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
Caldolor is approved for the use in pediatric patients 3 months and older. 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 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
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.
- 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.
INDICATIONS AND USAGE1
CALDOLOR is indicated in adults and pediatric patients three 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 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. In pediatric patients 3 months to less than 6 months of age, the dosage is limited to a single dose not to exceed 10 mg/kg or 100 mg, whichever is less.
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%).
CALDOLOR is a registered trademark of Cumberland Pharmaceuticals Inc.
© Cumberland Pharmaceuticals Inc. Nashville TN | WWW1470623 | June 2023