Glucagonside effects

The following clinically significant adverse reactions are described elsewhere in labeling: Substantial Increase in Blood Pressure in Patients with Pheochromocytoma. Hypoglycemia in Patients with Insulinoma. Serious Hypersensitivity Reactions. Lack of Efficacy in Patients with Decreased Hepatic Glycogen. Most common (≥10%) adverse reactions associated with BAQSIMI are nausea, vomiting, headache, upper respiratory tract irritation (i.e., rhinorrhea, nasal discomfort, nasal congestion, cough, and epistaxis), watery eyes, redness of eyes, itchy nose, throat and eyes. To report SUSPECTED ADVERSE REACTIONS, contact Amphastar Pharmaceuticals, Inc. at 1-800-423-4136 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 BAQSIMI cannot be directly compared with rates in clinical trials of other drugs and may not reflect the rates observed in practice. Adverse Reactions in Adult Patients Two similarly designed comparator-controlled trials, Study 1 and Study 2, evaluated the safety of a single intranasal dose of BAQSIMI compared to a 1 mg dose of intra-muscular glucagon (IMG) in adult patients with diabetes. Table 1 presents adverse reactions that occurred with BAQSIMI at an incidence of ≥2% in a pool of Study 1 and Study 2.

Table 1: Pooled Adverse Reactions (≥2%) in Adult Patients with Type 1 and Type 2 Diabetes in Study 1and Study 2 a Upper Respiratory Tract Irritation: rhinorrhea, nasal discomfort, nasal congestion, cough, and epistaxis. Adverse Reaction BAQSIMI 3 mg (N=153) % Nausea 26 Headache 18 Vomiting 15 Upper Respiratory Tract Irritation a 12 Nasal and ocular symptoms with BAQSIMI were solicited through a patient questionnaire in Study 1 and 2 and these adverse reactions are presented in Table 2.

Table 2: Solicited Nasal and Non-Nasal Adverse Reactions in Adult Patients with Type 1 and Type 2 Diabetes Pooled from Study 1 and 2 a Patients were asked to report whether they have the symptom, as well as severity (mild, moderate, severe) at baseline, and after glucagon administration. Adverse Reaction a BAQSIMI 3 mg (n=153) % Any increase in symptom severity a Watery eyes 59 Nasal congestion 43 Nasal itching 39 Runny nose 35 Redness of eyes 25 Itchy eyes 22 Sneezing 20 Itching of throat 12 Itching of ears 3 Adverse Reactions in Pediatric Patients Aged 1 Year and Above A single dose of BAQSIMI was compared to weight-based doses of 0.5 mg or 1 mg of IMG in pediatric patients aged 4 to less than 17 years with type 1 diabetes in Study 3. Table 3 presents adverse reactions that occurred with BAQSIMI in pediatric patients at an incidence of ≥2% in Study 3.

Table 3: Adverse Reactions (≥2%) Occurring in Pediatric Patients Aged 4 to less than 17 Years with Type 1 Diabetes in Study 3 a Upper Respiratory Tract Irritation: nasal discomfort, nasal congestion, sneezing. Adverse Reaction BAQSIMI 3 mg (n=36) % Vomiting 31 Headache 25 Nausea 17 Upper Respiratory Tract Irritation a 17 Nasal and ocular symptoms with BAQSIMI were solicited through a patient questionnaire in pediatric patients in Study 3 and these adverse reactions are presented in Table 4.

Table 4: Solicited Nasal and Non-Nasal Adverse Reactions in Pediatric Patients Aged 4 to less than 17 Years with Type 1 Diabetes in Study 3 a Subjects were asked to report whether they have the symptom, as well as severity (mild, moderate, severe) at baseline, and after glucagon administration. Adverse Reaction a BAQSIMI 3 mg (n=36) % Any increase in symptom severity a Watery eyes 47 Nasal congestion 42 Nasal itching 28 Runny nose 25 Sneezing 19 Itchy eyes 17 Redness of eyes 14 Itching of throat 3 Itching of ears 3 The safety of a single 3 mg intranasal dose of BAQSIMI was assessed in an open-label study of 7 pediatric patients aged 1 to less than 4 years with type 1 diabetes mellitus. The safety profile observed in this trial in pediatric patients was comparable to that observed in adults and pediatric patients aged 4 to less than 17 years. Other Adverse Reactions in Adult and Pediatric Patients Other observed adverse reactions with BAQSIMI-treated patients across clinical trials were, dysgeusia, pruritus, tachycardia, hypertension, and additional upper respiratory tract irritation events (nasal pruritus, throat irritation, and parosmia).