Indicated for OA, RA, AS, AP, primary dysmenorrhea and LBP¹

CELEBREX^® Indications

As the cardiovascular (CV) risks of Celecoxib may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used.

CELEBREX^® is an (NSAID) with anti-inflammatory, analgesic, and antipyretic activities¹

CELEBREX^® Mode of Action

CELEBREX^® is a non-steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic, and antipyretic activities¹

At therapeutic concentrations, CELEBREX^® does not inhibit cyclooxygenase-1 (COX-1)¹

• Unlike ns-NSAIDs, CELEBREX^® spares the beneficial functions of COX-1, e.g., gastric cytoprotection and platelet aggregation^2,3
• Like ns-NSAIDs, CELEBREX^® mediates its antipyretic, anti-inflammatory and analgesic effects by inhibiting COX-2^1,2

Chronic OA pain:

Effective relief of osteoarthritis (OA) pain within 24-48 hours¹

CELEBREX^®: Powerful and sustained control of pain and inflammation throughout 12 weeks^2*

CELEBREX^® 100 mg twice daily (BID) (n=197) demonstrated significant improvement in pain, physical function and joint stiffness, similar to naproxen 500 mg BID (n=198), as early as week 2 in patients with OA of the knee.²

*A 12-week, prospective, randomized, double-blind, parallel-group study to compare the efficacy and safety of CELEBREX^® 50 mg, 100 mg, and 200 mg BID with naproxen 500 mg BID or placebo in patients with OA of the knee. Primary endpoints were patients’ global assessment of arthritic condition, patients’ assessment of pain on a VAS, and physicians’ global assessment of arthritic condition. The secondary endpoint was the WOMAC score, a multidimensional, disease-specific, self-administered health status measure assessing pain, stiffness, and physical function in patients with OA. Range of possible scores is 0-96. The range of possible scores for physical functioning is 0-68.²

BID: twice a day; NSAIDs: non-steroidal anti-inflammatory drugs; VAS: visual analog scale; WOMAC: The Western Ontario and McMaster Universities Osteoarthritis Index.

Acute pain:

CELEBREX^® acted as early as 22 minutes

(median onset is about 30 minutes; range 22–33 minutes)^3*

Powerful Pain Relief⁴

CELEBREX^® 200 mg twice daily (BID) (n=147) demonstrated significant improvement in ankle pain (visual analog scale [VAS] on weight bearing)^† vs placebo (n=141)^‡, similar to ibuprofen 800 mg three times daily (TID) (n=155)^4‡

CELEBREX^® was shown to be non-inferior to ibuprofen at all time points.^4§

† Patients rated their ankle pain on a 100 mm VAS from 0 (no pain) to 100 (most severe pain).

‡ p<0.05 CELEBREX^® vs placebo.

§ The upper limit of the 95% confidence interval (CI) did not exceed the pre-defined limit of 20 mm.

CELEBREX^® also demonstrated control of pain and inflammation in:¹

• Rheumatoid arthritis

• Ankylosing spondylitis

CELEBREX^® demonstrated a lower incidence of clinically significant GI AEs^1,2

CELEBREX^® Safety and Tolerability

Consider CELEBREX^® for its superior GI tolerability profile in the elderly.³

Elderly patients experience better GI tolerability^§ with CELEBREX^® than naproxen, ibuprofen, or diclofenac.³

• Significantly fewer CELEBREX^® patients ≥65 years (4.0%) discontinued due to any GI AEs vs ibuprofen (7.3%, p<0.05 vs CELEBREX^®) or naproxen (8.1%, p<0.0001 vs CELEBREX^®)³

• No statistically significant difference in discontinuation rates between CELEBREX^® and diclofenac (4.2%, p=ns vs CELEBREX^®)³

§ GI intolerability was defined as the combined incidence of the 5 most common GI AEs: dyspepsia, abdominal pain, diarrhea, nausea, constipation or flatulence.³

The CELEBREX^® GI advantage

CELEBREX^® is the only COX-2 selective NSAID that demonstrated a lower incidence of clinically significant GI AEs vs ns-NSAIDS, with or without PPI.^1,2*†

