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NDC 00002-6145-27 Baqsimi 3 mg/1 Details
Baqsimi 3 mg/1
Baqsimi is a NASAL POWDER in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Eli Lilly and Company. The primary component is GLUCAGON.
MedlinePlus Drug Summary
Glucagon nasal powder is used along with emergency medical treatment to treat very low blood sugar in adults and children 4 years of age and older who have diabetes. Glucagon nasal powder is in a class of medications called glycogenolytic agents. It works by causing the liver to release stored sugar to the blood.
Related Packages: 00002-6145-27Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Glucagon Nasal Powder
Product Information
| NDC | 00002-6145 |
|---|---|
| Product ID | 0002-6145_f88837b4-7c0d-4200-aba0-e92561310058 |
| Associated GPIs | 27300010002920 |
| GCN Sequence Number | 080054 |
| GCN Sequence Number Description | glucagon SPRAY 3 MG NASAL |
| HIC3 | M4G |
| HIC3 Description | AGENTS TO TREAT HYPOGLYCEMIA (HYPERGLYCEMICS) |
| GCN | 46726 |
| HICL Sequence Number | 002795 |
| HICL Sequence Number Description | GLUCAGON |
| Brand/Generic | Brand |
| Proprietary Name | Baqsimi |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | glucagon |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | POWDER |
| Route | NASAL |
| Active Ingredient Strength | 3 |
| Active Ingredient Units | mg/1 |
| Substance Name | GLUCAGON |
| Labeler Name | Eli Lilly and Company |
| Pharmaceutical Class | Antihypoglycemic Agent [EPC], Decreased GI Motility [PE], Decreased GI Smooth Muscle Tone [PE], Decreased Glycolysis [PE], Gastrointestinal Motility Inhibitor [EPC], Increased Gluconeogenesis [PE], Increased Glycogenolysis [PE] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA210134 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 00002-6145-27 (00002614527)
| NDC Package Code | 0002-6145-27 |
|---|---|
| Billing NDC | 00002614527 |
| Package | 2 TUBE in 1 CARTON (0002-6145-27) / 1 BOTTLE, UNIT-DOSE in 1 TUBE (0002-6145-02) / 1 POWDER in 1 BOTTLE, UNIT-DOSE (0002-6145-01) |
| Marketing Start Date | 2019-08-06 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 269.066 |
| Pricing Unit | EA |
| Effective Date | 2024-02-21 |
| NDC Description | BAQSIMI 3 MG SPRAY TWO PACK |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1, 5 |
| Classification for Rate Setting | B |
| As of Date | 2024-02-21 |
Standard Product Labeling (SPL)/Prescribing Information SPL 3fdb4e92-2e19-487d-9f14-99871e9fd15a Details
HIGHLIGHTS OF PRESCRIBING INFORMATION
BAQSIMI (glucagon) nasal powder
Initial U.S. Approval: 1960
INDICATIONS AND USAGE
BAQSIMI™ is an antihypoglycemic agent indicated for the treatment of severe hypoglycemia in adult and pediatric patients with diabetes ages 4 years and above. (1)
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. (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)
DOSAGE FORMS AND STRENGTHS
Nasal powder: intranasal device containing one dose of glucagon 3 mg (3)
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
- Substantial Increase in Blood Pressure in Patients with Pheochromocytoma: Contraindicated in patients with pheochromocytoma because BAQSIMI may stimulate the release of catecholamines from the tumor. (4, 5.1)
- Hypoglycemia in Patients with Insulinoma: In patients with insulinoma, administration may produce an initial increase in blood glucose; however, BAQSIMI may stimulate exaggerated insulin release from an insulinoma and cause hypoglycemia. If a patient develops symptoms of hypoglycemia after a dose of BAQSIMI, give glucose orally or intravenously. (4, 5.2)
- Hypersensitivity and Allergic Reactions: Allergic reactions have been reported and include generalized rash, and in some cases anaphylactic shock with breathing difficulties, and hypotension. (4, 5.3)
- Lack of Efficacy in Patients with Decreased Hepatic Glycogen: BAQSIMI is effective in treating hypoglycemia only if sufficient hepatic glycogen is present. Patients in states of starvation, with adrenal insufficiency or chronic hypoglycemia may not have adequate levels of hepatic glycogen for BAQSIMI to be effective. Patients with these conditions should be treated with glucose. (5.4)
ADVERSE REACTIONS
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 Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 8/2021
Table Of Contents
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 and Above
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Substantial Increase in Blood Pressure in Patients with Pheochromocytoma
5.2 Hypoglycemia in Patients with Insulinoma
5.3 Hypersensitivity and Allergic Reactions
5.4 Lack of Efficacy in Patients with Decreased Hepatic Glycogen
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 information are not listed.
