FLECTOR (diclofenac)

FLECTOR (diclofenac)

SELF ADMINISTRATION - TOPICAL

Indication for Prior Authorization:

Treatment of acute pain due to minor strains, sprains, and contusions

Coverage Criteria:

• Diagnosis of minor strain, sprain, or contusion, AND
• Patient is 18 years of age or older, AND
• Patient has tried and failed 2 preferred oral prescription nonsteroidal anti-inflammatory drugs (NSAIDs), AND
• Patient has tried and failed diclofenac 1% gel

Dosing:

Apply 1 patch twice daily to most painful area

Coverage Duration:

1 month

Authorization is Not Covered for the Following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics Committee.

Additional Information:

• Flector® Patch is contraindicated in the following patients:
  • Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product
  • 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
  • Use on non-intact or damaged skin resulting from any etiology, including exudative dermatitis, eczema, infection lesions, burns or wounds
• Cardiovascular Thrombotic Events (black box warning): 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
• Gastrointestinal Bleeding, Ulceration, and Perforation (black box warning): NSAIDs, including diclofenac, cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the esophagus, stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs
• Hepatotoxicity: Physicians should measure transaminases at baseline and periodically in patients receiving long-term therapy with diclofenac, because severe hepatotoxicity may develop without a prodrome of distinguishing symptoms.  Severe hepatic reactions can occur at any time during treatment with diclofenac
• Hypertension: NSAIDs, including Flector®, can lead to new onset of hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events
• Heart Failure and Edema: Avoid the use of Flector® in patients with severe heart failure unless the benefits are expected to outweigh the risk of worsening heart failure. If Flector® 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. Increases in serum potassium concentration, including hyperkalemia, have been reported with use of NSAIDs, even in some patients without renal impairment
• Serious Skin Reactions: NSAIDs, including diclofenac, can cause serious skin adverse reactions such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal
• Premature Closure of Fetal Ductus Arteriosus: Diclofenac may cause premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including Flector®, in pregnant women starting at 30 weeks' gestation (third trimester)
• Hematologic Toxicity: Anemia has occurred in NSAID-treated patients
• Masking of Inflammation and Fever
• Accidental Exposure in Children: Even a used Flector® contains a large amount of diclofenac epolamine (as much as 170 mg). The potential therefore exists for a small child or pet to suffer serious adverse effects from chewing or ingesting a new or used Flector®. It is important for patients to store and dispose of Flector® out of the reach of children and pets
• Eye Exposure: Avoid contact of Flector® with eyes and mucosa. Advise patients that if eye contact occurs, immediately wash out the eye with water or saline and consult a physician if irritation persists for more than an hour
• Oral Nonsteroidal Anti-inflammatory Drugs: Concomitant use of oral and topical NSAIDs may result in a higher rate of hemorrhage, more frequent abnormal creatinine, urea and hemoglobin. Do not use combination therapy with Flector® and an oral NSAID unless the benefit outweighs the risk

Review History: 

• 10/12/20- Annual review, updated format
• 6/5/17- Criteria reviewed

References:

• Flector [package insert]. New York (NY): Pfizer Inc.; 2019.