Incidence of infusion reactions in the CLL-11 trial
Infusion-related reactions (IRRs) with GAZYVA (obinutuzumab) 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-related 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-related reaction||53% of patients experienced an infusion-related 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-related reactions.
- In the rituximab product + 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 product 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.