Myox Special Precautions

General: If any organ system functions deteriorate during treatment with etoricoxib, discontinuation of treatment should be considered and appropriate measures should be taken.
Cardiovascular Effects: Cardiovascular Thrombotic Events: Clinical trials using selective COX-2 inhibitors such as etoricoxib have shown an increased risk of serious cardiovascular (CV) thrombotic events, especially MI and stroke, compared to placebo and some NSAIDs. The lowest effective daily dose of etoricoxib should be used for the shortest duration possible to minimize the potential risk for an adverse CV event. Patients receiving long term treatment with etoricoxib should be reviewed regularly (e.g., every three months) with regards to efficacy, risk factors, and need for treatment, especially in patients with osteoarthritis.
Patients with known CV disease, history of atherosclerotic CV disease, or significant risk factors for CV events (e.g., hypertension, hyperlipidemia, diabetes mellitus, a first-degree relative with ischemic heart disease, cardiac failure, smoking) should be treated with etoricoxib with caution only after careful consideration of the patient's overall risk and potential risks and benefits of alternative analgesic therapies. Physicians and patients should be alert throughout the entire treatment course to observe the development of such events, even in the absence of previous CV symptoms. Patients should be informed on the signs and/or symptoms of serious CV events and the steps to take if they occur. Medically appropriate supervision should be maintained when using etoricoxib in patients with heart failure.
Two large, controlled, clinical trials of different COX-2 selective inhibitors for the treatment of pain found an increased incidence of MI and stroke in the first 10 to 14 days following CABG surgery. In the absence of comparable data with etoricoxib, it may be assumed that patients at high risk of cardiovascular disease (including patients with diabetes, hyperlipidemia, hypertension, or smokers) who are undergoing any major surgery may face an increased risk of developing a cardiovascular event.
Etoricoxib is not a substitute for aspirin for cardiovascular prophylaxis because of its lack of antiplatelet effect. Antiplatelet therapies should not be discontinued.
Fluid retention and Edema: As with other NSAIDs, etoricoxib is associated with new onset or recurrent congestive heart failure. Fluid retention and edema have been also observed in etoricoxib-treated patients due to its prostaglandin synthesis inhibition.
Etoricoxib should be used with caution in patients with a history of cardiac failure, left ventricular dysfunction, or hypertension, and in patients with pre-existing edema due to other reasons. These high-risk patients should be closely monitored during etoricoxib therapy. If there is a clinical evidence of deterioration in the condition of these patients, appropriate measures should be taken, including treatment discontinuation.
Hypertension: Etoricoxib is associated with more frequent and severe hypertension compared to some other NSAIDs and selective COX-2 inhibitors, particularly at high doses. Therefore, hypertension should be controlled before starting treatment with etoricoxib. Blood pressure should be strictly monitored two weeks after treatment initiation and periodically thereafter. If blood pressure increases significantly, alternative treatment should be considered.
Gastrointestinal Effects: Etoricoxib may cause upper gastrointestinal (GI) complications (such as perforations, ulcers, or bleeding), some of which are fatal. These events can occur any time of the treatment, even without warning symptoms. Although the likelihood of developing a serious GI event increases during the course of treatment, short-term etoricoxib therapy is not without risk. In addition, the risk of GI adverse effects is further increased when etoricoxib is coadministered with aspirin, even at low doses. NSAIDs are also known to exacerbate inflammatory bowel disease associated with spondyloarthropathies.
Etoricoxib should be used with caution in the elderly, patients with concomitant NSAID or aspirin therapy, or patients with a prior history of GI diseases, since they are at higher risk of developing a GI complication. Patients should be informed of the signs and/or symptoms of serious GI toxicity and the steps to take if they occur.
Renal Effects: Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Renal prostaglandins may play a compensatory role in the maintaining renal perfusion. Therefore, under conditions of compromised renal blood perfusion, etoricoxib may cause a reduction in prostaglandin formation and, subsequently, renal blood flow and thereby impair renal function. Patients at highest risk of this response are those with pre-existing significant renal function impairment, uncompensated renal failure, or cirrhosis. Monitoring of renal function should be considered in these patients.
