Company: Archimedes Pharma
Pharmacologic class: Opioid
Active ingredient: Fentanyl 100 μg, 400 μg; per 100 μL nasal spray.
Indication: Breakthrough pain in opioid-tolerant patients who are already receiving and tolerant to continuous opioid therapy for underlying persistent cancer pain.
Pharmacology: Like other pure opioid agonists, fentanyl acts on the mu-receptors in the central nervous system (CNS) to produce analgesia and CNS depression.
Clinical trials: The efficacy of Lazanda was evaluated in a clinical trial in opioid-tolerant adult patients experiencing breakthrough cancer pain. The trial included an open-label titration phase in which a dose was identified that provided adequate analgesia with tolerable side effects, within the range of 100 to 800 μg.
In the double-blind, placebo-controlled portion of the study, patients who were titrated to an adequate dose were randomized to a blinded sequence of 10 treatments, with seven being the identified dose of Lazanda and three being placebo. The mean sum of the pain-intensity difference at 30 minutes was statistically significantly higher for Lazanda than for placebo.
Adults: ≥18years: Initially one 100 μg 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 stepwise manner over consecutive episodes until adequate analgesia achieved; wait at least two hours before using for the next episode.
Titration steps: 100 μg using 1 x 100 μg spray; 200 μg using 2 x 100 μg spray (1 in each nostril); 400 μg using 1 x 400 μg; 800 μg using 2 x 400 μg (one in each nostril); maximum 800 μg.
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.
Contraindications: Opioid-nontolerant patients. Acute or postoperative pain (including headache/migraine, dental pain, or emergency department).
Warnings/Precautions: Do not substitute with other fentanyl products; not equivalent to other fentanyl products on a μg-to-μg basis. Respiratory disorders or depression. Head injury. Increased intracranial pressure. Bradyarrhythmias. Impaired pulmonary, cardio, renal, or hepatic function. Elderly. Debilitated. Pregnancy (Cat. C). Labor & delivery, nursing mothers: not recommended.
Interactions: Not recommended within 14 days of monoamine oxidase inhibitors. Potentiates CNS depression with alcohol, other CNS depressants (e.g., phenothiazines, skeletal muscle relaxants, antihistamines, hypnotics). Potentiated by CYP3A4 inhibitors (e.g., macrolides, azole antifungals, aprepitant, protease inhibitors, nefazodone, verapamil, diltiazem). Antagonized by CYP3A4 inducers (e.g., barbiturates, efavirenz, modafinil, nevirapine, anticonvulsants, pioglitazone, troglitazone, rifabutin, rifampin, St John’s wort). Efficacy may be lowered with concomitant vasoconstrictive nasal agents used to treat allergic rhinitis.
Adverse reactions: GI upset, constipation, dizziness, pyrexia.
Notes: Available by restricted distribution program. Call 855.841.4234 or visit www.LazandaREMS.com to enroll. Caution patients and caregivers in proper handling and disposal; may be fatal to children.
How supplied: Nasal spray (8 sprays/bottle) — 1
For more information, call 866.435.6775 or visit www.Lazanda.com.