ALOXI® has a well-established
safety profile1
Most frequently occurring adverse reactions1
- In clinical trials for the prevention
of CINV following MEC or HEC, adverse reactions were similar in frequency and severity
with ALOXI and ondansetron or dolasetron1
- No dose adjustments are required
for the elderly* or those with renal or hepatic impairment1
- The effect of ALOXI on blood pressure, heart rate, and ECG parameters
including QTc (<1%) were comparable with ondansetron and dolasetron in CINV clinical
trials1
* No overall differences in safety or effectiveness were observed between
cancer patients ≥65 years of age and younger subjects (18 to 64 years), but
greater sensitivity in some older individuals cannot be ruled out.
ALOXI had no significant effect on any ECG interval1
- A double-blind, randomized, parallel, placebo-controlled study
in 221 adults demonstrated no significant effect on any ECG interval including QTc
duration (cardiac repolarization) at doses up to 2.25 mg—9 times the FDA-approved
CINV dose of 0.25 mg1
Repeated dosing of ALOXI1
- The restriction on repeated dosing of ALOXI within a 7-day interval
was removed from
the label2