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Celecoxib) Capsules, for Oral Use Initial U.S

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Celecoxib) Capsules, for Oral Use Initial U.S HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ------------------------WARNINGS AND PRECAUTIONS------------------------­ CELEBREX safely and effectively. See full prescribing information • Hepatotoxicity: Inform patients of warning signs and symptoms of for CELEBREX. hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop (5.3) CELEBREX ® (celecoxib) capsules, for oral use Initial U.S. Approval: 1998 • Hypertension: Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. WARNING: RISK OF SERIOUS CARDIOVASCULAR AND Monitor blood pressure (5.4, 7) GASTROINTESTINAL EVENTS • Heart Failure and Edema: Avoid use of CELEBREX in patients with See full prescribing information for complete boxed warning. severe heart failure unless benefits are expected to outweigh risk of worsening heart failure (5.5) • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an • increased risk of serious cardiovascular thrombotic events, Renal Toxicity: Monitor renal function in patients with renal or hepatic including myocardial infarction and stroke, which can be fatal. impairment, heart failure, dehydration, or hypovolemia. Avoid use of This risk may occur early in the treatment and may increase CELEBREX in patients with advanced renal disease unless benefits are with duration of use. (5.1) expected to outweigh risk of worsening renal function (5.6) • CELEBREX is contraindicated in the setting of coronary artery • Anaphylactic Reactions: Seek emergency help if an anaphylactic bypass graft (CABG) surgery. (4, 5.1) reaction occurs (5.7) • Exacerbation of Asthma Related to Aspirin Sensitivity: CELEBREX is • NSAIDs cause an increased risk of serious gastrointestinal contraindicated in patients with aspirin-sensitive asthma. Monitor (GI) adverse events including bleeding, ulceration, and patients with preexisting asthma (without aspirin sensitivity) (5.8) perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without • Serious Skin Reactions: Discontinue CELEBREX at first appearance of warning symptoms. Elderly patients and patients with a prior skin rash or other signs of hypersensitivity (5.9) history of peptic ulcer disease and/or GI bleeding are at • Premature Closure of Fetal Ductus Arteriosus: Avoid use in pregnant greater risk for serious GI events. (5.2) women starting at 30 weeks of gestation (5.10, 8.1) • Hematologic Toxicity: Monitor hemoglobin or hematocrit in patients with -----------------------------RECENT MAJOR CHANGES---------------------------­ any signs or symptoms of anemia (5.11, 7) Warnings and Precautions (5.1, 5.4) 6/2018 -----------------------------ADVERSE REACTIONS---------------------------­ -----------------------------INDICATIONS AND USAGE----------------------------­ Most common adverse reactions in arthritis trials (>2% and CELEBREX is a nonsteroidal anti-inflammatory drug indicated for: >placebo) are: abdominal pain, diarrhea, dyspepsia, flatulence, • Osteoarthritis (OA) (1.1) peripheral edema, accidental injury, dizziness, pharyngitis, rhinitis, • Rheumatoid Arthritis (RA) (1.2) sinusitis, upper respiratory tract infection, rash (6.1). • Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older (1.3) • Ankylosing Spondylitis (AS) (1.4) To report SUSPECTED ADVERSE REACTIONS, contact • Acute Pain (AP) (1.5) Pfizer at 1-800-438-1985 or FDA at 1-800-FDA-1088 or • Primary Dysmenorrhea (PD) (1.6) www.fda.gov/medwatch -----------------------DOSAGE AND ADMINISTRATION--------------------------­ ---------------------------DRUG INTERACTIONS-------------------------­ • • Use the lowest effective dosage for shortest duration consistent Drugs that Interfere with Hemostasis (e.g. warfarin, aspirin, with individual patient treatment goals (2.1) SSRIs/SNRIs): Monitor patients for bleeding who are concomitantly taking CELEBREX with drugs that interfere with hemostasis. Concomitant • OA: 200 mg once daily or 100 mg twice daily (2.2, 14.1) use of CELEBREX and analgesic doses of aspirin is not generally • RA: 100 to 200 mg twice daily (2.3, 14.2) recommended (7) • JRA: 50 mg twice daily in patients 10-25 kg. 100 mg twice daily in patients more than 25 kg (2.4, 14.3) • ACE Inhibitors, Angiotensin Receptor Blockers (ARB), or Beta- • AS: 200 mg once daily single dose or 100 mg twice daily. If no effect is Blockers: Concomitant use with CELEBREX may diminish the observed after 6 weeks, a trial of 400 mg (single or divided doses) may antihypertensive effect of these drugs. Monitor blood pressure (7) be of benefit (2.5, 