• Basic Info
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• Clinical Info
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Uses

Consider potential benefits and risks of nabumetone therapy as well as alternative therapies before initiating therapy with the drug. Use lowest effective dosage and shortest duration of therapy consistent with the patient's treatment goals.

Inflammatory Diseases

Symptomatic treatment of osteoarthritis and rheumatoid arthritis.

Dosage and Administration

General

• Consider potential benefits and risks of nabumetone therapy as well as alternative therapies before initiating therapy with the drug.

Administration

Oral Administration

Administer orally once or twice daily without regard to meals.

Dosage

To minimize the potential risk of adverse cardiovascular and/or GI events, use lowest effective dosage and shortest duration of therapy consistent with the patient's treatment goals. Adjust dosage based on individual requirements and response; attempt to titrate to the lowest effective dosage.

Adults

Inflammatory Diseases

Osteoarthritis or Rheumatoid Arthritis

Oral

Initially, 1 g once daily. May increase dosage to 1.5–2 g daily, given as a single daily dose or 2 divided doses.

Patients weighing <50 kg may be less likely to need dosages >1 g daily.

Prescribing Limits

Adults

Inflammatory Diseases

Osteoarthritis or Rheumatoid Arthritis

Oral

Maximum 2 g daily.

Special Populations

Dosage in Renal Impairment

Dosage adjustment not necessary in patients with mild renal impairment (Cl_cr >50 mL/minute).

In patients with moderate renal impairment (Cl_cr 30–49 mL/minute), initiate at ≤750 mg daily (maximum initial dosage is 750 mg daily). Monitor renal function; may increase dosage to 1.5 g daily.

In patients with severe renal impairment (Cl_cr <30 mL/minute), initiate at ≤500 mg daily (maximum inital dosage is 500 mg daily). Monitor renal function; may increase dosage to 1 g daily.

Cautions

Contraindications

• Known hypersensitivity to nabumetone or any ingredient in the formulation.
• History of asthma, urticaria, or other sensitivity reaction precipitated by aspirin or other NSAIAs.
• Treatment of perioperative pain in the setting of CABG surgery.

Warnings/Precautions

Warnings

Cardiovascular Effects

Selective COX-2 inhibitors have been associated with an increased risk of serious adverse cardiovascular thrombotic events in certain situations. Several prototypical NSAIAs also have been associated with an increased risk of cardiovascular events. Current data insufficient to assess risk associated with nabumetone.

Use NSAIAs with caution and careful monitoring (e.g., monitor for development of cardiovascular events), and at the lowest effective dosage for the shortest duration necessary.

Short-term use to relieve acute pain, especially at low dosages, does not appear to be associated with increased risk of serious cardiovascular events (except immediately following CABG surgery).

No consistent evidence that concomitant use of low-dose aspirin mitigates the increased risk of serious adverse cardiovascular events associated with NSAIAs. (See Specific Drugs under Interactions.)

Hypertension and worsening of preexisting hypertension reported; either event may contribute to the increased incidence of cardiovascular events. Use with caution in patients with hypertension; monitor BP. Impaired response to certain diuretics may occur. (See Specific Drugs under Interactions.)

Fluid retention and edema reported. Caution in patients with fluid retention or heart failure.

GI Effects

Serious GI toxicity (e.g., bleeding, ulceration, perforation) can occur with or without warning symptoms; increased risk in those with a history of GI bleeding or ulceration, geriatric patients, smokers, those with alcohol dependence, and those in poor general health.

For patients at high risk for complications from NSAIA-induced GI ulceration (e.g., bleeding, perforation), consider concomitant use of misoprostol; alternatively, consider concomitant use of a proton-pump inhibitor (e.g., omeprazole) or use of an NSAIA that is a selective inhibitor of COX-2 (e.g., celecoxib).

Renal Effects

Direct renal injury, including renal papillary necrosis, reported in patients receiving long-term NSAIA therapy.

Potential for overt renal decompensation. Increased risk of renal toxicity in patients with renal or hepatic impairment or heart failure, in patients with volume depletion, in geriatric patients, and in those receiving a diuretic, ACE inhibitor, or angiotensin II receptor antagonist. (See Renal Impairment under Cautions.)

Sensitivity Reactions

Hypersensitivity Reactions

Anaphylactoid reactions reported.

Immediate medical intervention and discontinuance for anaphylaxis.

Avoid in patients with aspirin triad (aspirin sensitivity, asthma, nasal polyps); caution in patients with asthma.

Dermatologic Reactions

Serious skin reactions (e.g., exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis) reported; can occur without warning. Discontinue at first appearance of rash or any other sign of hypersensitivity (e.g., blisters, fever, pruritus).

Photosensitivity Reactions

Photosensitivity reactions possible.

General Precautions

Hepatic Effects

Severe reactions including jaundice, fatal fulminant hepatitis, liver necrosis, and hepatic failure (sometimes fatal) reported rarely with NSAIAs.

Elevations of serum ALT or AST reported.

Monitor for symptoms and/or signs suggesting liver dysfunction; monitor abnormal liver function test results. Discontinue if signs or symptoms of liver disease or systemic manifestations (e.g., eosinophilia, rash) occur or if liver function test abnormalities persist or worsen.

Hematologic Effects

Anemia reported rarely. Determine hemoglobin concentration or hematocrit in patients receiving long-term therapy if signs or symptoms of anemia occur.

May inhibit platelet aggregation and prolong bleeding time.

Other Precautions

Not a substitute for corticosteroid therapy; not effective in the management of adrenal insufficiency.

May mask certain signs of infection.

Obtain CBC and chemistry profile periodically during long-term use.

Specific Populations

Pregnancy

Category C. Avoid use in third trimester because of possible premature closure of the ductus arteriosus.

Lactation

Active metabolite is distributed into milk in rats; not known whether nabumetone or its metabolites are distributed into milk in humans. Discontinue nursing or the drug.

Pediatric Use

Safety and efficacy not established in children.

Geriatric Use

Caution advised. Safety and efficacy profiles similar to those in younger adults. However, fatal adverse GI effects reported more frequently in geriatric patients than in younger adults.

Hepatic Impairment

Caution advised in patients with severe hepatic impairment, since formation of the active metabolite depends on biotransformation in the liver.

Renal Impairment

Use with caution in patients with renal disease. Use not recommended in patients with advanced renal disease; close monitoring of renal function advised if used.

Dosage adjustments necessary in patients with moderate or severe renal impairment. (See Renal Impairment under Dosage and Administration.)

Oxidized and conjugated metabolites that are excreted in urine may accumulate in patients with renal failure, potentially resulting in adverse effects.

Common Adverse Effects

Abdominal pain, constipation, diarrhea, dizziness, dyspepsia, edema, flatulence, headache, nausea, positive stool guaiac test, pruritus, rash, tinnitus.