Tocilizumab

Source: UK SPC (eMC) §4.2 for Avtozma (tocilizumab) 162 mg/0.9 ml solution for injection pre-filled pen (https://www.medicines.org.uk/emc/product/101323/smpc). VERBATIM: 'RA patients — The recommended posology is subcutaneous 162 mg once every week.' 'GCA patients — The recommended posology is subcutaneous 162 mg once every week in combination with a tapering course of glucocorticoids.' IMPORTANT SCOPE LIMIT: this bundle contains the SUBCUTANEOUS pre-filled pen SPC only. The INTRAVENOUS tocilizumab posology (weight-based infusion) was NOT retrieved — do not assume the 162 mg figure applies to IV use; source the IV regimen separately. GCA: can be used alone following discontinuation of glucocorticoids, but monotherapy should not be used for the treatment of acute relapses; based on the chronic nature of GCA, treatment beyond 52 weeks should be guided by disease activity, physician discretion and patient choice. INITIATION: treatment should be initiated by healthcare professionals experienced in the diagnosis and treatment of RA, sJIA, pJIA and/or GCA; the first injection should be performed under the supervision of a qualified healthcare professional, and all patients must be given the Patient Card. SWITCHING FROM IV: patients transitioning from intravenous to subcutaneous should administer their first subcutaneous dose at the time of the next scheduled intravenous dose, under supervision. DOSE ADJUSTMENT FOR LIVER ENZYMES (RA/GCA): ALT/AST >1 to 3 x ULN — modify concomitant DMARDs/immunomodulatory agents if appropriate; for persistent increases reduce dosing frequency to every other week or interrupt until normalised. >3 to 5 x ULN — interrupt until <3 x ULN then follow the >1 to 3 x ULN advice; discontinue if persistent >3 x ULN on repeat testing. >5 x ULN — discontinue. NEUTROPENIA: do not initiate in tocilizumab-naive patients with ANC below 2 x 10^9/L; ANC >1 maintain dose; ANC 0.5 to 1 interrupt and, when ANC >1 x 10^9/L, resume every other week increasing to weekly as clinically appropriate; ANC <0.5 discontinue. PLATELETS: 50 to 100 x 10^3/microlitre interrupt and resume every other week when >100 x 10^3/microlitre; <50 discontinue. MISSED DOSE: a missed weekly injection within 7 days of the scheduled dose should be taken on the next scheduled day; a missed every-other-week injection within 7 days should be taken immediately with the next dose on the next scheduled day. ELDERLY: no dose adjustment required in patients over 65 years. HEPATIC IMPAIRMENT: not studied — no dose recommendations can be made. ADMINISTRATION: rotate injection sites (abdomen, thigh, upper arm); never inject into moles, scars, or skin that is tender, bruised, red, hard or not intact; do not shake the pen. PAEDIATRIC (fixed doses by weight band, NOT per-kg, so paedDose is null): sJIA in patients above 12 years — 162 mg subcutaneously once every week if weight >=30 kg, or 162 mg once every 2 weeks if weight <30 kg. pJIA in patients above 12 years — 162 mg subcutaneously once every 2 weeks if weight >=30 kg, or 162 mg once every 3 weeks if weight <30 kg. The pre-filled pen should NOT be used in paediatric patients under 12 years of age (risk of intramuscular injection due to a thinner subcutaneous tissue layer), and patients must have a minimum body weight of 10 kg when receiving tocilizumab subcutaneously. Safety and efficacy from birth to less than 1 year have not been established. A change in dose should only be based on a consistent change in the patient's body weight over time. Verify any under-18 use against a children's formulary. §4.5 was not retrieved from the UK SPC in this bundle — interactions below are from the US label (Tofidence, Biogen) §7.