MIAMI, Sept. 26, 2023 /PRNewswire/ — Gensco® Pharma, a specialty pharmaceutical company, in partnership with IntelGenx is announcing the anticipated launch of RizaFilm® for Q1-2024. RizaFilm® is based on IntelGenx’s proprietary VersaFilm® technology and is patent protected until 2034. As the NDA holder, Gensco® will begin commercialization of the 10mg Film and will continue to fund the expanded indications for the 5mg Pediatric dose.
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use RIZAFILM safely and effectively.
RizaFilm (rizatriptan) oral film
Initial U.S. Approval: 1998
—————————INDICATIONS AND USAGE———————-
RizaFilm is a serotonin (5-HT) 1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 12 to 17 years of age weighing 40 kg or more (1)
Limitations of Use:
• Use only after a clear diagnosis of migraine has been established (1)
• Not indicated for the preventive treatment of migraine (1)
• Not indicated for the treatment of cluster headache (1)
———————–DOSAGE AND ADMINISTRATION——————–
• RizaFilm is administered on the tongue (2.1)
• Adults: 10 mg single dose; separate repeat doses by at least two hours; maximum cumulative dosage in a 24-hour period is 30 mg (2.1)
• Pediatric patients 12 to 17 years of age weighing 40 kg or more: 10 mg single dose (2.2)
——————–DOSAGE FORMS AND STRENGTHS——————–
• Oral film: 10 mg rizatriptan. (3)
————————–CONTRAINDICATIONS————————–
• History of ischemic heart disease or coronary artery vasospasm (4)
• History of stroke or transient ischemic attack (4)
• Wolff-Parkinson-White syndrome or other cardiac accessory conduction pathway disorders (4)
• Peripheral vascular disease (4)
• Ischemic bowel disease (4)
• Uncontrolled hypertension (4)
• Recent (within 24 hours) use of another 5-HT1 agonist (e.g., another triptan), or of an ergotamine-containing medication (4)
• Hemiplegic or basilar migraine (4)
• MAO-A inhibitor used in the past 2 weeks (4)
• Co-administration with propranolol (4)
• Hypersensitivity to rizatriptan or any of the ingredients of RizaFilm (4)
——————–WARNINGS AND PRECAUTIONS ———————
• Myocardial ischemia, myocardial infarction, and Prinzmetal’s angina: Perform cardiac evaluation in patients with multiple cardiovascular risk factors (5.1)
• Arrhythmias: Discontinue dosing if occurs (5.2)
• Chest/throat/neck/jaw pain, tightness, pressure, or heaviness; Generally not associated with myocardial ischemia; Evaluate patients at high risk (5.3)
• Cerebral hemorrhage, subarachnoid hemorrhage, and stroke: Discontinue dosing if occurs (5.4)
• Gastrointestinal ischemic events, peripheral vasospastic reactions: Discontinue dosing if occurs (5.5)
• Hypersensitivity Reactions: angioedema and anaphylaxis have occurred (5.6)
• Medication overuse headache: Detoxification may be necessary (5.7)
• Serotonin syndrome: Discontinue dosing if occurs (5.8)
————————–ADVERSE REACTIONS————————–
The most common adverse reactions in adults were (incidence ≥5% and greater than placebo): asthenia/fatigue, somnolence, pain/pressure sensation, dizziness, and nausea. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Gensco Pharma at 1-866-608-6284 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
———————USE IN SPECIFIC POPULATIONS———————
• Pregnancy: Based on animal data, may cause fetal harm (8.1)
See 17 for PATIENT COUNSELING INFORMATION and FDA- approved patient labeling.
Revised: 10/2023