1. Name of the medicinal product
Imnovid 4 mg hard capsules
2. Qualitative and quantitative composition
Each hard capsule contains 4 mg of pomalidomide.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Hard capsule.
Imnovid 4 mg hard capsule: Dark blue opaque cap and blue opaque body, imprinted “POML 4 mg” in white ink, size 2, hard gelatin capsule.
4. Clinical particulars
4.1 Therapeutic indications
Imnovid in combination with dexamethasone is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.
4.2 Posology and method of administration
Treatment must be initiated and monitored under the supervision of physicians experienced in the management of multiple myeloma.
Posology
The recommended starting dose of Imnovid is 4 mg once daily taken orally on Days 1 to 21 of repeated 28-day cycles. The recommended dose of dexamethasone is 40 mg orally once daily on Days 1, 8, 15 and 22 of each 28-day treatment cycle.
Dosing is continued or modified based upon clinical and laboratory findings.
Treatment should be discontinued upon progression of disease.
Pomalidomide dose modification or interruption
Instructions for dose interruptions and reductions for pomalidomide related to haematologic adverse reactions are outlined in the table below:
• Pomalidomide dose modification instructions
|
Toxicity
|
Dose modification
|
|
Neutropenia
• ANC* < 0.5 x 109/l or Febrile neutropenia (fever ≥38.5°C and ANC <1 x 109/l)
|
Interrupt pomalidomide treatment, follow CBC** weekly.
|
|
• ANC return to ≥1 x 109/l
|
Resume pomalidomide treatment at 3 mg daily.
|
|
• For each subsequent drop < 0.5 x 109/l
|
Interrupt pomalidomide treatment
|
|
• ANC return to ≥1 x 109/l
|
Resume pomalidomide treatment at 1 mg less than the previous dose.
|
|
Thrombocytopenia
• Platelet count <25 x 109/l
|
Interrupt pomalidomide treatment, follow CBC** weekly
|
|
• Platelet count return to ≥50 x 109/l
|
Resume pomalidomide treatment at 3 mg daily
|
|
• For each subsequent drop <25 x 109/l
|
Interrupt pomalidomide treatment
|
|
• Platelet count return to ≥50 x 109/l
|
Resume pomalidomide treatment at 1 mg less than the previous dose
|
*ANC – Absolute Neutrophil Count; **CBC – Complete Blood Count;
To initiate a new cycle of pomalidomide, the neutrophil count must be ≥1 x 109/l and the platelet count must be ≥ 50 x 109/l.
In case of neutropaenia, the physician should consider the use of growth factors.
For other Grade 3 or 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 adverse reactions occur after dose reductions to 1 mg, then the medicinal product should be discontinued.
• Dexamethasone dose modification instructions
|
Toxicity
|
Dose Modification
|
|
Dyspepsia = Grade 1-2
Dyspepsia ≥ Grade 3
|
Maintain dose and treat with histamine (H2) blockers or equivalent. Decrease by one dose level if symptoms persist.
Interrupt dose until symptoms are controlled. Add H2 blocker or equi |
