Baqsimi 3 mg/1
glucagon · POWDER · Amphastar Pharmaceuticals, Inc.
Baqsimi is a powder containing glucagon at 3 mg/1, taken nasal. Manufactured by Amphastar Pharmaceuticals, Inc..
Key Facts
- Brand Name
- Baqsimi
- Generic Name
- glucagon
- NDC Code (Product)
0548-8352- Manufacturer
- Amphastar Pharmaceuticals, Inc.
- Strength
- 3 mg/1
- Dosage Form
- POWDER
- Route
- NASAL
- Marketing Status
- Application #
- NDA210134
- Drug Class
- Antihypoglycemic Agent [EPC]; Gastrointestinal Motility Inhibitor [EPC]
- Marketing Start
- 07/24/2019
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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 )
Dosage & Administration
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…
Contraindications
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 )
Drug Interactions
7 DRUG INTERACTIONS Beta-blockers : Patients taking beta-blockers may have a transient increase in pulse and blood pressure. ( 7.1 ) Indomethacin : In patients taking indomethacin BAQSIMI may lose its ability to raise glucose or may produce hypoglycemia. ( 7.2 ) Warfarin : BAQSIMI may increase the anticoagulant effect of warfarin. ( 7.3 ) 7.1 Beta-blockers Patients taking beta-blockers may have a transient increase in pulse and blood pressure when given BAQSIMI. 7.2 Indomethacin In patients taking indomethacin, BAQSIMI may lose its ability to raise blood glucose or may even produce hypoglycemia. 7.3 Warfarin BAQSIMI may increase the anticoagulant effect of warfarin.
Adverse Reactions
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. A…
Frequently Asked Questions
What is Baqsimi used for?
Baqsimi contains glucagon. It is a powder taken nasal. Consult your doctor for specific uses.
Is Baqsimi a controlled substance?
Baqsimi is not classified as a controlled substance by the DEA.
What is the generic name for Baqsimi?
The generic name for Baqsimi is glucagon. There are 11 other brand versions of glucagon.
What is the NDC code for Baqsimi 3 mg/1?
The NDC (National Drug Code) for Baqsimi 3 mg/1 is 0548-8352, listed by Amphastar Pharmaceuticals, Inc..