INDICATIONS and USAGE
Lazanda (fentanyl) nasal spray is indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking at least: 60 mg of oral morphine/day, 25 mcg of transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid for a week or longer. Patients must remain on around-the-clock opioids when taking Lazanda.
Lazanda is contraindicated for patients who are not already tolerant to opioids because life-threatening respiratory depression and death could occur in patients not taking chronic opioids. For this reason, Lazanda is contraindicated in the management of acute or postoperative pain, including headache/migraine, or dental pain. 
Lazanda is intended to be prescribed only by healthcare professionals who are knowledgeable of and skilled in the use of Schedule II opioids to treat cancer pain.
Limitations of Use:
As a part of the TIRF REMS Access program, Lazanda may be dispensed only to outpatients enrolled in the program. [see Warnings and Precautions (5.10)]. For inpatient administration of Lazanda (e.g. hospitals, hospices, and long-term care facilities that prescribe for inpatient use), patient enrollment is not required.
IMPORTANT SAFETY INFORMATION
WARNING: RISK OF RESPIRATORY DEPRESSION, MEDICATION ERRORS, ABUSE POTENTIAL
Fatal respiratory depression has occurred in patients treated with immediate-release transmucosal fentanyl, including following use in opioid non-tolerant patients and improper dosing. The substitution of Lazanda® for any other fentanyl product may result in fatal overdose.
Due to the risk of respiratory depression, Lazanda is contraindicated in the management of acute or postoperative pain including headache/migraine and in opioid non-tolerant patients. [see Contraindications]
Lazanda must be kept out of reach of children. [see Patient Counseling Information and How Supplied/Storage and Handling]
The concomitant use of Lazanda with CYP3A4 inhibitors may result in an increase in fentanyl plasma concentrations, and may cause potentially fatal respiratory depression [see Drug Interactions].
Substantial differences exist in the pharmacokinetic profile of Lazanda compared to other fentanyl products that result in clinically important differences in the extent of absorption of fentanyl that could result in fatal overdose.
- When prescribing, do not convert patients on a mcg per mcg basis from any other fentanyl products to Lazanda.
- When dispensing, do not substitute a Lazanda prescription for other fentanyl products.
Lazanda contains fentanyl, an opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics. Lazanda can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing Lazanda in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion.
Because of the risk for misuse, abuse, addiction, and overdose, Lazanda is available only through a restricted program required by the Food and Drug Administration, called a Risk Evaluation and Mitigation Strategy (REMS). Under the TIRF (Transmucosal Immediate Release Fentanyl) REMS Access program, outpatients, healthcare professionals who prescribe to outpatients, pharmacies, and distributors must enroll in the program. [see Warnings and Precautions] Further information is available at www.TIRFREMSaccess.com or by calling 1-866-822-1483.
- 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, or dental pain.
- 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
- 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.
- 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. Lazanda could be fatal to individuals for whom it is not prescribed and for those who are not opioid tolerant.
- Patients and their caregivers must be instructed that Lazanda contains medicine in an amount that could be fatal to a child and thus must keep both used and unused bottles in their child-resistant container and out of the reach of children at all times and all residual fentanyl must be emptied before disposal.
- Patients on concomitant CNS depressants must be monitored for a change in opioid effects and adjust the dose of Lazanda.
- Concomitant use with potent cytochrome P450 3A4 inhibitors may increase depressant effects including hypoventilation, hypotension, and profound sedation. Monitor and consider dosage adjustment if warranted.
- Cautiously adjust the dose of Lazanda in patients with chronic obstructive pulmonary disease or preexisting medical conditions predisposing them to respiratory depression.
- Administer Lazanda with extreme caution in patients particularly susceptible to intracranial effects of CO2 retention, such as those with evidence of increased intracranial pressure or impaired consciousness.
- Patients taking Lazanda must be warned that opioid analgesics impair the mental and/or physical ability required for the performance of potentially dangerous tasks (e.g., driving a car or operating machinery).
- Use Lazanda with caution in patients with bradyarrhythmias.
- Lazanda is not recommended for use in patients who have received MAO inhibitors within 14 days, because severe and unpredictable potentiation by MAO inhibitors has been reported with opioid analgesics.
- Due to the risk for misuse, abuse, addiction, and overdose, Lazanda is available only through a restricted program called the TIRF REMS Access program (www.TIRFREMSaccess.com or call 1-866-822-1483).
- Potential interactions may occur when Lazanda is given concurrently with agents that affect CYP3A4 activity. Monitor patients for signs of opioid toxicity who begin therapy with, or increase the dose of, inhibitors of CYP3A4 or stop therapy with, or decrease the dose of, inducers of CYP3A4. Monitor patients who are taking vasoconstrictive nasal agents to treat allergic rhinitis for potentially impaired pain management.
Use In Specific Populations
- Safety and efficacy below 18 years of age have not been established.
- There are no adequate and well-controlled studies of Lazanda in pregnant women. Do not use Lazanda during labor and delivery or in women who are nursing.
- Lazanda should be administered with caution in patients with impaired renal or hepatic function and titrated to clinical effect in patients with severe renal or hepatic disease.
- Most common adverse events (frequency ≥5%): vomiting, nausea, dizziness, pyrexia, and constipation.
Please see full Prescribing Information including boxed warning.
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V June 2012