Demonstrated 4X lower risk of clinically significant GI AEs vs ns-NSAIDs+PPI^2†

Demonstrated ~2X lower risk of clinically significant GI AEs vs ns-NSAIDs.^1*

* A double-blind, triple-dummy, parallel-group randomized trial.¹

† A prospective, randomized, open-label, blinded endpoint (PROBE).²

Established with Robust Evidence

In the large PRECISION study, CELEBREX^® demonstrated a similar incidence of CV events compared to naproxen or ibuprofen.^4‡

Although CELEBREX^® was associated with fewer APTC events, there was not a statistically significant difference between treatment arms.⁴

‡ PRECISION was a randomized, double-blind, parallel-group non-inferiority study evaluating the cardiovascular safety of CELEBREX^® and prescription strength naproxen or ibuprofen in 24,081 osteoarthritis or rheumatoid arthritis patients with, or at high risk for cardiovascular disease, who required daily NSAID treatment to maintain their quality of life. The primary endpoint (adjudicated) was the first occurrence of an APTC endpoint, defined as a composite of cardiovascular death (including hemorrhagic death), nonfatal myocardial infarction, or nonfatal stroke. To demonstrate non-inferiority, all four of the following criteria had to be met: in the intent-to-treat analysis, (i) the point estimate of the HR had to be ≤1.12 and (ii) the upper bound of the 97.5% CI for the HR had to be ≤1.33, and in the on-treatment analysis, (iii) the point estimate of the HR had to be ≤1.12 and (iv) the upper bound of the 97.5% CI for the HR had to be ≤1.40. The protocol pre-specified a minimum follow-up time of 18 months, with censoring of data from event-free patients after 30 months in the intent-to-treat population and after 43 months in the on- treatment population.⁴

APTC: Antiplatelet Trialists Collaboration; BID: twice daily; CI: confidence interval; CV: cardiovascular; HR: hazard ratio; NI: non-inferiority; NSAID: non-steroidal anti-inflammatory drug; QD: once daily; TID: three times daily.

CELEBREX^® is recommended by international guidelines for the management of pain in OA patients at increased GI risk, COX-2 selective NSAIDs are recommended for reduced GI toxicity.^5-8

EULAR: European Alliance of Associations for Rheumatology; Osteoarthritis Research Society International, OARSI: Osteoarthritis Research Society International

CELEBREX^® capsules, at doses up to 200 mg twice per day, can be taken with or without food¹. 

Symptomatic Treatment of Osteoarthritis (OA):

The recommended dose of celecoxib is 200 mg administered as a single dose or as 100 mg twice per day.¹

Symptomatic Relief in the Treatment of Rheumatoid Arthritis (RA):

The recommended daily dose of celecoxib is 100 mg or 200 mg twice per day.¹

Ankylosing Spondylitis (AS):

The recommended dose of celecoxib is 200 mg administered as a single dose or as 100 mg twice per day.¹

Management of Acute Pain in Adults:

The recommended dose of celecoxib is 400 mg, initially, followed by an additional 200 mg dose, if needed on the first day. On subsequent days, the recommended dose is 200 mg twice daily, as needed.¹

Management of Chronic Low Back Pain in Adults:

The recommended dose of celecoxib is 200 or 400 mg daily, administered as a 200 mg single dose, or as 100 or 200 mg twice per day. Some patients may benefit from a total daily dose of 400 mg.¹

Treatment of Primary Dysmenorrhea:

The recommended dose of celecoxib is 400 mg, initially, followed by an additional 200 mg dose, if needed on the first day. On subsequent days, the recommended dose is 200 mg twice daily, as needed.¹

* As the cardiovascular (CV) risks of CELEBREX^® may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used.¹

CELEBREX^® is recommended in International Guidelines for the management of pain ^1-3

Treatment modalities for the management of OA⁴

• A comprehensive plan for the management of OA requires a patient-centered, multimodal and multidisciplinary approach.⁵
• As OA spans decades of a patient’s life, treatment is likely to consist of different pharmaceutical and nonpharmaceutical interventions, often in combination.⁵
• CELEBREX^® is recommended in International Guidelines for the management of pain in patients with OA at an increased GI risk.^1-3

Diagnosis assessments, treatment options, as well as general information about OA

A fictional OA patient case, focusing on diagnosis assessments, treatment options, as well as general information about OA^1-11

Introduces patients to OA

Introduces patients to osteoarthritis with definitions, facts, and diagrams. It will help patients understand the condition, including its symptoms, most commonly affected joints, and treatment options. Patients are encouraged to work with their doctor to find a treatment that works well for them.^1-9

