Incidence of infusion reactions in the CLL-11 trial
Infusion-related reactions (IRRs) with GAZYVA may be severe and life threatening and can occur at any time 1
- Symptoms may include hypotension, tachycardia, dyspnea, and respiratory symptoms (eg, bronchospasm, larynx and throat irritation, wheezing, laryngeal edema)
- Most frequently reported symptoms include nausea, fatigue, dizziness, vomiting, diarrhea, hypertension, flushing, headache, pyrexia, and chills
First 1000 mg infused: 65% of patients experienced IRRs with GAZYVA 1
- Grade 3 or 4 reactions occurred in 20% of patients
Subsequent infusions: IRRs also occurred 1
- The incidence of IRRs with subsequent infusions was 3% with the second 1000 mg and <1% thereafter
- There were no Grade 3 or 4 IRRs reported after the first 1000 mg infused
Incidence of infusion reactions by cycle 1,7
Protocol modifications were implemented to help mitigate infusion reactions 1
- Protocol modifications in CLL-11 required premedication with a corticosteroid* an antihistamine, and acetaminophen. The first 1000 mg dose was also divided into two infusions (100 mg on Day 1 and 900 mg on Day 2)
BEFORE PROTOCOL MODIFICATIONS (n=53)
AFTER PROTOCOL MODIFICATIONS (n=140)
|89% of patients experienced an infusion reaction||53% of patients experienced a reaction with the first 1000 mg and <3% thereafter|
*Hydrocortisone is not recommended as it has not been effective in reducing the rate of infusion reactions.
- In the rituximab + Clb arm (n=321), the incidence of IRRs
during Cycle 1 was 27% (24% Grades 1-2, 3% Grades 3-4)
- In Cycle 2, the incidence of IRRs was 13% (12% Grades 1-2, 1% Grades 3-4)
- The incidence of IRRs was 6% for Cycle 3, 2% for Cycle 4, 2% for Cycle 5, and 1% for Cycle 6
- <1% of the rituximab treated arm discontinued therapy due
to an IRR
For dosing and administration information, click here.
For information on how to adjust infusions in case of IRRs, click here.