Active Ingredient: Pomalidomide
Pomalidomide in combination with bortezomib and dexamethasone is indicated in the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide.
Pomalidomide 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.
For this indication, competent medicine agencies globally authorize below treatments:
Oral
4 - 4 mg
From 4 To 4 mg once every day for 14 day(s)
The recommended starting dose of pomalidomide is 4 mg orally once daily on Days 1 to 14 of repeated 21-day cycles.
Pomalidomide is administered in combination with bortezomib and dexamethasone, as shown in Table 1. The recommended starting dose of bortezomib is 1.3 mg/m² intravenous or subcutaneous once daily, on the days shown in Table 1. The recommended dose of dexamethasone is 20 mg orally once daily, on the days shown in Table 1.
Treatment with pomalidomide combined with bortezomib and dexamethasone should be given until disease progression or until unacceptable toxicity occurs.
Table 1. Recommended dosing scheme for pomalidomide in combination with bortezomib and dexamethasone:
| Day (of 21-day cycle) | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | 16 | 17 | 18 | 19 | 20 | 21 | |
| Cycle 1-8 | |||||||||||||||||||||
| Pomalidomide (4 mg) | • | • | • | • | • | • | • | • | • | • | • | • | • | • | |||||||
| Bortezomib (1,3 mg/m²) | • | • | • | • | |||||||||||||||||
| Dexamethasone (20 mg)* | • | • | • | • | • | • | • | • | |||||||||||||
| Cycle 9 onwards | |||||||||||||||||||||
| Pomalidomide (4 mg) | • | • | • | • | • | • | • | • | • | • | • | • | • | • | |||||||
| Bortezomib (1,3 mg/m²) | • | • | |||||||||||||||||||
| Dexamethasone (20 mg)* | • | • | • | • | |||||||||||||||||
* For patients >75 years of age, see Special populations.
To initiate a new cycle of pomalidomide, the neutrophil count must be ≥1 × 109/l and the platelet count must be ≥50 × 109/l. Instructions on dose interruptions or reductions for pomalidomide related adverse reactions are outlined in the Table 2 and dose levels are defined in Table 3 below.
Table 2. Pomalidomide dose modification instructions∞:
| Toxicity | Dose modification |
|---|---|
| Neutropenia* | |
| ANC** <0.5 × 109/l or febrile neutropenia (fever ≥38.5°C and ANC <1 × 109/l) | Interrupt pomalidomide treatment for remainder of cycle. Follow CBC*** weekly |
| ANC return to ≥1 × 109/l | Resume pomalidomide treatment at one dose level lower than previous dose. |
| For each subsequent drop <0.5 × 109/l | Interrupt pomalidomide treatment. |
| ANC return to ≥1 × 109/l | Resume pomalidomide treatment at one dose level lower than the previous dose. |
| Thrombocytopenia | |
| Platelet coun <25 × 109/l | Interrupt pomalidomide treatment for remainder of cycle. Follow CBC*** weekly |
| Platelet count return to ≥50 × 109/l | Resume pomalidomide treatment at one dose level lower than previous dose. |
| For each subsequent drop <25 × 109/l | Interrupt pomalidomide treatment. |
| Platelet count return to ≥50 × 109/l | Resume pomalidomide treatment at one dose level lower than the previous dose. |
| Rash | |
| Rash = Grade 2-3 | Consider dose interruption or discontinuation of pomalidomide treatment. |
| Rash = Grade 4 or blistering (including angioedema, exfoliative or bullous rash or if Stevens-Johnson syndrome (SJS), Toxic Epidermal Necrolysis (TEN) or Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) is suspected) | Permanently discontinue treatment. |
| Other | |
| Other ≥ Grade 3 pomalidomide-related adverse events | Interrupt pomalidomide treatment for remainder of cycle. Resume at one dose level lower than previous dose at next cycle (adverse event must be resolved or improved to ≤ Grade 2 before restarting dosing). |
∞ Dose modification instructions in this table are applicable to pomalidomide in combination with bortezomib and dexamethasone and to pomalidomide in combination with dexamethasone.
* In case of neutropenia, the physician should consider the use of growth factors. **ANC – Absolute Neutrophil Count; ***CBC – Complete Blood Count.
Table 3. Pomalidomide dose reduction∞:
| Dose level | Oral pomalidomide dose |
|---|---|
| Starting dose | 4 mg |
| Dose level-1 | 3 mg |
| Dose level-2 | 2 mg |
| Dose level-3 | 1 mg |
∞ Dose reduction in this table is applicable to pomalidomide in combination with bortezomib and dexamethasone and to pomalidomide in combination with dexamethasone
If adverse reactions occur after dose reductions to 1 mg, then the medicinal product should be discontinued.
Pomalidomide in combination with bortezomib and dexamethasone:
No dose adjustment is required for pomalidomide.
For information on bortezomib given in combination with Imnovid, refer to the respective current SmPC.
For patients >75 years of age, the starting dose of dexamethasone is:
Pomalidomide in combination with dexamethasone:
No dose adjustment is required for pomalidomide.
For patients >75 years of age, the starting dose of dexamethasone is:
It should be taken orally at the same time each day. It should be swallowed whole, preferably with water, with or without food. If the patient forgets to take a dose of pomalidomide on one day, then the patient should take the normal prescribed dose as scheduled on the next day. Patients should not adjust the dose to make up for a missing dose on previous days.
Liability Disclaimer : RxReasoner has utilized reasonable care in providing content and services that are accurate, complete and up to date. However, RxReasoner does not accept any responsibility or liability about it. The content and services of RxReasoner are for informational purposes only and they are not intended to be a substitute for the knowledge, expertise, skill, and judgment of physicians, pharmacists, nurses, or other healthcare professionals involved in patient care. RxReasoner offers no medical advice. Users are responsible for the use of the provided content. A shown indication or treatment should not be construed to indicate that the medication is safe, appropriate, or effective in any given patient or under any particular circumstances. The absence of an indication or treatment should not roule out the existence of other appropriate medications. Always seek the advice of a physician or other qualified health provider with any questions you may have regarding a medical condition or medicament. RxReasoner is not liable for any damages allegedly sustained arising out of the use of its content and services.
