Development of Raynaud’s phenomenon and recurrence or worsening of pre-existing Raynaud’s phenomenon have been reported in the postmarketing setting following the use of CGRP antagonists, including Emgality. In reported cases with monoclonal antibody CGRP antagonists, symptom onset occurred after a median of 71 days following dosing. Many of the cases reported serious outcomes, including hospitalizations and disability, generally related to debilitating pain. In most reported cases, discontinuation of the CGRP antagonist resulted in resolution of symptoms.
Emgality should be discontinued if signs or symptoms of Raynaud’s phenomenon develop, and patients should be evaluated by a healthcare provider if symptoms do not resolve. Patients with a history of Raynaud’s phenomenon should be monitored for, and informed about the possibility of, worsening or recurrence of signs and symptoms.
References
Emgality. Prescribing Information. Lilly USA, LLC.
IMPORTANT SAFETY INFORMATION
Emgality is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients.
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.
Hypertension
Development of hypertension and worsening of pre-existing hypertension have been reported following the use of CGRP antagonists, including Emgality, in the postmarketing setting. Some of the patients who developed new-onset hypertension had risk factors for hypertension. There were cases requiring initiation of pharmacological treatment for hypertension and, in some cases, hospitalization. Hypertension may occur at any time during treatment but was most frequently reported within 7 days of therapy initiation. Emgality was discontinued in many of the reported cases.
Monitor patients treated with Emgality for new-onset hypertension or worsening of pre-existing hypertension, and consider whether discontinuation of Emgality is warranted if evaluation fails to establish an alternative etiology or blood pressure is inadequately controlled.
Raynaud’s Phenomenon
Development of Raynaud’s phenomenon and recurrence or worsening of pre-existing Raynaud’s phenomenon have been reported in the postmarketing setting following the use of CGRP antagonists, including Emgality. In reported cases with monoclonal antibody CGRP antagonists, symptom onset occurred after a median of 71 days following dosing. Many of the cases reported serious outcomes, including hospitalizations and disability, generally related to debilitating pain. In most reported cases, discontinuation of the CGRP antagonist resulted in resolution of symptoms.
Emgality should be discontinued if signs or symptoms of Raynaud’s phenomenon develop, and patients should be evaluated by a healthcare provider if symptoms do not resolve. Patients with a history of Raynaud’s phenomenon should be monitored for, and informed about the possibility of, worsening or recurrence of signs and symptoms.
The most common adverse reactions (incidence ≥2% and at least 2% greater than placebo) in Emgality clinical studies were injection site reactions.
Emgality is an injectable prescription medicine, available as:
prefilled single-dose pen with 120 mg/mL solution
prefilled single-dose syringe with 120 mg/mL solution
prefilled single-dose syringe with 100 mg/mL solution