14.4) • ACE Inhibitors and ARBs: Concomitant use with CELEBREX in • AP and PD: 400 mg initially, followed by 200 mg dose if needed on first elderly, volume depleted, or those with renal impairment may result in day. On subsequent days, 200 mg twice daily as needed (2.6, 14.5) deterioration of renal function. In such high risk patients, monitor for signs of worsening renal function (7) Hepatic Impairment: Reduce daily dose by 50% in patients with moderate hepatic impairment (Child-Pugh Class B). (2.7, 8.6, 12.3) • Diuretics: NSAIDs can reduce natriuretic effect of furosemide and thiazide diuretics. Monitor patients to assure diuretic efficacy including Poor Metabolizers of CYP2C9 Substrates: Consider a dose reduction by antihypertensive effects (7) 50% (or alternative management for JRA) in patients who are known or • Digoxin: Concomitant use with CELEBREX can increase serum suspected to be CYP2C9 poor metabolizers, (2.7, 8.8, 12.3). concentration and prolong half-life of digoxin. Monitor serum digoxin levels (7) ----------------------DOSAGE FORMS AND STRENGTHS---------------------­ CELEBREX (celecoxib) capsules: 50 mg, 100 mg, 200 mg and 400 mg (3) --------------------USE IN SPECIFIC POPULATIONS-----------------­ • Pregnancy: Use of NSAIDs during the third trimester of pregnancy -------------------------------CONTRAINDICATIONS--------------------------------­ increases the risk of premature closure of the fetal ductus arteriosus. • Known hypersensitivity to celecoxib, or any components of the drug Avoid use of NSAIDs in pregnant women starting at 30 weeks of product or sulfonamides (4) gestation (5.10, 8.1) • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs (4) • Infertility: NSAIDs are associated with reversible infertility. Consider • In the setting of CABG surgery (4) withdrawal of CELEBREX in women who have difficulties conceiving (8.3) See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. Revised: 6/2018 Reference ID: 4284129 FULL PRESCRIBING INFORMATION: CONTENTS* 8.5 Geriatric Use 8.6 Hepatic Insufficiency WARNING: RISK OF SERIOUS CARDIOVASCULAR AND 8.7 Renal Insufficiency GASTROINTESTINAL EVENTS 8.8 Poor Metabolizers of CYP2C9 Substrates 1. INDICATIONS AND USAGE 10. OVERDOSAGE 1.1 Osteoarthritis 1.2 Rheumatoid Arthritis 11. DESCRIPTION 1.3 Juvenile Rheumatoid Arthritis 12. CLINICAL PHARMACOLOGY 1.4 Ankylosing Spondylitis 12.1 Mechanism of Action 1.5 Acute Pain 12.2 Pharmacodynamics 1.6 Primary Dysmenorrhea 12.3 Pharmacokinetics 2. DOSAGE AND ADMINISTRATION 12.5 Pharmacogenomics 2.1 General Dosing Instructions 13. NONCLINICAL TOXICOLOGY 2.2 Osteoarthritis 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 2.3 Rheumatoid Arthritis 13.2 Animal Toxicology 2.4 Juvenile Rheumatoid Arthritis 2.5 Ankylosing Spondylitis 14. CLINICAL STUDIES 2.6 Management of Acute Pain and Treatment of Primary 14.1 Osteoarthritis Dysmenorrhea 14.2 Rheumatoid Arthritis 2.7 Special Populations 14.3 Juvenile Rheumatoid Arthritis 14.4 Ankylosing Spondylitis 3. DOSAGE FORMS AND STRENGTHS 14.5 Analgesia, Including Primary Dysmenorrhea 4. CONTRAINDICATIONS 14.6 Cardiovascular Outcomes Trial 5. WARNINGS AND PRECAUTIONS 14.7 Special Studies 5.1 Cardiovascular Thrombotic Events 16. HOW SUPPLIED/STORAGE AND HANDLING 5.2 Gastrointestinal Bleeding, Ulceration, and Perforation 5.3 Hepatotoxicity 17. PATIENT COUNSELING INFORMATION 5.4 Hypertension * Sections or subsections omitted from the full prescribing information 5.5 Heart Failure and Edema are not listed. 5.6 Renal Toxicity and Hyperkalemia 5.7 Anaphylactic Reactions 5.8 Exacerbation of Asthma Related to Aspirin Sensitivity 5.9 Serious Skin Reactions 5.10 Premature Closure of Fetal Ductus Arteriosus 5.11 Hematologic Toxicity 5.12 Masking of Inflammation and Fever 5.13 Laboratory Monitoring 5.14 Disseminated Intravascular Coagulation (DIC) 6. ADVERSE REACTIONS 6.1 Clinical Trials Experience 6.2 Postmarketing Experience 7. DRUG INTERACTIONS 8. USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Lactation 8.3 Females and Males of Reproductive Potential 8.4 Pediatric Use Reference ID: 4284129 FULL PRESCRIBING INFORMATION WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Thrombotic Events • Nonsteroidal 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 the treatment and may increase with duration of use. [see Warnings and Precautions (5.1)] • CELEBREX is contraindicated in the setting of coronary artery bypass graft (CABG) surgery. [see Contraindications (4) and Warnings and Precautions (5.1)] Gastrointestinal Bleeding, Ulceration, and Perforation • NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse
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