LAZANDA® (Fentanyl) Nasal Spray CII
INDICATIONS AND USAGE
LAZANDA 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 around-the-clock opioid therapy for their underlying persistent cancer pain.
Patients considered opioid tolerant are those who are taking, for one week or longer, around-the-clock medicine consisting of at least 60 mg of oral morphine per day, or at least 25 mcg of transdermal fentanyl per hour, or at least 30 mg oral oxycodone per day, or at least 8 mg oral hydromorphone per day, or at least 25 mg oral oxymorphone per day, or at least 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid for a week or longer. Patients must remain on around-the-clock opioids when taking LAZANDA.
Limitations of Use:
- Not for use in opioid non-tolerant patients.
- Not for use in the management of acute or postoperative pain, including headache/migraine, dental pain, or in the emergency department.
- As a part of the TIRF REMS Access program, LAZANDA may be dispensed only to outpatients enrolled in the program. 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
DOSAGE AND ADMINISTRATION
Initial Dosage, Titration and Maintenance Therapy
Initiate treatment with LAZANDA for all patients using ONE 100 mcg spray of LAZANDA (1 spray in one nostril).
If adequate analgesia is obtained within 30 minutes of administration of the initial dose, treat subsequent episodes of breakthrough pain with this dose.
Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.
If adequate analgesia is not achieved with the initial dose, dose escalate in a step-wise manner over consecutive episodes of breakthrough pain until adequate analgesia with tolerable side effects is achieved.
Patients MUST wait at least 2 hours before treating another episode of breakthrough cancer pain with LAZANDA.
LAZANDA is contraindicated in:
- Opioid non-tolerant patients: Life-threatening respiratory depression and death could occur at any dose
- Acute or postoperative pain including headache/migraine and dental pain, or in the emergency department
- Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
- Known or suspected gastrointestinal obstruction, including paralytic ileus
- Known hypersensitivity to fentanyl or components of LAZANDA
WARNINGS AND PRECAUTIONS
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. The risk is greatest during the initiation of therapy or following a dosage increase. The substitution of LAZANDA for any other fentanyl product may result in fatal overdose.
Increased Risk of Overdose in Children Due to Accidental Ingestion or Exposure
Death has been reported in children who accidentally ingested transmucosal immediate-release fentanyl products. Patients and their caregivers must be informed that LAZANDA contains a medicine in an amount which can be fatal to a child.
Risks of Concomitant Use or Discontinuation of Cytochrome P450 3A4 Inhibitors and Inducers
Concomitant use of a CYP3A4 inhibitor may increase plasma concentrations of fentanyl and prolong opioid adverse reactions, which may cause potentially fatal respiratory depression, particularly when an inhibitor is added after a stable dose of LAZANDA is achieved. Discontinuation of a CYP3A4 inducer may increase fentanyl plasma concentrations and prolong opioid adverse reactions.
Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants
Profound sedation, respiratory depression, coma, and death may result from the concomitant use of LAZANDA with benzodiazepines or other CNS depressants. Prescribe the lowest effective doses and minimum durations of concomitant use.
Risk of Medication Errors
When prescribing and dispensing, DO NOT convert a patient to LAZANDA from any other fentanyl product as LAZANDA and other fentanyl products are not equivalent. LAZANDA is NOT a generic version of other transmucosal immediate release fentanyl (TIRF) formulations.
Addiction, Abuse, and Misuse
LAZANDA contains fentanyl a Schedule II controlled substance.
Transmucosal Immediate Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS) Access Program
Because of the risk of misuse, abuse, addiction, and overdose, LAZANDA is available only through a restricted program under a REMS called the TIRF REMS Access program.
Neonatal Opioid Withdrawal Syndrome
Prolonged use of LAZANDA during pregnancy can result in withdrawal in the neonate. Neonatal opioid withdrawal syndrome may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts.
Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients
The use of LAZANDA in patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment is contraindicated.
Serotonin Syndrome with Concomitant Use of Serotonergic Drugs
Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of fentanyl with serotonergic drugs.
Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. If adrenal insufficiency is diagnosed, treat with corticosteroids.
LAZANDA may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients. There is increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs (e.g. phenothiazines or general anesthetics).
Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness
In patients who may be susceptible to the intracranial effects of CO2 retention (e.g., those with evidence of increased intracranial pressure or brain tumors), LAZANDA may reduce respiratory drive, and the resultant CO2 retention can further increase intracranial pressure.
Risks of Use in Patients with Gastrointestinal Conditions
LAZANDA is contraindicated in patients with known or suspected gastrointestinal obstruction, including paralytic ileus.
Increased Risk of Seizures in Patients with Seizure Disorders
LAZANDA may increase the frequency of seizures in patients with seizure disorders, and may increase the risk of seizures occurring in other clinical settings associated with seizures.
Risks of Driving and Operating Machinery
LAZANDA may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery. Warn patients not to perform such tasks until they know how they will react to the medication.
Intravenous fentanyl may produce bradycardia. Use LAZANDA with caution in patients with bradyarrhythmias.
COMMON ADVERSE REACTIONS (≥5%)
Vomiting, nausea, dizziness, pyrexia, and constipation.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please read Full Prescribing Information including Boxed Warning.