1 INDICATIONS AND USAGE
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 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.
- 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.
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 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.
3 DOSAGE FORMS AND STRENGTHS
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)]
- Known hypersensitivity 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)]
5 WARNINGS AND PRECAUTIONS
5.1 Substantial Increase in Blood Pressure in Patients with Pheochromocytoma
BAQSIMI is contraindicated in patients with pheochromocytoma because glucagon may stimulate release of catecholamines from the tumor [see Contraindications (4)]. If the patient develops a substantial increase in blood pressure and a previously undiagnosed pheochromocytoma is suspected, 5 to 10 mg of phentolamine mesylate, administered intravenously, has been shown to be effective in lowering blood pressure.
5.2 Hypoglycemia in Patients with Insulinoma
In patients with insulinoma, administration of glucagon may produce an initial increase in blood glucose; however, BAQSIMI administration may directly or indirectly (through an initial rise in blood glucose) stimulate exaggerated insulin release from an insulinoma and cause hypoglycemia. BAQSIMI is contraindicated in patients with insulinoma [see Contraindications (4)]. If a patient develops symptoms of hypoglycemia after a dose of BAQSIMI, give glucose orally or intravenously.
5.3 Hypersensitivity and Allergic Reactions
Allergic reactions have been reported with glucagon, these include generalized rash, and in some cases anaphylactic shock with breathing difficulties and hypotension. BAQSIMI is contraindicated in patients with a prior hypersensitivity reaction [see Contraindications (4)].
5.4 Lack of Efficacy in Patients with Decreased Hepatic Glycogen
BAQSIMI is effective in treating hypoglycemia only if sufficient hepatic glycogen is present. Patients in states of starvation, with adrenal insufficiency or chronic hypoglycemia may not have adequate levels of hepatic glycogen for BAQSIMI administration to be effective. Patients with these conditions should be treated with glucose.
6 ADVERSE REACTIONS
The following serious adverse reactions are described below and elsewhere in labeling:
- Hypersensitivity and Allergic Reactions [see Warnings and Precautions (5.3)].
6.1 Clinical Trial Data
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 dose of BAQSIMI compared to a 1 mg dose of intra-muscular glucagon (IMG) in adult patients with diabetes [see Clinical Studies (14)].
Table 1 presents adverse reactions that occurred with BAQSIMI at an incidence of ≥2% in a pool of Study 1 and Study 2.
|
a Upper Respiratory Tract Irritation: rhinorrhea, nasal discomfort, nasal congestion, cough, and epistaxis. |
|
| Adverse Reaction | BAQSIMI 3 mg
(N=153) % |
| Nausea | 26.1 |
| Headache | 18.3 |
| Vomiting | 15.0 |
| Upper Respiratory Tract Irritationa | 12.4 |
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.
|
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 Reactiona | BAQSIMI 3 mg
(n=153) % |
| Any increase in symptom severitya | |
| Watery eyes | 58.8 |
| Nasal congestion | 42.5 |
| Nasal itching | 39.2 |
| Runny nose | 34.6 |
| Redness of eyes | 24.8 |
| Itchy eyes | 21.6 |
| Sneezing | 19.6 |
| Itching of throat | 12.4 |
| Itching of ears | 3.3 |
Adverse Reactions in Pediatric Patients Aged 4 Years 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 with type 1 diabetes in Study 3 [see Clinical Studies (14)].
