VYSCOXA

Celecoxib has extensive distribution and high protein binding. It is primarily metabolized by CYP2C9 with a half-life of approximately 11 hours.

AbsorptionFollowing a single dose administration of 200 mg VYSCOXA and 200 mg celecoxib capsules under fasting condition in 52 healthy subjects, the median time to peak plasma levels (i.e.,Tmax) of celecoxib was 1.5 hours (range 0.67 – 8.00 hours) and 2.5 hours (range 1.00 – 8.00 hours), respectively. The overall systemic exposure (AUC) of a 200 mg dos...

The effectiveness of VYSCOXA has been established based on adequate and well-controlled studies of another formulation of celecoxib [see Clinical Pharmacology (12.3) ]. Below is a display of the efficacy results of the adequate and well-controlled studies of celecoxib. 14.1 Osteoarthritis Celecoxib has demonstrated significant reduction in joint pain compared to placebo. Celecoxib was evaluated for treatment of the signs and the symptoms of OA of the knee and hip in placebo- and active-controlled clinical trials of up to 12 weeks duration. In patients with OA, treatment with celecoxib 100 mg ...

The following adverse reactions are discussed in greater detail in other sections of the labeling:

• Cardiovascular Thrombotic Events [see Warnings and Precautions (5.1) ]
• GI Bleeding, Ulceration and Perforation [see Warnings and Precautions (5.2) ]
• Hepatotoxicity [see Warnings and Precautions (5.3) ]
• Hypertension [see Warnings and Precautions (5.4) ]
• Heart Failure and Edema [see Warnings and Precautions (5.5) ]
• Renal Toxicity and Hyperkalemia [ see Warnings and Precautions (5.6) ...

VYSCOXA is contraindicated in the following patients:

• Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to celecoxib, any components of the drug product [see Warnings and Precautions (5.7 , 5.9) ].
• History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs, have b...

• Hepatotoxicity : Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop. ( 5.3 )
• Hypertension : Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure. ( 5.4 , 7 )
• Heart Failure and Edema : Avoid use of VYSCOXA in patients with severe heart failure unless benefits are expected to outwei...

7. DRUG INTERACTIONS See Table 3 for clinically significant drug interactions with celecoxib.

Table 3Clinically Significant Drug Interactions with Celecoxib Drugs That Interfere with Hemostasis Clinical Impact:

• Celecoxib and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of Celecoxib and anticoagulants have an increased risk of serious bleeding compa...