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Important Safety Information

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Important Safety Information

Important Safety Information and Indications

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

Cardiovascular Thrombotic Events

  • Non-steroidal anti-inflammatory drugs (NSAIDs) cause an increase in the risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction, and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.
  • DYLOJECT is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal Bleeding, Ulceration, and Perforation

  • NSAIDs 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.

Use DYLOJECT at the lowest daily dose for the shortest duration possible to minimize risk of CV, GI and hepatic adverse events.

Contraindications

  • DYLOJECT is contraindicated in patients with:
    • Known hypersensitivity to diclofenac or any components of the drug product.
    • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.
    • In the setting of CABG surgery.
    • Moderate to severe renal insufficiency in the perioperative period and who are at risk for volume depletion.

Warnings and Precautions

  • Hepatotoxicity: Elevations of ALT or AST have been reported in patients with NSAIDS. In addition rare, sometimes fatal, cases of severe hepatic injury including fulminant hepatitis, liver necrosis, and hepatic failure have been reported. Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen, or if clinical signs and symptoms of liver disease develop. Exercise caution when prescribing DYLOJECT with concomitant drugs that are known to be potentially hepatotoxic (e.g. acetaminophen, antibiotics, anti-epileptics).
  • Hypertension: NSAIDs can lead to new onset of hypertension or worsening of preexisting hypertension, which may contribute to the increased incidence of CV events. Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure.
  • Heart Failure and Edema: NSAID use increased the risk of MI, hospitalization for heart failure, and death. Avoid use of DYLOJECT in patients with severe heart failure unless the benefits are expected to outweigh the risk of worsening heart failure. If DYLOJECT is used in patients with severe heart failure, monitor patients for signs of worsening heart failure.
  • Post MI Patients: Avoid the use of DYLOJECT in patients with recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If DYLOJECT is used in these patients, monitor for signs of cardiac ischemia.
  • Renal Toxicity: Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. DYLOJECT is not recommended in patients with moderate to severe renal insufficiency and is contraindicated in patients with moderate to severe renal insufficiency in the perioperative period and who are at risk for volume depletion. Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of DYLOJECT in patients with advanced renal disease unless the benefits are expected to outweigh the risk of worsening renal function.
  • Anaphylactic Reactions: Diclofenac has been associated with anaphylactic reactions in patients with and without known hypersensitivity to diclofenac and in patients with aspirin-sensitive asthma. Seek emergency help if an anaphylactic reaction occurs.
  • Exacerbation of Asthma Related to Aspirin Sensitivity: DYLOJECT is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity).
  • Serious Skin Reactions: NSAIDs, including diclofenac, can cause serious skin reactions, including exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal and can occur without warning. Discontinue DYLOJECT at first appearance of skin rash or other signs of hypersensitivity.
  • Hematologic Toxicity: Anemia has occurred in NSAID-treated patients. Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia. NSAIDs, including DYLOJECT, may increase the risk of bleeding events. Monitor patients for signs of bleeding.

Drug Interactions

  • Drugs that Interfere with Hemostasis (e.g. warfarin, aspirin, SSRIs/SNRIs): Monitor patients for bleeding who are concomitantly taking DYLOJECT with drugs that interfere with hemostasis. Concomitant use of DYLOJECT and analgesic doses of aspirin is not generally recommended.
  • ACE Inhibitors, Angiotensin Receptor Blockers (ARB), or Betablockers: Concomitant use with DYLOJECT may diminish the antihypertensive effect of these drugs. Monitor blood pressure.
  • ACE Inhibitors and ARBs: Concomitant use with DYLOJECT in 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 natriuretic effect of furosemide and thiazide diuretics. Monitor patients to assure diuretic efficacy including antihypertensive effects.
  • Digoxin: Concomitant use with DYLOJECT can increase serum concentration and prolong half-life of digoxin. Monitor serum digoxin levels.

Adverse Reactions

  • The most common adverse reactions (>5%) in controlled clinical trials include nausea, constipation, headache, infusion site pain, dizziness, flatulence, vomiting, and insomnia.

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 gestation.
  • Infertility: NSAIDs are associated with reversible infertility. Consider withdrawal of DYLOJECT in women who have trouble conceiving.

Indications

DYLOJECT is indicated in adults for the management of mild to moderate pain and moderate to severe pain alone or in combination with opioid analgesics.

Please see Full Prescribing Information, including BOXED WARNING.