The following clinically significant adverse reactions are described elsewhere in the labeling: Serious Hypersensitivity Reactions [see Contraindications and Hypersensitivity Reactions under Precautions].
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 PONTEVIA has been evaluated in 2586 patients with migraine who received at least one dose of PONTEVIA, representing 1487 patient-years of exposure. Of these, 1920 patients were exposed to PONTEVIA 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 PONTEVIA 120 mg once monthly, and 1451 patients received placebo, during 3 months or 6 months of double-blind treatment [see Pharmacology: Pharmacodynamics: Clinical Studies: Migraine under Actions]. Of the PONTEVIA-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 3 summarizes the adverse reactions that occurred within up to 6 months of treatment in the migraine studies. (See Table 3.)
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Immunogenicity: As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease.
For these reasons, comparison of the incidence of antibodies to galcanezumab in the studies described as follows with the incidence of antibodies in other studies or to other products may be misleading.
The immunogenicity of PONTEVIA has been evaluated using an in vitro immunoassay for the detection of binding anti-galcanezumab antibodies. For patients whose sera tested positive in the screening immunoassay, an in vitro ligand-binding immunoassay was performed to detect neutralizing antibodies.
In controlled studies with PONTEVIA up to 6 months (Study 1, Study 2, and Study 3), the incidence of anti-galcanezumab antibody development was 4.8% (33/688) in patients receiving PONTEVIA once monthly (32 out of 33 of whom had in vitro neutralizing activity). With 12 months of treatment in an open-label study, up to 12.5% (16/128) of PONTEVIA-treated patients developed anti-galcanezumab antibodies, most of whom tested positive for neutralizing antibodies.
Although anti-galcanezumab antibody development was not found to affect the pharmacokinetics, safety or efficacy of PONTEVIA in these patients, the available data are too limited to make definitive conclusions.
Postmarketing Experience: The following adverse reactions have been identified during post-approval use of PONTEVIA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to PONTEVIA exposure.
Immune System Disorders - Anaphylaxis, angioedema [see Contraindications and Hypersensitivity Reactions under Precautions].
Skin and Subcutaneous Tissue Disorders - rash, pruritus rash, urticaria.
Ear and Labyrinth disorders - vertigo.
Gastrointestinal disorders - constipation.