VYSCOXA is indicated
In adults for the management of the signs and symptoms of:
• Osteoarthritis
• Rheumatoid Arthritis
• Ankylosing Spondylitis
In pediatric patients two years of age and older for the management of the signs and symptoms of:
Juvenile Rheumatoid Arthritis
Limitations of Use
VYSCOXA must be administered on an empty stomach at least 2 hours before or 1 hour after food. Taking VYSCOXA with food results in plasma exposures of celecoxib up to 50% higher than intended. If patients cannot tolerate VYSCOXA in the fasted state, discontinue use of VYSCOXA.
VYSCOXA is NOT indicated for the management of acute pain or treatment of primary dysmenorrhea.
Carefully consider the potential benefits and risks of VYSCOXA and other treatment options before deciding to use VYSCOXA. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.
The maximum single dose of VYSCOXA is 200 mg (20 mL). Administering more than 200 mg (20 mL) in a single dose of the VYXCOXA suspension may result in higher than intended plasma concentrations of celecoxib. In patients requiring a single dose greater than 200 mg (20 mL), use a different product.
VYSCOXA must be taken on an empty stomach at least 2 hours before or 1 hour after food.
For patients who cannot tolerate dosing with VYSCOXA on an empty stomach, discontinue the use of this product. Do not advise the patient to take VYSCOXA with food.
For OA, the dosage is 200 mg (20 mL) per day administered as a single dose or as 100 mg (10 mL) twice daily.
For RA, the dosage is 100 mg (10 mL) to 200 mg (20 mL) twice daily.
For AS, the dosage is 200 mg (20 mL) daily in single (once per day) dose or 100 mg (10 mL) twice daily. If no effect is observed after 6 weeks, a trial of 200 mg (20 mL) twice daily may be worthwhile. If no effect is observed after 6 weeks on 200 mg (20 mL) twice daily, a response is not likely and consideration should be given to alternate treatment options.
For JRA, the dosage for pediatric patients (age 2 years and older) is based on weight. For patients weighing 10 kg to 25 kg the recommended dose is 50 mg (5 mL) twice daily. For patients greater than 25 kg the recommended dose is 100 mg (10 mL) twice daily.
Hepatic Impairment
In patients with moderate hepatic impairment (Child-Pugh Class B), reduce the dose by 50%. The use of VYSCOXA in patients with severe hepatic impairment is not recommended.
Poor Metabolizers of CYP2C9 Substrates
In adult patients who are known or suspected to be poor CYP2C9 metabolizers based on genotype or previous history/experience with other CYP2C9 substrates (such as warfarin, phenytoin), initiate treatment with half of the lowest recommended dose.
In patients with JRA who are known or suspected to be poor CYP2C9 metabolizers, consider using alternative treatments.
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.
•History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs, have been reported in such patients.
•In the setting of CABG surgery.
•In patients who have demonstrated allergic-type reactions to sulfonamides.
Before taking VYSCOXA tell your healthcare provider about all of your medical conditions, including if you:
•have heart problems
•have bleeding problems
•have had ulcers
•have liver or kidney problems
•have high blood pressure
•have asthma•are pregnant or plan to become pregnant. Taking VYSCOXA at about 20 weeks of pregnancy or later may harm your unborn baby. If you need to take VYSCOXA for more than 2 days when you are between 20 and 30 weeks of pregnancy, your healthcare provider may need to monitor the amount of fluid in your womb around your baby. You should not take VYSCOXA after about 30 weeks of pregnancy.
•are breastfeeding or plan to breastfeed. Talk to your healthcare provider about the best way to feed your baby during treatment with VYSCOXA.
Full Prescribing Information: DailyMed
