Nerivio Remote Electrical Neuromodulation Device for Migraine

Nerivio is approved for the following uses:

• Acute treatment of migraine with or without aura in patients aged 12 years and above.
• Can be used for episodic and chronic migraine management.

Nerivio works by delivering electrical pulses to the C-fiber nerves in the upper arm, which transmit signals to the brainstem. This process activates the brain’s Conditioned Pain Modulation (CPM) mechanism, leading to the release of pain-inhibiting chemicals such as serotonin and norepinephrine. These neurotransmitters reduce pain perception and alleviate migraine symptoms effectively.

By modulating pain at the source and promoting natural pain-relief mechanisms, Nerivio helps manage both the intensity and duration of migraine attacks without the need for pharmaceutical interventions.

Nerivio should not be used in the following conditions due to potential safety risks:

• Cardiac and Cerebrovascular Conditions: Patients with severe cardiac disorders, cerebrovascular disease, or congestive heart failure should avoid using this device as electrical stimulation may interfere with heart rhythm.
• Epilepsy and Seizure Disorders: Patients with a history of epilepsy or seizure disorders should not use Nerivio, as electrical neuromodulation may trigger seizures.
• Implantable Medical Devices: Individuals using pacemakers, hearing aids, cochlear implants, or any other electronic or implantable medical device should avoid Nerivio to prevent device interference.
• Pregnancy and Breastfeeding: Safety data is limited, and patients should consult a doctor before using Nerivio during pregnancy or lactation.

• Store the device in a cool, dry place away from direct sunlight.
• Since this is a device-based therapy, missed doses do not apply. However, it is best to use the device as prescribed.
• Do not extend therapy sessions beyond 45 minutes without medical consultation. Overuse may result in increased skin irritation or discomfort.
• Ensure the device is charged and properly maintained between uses.

To use the Nerivio device effectively, place it on the upper arm of the non-dominant side (opposite hand to the one you write with) and secure it properly. Activate the device using the companion smartphone app, which allows you to control the intensity and duration of the session. For acute migraine attacks, use the device within 60 minutes of headache onset, with a standard session lasting 45 minutes. For preventive treatment, use the device for 45 minutes every alternate day. Always follow the instructions provided in the user manual and consult your doctor before adjusting the duration or frequency of sessions.

Common side effects:

• Mild skin irritation or redness at the application site.
• Tingling or numbness in the arm during or after use.

Serious side effects:

• Severe skin irritation or allergic reaction.
• Electrical sensitivity or increased discomfort during use.

Patients with a history of heart conditions, epilepsy, or implantable devices should avoid using Nerivio. It is essential to follow the prescribed usage duration to prevent any discomfort or adverse effects. Do not extend the therapy beyond 45 minutes without medical supervision. Ensure the device is properly charged and maintained for consistent performance. Seek immediate medical advice if you experience any severe skin reactions or unusual sensations during use.