Table 3 presents adverse reactions that occurred with BAQSIMI in pediatric patients at an incidence of ≥2% in Study 3.
|
a Upper Respiratory Tract Irritation: nasal discomfort, nasal congestion, sneezing. |
|
| Adverse Reaction | BAQSIMI 3 mg
(n=36) % |
| Vomiting | 30.6 |
| Headache | 25.0 |
| Nausea | 16.7 |
| Upper Respiratory Tract Irritationa | 16.7 |
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.
|
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 Reactiona | BAQSIMI 3 mg
(n=36) % |
| Any increase in symptom severitya | |
| Watery eyes | 47.2 |
| Nasal congestion | 41.7 |
| Nasal itching | 27.8 |
| Runny nose | 25.0 |
| Sneezing | 19.4 |
| Itchy eyes | 16.7 |
| Redness of eyes | 13.9 |
| Itching of throat | 2.8 |
| Itching of ears | 2.8 |
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).
6.2 Immunogenicity
As with all therapeutic peptides, there is the 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 incidence of antibodies to BAQSIMI with the incidences of antibodies to other products may be misleading.
In 3 clinical trials, 3/124 (2%) of BAQSIMI-treated patients had treatment-emergent anti-drug antibodies as detected by an affinity capture elution (ACE) ligand-binding immunogenicity assay. No neutralizing antibodies were detected.
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Available data from case reports and a small number of observational studies with glucagon use in pregnant women over decades of use have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Multiple small studies have demonstrated a lack of transfer of pancreatic glucagon across the human placental barrier during early gestation. In a rat reproduction study, no embryofetal toxicity was observed with glucagon administered by injection during the period of organogenesis at doses representing up to 40 times the human dose, based on body surface area (mg/m2) (see Data).
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
8.2 Lactation
Risk Summary
There is no information available on the presence of glucagon in human or animal milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. However, glucagon is a peptide and would be expected to be broken down to its constituent amino acids in the infant's digestive tract and is therefore, unlikely to cause harm to an exposed infant.
8.4 Pediatric Use
The safety and effectiveness of BAQSIMI for the treatment of severe hypoglycemia in patients with diabetes have been established in pediatric patients ages 4 years and above. Use of BAQSIMI for this indication is supported by evidence from a study in 48 pediatric patients from 4 to <17 years of age with type 1 diabetes mellitus. [see Clinical Studies (14.2)].
The safety and effectiveness of BAQSIMI have not been established in pediatric patients younger than 4 years of age.
10 OVERDOSAGE
If overdosage occurs, the patient may experience nausea, vomiting, inhibition of GI tract motility, increase in blood pressure and pulse rate. In case of suspected overdosing, serum potassium levels may decrease and should be monitored and corrected if needed. If the patient develops a dramatic increase in blood pressure, phentolamine mesylate has been shown to be effective in lowering blood pressure for the short time that control would be needed.
11 DESCRIPTION
BAQSIMI contains glucagon, an antihypoglycemic agent used to treat severe hypoglycemia. Glucagon is a single-chain polypeptide containing 29 amino acid residues and has a molecular weight of 3483, and is identical to human glucagon.
Its molecular formula is C153H225N43O49S, with the following molecular structure:
BAQSIMI is a preservative-free, white powder for intranasal administration in an intranasal device containing one dose of 3 mg glucagon. BAQSIMI contains glucagon as the active ingredient and betadex, and dodecylphosphocholine as the excipients.
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Glucagon increases blood glucose concentration by activating hepatic glucagon receptors, thereby stimulating glycogen breakdown and release of glucose from the liver. Hepatic stores of glycogen are necessary for glucagon to produce an antihypoglycemic effect.
12.2 Pharmacodynamics
After administration of BAQSIMI in adult patients with diabetes, the mean maximum glucose increase from baseline was 140 mg/dL (Figure 1).
In pediatric patients with type 1 diabetes (4 to <17 years), the mean maximum glucose increase from baseline was 138 mg/dL (4 to <8 years), 133 mg/dL (8 to <12 years), and 102 mg/dL (12 to <17 years) (Figure 2).
Sex and body weight had no clinically meaningful effects on the pharmacodynamics of BAQSIMI.
Common cold with nasal congestion tested with or without use of decongestant did not impact pharmacodynamics of BAQSIMI.