Educates patients on what OA is and gives advice on how to effectively communicate with their doctor

• Details how patients can self-manage their OA with non-pharmacological options^1-7
• Educates patients on what OA is and gives advice on how to effectively communicate with their doctor^1-7

Overview about OA including the causes, treatments and impacts on patient quality of life^1-9

• Overview about OA including the causes, treatments and impacts on patient quality of life^1-9
• Based on an infographic designed by the Osteoarthritis Research Society International (OARSI)^1-9

CELEBREX

Contents: Celecoxib Indications: Symptomatic treatment of osteoarthritis (OA) and rheumatoid arthritis (RA). Management of acute pain in adults and chronic low back pain. Primary dysmenorrhoea. Relief of signs and symptoms of ankylosing spondylitis (AS). Dosage: Adult OA 200 mg as a single dose or 100 mg twice daily. RA 100 or 200 mg twice daily. AS 200 mg as a single dose or 100 mg twice daily. Maximum (OA, RA, AS): 400 mg. Acute pain and primary dysmenorrhoea Initially 400 mg followed by 200 mg if needed on the first day. Subsequently, 200 mg twice daily as needed. Chronic low back pain 200 or 400 mg daily, administered as a 200 mg single dose or 100 or 200 mg twice daily. Total daily dose: 400 mg/day. Administration: Doses up to 200 mg twice daily can be taken with or without food. For patients with difficulty swallowing, the entire contents of the capsule can be carefully emptied onto a level teaspoon of cool/room temp applesauce/rice gruel/yogurt/mashed banana and should be ingested immediately with water. Contraindications: Hypersensitivity to celecoxib or sulfonamides. Active peptic ulceration or gastrointestinal (GI) bleeding. Patients who have experienced asthma, urticaria or allergic-type reactions after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs) including other cyclooxygenase-2 (COX-2) specific inhibitors. Treatment of peri-operative pain in the setting of coronary bypass graft (CABG) surgery. Congestive heart failure (CHF) (NYHA II-IV); established ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease.Special Precautions: Increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction (MI) and stroke. Monitor blood pressure during initiation and throughout the course of therapy in patients with hypertension (HTN); preexisting CHF, edema or other conditions predisposing to or worsened by fluid retention including those taking diuretics or otherwise at risk of hypovolemia. Risk of developing GI complications in patients with CV disease, concomitant use with glucocorticoids, antiplatelet drugs (such as aspirin) or other NSAIDs, alcohol; history of active GI disease eg, ulceration, GI bleeding or inflammatory conditions; concurrent therapy with anticoagulants including warfarin/coumarin-type and novel oral anticoagulants (eg, apixaban, dabigatran and rivaroxaban). Dehydration. Closely monitor patients with advanced renal disease. Severe hepatic impairment. Anaphylactoid reactions. Serious skin reactions, some of them fatal, including drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of celecoxib. Discontinue at the first appearance of skin rash, mucosal lesions or any other signs of hypersensitivity. Galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Avoid concomitant use with non-aspirin NSAIDs. Pregnancy and lactation. Children less than 18 years. Elderly. Adverse Reactions: Bronchitis, sinusitis, upper respiratory tract infection, urinary tract infection; insomnia; dizziness; HTN (including aggravated HTN); cough; vomiting, abdominal pain, diarrhea, dyspepsia, flatulence; pruritus (including generalized pruritus), rash; peripheral oedema; ear and fungal infection, MI, angina pectoris; dyspnea, increased hepatic enzyme; muscle spasms; nephrolithiasis, vaginal haemorrhage, prostatitis, benign prostatic hyperplasia; increased blood creatinine, prostatic specific antigen and weight. Drug Interactions: Increased plasma concentration with CYP2C9 inhibitors, fluconazole and ketoconazole. Decreased plasma concentration with CYP2C9 inducers eg, rifampicin, carbamazepine and barbiturates. Increased risk of bleeding with oral anticoagulants. May diminish antihypertensive effects of angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, diuretics and beta-blockers. Increased risk of nephrotoxicity with cyclosporine. Increased plasma concentration of dextromethorphan and metoprolol. Reduced natriuretic effect of furosemide and thiazides. Increased plasma levels of lithium. Presentation and Packing: Capsule 200 mg x 10's, 30's, 100's. 400 mg x 10's. Pregnancy Safety (US): C, D (in third trimester or near delivery)

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