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Archimedes Pharma Launches Lazanda® - the Only Fentanyl Nasal Spray for the Management of Breakthrough Pain in Cancer in the U.S.
Date:10/17/2011

e only through a restricted program, required by the Food and Drug Administration, called the Lazanda REMS® (Risk Evaluation and Mitigation Strategy) program.  Under the Lazanda® REMS program, healthcare professionals who prescribe to outpatients, pharmacies, and distributors must enroll in the program to prescribe, receive, dispense, and distribute Lazanda, respectively. [see Warnings and Precautions].  Further information is available at www.LazandaREMS.com or by calling 1-855-841-4234.Contraindications

  • Lazanda is contraindicated in the management of pain in opioid non-tolerant patients, because life-threatening hypoventilation could occur at any dose in patients not already taking around-the-clock opioid therapy.
  • Lazanda is contraindicated in the management of acute or postoperative pain, including headache/migraine, dental pain, or use in the emergency room.
  • Lazanda is contraindicated in patients with known intolerance or hypersensitivity to any of its components or the drug fentanyl. Anaphylaxis and hypersensitivity have been reported in association with the use of other oral transmucosal fentanyl products.

  • Warnings And Precautions

  • Patients must not be converted to Lazanda from other fentanyl products because it is not equivalent to other fentanyl products on a mcg per mcg basis, and such substitution could result in a fatal overdose; do not substitute Lazanda for another fentanyl product when being dispensed.
  • Serious or fatal respiratory depression can occur even at recommended doses in patients using Lazanda. Respiratory depression is more likely to occur in patients with underlying respiratory disorders and elderly or debilitated patients, in opioid non-tolerant patients, or when opioids are given in conjunction with other drugs that depress respiration.
  • Lazanda could be fatal to individuals for whom it is not pres
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  • SOURCE Archimedes Pharma Ltd.
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