What is the recommended course of Vimovo (esomeprazole/naproxen) for a patient with Juvenile Idiopathic Arthritis (JIA)?

From the Guidelines

Vimovo (esomeprazole/naproxen) is not recommended for patients with Juvenile Idiopathic Arthritis (JIA). While naproxen alone is commonly used for JIA at doses of 10-20 mg/kg/day divided twice daily, Vimovo is specifically approved only for adults and is not indicated for pediatric patients. The fixed combination contains 375 mg or 500 mg of naproxen with 20 mg esomeprazole, which makes appropriate pediatric dosing impossible. According to the 2019 American College of Rheumatology guideline for the treatment of JIA, NSAIDs are conditionally recommended as adjunct therapy 1. However, the guideline does not specifically address the use of Vimovo in JIA patients. For children with JIA requiring an NSAID with gastroprotection, the better approach is to prescribe separate medications with appropriate pediatric dosing of both the anti-inflammatory agent and gastroprotective agent, as recommended in the guideline 1. This allows for proper weight-based dosing of naproxen while providing gastric protection if needed. The adult formulation of Vimovo could lead to inappropriate dosing in children, potentially causing adverse effects or inadequate treatment of the underlying condition.

Key Considerations

• The use of NSAIDs, including naproxen, is conditionally recommended as adjunct therapy in JIA patients 1
• The guideline recommends using methotrexate as the first-line DMARD, with conditional recommendations for other DMARDs and biologics 1
• Separate medications with appropriate pediatric dosing are recommended for children with JIA requiring an NSAID with gastroprotection
• The adult formulation of Vimovo is not suitable for pediatric patients due to the fixed combination of naproxen and esomeprazole.

Treatment Approach

• For JIA patients requiring an NSAID, naproxen can be used at doses of 10-20 mg/kg/day divided twice daily
• Gastroprotection can be provided using a separate medication, such as esomeprazole, with appropriate pediatric dosing
• The treatment approach should be individualized based on the patient's disease activity, risk factors, and response to therapy, as recommended in the guideline 1.

From the FDA Drug Label

The recommended total daily dose of naproxen is approximately 10 mg/kg given in 2 divided doses (i.e., 5 mg/kg given twice a day). The recommended course of Vimovo (esomeprazole/naproxen) for a patient with Juvenile Idiopathic Arthritis (JIA) is approximately 10 mg/kg of naproxen per day, given in 2 divided doses.

• The dose should be adjusted based on the individual patient's response to the medication.
• It is recommended to use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
• Naproxen tablets are not well suited to this dosage, so use of naproxen oral suspension is recommended for this indication 2.

From the Research

Vimovo Course for JIA Patients

The recommended course of Vimovo (esomeprazole/naproxen) for a patient with Juvenile Idiopathic Arthritis (JIA) can be based on the following evidence:

• A 6-month study 3 on adolescent patients with JIA showed that fixed-dose naproxen/esomeprazole was well-tolerated and effective in improving JIA signs and symptoms.
• The study 3 used doses of naproxen/esomeprazole based on baseline weight, but the exact dosing regimen is not specified.

Key Considerations

When considering the use of Vimovo for JIA patients, the following points should be taken into account:

• The safety and efficacy of esomeprazole in reducing the risk of gastric ulcers associated with NSAID use have been established in several studies 4, 5, 6.
• A pharmacokinetic study 7 showed that a combination of 500 mg of naproxen and 20 mg of esomeprazole was bioequivalent to a reference formulation and was well-tolerated in healthy men.
• The NASA/SPACE studies 6 demonstrated the efficacy and tolerability of esomeprazole in managing upper gastrointestinal symptoms in patients who require NSAIDs.

Dosage and Administration

While the exact dosing regimen for Vimovo in JIA patients is not specified, the following general guidelines can be considered:

• The dose of naproxen/esomeprazole should be based on the patient's weight and medical condition.
• The patient should be monitored regularly for signs and symptoms of JIA, as well as for potential adverse effects of the medication.
• The use of Vimovo should be considered as part of a comprehensive treatment plan for JIA, which may include other medications and therapies.