12.3 Pharmacokinetics
Absorption
Glucagon absorption via the intranasal route, achieved mean peak plasma levels of 6130 pg/mL at around 15 minutes.
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Long term studies in animals to evaluate carcinogenic potential have not been performed. Recombinant glucagon was positive in the bacterial Ames assay. It was determined that an increase in colony counts was related to technical difficulties in running this assay with peptides. Studies in rats have shown that glucagon does not cause impaired fertility.
14 CLINICAL STUDIES
14.1 Adult Patients
Study 1 (NCT03339453) was a randomized, multicenter, open-label, 2-period, crossover study in adult patients with type 1 diabetes. The efficacy of a single 3 mg dose of BAQSIMI was compared to a 1 mg dose of intra-muscular glucagon (IMG). Insulin was used to reduce blood glucose levels to <60 mg/dL. Seventy patients were enrolled, with a mean age of 41.7 years and a mean diabetes duration of 20.1 years. Twenty-seven (39%) were female.
The primary efficacy outcome measure was the proportion of patients achieving treatment success, which was defined as either an increase in blood glucose to ≥70 mg/dL or an increase of ≥20 mg/dL from glucose nadir within 30 minutes after receiving study glucagon, without receiving additional actions to increase the blood glucose level. Glucose nadir was defined as the minimum glucose measurement at the time of, or within 10 minutes, following glucagon administration.
The mean nadir blood glucose was 54.5 mg/dL for BAQSIMI and 55.8 mg/dL for IMG. BAQSIMI demonstrated non-inferiority to IMG in reversing insulin-induced hypoglycemia with 100% of BAQSIMI-treated patients and 100% of IMG-treated patients achieving treatment success. The mean time to treatment success was 11.6 and 9.9 minutes in the BAQSIMI and IMG 1 mg treatment groups, respectively.
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a The Efficacy Analysis Population consisted of all patients who received both doses of the Study Drug with evaluable primary outcome. |
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b Difference calculated as (percentage with success in BAQSIMI) – (percentage with success in IMG). |
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c 2-sided 95% confidence interval (CI) of paired differences using a Wald-Min correction; non-inferiority margin = -10%. |
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| Type 1 Diabetes (N=66)a |
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| BAQSIMI 3 mg | IMG
1 mg |
|
| Treatment Success – n (%) | 66 (100%) | 66 (100%) |
| Treatment Difference (2-sided 95% confidence limit)b, c | 0% (-2.9%, 2.9%) | |
| Glucose criterion met – n (%) | ||
| (i) ≥70 mg/dL (ii) Increase by ≥20 mg/dL from nadir Both (i) and (ii) | 66 (100%) 66 (100%) 66 (100%) | 66 (100%) 66 (100%) 66 (100%) |
Study 2 (NCT01994746) was a randomized, multicenter, open-label, 2-period, crossover study in adult patients with type 1 diabetes or type 2 diabetes. The efficacy of a single 3 mg dose of BAQSIMI was compared to a 1 mg dose of intra-muscular glucagon (IMG). Insulin was used to reduce blood glucose levels to the hypoglycemic range with a target blood glucose nadir of <50 mg/dL.
Study 2 enrolled 83 patients 18 to <65 years of age. The mean age of patients with type 1 diabetes (N=77) was 32.9 years and a mean diabetes duration of 18.1 years, and 45 (58%) patients were female. The mean age of patients with type 2 diabetes (N=6) was 47.8 years, with a mean diabetes duration of 18.8 years, and 4 (67%) patients were female.
The mean nadir blood glucose was 44.2 mg/dL for BAQSIMI and 47.2 mg/dL for IMG. BAQSIMI demonstrated non-inferiority to IMG in reversing insulin-induced hypoglycemia with 98.8% of BAQSIMI-treated patients and 100% of IMG-treated patients achieving treatment success within 30 minutes.