Etoricoxib should be used with caution in patients with considerable dehydration. Patients should be rehydrated prior to starting therapy with etoricoxib.
Advanced renal disease: Since the clinical experience in patients with advanced renal disease (CrCl <30 mL/min) is very limited, the use of etoricoxib in these patients is not recommended.
Hepatic Effects: Elevations of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) (approximately three or more times the upper limit of normal) have been reported in approximately 1% of patients in clinical trials treated for up to one year with etoricoxib 30 mg, 60 mg, and 90 mg daily.
There have been rare reports of jaundice during post-marketing experience. While there are limited reports of hepatic failure, it was not clear if these reactions were associated with etoricoxib.
Physician and patients must be alert for hepatotoxicity. Physicians must inform their patients on the warning signs and symptoms of hepatotoxicity. Patients with symptoms and/or signs indicating liver dysfunction (e.g., nausea, fatigue, pruritus, jaundice, abdominal tenderness in the right upper quadrant, and "flu-like" symptoms), or in whom an abnormal liver function test has occurred, should be monitored and evaluated.
If clinical signs and symptoms consistent with hepatic insufficiency develop, or if abnormal liver enzyme tests persist (approximately three or more times the upper limit of normal), treatment with etoricoxib should be discontinued immediately.
Hypersensitivity Reactions: Serious hypersensitivity reactions such as anaphylaxis and angioedema have been reported in patients treated with etoricoxib. Etoricoxib therapy should be discontinued at the first appearance of signs of hypersensitivity.
Etoricoxib should be used with caution in patients who have previous acute asthmatic attacks, urticaria, or rhinitis precipitated by salicylates or non-selective COX inhibitors. Since the pathophysiology of these reactions is unknown, physicians must weigh the potential benefits and risks of prescribing etoricoxib in these patients.
Serious Skin Reactions: Serious skin reactions, some of which are fatal, including exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), have been very rarely reported with the use of NSAIDs and some selective COX-2 inhibitors during post-marketing surveillance. These serious events may occur without warning. Some selective COX-2 inhibitors have been associated with increased risk of skin reactions in patients with history of any drug allergy. Patients appear to be at a higher risk during the early phase of treatment; majority of the cases have an onset within the first month of treatment. Etoricoxib therapy should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Hematologic Effects: NSAIDs may increase the risk of bleeding events. Etoricoxib should be used with caution in patients with co-morbid conditions such as coagulation disorders or concomitant use of drugs that increase the risk of bleeding (see Interactions). Signs of bleeding should be monitored during treatment.
Masking of Fever and Inflammation: Due to its anti-inflammatory and antipyretic effects, etoricoxib may mask fever and other usual signs and symptoms of infection. The physician should be aware of this when using etoricoxib in patients being treated for infection.
Patients with Renal or Hepatic Impairment: Etoricoxib should be used with caution in patients with renal and/or hepatic impairment. Medically appropriate supervision should be conducted during treatment. If these patients deteriorate during treatment, appropriate measures should be taken, including treatment discontinuation.
Effects on Ability to Drive and Use Machines: Although there are no studies have been conducted on the effect of etoricoxib on the ability to drive or use machines, patients who experience dizziness, vertigo, or somnolence while taking etoricoxib should not drive or operate machinery.
Use in Pregnancy & Lactation: Effects on Sexual Function and Fertility: As with any medicinal product that inhibits COX/prostaglandin synthesis, the use of etoricoxib is not recommended in women attempting to conceive.
Use in Children: The safety and effectiveness of etoricoxib in pediatric patients have not been established. Etoricoxib is contraindicated in children and adolescents under 16 years of age.
Use in the Elderly: A higher incidence of adverse experiences was observed in older patients compared to younger patients receiving etoricoxib. Greater sensitivity of some patients cannot be ruled out. Elderly patients should be treated with caution and should be medically supervised during etoricoxib treatment.