ICARIA-MM: SARCLISA + POMALIDOMIDE AND DEXAMETHASONE (Pd)
Adverse Reactions for SARCLISA + Pd
Discontinuation rates
Permanent treatment discontinuation due to adverse reactions (grades 1 to 4)1,2
- Dosage interruptions due to an adverse
reaction occurred in 31% of patients who received SARCLISA + Pd1
- Discontinuations from treatment due to infection were reported in 2.6% of patients receiving SARCLISA + Pd vs 5% of patients receiving Pd alone
- The most frequent adverse reaction requiring dosage interruption was IRR (28%)
The addition of SARCLISA to Pddid not increase treatment discontinuations due to adverse reactions vs Pd alone1,2
Adverse reactions (≥10%) in patients receiving SARCLISA + Pd with a difference between arms of ≥5% compared with Pd alone1
(n=152)
aIRR includes IRR, cytokine release syndrome, and drug hypersensitivity.
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.
cPneumonia includes atypical pneumonia, bronchopulmonary aspergillosis, pneumonia, pneumonia haemophilus, pneumonia influenzal, pneumonia pneumococcal, pneumonia streptococcal, pneumonia viral, candida pneumonia, pneumonia bacterial, haemophilus infection, lung infection, pneumonia fungal, and Pneumocystis jirovecii pneumonia.
dDyspnea includes dyspnea, dyspnea exertional, and dyspnea at rest.
IRR=infusion-related reaction.
See the types of IRRs that occurred in the ICARIA-MM trial and how to manage them
Serious adverse reactions1,2
- Serious adverse reactions occurred in 62% of patients
receiving SARCLISA + Pd
- Serious adverse reactions in >5% of patients who received SARCLISA + Pd included pneumonia (26%), upper respiratory tract infection (7%), and febrile neutropenia (7%)
- Fatal adverse reactions occurred in 11% of patients in the SARCLISA + Pd arm (those that occurred in >1% of patients were pneumonia and other infections [3%]) vs 11% in the Pd arm
Hematology laboratory
abnormalities in patients receiving
SARCLISA + Pd vs
Pd alone1
parameter
(n=152)
The denominator used to calculate the percentages was based on the safety population.
Complete blood cell counts should be monitored periodically during treatment. Patients with neutropenia should be monitored for signs of infection. In case of infection, appropriate standard therapy should be instituted. Antibacterial and antiviral prophylaxis can be considered during treatment.
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