Select therapeutic use:

Arthritis/rheumatic disorders:

Indications for: CELEBREX

Osteoarthritis (OA). Rheumatoid arthritis (RA). Ankylosing spondylitis (AS). Juvenile rheumatoid arthritis (JRA).

Clinical Trials:

Osteoarthritis (OA)

  • The efficacy of Celebrex was evaluated for the treatment of the signs/symptoms of OA of the knee and hip in placebo- and active-controlled trial of up to 12 weeks duration. Celebrex 100mg twice daily or 200mg once daily achieved improvement in WOMAC osteoarthritis index, a composite of pain, stiffness, and functional measures in OA.

  • In three 12-week studies of pain accompanying OA flare, Celebrex 100mg twice daily and 200mg twice daily achieved pain reduction within 24 to 48 hours of initiation.

  • Celebrex 100mg twice daily or 200mg twice daily was similar in efficacy to that of naproxen 500mg twice daily. There was no benefit seen with Celebrex 200mg twice daily compared to 100mg twice daily.

Rheumatoid Arthritis

  • In placebo- and active-controlled trials of up to 24 weeks duration, Celebrex achieved significant reduction in joint tenderness/pain and joint swelling compared with placebo using the ACR20 Responder Index. Celebrex 100mg twice daily or 200mg twice daily was similar in efficacy to that of naproxen 500mg twice daily. Overall efficacy was similar between Celebrex 100mg twice daily and 200mg twice daily, but some patients had additional benefit from the 200mg twice daily dose.

Juvenile Rheumatoid Arthritis (NCT00652925)

  • The efficacy of Celebrex was evaluated in a 12-week, randomized, double-blind active-controlled, parallel-group, multicenter, non-inferiority study in patients 2 to 17 years of age with pauciarticular, polyarticular course JRA or systemic onset JRA.

  • Patients received either: celecoxib 3 mg/kg (to a maximum of 150 mg) twice daily; celecoxib 6 mg/kg (to a maximum of 300 mg) twice daily; or naproxen 7.5 mg/kg (to a maximum of 500 mg) twice daily.

  • The JRA DOI 30 response rates at week 12 were: 69% for celecoxib 3mg/kg twice daily; 80% for celecoxib 6mg/kg twice daily; and 67% for naproxen 7.5mg/kg twice daily.

  • The safety and efficacy has not been established beyond 6 months in children. The long-term cardiovascular toxicity in children exposed to Celebrex has not been evaluated and it is unknown if long-term risks may be similar to that seen in adults exposed to Celebrex or other COX-2 selective and nonselective NSAIDs.

Ankylosing Spondylitis

  • The efficacy of Celebrex was evaluated in 2 placebo- and active-controlled trials of 6 and 12 weeks duration. 

  • Celebrex 100mg twice daily, 200mg once daily, and 400mg once daily achieved superiority to placebo in these studies for all 3 co-primary efficacy measures assessing global pain intensity (Visual Analogue Scale), global disease activity (Visual Analogue Scale) and functional impairment (Bath Ankylosing Spondylitis Functional Index).

  • There was no difference in improvement between the 200mg and 400mg Celebrex doses in the 12-week study, but a greater proportion of patients treated with Celebrex 400mg responded vs 200mg using the ASAS 20 (53% vs 44%, respectively).

  • Responder analysis also showed no change in the responder rates beyond 6 weeks.

Cardiovascular Outcomes Trial: Prospective Randomized Evaluation of Celecoxib Integrated Safety vs. Ibuprofen Or Naproxen (PRECISION; NCT00346216)

  • PRECISION was a long-term non-inferiority trial of 24,081 OA and RA patients designed to assess the cardiovascular safety of celecoxib vs. prescription strength doses of ibuprofen and naproxen. 

