Baqsimi

Baqsimi is an FDA-registered drug product whose active ingredient is GLUCAGON. It is labelled by Sportpharm LLC taken by nasal and marketed as a human prescription drug product. Identifiers on file: NDC 85766-212, application NDA210134, label effective 20260619. It is one of 7 FDA drug label records sharing the active ingredient GLUCAGON. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing GLUCAGON are most often described in connection with: treatment severe, hypoglycemia adults, pediatric patients, aged year, usage baqsimi, antihypoglycemic agent. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE BAQSIMI™ is indicated for the treatment of severe hypoglycemia in adults and pediatric patients aged 1 year and older with diabetes. BAQSIMI ® is an antihypoglycemic agent indicated for the treatment of severe hypoglycemia in adults and pediatric patients aged 1 year and older with diabetes. ( 1 )

2 DOSAGE AND ADMINISTRATION BAQSIMI is for intranasal use only. ( 2.1 ) The recommended dose of BAQSIMI is 3 mg administered as one actuation of the intranasal device into one nostril. ( 2.2 ) Administer BAQSIMI according to the printed instructions on the shrink-wrapped tube label and the Instructions for Use. ( 2.1 ) Administer the dose by inserting the tip into one nostril and pressing the device plunger all the way in until the green line is no longer showing. The dose does not need to be inhaled. ( 2.1 ) Call for emergency assistance immediately after administering the dose. ( 2.1 ) When the patient responds to treatment, give oral carbohydrates. ( 2.1 ) Do not attempt to reuse BAQSIMI. Each BAQSIMI device contains one dose of glucagon and cannot be reused. Discard any unused portion. ( 2.1 ) If there has been no response after 15 minutes, an additional 3 mg dose may be administered while waiting for emergency assistance. ( 2.2 ) 2.1 Important Administration Instructions BAQSIMI is for intranasal use only. Instruct patients and their caregivers on the signs and symptoms of severe hypoglycemia. Because severe hypoglycemia requires help of others to recover, instruct the patient to inform those around them about BAQSIMI and its Instructions for Use. Administer BAQSIMI as soon as possible when severe hypoglycemia is recognized. Instruct the patient or caregiver to read the Instructions for Use at the time they receive a prescription for BAQSIMI. Emphasize the following instructions to the patient or caregiver: Do not push the plunger or test the device prior to administration. Administer BAQSIMI according to the printed instructions on the shrink-wrapped tube label and the Instructions for Use. Administer the dose by inserting the tip into one nostril and pressing the device plunger all the way in until the green line is no longer showing. The dose does not need to be inhaled. Call for emergency assistance immediately after administering the dose. If there has been no response after 15 minutes, an additional dose of BAQSIMI may be administered while waiting for emergency assistance. When the patient responds to treatment, give oral carbohydrates to restore the liver glycogen and prevent recurrence of hypoglycemia. Do not attempt to reuse BAQSIMI. Each BAQSIMI device contains one dose of glucagon and cannot be reused. Discard any unused portion. 2.2 Dosage in Adults and Pediatric Patients Aged 1 Year and Older The recommended dose of BAQSIMI is 3 mg administered as one actuation of the intranasal device into one nostril. If there has been no response after 15 minutes, an additional 3 mg dose of BAQSIMI from a new device may be administered while waiting for emergency assistance.

4 CONTRAINDICATIONS BAQSIMI is contraindicated in patients with: Pheochromocytoma because of the risk of substantial increase in blood pressure [see Warnings and Precautions ( 5.1 )] Insulinoma because of the risk of hypoglycemia [see Warnings and Precautions ( 5.2 )] Prior hypersensitivity reaction to glucagon or to any of the excipients in BAQSIMI. Allergic reactions have been reported with glucagon and include anaphylactic shock with breathing difficulties and hypotension [see Warnings and Precautions ( 5.3 )] Pheochromocytoma ( 4 ) Insulinoma ( 4 ) Known hypersensitivity to glucagon or to any of the excipients ( 4 )

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in labeling: Substantial Increase in Blood Pressure in Patients with Pheochromocytoma [see Warnings and Precautions ( 5.1 )] . Hypoglycemia in Patients with Insulinoma [see Warnings and Precautions ( 5.2 )] . Serious Hypersensitivity Reactions [see Warnings and Precautions ( 5.3 )] . Lack of Efficacy in Patients with Decreased Hepatic Glycogen [see Warnings and Precautions ( 5.4 )] . 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. ( 6.1 ) 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 [see Clinical Studies ( 14.1 )]. 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 [see Clinical Studies ( 14.2 )]. 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 [see Clinical Studies ( 14.2 )] . 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 [see Clinical Pharmacology ( 12.2 , 12.3 )] . 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).

FDA lists 7 drug label records with GLUCAGON as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Baqsimi used for?
1 INDICATIONS AND USAGE BAQSIMI™ is indicated for the treatment of severe hypoglycemia in adults and pediatric patients aged 1 year and older with diabetes. BAQSIMI ® is an antihypoglycemic agent indicated for the treatment of severe hypoglycemia in adults and pediatric patients aged 1 year and older with diabetes. ( 1 )

Who makes Baqsimi?
Sportpharm LLC is the labeler of record for Baqsimi. 7 FDA label records share the active ingredient GLUCAGON, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Baqsimi come in?
administered by nasal. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Baqsimi prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing GLUCAGON?
Yes. 7 FDA drug label records list GLUCAGON as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Baqsimi been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.