The new SARCLISA J-code J9227 is now available, effective October 1, 2020, to be used for reimbursement claims. Refer to the Billing and Coding Guide on the Resources page for additional details. MAT-US-2018558-v1.0-08/2020

Safety

Adverse Reactions for SARCLISA + Pd

Adverse reactions (≥10%) in patients receiving SARCLISA + Pd with a difference between arms of ≥5% compared with control arm1

Adverse
reaction
SARCLISA + Pd
(n=152)
All grades
All grades
Grade 3
Grade 4
Pd (n=149)
All grades
All grades
Grade 3
Grade 4
IRRs
38%
1.3%
1.3%
0%
0%
0%
Infections
Pneumoniaa
31%
22%
3.3%
23%
16%
2.7%
Upper respiratory tract infectionb
57%
9%
0%
42%
3.4%
0%
Blood and lymphatic system disorders
Febrile
neutropenia
12%
11%
1.3%
2%
1.3%
0.7%
Respiratory, thoracic, and mediastinal disorders
Dyspneac
17%
5%
0%
12%
1.3%
0%
Gastrointestinal disorders
Diarrhea
26%
2%
0%
19%
0.7%
0%
Nausea
15%
0%
0%
9%
0%
0%
Vomiting
12%
1.3%
0%
3.4%
0%
0%

aPneumonia 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.

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.

Serious and fatal adverse reactions1

  • 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 (those that occurred in more than 1% of patients were pneumonia and other infections [3%])
Laboratory
parameter
SARCLISA + Pd
(n=152)
All grades
All grades
Grade 3
Grade 4
Pd (n=149)
All grades
All grades
Grade 3
Grade 4
Anemia
99%
32%
0%
97%
28%
0%
Neutropenia
96%
24%
61%
92%
38%
31%
Lymphopenia
92%
42%
13%
92%
35%
8%
Thrombocytopenia
84%
14%
16%
79%
9%
15%
Expert review Join Joseph Mikhael, MD, and Kenneth Shain, MD, PhD, as they review the safety information for SARCLISA
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Discontinuation rates1

  • Dosage interruptions due to an adverse reaction occurred in 31% of patients who received SARCLISA + Pd. The most frequent adverse reaction requiring dosage interruption was IRR (28%)
  • 7% of patients receiving SARCLISA + Pd permanently discontinued treatment due to adverse reactions
    • Discontinuations from treatment due to infection were reported in 2.6% of patients receiving SARCLISA + Pd vs 5.4% of patients receiving Pd alone
    • SARCLISA alone was discontinued in 3% of patients due to IRRs

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