Important Safety Information

• 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.
• The acute treatment of pain associated with migraine headache in adult patients.

• The safety and effectiveness of gammaCore (nVNS) have not been established in the acute treatment of chronic cluster headache
• gammaCore has not been shown to be effective for the preventive treatment of migraine headache
• The long-term effects of the chronic use of gammaCore have not been evaluated
• Safety and efficacy of gammaCore have not been evaluated in the following patients, and therefore gammaCore is NOT indicated for:
  • Patients with an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
  • 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
  • Pregnant women
  • Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia
• Patients should not use gammaCore if they:
  • Have a metallic device such as a stent, bone plate, or bone screw implanted at or near their neck
  • Are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)

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.