CALDOLOR®

Adverse Reactions

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%).

Integrated Safety Analysis, Adult Patients9

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.

The most common (≥5%) adverse events experienced by adult patients (18 – 92 years) receiving intravenous ibuprofen or placebo in Phase 2 through 4 studiesa

  IV Ibuprofen
N = 1149
N (%)b
Placebo
N = 452
N (%)
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

Safety, Pediatrics

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.

 Latex Statement

The CALDOLOR vial stopper is NOT made with natural rubber latex.

CALDOLOR must be diluted prior to use. Infusion of the drug product without dilution can cause hemolysis. CALDOLOR should not be given as an IV bolus or IM injection.1

INDICATIONS AND USAGE1
CALDOLOR is indicated in adults and pediatric patients 6 months and older for the:

  • Management of mild to moderate pain and the management of moderate to severe pain as an adjunct to opioid analgesics
  • Reduction of fever

IMPORTANT DOSAGE AND ADMINISTRATION INSTRUCTIONS1
CALDOLOR must be diluted prior to administration.
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
CONTRAINDICATIONS
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.

ADVERSE REACTIONS1
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

  • Non-steroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.
  • CALDOLOR is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
Gastrointestinal Bleeding, Ulceration and Performation
  • NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

PLEASE SEE FULL PRESCRIBING INFORMATION INCLUDING BOXED WARNING