ELYXYB - celecoxib

Warning

Risk of serious cardiovascular and gastrointestinal events

Contraindications

• Known hypersensitivity to celecoxib or sulfonamides
• History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs
• Severe, sometimes fatal, anaphylactic reactions to NSAIDs
• In the setting of CABG surgery

Adverse Reactions

• Cardiovascular thrombotic events
• Gastrointestinal bleeding, ulceration, and perforation
• Hepatotoxicity
• Hypertension
• Heart failure and edema
• Renal toxicity and hyperkalemia
• Anaphylactic reactions
• Serious skin reactions
• Hematologic toxicity

General Guidance

Reduce daily dose by 50% in patients with moderate hepatic impairment, and consider dose reduction in patients who are poor metabolizers of CYP2C9 substrates

Pregnancy

• Use of NSAIDs, including celecoxib, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios
• Avoid use of celecoxib in patients at about 30 weeks gestation and later in pregnancy

Nursing Mothers

• Celecoxib is excreted in human milk, and caution should be exercised when administering celecoxib to nursing women

Pediatric Use

• Celecoxib is approved for relief of the signs and symptoms of Juvenile Rheumatoid Arthritis in patients 2 years and older
• Safety and efficacy have not been studied beyond six months in children

Geriatric Use

• Elderly patients, compared to younger patients, are at greater risk for NSAID-associated serious cardiovascular, gastrointestinal, and/or renal adverse reactions
• Start dosing at the low end of the dosing range, and monitor patients for adverse effects