  • Results showed that the primary endpoint of CV death, non-fatal myocardial infarction (MI) or non-fatal stroke occurred in 2.3% of celecoxib (100–200mg twice daily) treated individuals compared to 2.5% of the naproxen (375–500mg twice daily) and 2.7% of ibuprofen (600–800mg three times a day) treated individuals. Additionally, the celecoxib group had less serious gastrointestinal events (1.1%) compared to the naproxen (1.5%) and ibuprofen (1.6%) group. 

Adult Dosage:

Use lowest effective dose for shortest duration. ≥18yrs: OA: 200mg once daily or 100mg twice daily. RA: 100–200mg twice daily. AS: 200mg in 1–2 divided doses; if no response after 6 weeks, 400mg once daily may be tried. <50kg: start at lowest recommended dose. Moderate hepatic impairment, CYP2C9 poor metabolizers: reduce dose by 50%.

Children Dosage:

<2yrs or <10kg: not studied. Use lowest effective dose for shortest duration. May sprinkle capsule contents into applesauce. See full labeling. JRA: ≥2yrs (≥10kg to ≤25kg): 50mg twice daily; (>25kg): 100mg twice daily. CYP2C9 poor metabolizers: consider alternatives.

CELEBREX Contraindications:

Sulfonamide, aspirin or other NSAID allergy. Coronary artery bypass graft surgery.

Boxed Warning:

Risk of serious cardiovascular and gastrointestinal events.

CELEBREX Warnings/Precautions:

Increased risk of serious cardiovascular events (including MI, stroke). Avoid in recent MI, severe heart failure; if necessary, monitor. Increased risk of serious GI adverse events (including inflammation, bleeding, ulceration, perforation). History of ulcer disease and/or GI bleeding. Hypertension; monitor BP closely. Discontinue if signs/symptoms of liver or renal disease develop, or if abnormal liver function tests persist or worsen. Severe hepatic or severe renal impairment: not recommended. Dehydration. Hypovolemia. Hyperkalemia. Coagulation disorders. Monitor CBCs, blood chemistry, hepatic, renal, and ocular function in long-term therapy. Pre-existing asthma. Discontinue at 1st sign of skin rash or any other hypersensitivity. May mask signs of infection or fever. Elderly. Debilitated. Labor & delivery. May be associated with a reversible delay in ovulation in females of reproductive potential. Pregnancy (avoid during ≥30 weeks gestation): increased risk of premature closure of the fetal ductus arteriosus; (20–30 weeks gestation): may cause fetal renal dysfunction/oligohydramnios; if treatment needed, limit dose and duration of use. Nursing mothers.

CELEBREX Classification:

NSAID (COX-2 inhibitor).

CELEBREX Interactions:

Avoid concomitant aspirin, salicylates (eg, diflunisal, salsalate) or other NSAIDs. Increased risk of GI bleed with anticoagulants, antiplatelets, oral corticosteroids, SSRIs, SNRIs, smoking, alcohol, or prolonged NSAID therapy; monitor. May antagonize, or increase risk of renal failure with diuretics (eg, loop or thiazide), ACE inhibitors (eg, captopril), ARBs (eg, losartan), or β-blockers; monitor closely. Potentiates digoxin; monitor levels. May potentiate lithium, methotrexate, cyclosporine; monitor for toxicity. Concomitant with pemetrexed may increase risk of pemetrexed-associated myelosuppression, renal, and GI toxicity. Caution with CYP2C9 inhibitors (eg, fluconazole), CYP2C9 inducers (eg, rifampin), or drugs that are metabolized by CYP2D6 (eg, atomoxetine).

Adverse Reactions:

Abdominal pain, diarrhea, dyspepsia, flatulence, peripheral edema, accidental injury, dizziness, pharyngitis, rhinitis, sinusitis, upper RTI; cardiovascular thrombotic events, GI ulcer/bleed, hepatotoxicity, renal toxicity, hypertension, anaphylaxis, anemia, serious skin reactions (eg, erythema multiforme, exfoliative dermatitis, SJS, TEN, DRESS, AGEP); also children: headache, fever, cough.

Metabolism:

Hepatic (CYP2C9). 

Drug Elimination:

  • Half-life: 11.2 hours.

