Lazanda nasal spray is a new formulation of a fentanyl citrate, a synthetic opioid, to be used for breakthrough cancer pain in individuals who are tolerant to opioid pain medications.¹ The drug is produced by Archimedes Pharma and was approved in 2011. The nasal spray is indicated for adult patients over 18 years of age.

Lazanda stimulates opioid receptors in the central nervous system (CNS) to promote relief of pain. From a risk standpoint, inadvertent or intentional overdose can lead to respiratory depression and death. Lazanda has been designated a Schedule II drug by the Drug Enforcement Agency due to the potential for abuse and misuse.

This new opioid nasal spray may be prescribed in a patient who is receiving other opioid pain relievers. Individuals with chronic cancer pain are managed with around-the-clock therapy to achieve persistent drug concentrations of opioids within the body. Due to the risk of respiratory and cardiovascular depression, individuals who are chronically managed on opioids and are deemed tolerant can be considered candidates for the nasal spray. Specific definitions of opioid dose thresholds considered to represent opioid tolerance are listed in the package insert.

Clinical trial results demonstrated adequate pain relief with six percent of patients withdrawing from the study due to inadequate pain relief. Five percent withdrew due to adverse events.¹ The onset of pain relief was reported to occur 5-10 minutes following the dose administration in one clinical trial enrolling patients experiencing four breakthrough cancer pain events per day.² The nasal spray will most likely play a role in special situations of chronically managed patients with cancer experiencing severe pain despite optimal management with chronic opioid analgesia.²

The drug is supplied in two different concentrations: 100 mcg per spray and 400 mcg per spray. The dose must be individualized for each patient using a titration method. The initial dose is 100 mcg, and 1 spray is administered into one nostril. After a single dose, wait at least 2 hours before treating the patient with a repeat dose. The medication is limited to four doses per 24-hour period. The recommended dosage titration is to increase the dose in response to patient's need to control pain. Following an initial dose of 100 mcg, the next titration step is 200 mcg, followed by 400 mcg while following the recommended intervals and daily dose limit. The maximum dose is 800 mcg.

There are specific instructions for priming the spray device. A counting window on the spray bottle documents the number of doses administered. An individualized approach to dosing the nasal spray starts with the lowest possible dose and gradually increases the dose only when pain symptoms are uncontrolled.

Prescribers are alerted to avoid attempting to make a dosage conversions or substitutions with another fentanyl product. This concern is due to the risks of dosing Lazanda at higher doses which may result in a fatal overdose. Cost information was not available at the time of this publication.

Fentanyl nasal spray is absorbed from the nasal mucosa within 21 minutes. If the dose is increased, greater drug concentrations will be absorbed with higher doses. The drug absorption does not appear to be affected by seasonal allergic rhinitis which affects the nasal passage.

The maximum drug concentration is achieved within 30 minutes following administration of the nasal spray which is independent of the mcg dose. The half-life ranges 15-25 hours. The drug is metabolized by the liver and other minor routes, and is primarily transformed to inactive metabolites. A small amount of the drug is eliminated in the urine.

Drug interactions affecting the cytochrome P450 3A4 enzymes system can increase the levels of opioid drugs in the body, and increase the risk of respiratory depression. There are a number of anti-infective drugs that interact with Lazenda; consult a pharmacist for complete list of potential drug interactions in a clinical setting. When used in patients with complicated regimens, combination with other drugs that depress the respiratory system or CNS may result in additive side effects. Drugs that may have additive effects include drugs to treat insomnia, anxiety and phenothiazines, as well as drinks that contain alcohol.

The most commonly reported side effects include nausea, vomiting and constipation. Other frequent side effects were somnolence, dizziness and fever. Lazanda has the potential to cause serious respiratory and CNS depression which could be life-threatening and fatal.

Caution is advised when using this drug in patients with chronic obstructive pulmonary disease or other conditions likely to increase sensitivity to respiratory depression; in individuals with acute or chronic intracranial damage; and in the elderly. There is no data on use during pregnancy.

Patients should be monitored closely during dose titration. Symptom relief should occur within 30 minutes. Patients with significant changes in vital signs should be stimulated to determine alertness and orientation. Administration of fentanyl can cause bradycardia.

Prescribers should be aware of the potential for respiratory depression when used in opiate-intolerant individuals. Fentanyl is designed for management of chronic pain, and contraindicated in acute pain management and postoperative pain. It should not be used to treat headaches, migraines or acute dental pain.

The FDA requires patients be asked to enroll in the Transmucosal Immediate Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy Access Program for this drug. Inpatients will not need to register with TIRF. Refer to the FDA blackbox warning to increase awareness of restricted use in children, potentially fatal drug interactions and the dangers of converting from other forms of fentanyl. The medication container should be kept away from children to avoid inadvertent usage.

References for this article can be accessed here.

Grace Earl is an ambulatory care pharmacist at the University of the Sciences, and her practice site is at Hahnemann University Hospital, both in Philadelphia.