For each subsequent drop below Interrupt treatment < 0.5 x 109/L Return to 1 x 109/L Resume treatment at 1 mg less than previous dose ≥ ANC Absolute Neutrophil Count; CBC Complete Blood Count; G-CSF Granulocyte- Colony Stimulating Factor – – – For other Grade 3/4 adverse reactions judged to be related to pomalidomide, stop treatment and restart treatment at 1 mg less than the previous dose when an adverse reaction has resolved to Grade 2 at the ≤ physician’s discretion. If toxicities occur after dose reductions to 1 mg, then the medicine should be discontinued. 11. Overdosage Pomalidomide doses as high as 50 mg as a single dose in healthy volunteers and 10 mg as once-daily multiple doses in multiple myeloma patients have been studied without reported serious adverse events related to overdose. No specific information is available on the treatment of overdose with pomalidomide, and it is unknown whether pomalidomide or its metabolites are dialyzable. In the event of overdose, supportive care is advised. In Australia, contact the Poisons Advisory Centre on 13 11 26 for advice on management. In New Zealand, contact the National Poison Centre on 0800 POISON or 0800 764 766 for advice on management. 12. Presentation and storage conditions 12.1 Presentation Pomalyst is available as 1 mg, 2 mg, 3 mg and 4 mg capsules in blister packs containing 21 capsules each. Pomalyst 1 mg capsules: dark blue/yellow size 4 gelatin capsules marked in white ink and “POML” mg” in black ink. Each 1 mg capsule contains 1 mg of pomalidomide. “1 Pomalyst 2 mg capsules: dark blue/orange size 2 gelatin capsules marked 2 mg” in ink. “POML Each 2 mg capsule contains 2 mg of pomalidomide. Pomalyst 3 mg capsules: dark blue/green size 2 gelatin capsules marked 3 mg” in white ink. “POML Each 3 mg capsule contains 3 mg of pomalidomide. Pomalyst 4 mg capsules: dark blue/blue size 2 gelatin capsules marked 4 mg” in white ink. “POML Each 4 mg capsule contains 4 mg of pomalidomide. 12.2 Composition Active Pomalidomide Excipients See section 2-Description, for a list of the excipients.
For each subsequent drop below < 0.5 x 109/L Interrupt treatment Return to ≥ 1 x 109/L Resume treatment at 1 mg less than previous dose ANC – Absolute Neutrophil Count; CBC – Complete Blood Count; G-CSF – Granulocyte- Colony Stimulating Factor For other Grade 3/4 adverse reactions judged to be related to pomalidomide, stop treatment and restart treatment at 1 mg less than the previous dose when an adverse reaction has resolved to ≤ Grade 2 at the physician’s discretion. If toxicities occur after dose reductions to 1 mg, then the medicine should be discontinued. 11. Overdosage Pomalidomide doses as high as 50 mg as a single dose in healthy volunteers and 10 mg as once-daily multiple doses in multiple myeloma patients have been studied without reported serious adverse events related to overdose. No specific information is available on the treatment of overdose with pomalidomide, and it is unknown whether pomalidomide or its metabolites are dialyzable. In the event of overdose, supportive care is advised. In Australia, contact the Poisons Advisory Centre on 13 11 26 for advice on management. In New Zealand, contact the National Poison Centre on 0800 POISON or 0800 764 766 for advice on management. 12. Presentation and storage conditions 12.1 Presentation Pomalyst is available as 1 mg, 2 mg, 3 mg and 4 mg capsules in blister packs containing 21 capsules each. Pomalyst 1 mg capsules: dark blue/yellow size 4 gelatin capsules marked “POML” in white ink and “1 mg” in black ink. Each 1 mg capsule contains 1 mg of pomalidomide. Pomalyst 2 mg capsules: dark blue/orange size 2 gelatin capsules marked “POML 2 mg” in ink. Each 2 mg capsule contains 2 mg of pomalidomide. Pomalyst 3 mg capsules: dark blue/green size 2 gelatin capsules marked “POML 3 mg” in white ink. Each 3 mg capsule contains 3 mg of pomalidomide. Pomalyst 4 mg capsules: dark blue/blue size 2 gelatin capsules marked “POML 4 mg” in white ink. Each 4 mg capsule contains 4 mg of pomalidomide. 12.2 Composition Active Pomalidomide Excipients See section 2-Description, for a list of the excipients.
auspar-pomalidomide-131014-pi.docx