For Healthcare Providers

This information is intended for US healthcare professionals only.

Click for information about:

Migraine Pregnancy Registry Overview

The Migraine Pregnancy Registry enrolls pregnant or previously pregnant people experiencing migraines who are exposed and unexposed to migraine medications during pregnancy.

This registry will assess maternal, fetal, and infant outcomes. Results from the registry will be shared with regulatory bodies (e.g. FDA) and may be added to product labeling to provide Healthcare Providers additional prescribing information.

To get more HCP-related information about Lilly migraine medications, select from available medications shown in the buttons above.

The learnings from this registry may help patients and Healthcare Providers weigh the risks and benefits of being treated with migraine medications around the time of conception and during pregnancy.

Registry enrollment is voluntary. No medication will be given and participation in the registry will not influence or interfere with the treatment plan recommended by you or other Healthcare Providers.

Steps to Enroll Patients

Step 1: Discuss the registry with potentially eligible patients and invite them to enroll.

Step 2: Complete registration.

  • You or your patient can call the registry at 833-464-4724 to enroll.

Participation after enrollment

Complete outcome data forms at specified intervals as requested by the registry.

  • Healthcare Provider follow-up information is requested at the end of each trimester and the end of the pregnancy.
  • Pediatric Healthcare Provider: follow-up information is requested at birth, 2, 4, 6, 9, and 12 months of age.

Indication and Important Safety Information For Emgality®

(galcanezumab-gnlm)

Indication

Emgality is indicated for the preventive treatment of migraine in adults.

Important Safety Information

Contraindications

Emgality is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients.

Warnings and Precautions

Hypersensitivity Reactions

Hypersensitivity reactions, including dyspnea, urticaria, and rash, have occurred with Emgality in clinical studies and the postmarketing setting. Cases of anaphylaxis and angioedema have also been reported in the postmarketing setting. If a serious or severe hypersensitivity reaction occurs, discontinue administration of Emgality and initiate appropriate therapy. Hypersensitivity reactions can occur days after administration and may be prolonged.

Adverse Reactions

The most common adverse reactions (incidence ≥2% and at least 2% greater than placebo) in Emgality clinical studies were injection site reactions.

Please see Full Prescribing Information, including Patient Information, for Emgality. See Instructions for Use included with the 120 mg Pen or 120 mg Syringe.

GZ HCP ISI 10DEC2019

Indication and Important Safety Information For REYVOW®

(lasmiditan)

Indication

REYVOW is indicated for the acute treatment of migraine with or without aura in adults.

Limitations of Use: REYVOW is not indicated for the preventive treatment of migraine.

Important Safety Information

Warnings and Precautions

Driving Impairment

REYVOW may cause significant driving impairment. In a driving study, administration of single 50 mg, 100 mg, or 200 mg doses of REYVOW significantly impaired subjects’ ability to drive. Additionally, more sleepiness was reported at 8 hours following a single dose of REYVOW compared to placebo. Advise patients not to engage in potentially hazardous activities requiring complete mental alertness, such as driving a motor vehicle or operating machinery, for at least 8 hours after each dose of REYVOW. Patients who cannot follow this advice should not take REYVOW. Prescribers and patients should be aware that patients may not be able to assess their own driving competence and the degree of impairment caused by REYVOW.

Central Nervous System Depression

REYVOW may cause central nervous system (CNS) depression, including dizziness and sedation. Because of the potential for REYVOW to cause sedation, other cognitive and/or neuropsychiatric adverse reactions, and driving impairment, REYVOW should be used with caution if used in combination with alcohol or other CNS depressants. Patients should be warned against driving and other activities requiring complete mental alertness for at least 8 hours after REYVOW is taken.

Serotonin Syndrome

In clinical trials, reactions consistent with serotonin syndrome were reported in patients treated with REYVOW who were not taking any other drugs associated with serotonin syndrome. Serotonin syndrome may also occur with REYVOW during coadministration with serotonergic drugs. Serotonin syndrome symptoms may include mental status changes, autonomic instability, neuromuscular signs, and/or gastrointestinal signs and symptoms. The onset of symptoms usually occurs within minutes to hours of receiving a new or a greater dose of a serotonergic medication. Discontinue REYVOW if serotonin syndrome is suspected.

Medication Overuse Headache

Overuse of acute migraine drugs may lead to exacerbation of headache. Medication overuse headache may present as migraine-like daily headaches or as a marked increase in frequency of migraine attacks. Detoxification of patients including withdrawal of the overused drugs and treatment of withdrawal symptoms (which often includes a transient worsening of headache) may be necessary.

Adverse Reactions

The most common adverse reactions associated with REYVOW (≥2% and greater than placebo in clinical studies) were dizziness, fatigue, paresthesia, sedation, nausea and/or vomiting, and muscle weakness.

Abuse

REYVOW contains lasmiditan, a Schedule V controlled substance (C-V).

REYVOW has abuse potential. Evaluate patients for risk of drug abuse and observe them for signs of lasmiditan misuse or abuse.

Please see Prescribing Information and Medication Guide for REYVOW.

LM HCP ISI 28SEP2020