Important Safety Information

• The preventive treatment of migraine headache in adolescent (age 12 and older) and adult patients.
• The acute treatment of pain associated with migraine headache in adolescent (age 12 and older) and adult patients.
• Adjunctive use for the preventive treatment of cluster headache in adult patients.
• The acute treatment of pain associated with episodic cluster headache in adult patients.
• Treatment of hemicrania continua in adults.
• Treatment of paroxysmal hemicrania in adults.

• The effectiveness of gammaCore has not been established in the acute treatment of chronic cluster headache
• gammaCore is contraindicated for patients if they:
  • Have an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
  • Have a metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck
  • Are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)
• Safety and efficacy of gammaCore have not been evaluated in the following patients:
  • Adolescent patients with congenital cardiac issues
  • Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
  • Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
  • Pediatric patients (younger than 12 years)
  • Pregnant women
  • Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia

NOTE: This list is not all inclusive. Please refer to the gammaCore Instructions for Use for all of the important warnings and precautions before using or prescribing this product.