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warnings and cautions
5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: If a serious hypersensitivity reaction occurs, discontinue administration of EMGALITY and initiate appropriate therapy. Hypersensitivity reactions can occur days after administration, and may be prolonged. ( 5.1 ) Constipation with Serious Complications: Serious complications of constipation may occur. ( 5.2 ) Hypertension: New-onset or worsening of pre-existing hypertension may occur. ( 5.3 ) Raynaud's Phenomenon: New-onset or worsening of pre-existing Raynaud's phenomenon may occur. ( 5.4 ) 5.1 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 [see Contraindications ( 4 ), Adverse Reactions ( 6.1 ), and Patient Counseling Information ( 17 )] . Hypersensitivity reactions can occur days after administration and may be prolonged. 5.2 Constipation with Serious Complications Constipation with serious complications has been reported following the use of monoclonal antibody CGRP antagonists, including EMGALITY, in the postmarketing setting. There were cases with monoclonal antibody CGRP antagonists that required hospitalization, including cases where surgery was necessary. In a majority of these cases, the onset of constipation was reported after the first dose; however, patients have also presented with constipation later on in treatment. The monoclonal antibody CGRP antagonist was discontinued in many of the reported cases of constipation with serious complications. Monitor patients treated with EMGALITY for severe constipation and manage as clinically appropriate. The concurrent use of medications that reduce gastrointestinal motility may increase the risk for more severe constipation and the potential for constipation-related complications. 5.3 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 p...
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adverse reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )] Constipation with Serious Complications [see Warnings and Precautions ( 5.2 )] Hypertension [see Warnings and Precautions ( 5.3 )] Raynaud's Phenomenon [see Warnings and Precautions ( 5.4 )] The most common adverse reactions (incidence ≥2% and at least 2% greater than placebo) in EMGALITY clinical studies were injection site reactions. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in clinical trials of another drug and may not reflect the rates observed in clinical practice. Migraine The safety of EMGALITY has been evaluated in 2586 patients with migraine who received at least one dose of EMGALITY, representing 1487 patient-years of exposure. Of these, 1920 patients were exposed to EMGALITY once monthly for at least 6 months, and 526 patients were exposed for 12 months. In placebo-controlled clinical studies (Studies 1, 2, and 3), 705 patients received at least one dose of EMGALITY 120 mg once monthly, and 1451 patients received placebo, during 3 months or 6 months of double-blind treatment [see Clinical Studies ( 14.1 )] . Of the EMGALITY-treated patients, approximately 85% were female, 77% were white, and the mean age was 41 years at study entry. The most common adverse reaction was injection site reactions. In Studies 1, 2, and 3, 1.8% of patients discontinued double-blind treatment because of adverse events. Table 1 summarizes the adverse reactions that occurred within up to 6 months of treatment in the migraine studies. Table 1: Adverse Reactions Occurring in Adults with Migraine with an Incidence of at least 2% for EMGALITY and at least 2% Greater than Placebo (up to 6 Months of Treatment) in Studies 1, 2, and 3 a Injection site reactions include multiple related adverse event terms, such as injection site pain, injection site reaction, injection site erythema, and injection site pruritus. Adverse Reaction EMGALITY 120 mg Monthl...
adverse reactions table
Table 1: Adverse Reactions Occurring in Adults with Migraine with an Incidence of at least 2% for EMGALITY and at least 2% Greater than Placebo (up to 6 Months of Treatment) in Studies 1, 2, and 3 a Injection site reactions include multiple related adverse event terms, such as injection site pain, injection site reaction, injection site erythema, and injection site pruritus. Adverse ReactionEMGALITY 120 mg Monthly (N=705) %Placebo Monthly (N=1451) %Injection site reactionsa18 13