  • Eliminated predominantly by hepatic metabolism.

  • Fecal (57%), renal (27%).

  • Plasma clearance: ~500 mL/min.

Generic Drug Availability:

YES

How Supplied:

Caps 100mg, 200mg—100, 500; 50mg, 400mg—60

Dysmenorrhea:

Indications for: CELEBREX

Dysmenorrhea.

Clinical Trials:

Analgesia, including Primary Dysmenorrhea

  • Celebrex achieved pain relief in acute analgesic models of post-oral surgery pain, post-orthopedic surgical pain, and primary dysmenorrhea.

  • Single doses of Celebrex achieved pain relief within 60 minutes.

Adult Dosage:

Use lowest effective dose for shortest duration. ≥18yrs: 400mg once then 200mg more on 1st day if needed, then 200mg twice daily. <50kg: start at lowest recommended dose. Moderate hepatic impairment, CYP2C9 poor metabolizers: reduce dose by 50%.

Children Dosage:

<18yrs: not recommended.

CELEBREX Contraindications:

Sulfonamide, aspirin or other NSAID allergy. Coronary artery bypass graft surgery.

Boxed Warning:

Risk of serious cardiovascular and gastrointestinal events.

CELEBREX Warnings/Precautions:

Increased risk of serious cardiovascular events (including MI, stroke). Avoid in recent MI, severe heart failure; if necessary, monitor. Increased risk of serious GI adverse events (including inflammation, bleeding, ulceration, perforation). History of ulcer disease and/or GI bleeding. Hypertension; monitor BP closely. Discontinue if signs/symptoms of liver or renal disease develop, or if abnormal liver function tests persist or worsen. Severe hepatic or severe renal impairment: not recommended. Dehydration. Hypovolemia. Hyperkalemia. Coagulation disorders. Monitor CBCs, blood chemistry, hepatic, renal, and ocular function in long-term therapy. Pre-existing asthma. Discontinue at 1st sign of skin rash or any other hypersensitivity. May mask signs of infection or fever. Elderly. Debilitated. Labor & delivery. May be associated with a reversible delay in ovulation in females of reproductive potential. Pregnancy (avoid during ≥30 weeks gestation): increased risk of premature closure of the fetal ductus arteriosus; (20–30 weeks gestation): may cause fetal renal dysfunction/oligohydramnios; if treatment needed, limit dose and duration of use. Nursing mothers.

CELEBREX Classification:

NSAID (COX-2 inhibitor).

CELEBREX Interactions:

Avoid concomitant aspirin, salicylates (eg, diflunisal, salsalate) or other NSAIDs. Increased risk of GI bleed with anticoagulants, antiplatelets, oral corticosteroids, SSRIs, SNRIs, smoking, alcohol, or prolonged NSAID therapy; monitor. May antagonize, or increase risk of renal failure with diuretics (eg, loop or thiazide), ACE inhibitors (eg, captopril), ARBs (eg, losartan), or β-blockers; monitor closely. Potentiates digoxin; monitor levels. May potentiate lithium, methotrexate, cyclosporine; monitor for toxicity. Concomitant with pemetrexed may increase risk of pemetrexed-associated myelosuppression, renal, and GI toxicity. Caution with CYP2C9 inhibitors (eg, fluconazole), CYP2C9 inducers (eg, rifampin), or drugs that are metabolized by CYP2D6 (eg, atomoxetine).

Adverse Reactions:

Abdominal pain, diarrhea, dyspepsia, flatulence, peripheral edema, accidental injury, dizziness, pharyngitis, rhinitis, sinusitis, upper RTI; cardiovascular thrombotic events, GI ulcer/bleed, hepatotoxicity, renal toxicity, hypertension, anaphylaxis, anemia, serious skin reactions (eg, erythema multiforme, exfoliative dermatitis, SJS, TEN, DRESS, AGEP).

Metabolism:

Hepatic (CYP2C9). 

Drug Elimination:

  • Half-life: 11.2 hours.

