ZORVOLEX™ is a nonsteroidal anti-inflammatory drug (NSAID) indicated for treatment of mild to moderate acute pain in adults.
ZORVOLEX™ is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.
NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events.
ZORVOLEX™ is contraindicated in patients with: a known hypersensitivity to diclofenac or its inactive ingredients; a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.
ZORVOLEX™ should be used at the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
Elevation of one or more liver tests may occur during therapy with ZORVOLEX™. Physicians should measure transaminases (ALT and AST) periodically in patients receiving long-term therapy with ZORVOLEX™. ZORVOLEX™ should be discontinued immediately if abnormal liver tests persist or worsen.
NSAIDs, including ZORVOLEX™, can lead to the new onset or worsening of existing hypertension, which may contribute to the increased incidence of cardiovascular events. Blood pressure should be monitored closely during treatment with ZORVOLEX™. NSAIDs may diminish the antihypertensive activity of thiazides, loop diuretics, ACE inhibitors and angiotensin II antagonists.
Fluid retention and edema have been observed in some patients taking NSAIDs. ZORVOLEX™ should be used with caution in patients with fluid retention or heart failure.
Long-term administration of NSAIDs can result in renal papillary necrosis and other renal injury. ZORVOLEX™ should be used with caution in patients at greatest risk of this reaction, including the elderly, those with impaired renal function, heart failure, liver dysfunction, and those taking diuretics and ACE inhibitors. Treatment with ZORVOLEX™ in patients with advanced renal disease is not recommended.
Anaphylactoid reactions may occur in patients with the aspirin triad or in patients without prior exposure to ZORVOLEX™ and should be discontinued immediately if an anaphylactoid reaction occurs.
NSAIDs can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. ZORVOLEX™ should be discontinued if rash or other signs of local skin reaction occur.
Starting at 30 weeks’ gestation, ZORVOLEX™ and other NSAIDs should be avoided by pregnant women as premature closure of the ductus arteriosus in the fetus may occur.
Concomitant administration of diclofenac and aspirin or anticoagulants is not generally recommended because of the risk of increased GI bleeding higher than users of either drug alone.
Most common adverse reactions in clinical trials (incidence ≥2%) include: edema, nausea, headache, dizziness, vomiting, constipation, pruritus, flatulence, pain in extremity, and dyspepsia.
ZORVOLEX™ capsules do not result in an equivalent systemic exposure to diclofenac as other oral formulations. Therefore, do not substitute similar dosing strengths of other diclofenac products for ZORVOLEX™.
Please see full Prescribing Information for additional important safety and dosing information.
SoluMatrix Fine Particle Technology™ is a trademark of iCeutica Inc., and is licensed to Iroko for exclusive use in NSAIDs.
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Patients must present their card to the pharmacist along with their prescription to participate in this program. Card valid at participating pharmacies only. If patients have any questions regarding their eligibility or benefits, or if they wish to discontinue their participation, they can call the ZORVOLEX™ co-pay card program at 1-877-264-2440 (8:00 AM-8:00 PM EST, Monday-Friday). When patients use this card, they are certifying that they are 18 years of age or older; they understand the program rules, regulations, and terms and conditions; and they agree to comply with all program requirements. Patients are not eligible if their prescription is covered by any state or federally funded program, including but not limited to any state pharmaceutical assistance program, Medicare (Part D or otherwise), Medicaid, Medigap, VA or DOD, or TriCare; if patients are Medicare eligible and enrolled in an employer-sponsored health plan or prescription benefit program for retirees; or if their insurance plan is paying the entire cost of this prescription. Void outside the US and its territories or where prohibited by law, taxed, or restricted. This card is not health insurance. Patients’ acceptance of this offer must be consistent with the terms of any drug benefit provided by their health insurer. Patients agree to report the use of this card to their insurer if required.