* The most common adverse reactions (reported in [greater than or equal to] 10% of patients) with POTELIGEO in the clinical trial were rash, including drug eruption (35%), infusion reaction
(33%), fatigue (31%), diarrhea (28%), drug eruption (24%), upper respiratory tract infection (22%), musculoskeletal pain (22%), skin infection (19%), pyrexia (17%), edema (16%), nausea (16%), headache (14%), thrombocytopenia (14%), constipation (13%), anemia (12%), mucositis (12%), cough (11%), and hypertension (10%).
This was promptly followed by ustekinumab for 9 months but had to be discontinued because of primary inefficacy.Then, he was then on infliximab for a year, which again had to be terminated following an inadeguate response and a possible infusion reaction
. All these therapies were prescribed at a different center.
Two patients experienced an infusion reaction
and none developed antibodies to Factor Xa or Factor X or neutralizing antibodies to Andexxa.
The drug was well tolerated, with no opportunistic infections or tuberculosis, and the infusion reaction
rate was below 2% (Arthritis Rheumatol.
Demographic, clinical symptoms, and infusion reaction
data were recorded from the patients' charts.
* In controlled clinical trials, 71.2% of patients in the sipuleucel-T group developed an acute infusion reaction
Extensive forearm deep vein thrombosis following a severe infliximab infusion reaction
. Eur J Gastroenterol Hepatol 2004; 16: 941-2.
Rare deaths associated with an infusion reaction
symptom complex have occurred within 24 hours of rituximab (Rituxan) infusions.
It's really a rate-dependent infusion reaction
, said Dr.
These initial infusion reaction
effects can be treated symptomatically and occur infrequently in subsequent infusions.
Also, if they don't have such a robust response, it probably means they have antibodies to pegylated uricase, which increases the risk of infusion reaction
. In that case, "stop the drug," he said.
During an infusion reaction
, early intervention may prevent serious side effects and death.