Axitinib

Source: UK SPC (eMC) §4.2 for Axitinib 1 mg Film-coated Tablets (https://www.medicines.org.uk/emc/product/101177/smpc). Treatment should be conducted by a physician experienced in the use of anticancer therapies. VERBATIM: 'The recommended dose of axitinib is 5 mg twice daily.' DOSE ESCALATION: patients who tolerate 5 mg twice daily with no adverse reactions above Grade 2 (CTCAE v3.0) for two consecutive weeks may be increased to 7 mg twice daily, unless blood pressure is above 150/90 mmHg or the patient is receiving antihypertensive treatment; using the same criteria, patients tolerating 7 mg twice daily may be increased to a maximum of 10 mg twice daily. DOSE REDUCTION: when reduction is necessary, the dose may be reduced to 3 mg twice daily and further to 2 mg twice daily; management of some adverse reactions may require temporary or permanent discontinuation. NO ADJUSTMENT is required on the basis of patient age, race, gender or body weight. MISSED DOSE / VOMITING: if the patient vomits or misses a dose, an additional dose should not be taken — the next prescribed dose should be taken at the usual time. STRONG CYP3A4/5 INHIBITORS: select an alternative concomitant medicine with no or minimal CYP3A4/5 inhibition potential; if a strong inhibitor must be co-administered, a dose decrease to approximately half the dose is recommended (e.g. the starting dose reduced from 5 mg twice daily to 2 mg twice daily); if the strong inhibitor is discontinued, consider returning to the previous axitinib dose. STRONG CYP3A4/5 INDUCERS: select an alternative; if one must be co-administered, a gradual dose increase of axitinib is recommended (maximal induction with high-dose strong inducers occurs within one week) with careful monitoring for toxicity; if the inducer is discontinued, immediately return to the dose used before it was started. ELDERLY (65 years and over): no dose adjustment required. HEPATIC IMPAIRMENT: no dose adjustment in mild impairment (Child-Pugh A); a dose decrease is recommended in moderate impairment (Child-Pugh B) — e.g. starting dose reduced from 5 mg twice daily to 2 mg twice daily; not studied in severe impairment (Child-Pugh C) and should not be used in this population. PAEDIATRIC: safety and efficacy in children and adolescents under 18 years have not been established; no data are available. MONITORING: blood pressure should be well-controlled before initiating and monitored throughout; thyroid function should be monitored before initiation and periodically. §4.5 was not present in the fetched bundle — the interactions listed are those named within §4.2.