ZORVOLEX is indicated for:
- Management of mild to moderate acute pain
- Management of osteoarthritis pain
Important Safety Information About Zorvolex
Cardiovascular Thrombotic EventsNonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.
ZORVOLEX is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
Gastrointestinal Bleeding, Ulceration, and PerforationNSAIDs cause an increased risk of serious gastrointestinal (GI) 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 and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.
ZORVOLEX is contraindicated in the following patients:
- a known hypersensitivity to diclofenac or any components of the drug
- a 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 coronary artery bypass graft (CABG) surgery
Warnings and Precautions
Post-MI Patients: Avoid the use of ZORVOLEX in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. Monitor these patients for signs of cardiac ischemia.
Hepatotoxicity: Elevation of one or more liver tests may occur during therapy with NSAIDs including ZORVOLEX. Rare, sometimes fatal, cases of severe hepatic injury have been reported. Inform patients of the warning signs and symptoms of hepatotoxicity. Discontinue immediately if clinical signs and symptoms of liver disease develop.
Hypertension: NSAIDs, including ZORVOLEX, can lead to the new onset or worsening of existing hypertension, either of which may contribute to the increased incidence of CV events. Monitor blood pressure during treatment with ZORVOLEX.
Heart Failure and Edema: Avoid use of ZORVOLEX in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure. If ZORVOLEX is used in patients with severe heart failure, monitor patients for signs of worsening heart failure.
Renal Toxicity and Hyperkalemia: Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Avoid the use of ZORVOLEX in patients with advanced renal disease unless the benefits are expected to outweigh the risk. Monitor for signs of worsening renal function.
Anaphylactic Reactions: Anaphylactic reactions may occur in patients taking diclofenac or those with or without a known hypersensitivity to ZORVOLEX and in patients with aspirin-sensitive asthma. Seek emergency help if an anaphylactic reaction occurs.
Serious Skin Reactions: NSAIDs can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Discontinue ZORVOLEX if rash or other signs of local skin reaction occur.
Premature Closure of Fetal Ductus Arteriosus: Starting at 30 weeks of gestation, ZORVOLEX and other NSAIDs should be avoided by pregnant women as premature closure of the ductus arteriosus in the fetus may occur.
Hematologic Toxicity: Anemia has occurred in patients treated with NSAIDs. Monitor hemoglobin or hematocrit in patients showing symptoms of anemia. ZORVOLEX may increase the risk of bleeding.
Most common adverse reactions (incidence ≥2%) in clinical trials with ZORVOLEX include: edema, nausea, headache, dizziness, vomiting, constipation, pruritus, diarrhea, flatulence, pain in extremity, abdominal pain, sinusitis, alanine aminotransferase increased, blood creatinine increased, hypertension, and dyspepsia.
Drugs that Interfere with Hemostasis (e.g. warfarin, aspirin, SSRIs/SNRIs): Monitor patients for bleeding who are concomitantly taking ZORVOLEX with drugs that interfere with hemostasis. Concomitant use of ZORVOLEX and analgesic dose of aspirin is not generally recommended.
ACE Inhibitors, Angiotensin Receptor Blockers (ARB), or Beta Blockers: Concomitant use with ZORVOLEX may diminish the antihypertensive effect of these drugs. Monitor blood pressure.
ACE Inhibitors and ARBs: Concomitant use with ZORVOLEX in the elderly, volume depleted, or those with renal impairment may result in deterioration of renal function. In such high-risk patients, monitor for signs of worsening renal function.
Diuretics: NSAIDs can reduce the natriuretic effect of furosemide and thiazide diuretics. Monitor patients to assure diuretic efficacy including antihypertensive effects.
Digoxin: Concomitant use with ZORVOLEX can increase serum concentration and prolong half-life of digoxin levels.
Use in Specific Populations
Pregnancy: Use of NSAIDs during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs in pregnant women starting at 30 weeks of gestation.
Infertility: NSAIDs are associated with reversible infertility. Consider withdrawal of ZORVOLEX in women who have difficulties conceiving.
Please see full Prescribing Information including Boxed Warning and Medication Guide.
To report SUSPECTED ADVERSE REACTIONS, contact Zyla Life Sciences at 1-800-518-1084 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.