Indicated for:

• The relief of the signs and symptoms of rheumatoid arthritis.

• The relief of the signs and symptoms of osteoarthritis.

Dosages greater than 2000 mg per day have not been studied. The lowest effective dose should be used for chronic treatment.

Nabumetone should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients.

Nabumetone is contraindicated In the setting of coronary artery bypass graft (CABG) surgery.

Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs.

Observational studies conducted in the Danish National Registry have demonstrated that patients treated with NSAIDs in the post-MI period were at increased risk of reinfarction, CV-related death, and all-cause mortality beginning in the first week of treatment.

Avoid the use of nabumetone tablets in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If nabumetone tablets are used in patients with a recent MI, monitor patients for signs of cardiac ischemia.

NSAIDs, including nabumetone, can lead to onset of new hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events. Patients taking thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs. NSAIDs, including nabumetone, should be used with caution in patients with hypertension. Blood pressure (BP) should be monitored closely during the initiation of NSAID treatment and throughout the course of therapy.

Fluid retention and edema have been observed in some patients treated with NSAIDs.

Dosage adjustment of nabumetone generally is not necessary in patients with mild renal insufficiency (greater than or equal to 50 mL/min). Caution should be used in prescribing nabumetone to patients with moderate or severe renal insufficiency. The maximum starting doses of nabumetone in patients with moderate or severe renal insufficiency should not exceed 750 mg or 500 mg, respectively once daily. Following careful monitoring of renal function in patients with moderate or severe renal insufficiency, daily doses may be increased to a maximum of 1,500 mg and 1,000 mg, respectively.

Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of an NSAID results in a dose-dependent decrease in prostaglandin synthesis and, secondarily, in a reduction of renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics, and the elderly. Discontinuation of NSAID therapy is typically followed by recovery to the pretreatment state.

As with other NSAIDs, anaphylactoid reactions may occur in patients without known prior exposure to nabumetone. Nabumetone should not be given to patients with the aspirin triad. This symptom complex typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs.

Patients with asthma may have aspirin-sensitive asthma. The use of aspirin in patients with aspirin sensitive asthma has been associated with the severe bronchospasm which can be fatal. Since cross reactivity, including bronchospasm, between aspirin and other nonsteroidal anti-inflammatory drugs has been reported in such aspirin-sensitive patients, nabumetone should not be administered to patients with this form of aspirin sensitivity and should be used with caution in patients with preexisting asthma.

NSAIDs, including nabumetone, can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. These serious events may occur without warning.

NSAIDs should be prescribed with extreme caution in those with a prior history of ulcer disease or gastrointestinal bleeding. Patients with a prior history of peptic ulcer disease and/or gastrointestinal bleeding who use NSAIDs have a greater than 10-fold increased risk for developing a GI bleed compared to patients with neither of these risk factors. Other factors that increase the risk for GI bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAID therapy, smoking, use of alcohol, older age, and poor general health status. Most spontaneous  reports of fatal GI events are in elderly or debilitated patients and therefore, special care should be taken in treating this population.

Anemia is sometimes seen in patients receiving NSAIDs, including nabumetone. This may be due to fluid retention, occult or gross GI blood loss, or an incompletely described effect upon erythropoiesis. Patients on long-term treatment with NSAIDs, including nabumetone, should have their hemoglobin or hematocrit checked if they exhibit any signs or symptoms of anemia.

NSAIDs inhibit platelet aggregation and have been shown to prolong bleeding time in some patients. Unlike aspirin, their effect on platelet function is quantitatively less, of shorter duration, and reversible. Patients receiving nabumetone who may be adversely affected by alterations in platelet function, such as those with coagulation disorders or patients receiving anticoagulants, should be carefully monitored.

Based on ultraviolet (U.V.) light photosensitivity testing, nabumetone may be associated with more reactions to sun exposure than might be expected based on skin tanning types.

The concurrent use of aspirin and an NSAID, such as nabumetone, increases the risk of serious gastrointestinal (GI) events. Concomitant administration of nabumetone and aspirin is not generally recommended because of the potential of increased adverse effects.

Nabumetone cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency.

Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE-inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE-inhibitors.

Clinical studies, as well as post-marketing observations, have shown that nabumetone can reduce the natriuretic effect of furosemide and thiazides in some patients.

NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance.

Caution should be used when NSAIDs are administered concomitantly with methotrexate.

The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious GI bleeding higher than users of either drug alone.

In late pregnancy, as with other NSAIDs, nabumetone should be avoided because it may cause premature closure of the ductus arteriosus.

It is not known whether this drug is excreted in human milk, however 6MNA is excreted in the milk of lactating rats. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from nabumetone, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

GoToSource

• Use in patients under the age of 18. GoToSource

• Primary dysmenorrhea. GoToSource

• Soft tissue injuries. GoToSource

Somnolence, dyspepsia (indigestion), liver injury, peripheral edema (swelling from fluid accumulation in body tissues) and hypersensitivity reactions. GoToSource

Diarrhea and gastrointestinal ulcers. GoToSource

Pseudoporphyria (photosensitivity). GoToSource

Pancreatitis (inflammation of the pancreas). GoToSource

Interstitial nephritis (kidney disorder). GoToSource

Pulmonary fibrosis (scarring of lung tissue). GoToSource

Stevens-johnson syndrome (severe drug reaction). GoToSource

Hypertension (high blood pressure). GoToSource

Gastrointestinal bleeding. GoToSource

Increased risk of heart failure. GoToSource

Lawsuits filed for birth defects and stevens-johnson syndrome.