Table of Contents
- Lazanda Use and Addiction Risks
- Accidental Exposure
- Cytochrome P450 3A4 Interaction
- Risks from Concurrent Use with Benzodiazepines or Other CNS Depressants
- Risk of Medication Errors
- Addiction, Abuse, and Misuse
- Risk Evaluation and Mitigation Strategy (REMS) Access Program
- Neonatal Opioid Withdrawal Syndrome
- References and Resources
Serious, life-threatening, and/or lethal respiratory depression has occurred in patients taking LAZANDA, including following use in opioid non-tolerant individuals and improper dosing.
Physicians should monitor for respiratory depression, particularly during the initiation of LAZANDA or following the dose increase.
The replacement of LAZANDA for any other fentanyl product may culminate in a fatal overdose.
Because of the risk of respiratory depression, LAZANDA is contraindicated in the supervision of acute or postoperative pain, including headache/migraine, and opioid non-tolerant patients.
Accidental Exposure
Accidental exposure to even one dose of LAZANDA, especially in children, can cause a fatal overdose of fentanyl. There are reports of deaths of children who have accidentally consumed transmucosal immediate-release fentanyl products.
Cytochrome P450 3A4 Interaction
The simultaneous use of LAZANDA with all cytochrome P450 3A4 inhibitors may end in an increase in fentanyl plasma concentrations, which could increase or prolong adverse reactions and potentially cause fatal respiratory depression.
Besides, discontinuation of a concurrently used cytochrome P450 3A4 inducer may increase fentanyl plasma concentration. Doctors should monitor patients receiving LAZANDA and any CYP3A4 inhibitor or inducer.
Risks from Concurrent Use with Benzodiazepines or Other CNS Depressants
The concurrent use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death [see Warnings and Precautions, Drug Interactions.
- Reserve concomitant prescribing of LAZANDA and benzodiazepines or other CNS depressants for use in individuals for whom alternative treatment options are insufficient.
- Observe patients for signs and symptoms of respiratory depression and sedation.
- Limit dosages and durations to the minimum requirements.
Risk of Medication Errors
Considerable differences exist in the pharmacokinetic profile of LAZANDA compared to other fentanyl products that result in clinically significant differences in the extent of absorption of fentanyl that could result in a fatal overdose.
- When prescribing, do not convert patients on an mcg per mcg basis from any other fentanyl products to LAZANDA.
- When dispensing, do not use a LAZANDA prescription to replace other fentanyl products.
Addiction, Abuse, and Misuse
LAZANDA puts patients and other users under the risks of opioid addiction, abuse, and misuse, which can cause overdose and death.
Assess each patient’s risk before prescribing LAZANDA and monitor all patients regularly for the development of these behaviors and conditions.
Risk Evaluation and Mitigation Strategy (REMS) Access Program
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 Transmucosal Immediate Release Fentanyl (TIRF) REMS Access program, outpatients, healthcare professionals who prescribe to outpatients, pharmacies, and distributors must enroll in the program. Further information is available at www.TIRFREMSaccess.com or by calling 1-866-822-1483.
Neonatal Opioid Withdrawal Syndrome
Prolonged use of LAZANDA during pregnancy can cause neonatal opioid withdrawal syndrome, which may be fatal if not recognized and treated. It requires management according to protocols formed by neonatology experts.
If opioid use is needed for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