The mean time to treatment success was 15.9 and 12.1 minutes in the BAQSIMI and IMG 1 mg treatment groups, respectively.
|
a The Efficacy Analysis Population consisted of all patients who received both doses of the Study Drug with evaluable primary outcome. |
||
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b Difference calculated as (percentage with success in BAQSIMI) – (percentage with success in IMG). |
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c 2-sided 95% confidence interval (CI) of paired differences using a Wald-Min correction; non-inferiority margin = -10%. |
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d Percentage based on number of patients. |
||
| Type 1 and Type 2 Diabetes (N=80)a | ||
| BAQSIMI
3 mg | IMG
1 mg |
|
| Treatment Success – n (%) | 79 (98.8%) | 80 (100%) |
| Treatment Difference (2-sided 95% confidence limit) b,c | -1.3% (-4.6%, 2.2%) | |
| Glucose criterion met – n (%)d | ||
| (i) ≥70 mg/dL | 77 (96%) | 79 (99%) |
| (ii) Increase by ≥20 mg/dL from nadir | 79 (99%) | 80 (100%) |
| Both (i) and (ii) | 77 (96%) | 79 (99%) |
14.2 Pediatric Patients
Study 3 (NCT01997411) was a randomized, multicenter, clinical study that assessed BAQSIMI compared to intra-muscular glucagon (IMG) in pediatric patients aged 4 years and older with type 1 diabetes. Insulin was used to reduce blood glucose levels, and glucagon was administered after glucose reached <80 mg/dL. Efficacy was assessed based on percentage of patients with a glucose increase of ≥20 mg/dL from glucose nadir within 30 minutes following BAQSIMI administration.
Forty-eight patients were enrolled and received at least one dose of study drug. The mean age in the Young Children cohort (4 to <8 years) was 6.5 years. In the Children cohort (8 to <12 years), mean age was 11.1 years and in the Adolescents cohort (12 to <17 years) mean age was 14.6 years. In all age cohorts, the population was predominantly male and white.
Across all age groups, all (100%) patients in both treatment arms achieved an increase in glucose ≥20 mg/dL from glucose nadir within 20 minutes of glucagon administration. The mean time to reach a glucose increase of ≥20 mg/dL for BAQSIMI and IMG for all age groups is shown in Table 7.
| Increase from Nadir | Mean Time Post-Glucagon Administration (minutes) | |||||
|---|---|---|---|---|---|---|
| Young Children
(4 to <8 years old) | Children
(8 to <12 years old) | Adolescents
(12 to <17 years old) |
||||
| IMGa
N=6 | BAQSIMI
3 mg N=12 | IMGa
N=6 | BAQSIMI
3 mg N=12 | IMGa
N=12 | BAQSIMI
3 mg N=12 |
|
|
a 0.5 mg or 1 mg of IMG (based upon body weight) |
||||||
| ≥20 mg/dL | 10.8 | 10.8 | 12.5 | 11.3 | 12.5 | 14.2 |
16 HOW SUPPLIED/STORAGE AND HANDLING
BAQSIMI is supplied as an intranasal device containing one 3 mg dose of glucagon as a preservative free, white powder.
- BAQSIMI One Pack™ carton contains 1 intranasal device (NDC 0002-6145-11)
- BAQSIMI Two Pack™ carton contains 2 intranasal devices (NDC 0002-6145-27)
- Store at temperatures up to 86°F (30°C) in the shrink wrapped tube provided.
- Keep BAQSIMI in the shrink wrapped tube until ready to use. If the tube has been opened, BAQSIMI may have been exposed to moisture and may not work as expected.
- Discard BAQSIMI and tube after use.
17 PATIENT COUNSELING INFORMATION
Advise the patient and family members or caregivers to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
Recognition of Severe Hypoglycemia:
Inform patient and family members or caregivers on how to recognize the signs and symptoms of severe hypoglycemia and the risks of prolonged hypoglycemia.
Administration:
Review the Patient Information and Instructions for Use with the patient and family members or caregivers.
Serious Hypersensitivity:
Inform patients that allergic reactions can occur with BAQSIMI. Advise patients to seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions [see Warnings and Precautions (5.3)].
Literature revised: October 2020
Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA
Copyright © 2019, 2020, Eli Lilly and Company. All rights reserved.
BAQ-0002-USPI-20201027
SPL UNCLASSIFIED SECTION
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This Patient Information has been approved by the U.S. Food and Drug Administration |
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Issued: July 2019 |
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| PATIENT INFORMATION
BAQSIMI™ (BAK-see-mee) (glucagon) nasal powder |
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| What is BAQSIMI?
