of Ig secretion, initiation of hepatic acute phase protein synthesis, and stimulation of haematopoiesis. It binds specifically to both soluble and membrane-bound IL-6 receptors and inhibits IL-6-mediated signaling, thereby resulting in a reduction in inflammatory mediator production.
Pharmacokinetics:
Absorption: Bioavailability: 80% (SC).
Distribution: Volume of distribution: 6.4L (IV).
Excretion: Elimination half-life: IV: Concentration-dependent: 6.3 days (up to 11-13 days); SC: up to 13 days.
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Store between 2-8°C. Do not freeze. Protect from light.
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L04AC07 - tocilizumab ; Belongs to the class of interleukin inhibitors. Used as immunosuppressants.
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Actemra Injection, Solution (Genentech, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 05/04/2017. Anon. Tocilizumab. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 05/04/2017. Buckingham R (ed). Tocilizumab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 05/04/2017 . Joint Formulary Committee. Tocilizumab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 05/04/2017. McEvoy GK, Snow EK, Miller J et al (eds). Tocilizumab. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 05/04/2017.
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