  • Eliminated predominantly by hepatic metabolism.

  • Fecal (57%), renal (27%).

  • Plasma clearance: ~500 mL/min.

Generic Drug Availability:

YES

How Supplied:

Caps 100mg, 200mg—100, 500; 50mg, 400mg—60

Nonnarcotic analgesics:

Indications for: CELEBREX

Acute pain.

Clinical Trials:

Osteoarthritis (OA)

  • The efficacy of Celebrex was evaluated for the treatment of the signs/symptoms of OA of the knee and hip in placebo- and active-controlled trial of up to 12 weeks duration. Celebrex 100mg twice daily or 200mg once daily achieved improvement in WOMAC osteoarthritis index, a composite of pain, stiffness, and functional measures in OA.

  • In three 12-week studies of pain accompanying OA flare, Celebrex 100mg twice daily and 200mg twice daily achieved pain reduction within 24 to 48 hours of initiation.

  • Celebrex 100mg twice daily or 200mg twice daily was similar in efficacy to that of naproxen 500mg twice daily. There was no benefit seen with Celebrex 200mg twice daily compared to 100mg twice daily.

Rheumatoid Arthritis

  • In placebo- and active-controlled trials of up to 24 weeks duration, Celebrex achieved significant reduction in joint tenderness/pain and joint swelling compared with placebo using the ACR20 Responder Index. Celebrex 100mg twice daily or 200mg twice daily was similar in efficacy to that of naproxen 500mg twice daily. Overall efficacy was similar between Celebrex 100mg twice daily and 200mg twice daily, but some patients had additional benefit from the 200mg twice daily dose.

Juvenile Rheumatoid Arthritis (NCT00652925)

  • The efficacy of Celebrex was evaluated in a 12-week, randomized, double-blind active-controlled, parallel-group, multicenter, non-inferiority study in patients 2 to 17 years of age with pauciarticular, polyarticular course JRA or systemic onset JRA.

  • Patients received either: celecoxib 3 mg/kg (to a maximum of 150 mg) twice daily; celecoxib 6 mg/kg (to a maximum of 300 mg) twice daily; or naproxen 7.5 mg/kg (to a maximum of 500 mg) twice daily.

  • The JRA DOI 30 response rates at week 12 were: 69% for celecoxib 3mg/kg twice daily; 80% for celecoxib 6mg/kg twice daily; and 67% for naproxen 7.5mg/kg twice daily.

  • The safety and efficacy has not been established beyond 6 months in children. The long-term cardiovascular toxicity in children exposed to Celebrex has not been evaluated and it is unknown if long-term risks may be similar to that seen in adults exposed to Celebrex or other COX-2 selective and nonselective NSAIDs.

Ankylosing Spondylitis

  • The efficacy of Celebrex was evaluated in 2 placebo- and active-controlled trials of 6 and 12 weeks duration. 

  • Celebrex 100mg twice daily, 200mg once daily, and 400mg once daily achieved superiority to placebo in these studies for all 3 co-primary efficacy measures assessing global pain intensity (Visual Analogue Scale), global disease activity (Visual Analogue Scale) and functional impairment (Bath Ankylosing Spondylitis Functional Index).

  • There was no difference in improvement between the 200mg and 400mg Celebrex doses in the 12-week study, but a greater proportion of patients treated with Celebrex 400mg responded vs 200mg using the ASAS 20 (53% vs 44%, respectively).

  • Responder analysis also showed no change in the responder rates beyond 6 weeks.

Cardiovascular Outcomes Trial: Prospective Randomized Evaluation of Celecoxib Integrated Safety vs. Ibuprofen Or Naproxen (PRECISION; NCT00346216)

  • PRECISION was a long-term non-inferiority trial of 24,081 OA and RA patients designed to assess the cardiovascular safety of celecoxib vs. prescription strength doses of ibuprofen and naproxen. 

