Reslizumab

SOURCE: openFDA / DailyMed US prescribing information, productName 'CINQAIR' (Teva Respiratory, LLC, label date 2020-02-29, https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a509df2c-67b6-40c3-8b6d-f9de54b62c8a), §2.1. VERBATIM: 'The recommended dosage regimen is 3 mg/kg once every 4 weeks administered by intravenous infusion over 20-50 minutes.' NO UK SPC (eMC) RECORD WAS RETRIEVED IN THIS BUNDLE — this is US labelling and must be verified against UK labelling before publishing. ADMINISTRATION SETTING: 'CINQAIR should be administered by a healthcare professional prepared to manage anaphylaxis.' Observe the patient over the infusion and for an appropriate period following it. Discontinue the infusion immediately if the patient experiences a severe systemic reaction, including anaphylaxis. PREPARATION: supplied as 100 mg/10 mL (10 mg/mL) solution in single-use vials. Withdraw the volume based on the weight-based dose, discard any unused portion, and dispense the syringe contents slowly into an infusion bag containing 50 mL of 0.9% Sodium Chloride Injection to minimise foaming; gently invert to mix, do not shake. Do not mix or dilute with other drugs and do not infuse concomitantly in the same intravenous line with other agents. Administer immediately after preparation; if not used immediately, store the diluted solution at 2-8 degrees C or at room temperature up to 25 degrees C, protected from light, for up to 16 hours (time between preparation and administration must not exceed 16 hours). Use an infusion set with an in-line low protein-binding filter (0.2 micron pore size). Infusion time may vary depending on the total volume to be infused as based upon patient weight. Flush the intravenous administration set with 0.9% Sodium Chloride Injection on completion. PAEDIATRIC: 'CINQAIR is not indicated for use in pediatric patients less than 18 years of age. The safety and effectiveness in pediatric patients (aged 17 years and younger) have not been established' — hence paedDose is null despite the adult dose being weight-based. In two 52-week exacerbation studies the asthma exacerbation rate was HIGHER in adolescent patients treated with CINQAIR than placebo. GERIATRIC: no adjustment of dosage in geriatric patients is necessary. OTHER WARNINGS (§5): do not discontinue systemic or inhaled corticosteroids abruptly on initiation — decrease gradually if appropriate; treat pre-existing helminth infections before therapy, and if a patient becomes infected during treatment and does not respond to anti-helminth treatment, discontinue until the parasitic infection resolves. SECTION COVERAGE: the §6.1 adverse reactions table, §5 warnings and §8.1 pregnancy were truncated at the source-fetch limit, so the side-effect list below is incomplete. No renal dose adjustment statement appears in the fetched sections.