In pivotal trials, the most common adverse reactions in adult patients are nausea, vomiting, headache, hemorrhage and dizziness (>5%). The most common adverse reactions in pediatric patients are infusion site pain, vomiting, nausea, anemia and headache (≥2%).
An integrated analysis of data from ten sponsored clinical studies was performed to assess the safety of CALDOLOR in adults. Overall, 1,752 adult patients have been included in safety and efficacy trials over 11 years; 1,220 of these patients have received CALDOLOR and 532 received either placebo or comparator medication.
N = 1149
N = 452
|Any Adverse Event||691 (60)||384 (85)|
|Nausea||299 (26)||213 (47)|
|Vomiting||109 (9)||64 (14)|
|Constipation||85 (7)||62 (14)|
|Flatulence||77 (7)||44 (10)|
|Pruritus||72 (6)||65 (14)|
|Infusion Site Pain||62 (5)||1 (1)|
|Headache||59 (5)||37 (8)|
|Pyrexia||41 (4)||47 (10)|
|Anemia||50 (4)||23 (5)|
Notes: aExcludes studies NCT01650519 and NCT01901393 where non-serious AEs were not collected. bPercentages less than 1 were rounded to 1.
Abbreviations: N, number
A total of 143 pediatric patients ages 6 months and older have received CALDOLOR in controlled clinical trials. In the pediatric fever study, patients received an average of four doses of CALDOLOR (range 1-23 doses). In the pediatric pain study, patients received a single dose of CALDOLOR prior to a tonsillectomy surgery. The most common adverse reactions (incidence greater than or equal to 2%) in pediatric patients treated with CALDOLOR were infusion site pain, vomiting, nausea, anemia and headache.
The CALDOLOR vial stopper is NOT made with natural rubber latex.
CALDOLOR in vials must be diluted prior to use. Infusion of the drug product in the vial without dilution can cause hemolysis. CALDOLOR in the vial should not be given as an IV bolus or IM injection.1
CALDOLOR is also available in a ready-to-use bag that requires no dilution prior to use. 1
INDICATIONS AND USAGE1
CALDOLOR is indicated in adults and pediatric patients 6 months and older for the:
IMPORTANT DOSAGE AND ADMINISTRATION INSTRUCTIONS1
CALDOLOR Injection 800 mg/8 mL (100 mg/mL) vials must be diluted prior to administration.
CALDOLOR Injection 800 mg/200 mL (4 mg/mL) bags are ready to use and require no dilution prior to use.
Do not exceed 3,200 mg total daily dose in adults. Do not exceed 40 mg/kg or 2,400 mg, whichever is less, total daily dose in pediatric patients less than 17 years of age.
IMPORTANT SAFETY INFORMATION1
CALDOLOR is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to ibuprofen or any components of the drug product, and in patients who have a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients. CALDOLOR is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
WARNINGS AND PRECAUTIONS1
CALDOLOR should be used with caution in patients with known cardiovascular (CV) disease or risk factors for CV disease, a history of peptic ulcer disease and/or GI bleeding, liver disease or symptoms of, hypertension, and heart failure. When used in such patients, attention to using the lowest effective dose for the shortest time period is important to reduce the risk of serious adverse events. Avoid use in pregnant women starting at 30 weeks gestation.
The most common adverse reactions are nausea, flatulence, vomiting, headache, hemorrhage and dizziness (>5%). The most common adverse reactions in pediatric patients are infusion site pain, vomiting, nausea, anemia and headache (≥2%).
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS1
Cardiovascular Thrombotic Events