POMALYST® (pomalidomide) is a thalidomide analogue indicated, in combination with dexamethasone, for adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.
Safety profile of POMALYST® (pomalidomide) + dex + isatuximab and POMALYST + dex alone.1
7% of patients on POMALYST + dex + isa discontinued treatment
due to adverse reaction(s)1*
Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
*Grades 1-4.
aPneumonia includes atypical pneumonia, bronchopulmonary aspergillosis, pneumonia, pneuomonia haemophilus, pneumonia influenzal, pneumonia pneumococcal, pneumonia streptococcal, pneumonia viral, candida pneumonia, pneumonia bacterial, haemophilus infection, lung infection, pneumonia fungal, and pneuomocystis jirovecii pneumonia.
bUpper respiratory tract infection includes bronchiolitis, bronchitis, bronchitis viral, chronic sinusitis, fungal pharyngitis, influenza-like illness, laryngitis, nasopharyngitis, parainfluenzae virus infection, pharyngitis, respiratory tract infection, respiratory tract infection viral, rhinitis, sinusitis, tracheitis, upper respiratory tract infection, and upper respiratory tract infection bacterial.
cDyspnea includes dyspnea, dyspnea exertional, and dyspnea at rest.
- Median duration of treatment was 41 weeks with POMALYST + dex + isa compared with 24 weeks for POMALYST + dex
Information about POMALYST + dexamethasone + isatuximab does not appear in the POMALYST Prescribing Information (PI). Please see the isatuximab-irfc full PI for a discussion of Important Safety Information at www.sarclisa.com
Indication for POMALYST + dexamethasone + Isa
POMALYST + dexamethasone + Isatuximab-irfc is indicated for the treatment of adult patients with MM who have received at least two prior therapies including lenalidomide and a PI.
ADVERSE REACTIONS FOR POMALYST + dexamethasone + isatuximab-irfc (Pd-Isa)
The most common adverse reactions (≥20% of patients receiving Pd-Isa or Pd, respectively) were neutropenia (laboratory abnormality, 96%, 92%), infusion-related reactions (38%, 0%), pneumonia (31%, 23%), upper respiratory tract infection (57%, 42%), and diarrhea (26%, 19%). The most common hematology laboratory abnormalities (≥80% of patients) were anemia, neutropenia, lymphopenia, and thrombocytopenia.
Serious adverse reactions in ≥5% of patients who received Pd-Isa included pneumonia (26%), upper respiratory tract infections (7%), and febrile neutropenia (7%).
dex, dexamethasone; isa, isatuximab-irfc.
Reference: 1. Isatuximab-irfc [package insert]. Bridgewater, NJ: sanofi-aventis U.S. LLC.