  • Results showed that the primary endpoint of CV death, non-fatal myocardial infarction (MI) or non-fatal stroke occurred in 2.3% of celecoxib (100–200mg twice daily) treated individuals compared to 2.5% of the naproxen (375–500mg twice daily) and 2.7% of ibuprofen (600–800mg three times a day) treated individuals. Additionally, the celecoxib group had less serious gastrointestinal events (1.1%) compared to the naproxen (1.5%) and ibuprofen (1.6%) group. 

Adult Dosage:

Use lowest effective dose for shortest duration. ≥18yrs: 400mg once then 200mg more on 1st day if needed, then 200mg twice daily. <50kg: start at lowest recommended dose. Moderate hepatic impairment, CYP2C9 poor metabolizers: reduce dose by 50%.

Children Dosage:

<18yrs: not recommended.

CELEBREX Contraindications:

Sulfonamide, aspirin or other NSAID allergy. Coronary artery bypass graft surgery.

Boxed Warning:

Risk of serious cardiovascular and gastrointestinal events.

CELEBREX Warnings/Precautions:

Increased risk of serious cardiovascular events (including MI, stroke). Avoid in recent MI, severe heart failure; if necessary, monitor. Increased risk of serious GI adverse events (including inflammation, bleeding, ulceration, perforation). History of ulcer disease and/or GI bleeding. Hypertension; monitor BP closely. Discontinue if signs/symptoms of liver or renal disease develop, or if abnormal liver function tests persist or worsen. Severe hepatic or severe renal impairment: not recommended. Dehydration. Hypovolemia. Hyperkalemia. Coagulation disorders. Monitor CBCs, blood chemistry, hepatic, renal, and ocular function in long-term therapy. Pre-existing asthma. Discontinue at 1st sign of skin rash or any other hypersensitivity. May mask signs of infection or fever. Elderly. Debilitated. Labor & delivery. May be associated with a reversible delay in ovulation in females of reproductive potential. Pregnancy (avoid during ≥30 weeks gestation): increased risk of premature closure of the fetal ductus arteriosus; (20–30 weeks gestation): may cause fetal renal dysfunction/oligohydramnios; if treatment needed, limit dose and duration of use. Nursing mothers.

CELEBREX Classification:

NSAID (COX-2 inhibitor).

CELEBREX Interactions:

Avoid concomitant aspirin, salicylates (eg, diflunisal, salsalate) or other NSAIDs. Increased risk of GI bleed with anticoagulants, antiplatelets, oral corticosteroids, SSRIs, SNRIs, smoking, alcohol, or prolonged NSAID therapy; monitor. May antagonize, or increase risk of renal failure with diuretics (eg, loop or thiazide), ACE inhibitors (eg, captopril), ARBs (eg, losartan), or β-blockers; monitor closely. Potentiates digoxin; monitor levels. May potentiate lithium, methotrexate, cyclosporine; monitor for toxicity. Concomitant with pemetrexed may increase risk of pemetrexed-associated myelosuppression, renal, and GI toxicity. Caution with CYP2C9 inhibitors (eg, fluconazole), CYP2C9 inducers (eg, rifampin), or drugs that are metabolized by CYP2D6 (eg, atomoxetine).

Adverse Reactions:

Abdominal pain, diarrhea, dyspepsia, flatulence, peripheral edema, accidental injury, dizziness, pharyngitis, rhinitis, sinusitis, upper RTI; cardiovascular thrombotic events, GI ulcer/bleed, hepatotoxicity, renal toxicity, hypertension, anaphylaxis, anemia, serious skin reactions (eg, erythema multiforme, exfoliative dermatitis, SJS, TEN, DRESS, AGEP).

Metabolism:

Hepatic (CYP2C9). 

Drug Elimination:

  • Half-life: 11.2 hours.

  • Eliminated predominantly by hepatic metabolism.

  • Fecal (57%), renal (27%).

  • Plasma clearance: ~500 mL/min.

Generic Drug Availability:

YES

How Supplied:

Caps 100mg, 200mg—100, 500; 50mg, 400mg—60