Indications for LAZANDA:
Breakthrough pain, in opioid-tolerant patients already receiving and who are tolerant to continuous opioid therapy for underlying persistent cancer pain. Opioid-tolerant patients are those taking oral morphine ≥60mg/day, transdermal fentanyl ≥25mcg/hr, oral oxycodone ≥30mg/day, oral hydromorphone ≥8mg/day, oral oxymorphone ≥25mg/day, oral hydrocodone ≥60mg/day, or equianalgesic dose of another opioid for ≥1 week.
Do not substitute with other fentanyl products; not equivalent to other fentanyl products on a mcg to mcg basis. Use lowest effective dose for shortest duration. ≥18yrs: Prime device before use. Initially one 100mcg spray in one nostril; if adequate analgesia obtained within 30 minutes, treat subsequent episodes with this dose. If adequate analgesia not achieved, dose escalate in a step-wise manner over consecutive episodes until adequate analgesia achieved; wait at least 2 hours before using for the next episode. Titration steps: 100mcg using 1 x 100mcg spray; 200mcg using 2 x 100mcg spray (1 in each nostril); 300mcg using 3 x 100mcg (alternating spray in each nostril); 400mcg using 1 x 400mcg or 4 x 100mcg (alternating spray in each nostril); 600mcg using 2 x 300mcg (1 in each nostril); 800mcg using 2 x 400mcg (1 in each nostril); max 800mcg. Maintenance: once an appropriate dose has been established, use that dose for subsequent breakthrough episodes. Limit to ≤4 doses per day. May use rescue medication if there is inadequate pain relief after 30 minutes of Lazanda dosing or if a separate episode occurs before the next dose of Lazanda is permitted (ie, within 2 hours). Concomitant use or discontinuation of CYP3A4 inhibitors or inducers: monitor closely and consider dose adjustments (see full labeling).
<18yrs: not established.
Opioid non-tolerant patients. Acute or post-op pain (including headache/migraine, dental pain, or ER). Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment. Known or suspected GI obstruction, including paralytic ileus.
Life-threatening respiratory depression. Accidental ingestion. Cytochrome P450 3A4 interaction. Risks from concomitant use with benzodiazepines or other CNS depressants. Risk of medication errors. Addiction, abuse, and misuse. REMS access program. Neonatal opioid withdrawal syndrome.
Life-threatening respiratory depression; monitor within first 24–72hrs of initiating therapy and following dose increases. Accidental exposure may cause fatal overdose (esp. in children). Sleep-related breathing disorders (including central sleep apnea (CSA), sleep-related hypoxemia); consider dose reduction if CSA develops. COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression; monitor and consider non-opioid analgesics. Abuse potential (monitor). Adrenal insufficiency. Head injury. Increased intracranial pressure, brain tumors; monitor. Seizure disorders. CNS depression. Impaired consciousness, coma, shock; avoid. Biliary tract disease. Acute pancreatitis. Bradyarrhythmias. Drug abusers. Renal or hepatic impairment. Reevaluate periodically. Avoid abrupt cessation. Elderly. Cachectic. Debilitated. Pregnancy; potential neonatal opioid withdrawal syndrome during prolonged use. Labor & delivery, nursing mothers: not recommended.
Increased risk of hypotension, respiratory depression, sedation with benzodiazepines or other CNS depressants (eg, non-benzodiazepine sedatives/hypnotics, anxiolytics, general anesthetics, phenothiazines, tranquilizers, muscle relaxants, antipsychotics, alcohol, other opioids); reserve concomitant use in those for whom alternative options are inadequate; limit dosages/durations to minimum required; monitor. During or within 14 days of MAOIs: not recommended. Risk of serotonin syndrome with serotonergic drugs (eg, SSRIs, SNRIs, TCAs, triptans, 5-HT3 antagonists, mirtazapine, trazodone, tramadol, cyclobenzaprine, metaxalone, MAOIs, linezolid, IV methylene blue); monitor and discontinue if suspected. Avoid concomitant mixed agonist/antagonist opioids (eg, butorphanol, nalbuphine, pentazocine) or partial agonist (eg, buprenorphine); may reduce effects and/or precipitate withdrawal symptoms. Potentiated by CYP3A4 inhibitors (eg, macrolides, azole antifungals, protease inhibitors, grapefruit juice). Antagonized by CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin). May be antagonized by concomitant vasoconstrictive nasal decongestant (eg, oxymetazoline) used to treat allergic rhinitis; avoid and consider alternatives with different route of administration. May antagonize diuretics; monitor. Paralytic ileus may occur with anticholinergics.
Vomiting, nausea, dizziness, pyrexia, constipation; respiratory depression, severe hypotension, syncope.
Available by restricted distribution program. Call (866) 822-1483 or visit www.tirfremsaccess.com to enroll. Caution patients and caregivers in proper handling and disposal; may be fatal to children.
Nasal spray (8 sprays/bottle)—1