BAQSIMI is a prescription medicine used to treat very low blood sugar (severe hypoglycemia) in people with diabetes ages 4 years and above. It is not known if BAQSIMI is safe and effective in children under 4 years of age. |
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Do not use BAQSIMI if you:
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Before using BAQSIMI, tell your healthcare provider about all of your medical conditions, including if you:
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| Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. | ||
How should I use BAQSIMI?
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| What are the possible side effects of BAQSIMI?
BAQSIMI may cause serious side effects, including:
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| The most common side effects of BAQSIMI include:
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| These are not all the possible side effects of BAQSIMI. For more information, ask your healthcare provider. Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. |
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How should I store BAQSIMI?
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| Keep BAQSIMI and all medicines out of the reach of children. | ||
| General Information about the safe and effective use of BAQSIMI.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use BAQSIMI for a condition for which it was not prescribed. Do not give BAQSIMI to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about BAQSIMI that is written for healthcare professionals. |
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| What are the ingredients in BAQSIMI?
Active Ingredient: glucagon Inactive Ingredients: betadex and dodecylphosphocholine |
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| Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA
www.baqsimi.com Copyright © 2019, Eli Lilly and Company. All rights reserved. |
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| For more information, call 1-800-LillyRx (1-800-545-5979) or go to the following website: www.baqsimi.com. | ||
BAQ-0001-PPI-20190724
INSTRUCTIONS FOR USE
INSTRUCTIONS FOR USE
BAQSIMI™
(glucagon) nasal powder
3 mg
Read the Instructions for Use for BAQSIMI before using it. BAQSIMI is used to treat very low blood sugar (severe hypoglycemia) that may cause you to need help from others. You should make sure you show your caregivers, family and friends where you keep BAQSIMI and explain how to use it by sharing these instructions. They need to know how to use BAQSIMI before an emergency happens.
Important Information to Know
- Do not remove the Shrink Wrap or open the Tube until you are ready to use it.
- If the Tube has been opened, BAQSIMI could be exposed to moisture. This could cause BAQSIMI not to work as expected.
- Do not push the plunger or test BAQSIMI before you are ready to use it.
- BAQSIMI contains 1 dose of glucagon nasal powder and cannot be reused.
- BAQSIMI is for nasal (nose) use only.
- BAQSIMI will work even if you have a cold or are taking cold medicine.
Preparing the Dose
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Giving the Dose
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After giving BAQSIMI
- Call for emergency medical help right away.
- If the person is unconscious turn the person on their side.
- Throw away the used Device and Tube.
- Encourage the person to eat as soon as possible. When they are able to safely swallow, give the person a fast acting source of sugar, such as juice. Then encourage the person to eat a snack, such as crackers with cheese or peanut butter.
- If the person does not respond after 15 minutes, another dose may be given, if available.
Storage and Handling
- Do not remove the Shrink Wrap or open the Tube until you are ready to use it.
- Store BAQSIMI in the shrink wrapped Tube at temperatures up to 86º F (30ºC ).
- Replace BAQSIMI before the expiration date printed on the Tube or carton.
Other Information
- Caution: Replace the used BAQSIMI right away so you will have a new BAQSIMI in case you need it.
- Keep BAQSIMI and all medicines out of the reach of children.
For Questions or More Information about BAQSIMI
- Call your healthcare provider
- Call Lilly at 1-800-Lilly-Rx (1-800-545-5979)
- Visit www.baqsimi.com
BAQSIMI is a trademark of Eli Lilly and Company.
Marketed by: Lilly USA, LLC
Indianapolis, IN 46285, USA
Copyright © 2019, Eli Lilly and Company. All rights reserved.
| BAQSIMI Device meets all applicable requirements defined in ISO 20072 |
This Instructions for Use has been approved by the U.S. Food and Drug Adminstration
Issued: July 2019
BAQ-0001-IFU-20190724
PACKAGE LABEL – Baqsimi 3 mg Nasal Powder Two Pack
INGREDIENTS AND APPEARANCE
| BAQSIMI
glucagon powder |
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| Labeler - Eli Lilly and Company (006421325) |