)
• Indomethacin: In patients taking indomethacin BAQSIMI may loseits ability to raise glucose or may produce hypoglycemia. (7.2)
• Warfarin: BAQSIMI may increase the anticoagulant effect ofwarfarin. (7.3)
See 17 for PATIENT COUNSELING INFORMATION and FDAapproved
patient labeling.
Revised: 07/2019
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FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Important Administration Instructions
2.2 Dosage in Adults and Pediatric Patients Aged 4 Years andAbove
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Catecholamine Release in Patients with
Pheochromocytoma
5.2 Lack of Efficacy in Patients with Insulinoma
5.3 Hypersensitivity and Allergic Reactions
5.4 Lack of Efficacy in Patients with Decreased HepaticGlycogen
6 ADVERSE REACTIONS
6.1 Clinical Trial Data
6.2 Immunogenicity
7 DRUG INTERACTIONS
7.1 Beta-blockers
7.2 Indomethacin
7.3 Warfarin
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Adult Patients
14.2 Pediatric Patients
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing informationare not list
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FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
BAQSIMI™ is indicated for the treatment of severe hypoglycemia in patients with diabetes ages 4 years andabove.
2 DOSAGE AND ADMINISTRATION
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 severehypoglycemia requires help of others to recover, instruct the patient to inform those around them about BAQSIMIand 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 theInstructions for Use.
Administer the dose by inserting the tip into one nostril and pressing the device plunger all the way in until thegreen line is no longer showing. The dose does not need to be inhaled.
Call for emergency assistance immediately after administering the dose.
When the patient responds to treatment, give oral carbohydrates to restore the liver glycogen and preventrecurrence of hypoglycemia.
Do not attempt to reuse BAQSIMI. Each BAQSIMI device contains one dose of glucagon and cannot bereused.
2.2 Dosage in Adults and Pediatric Patients Aged 4 Years and Above
The recommended dose of BAQSIMI is 3 mg administered as one actuation of the intranasal device into onenostril.
If there has been no respons
