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BAQSIMI
(glucagon) Nasal Powder
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:
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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.
BAQSIMI™ is indicated for the treatment of severe hypoglycemia in patients with diabetes ages 4 years and above.
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:
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.
Nasal Powder:
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)
Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA. Revised: Jul 2019
The following serious adverse reactions are described below and elsewhere in labeling:
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.
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].
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 1 and Study 2
| Adverse Reaction | BAQSIMI 3 mg (N=153) % |
| Nausea | 26.1 |
| Headache | 18.3 |
| Vomiting | 15.0 |
| Upper Respiratory Tract Irritationa | 12.4 |
| a Upper Respiratory Tract Irritation: rhinorrhea, nasal discomfort, nasal congestion, cough, and epistaxis. | |
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
| 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 |
| a Subjects were asked to report whether they have the symptom, as well as severity (mild, moderate, severe) at baseline, and after glucagon administration. | |
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].
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 with Type 1 Diabetes in Study 3
| Adverse Reaction | BAQSIMI 3 mg (n=36) % |
| Vomiting | 30.6 |
| Headache | 25.0 |
| Nausea | 16.7 |
| Upper Respiratory Tract Irritationa | 16.7 |
| a Upper Respiratory Tract Irritation: nasal discomfort, nasal congestion, sneezing. | |
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 with Type 1 Diabetes in Study 3
| 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 |
| a Subjects were asked to report whether they have the symptom, as well as severity (mild, moderate, severe) at baseline, and after glucagon administration. | |
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).
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.
Patients taking beta-blockers may have a transient increase in pulse and blood pressure when given BAQSIMI.
In patients taking indomethacin, BAQSIMI may lose its ability to raise blood glucose or may even produce hypoglycemia.
BAQSIMI may increase the anticoagulant effect of warfarin.
Included as part of the PRECAUTIONS section.
BAQSIMI is contraindicated in patients with pheochromocytoma because glucagon may stimulate release of catecholamines from the tumor [see CONTRAINDICATIONS]. If the patient develops a dramatic 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.
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]. If a patient develops symptoms of hypoglycemia after a dose of BAQSIMI, give glucose orally or intravenously.
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].
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.
Advise the patient and family members or caregivers to read the FDA-approved patient labeling (PATIENT INFORMATION and Instructions for Use).
Inform patient and family members or caregivers on how to recognize the signs and symptoms of severe hypoglycemia and the risks of prolonged hypoglycemia.
Review the Patient Information and Instructions for Use with the patient and family members or caregivers.
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].
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.
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.
Animal Data
In pregnant rats given animal sourced glucagon twice-daily by injection at doses up to 2 mg/kg (up to 40 times the human dose based on body surface area extrapolation, mg/m²) during the period of organogenesis, there was no evidence of increased malformations or embryofetal lethality.
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.
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].
The safety and effectiveness of BAQSIMI have not been established in pediatric patients younger than 4 years of age.
Clinical studies of BAQSIMI did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Limited clinical trial experience has not identified differences in responses between the elderly and younger patients.
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.
BAQSIMI is contraindicated in patients with:
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.
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.
Figure 1 : Mean glucose concentration over time after
glucagon dose in adult Type 1 Diabetes patients with insulin-induced
hypoglycemia.
 |
Figure 2 : Mean glucose concentration over time in
pediatric Type 1 Diabetes patients administered BAQSIMI
 |
Glucagon absorption via the intranasal route, achieved mean peak plasma levels of 6130 pg/mL at around 15 minutes.
The apparent volume of distribution was approximately 885 L.
The median half-life was approximately 35 minutes.
Metabolism
Glucagon is known to be degraded in the liver, kidneys, and plasma.
In pediatric patients (4 to <17 years), glucagon via the intranasal route, achieved mean peak plasma levels between 15 and 20 minutes. The median half-life was 21 to 31 minutes.
Common cold with nasal congestion did not impact the pharmacokinetics of BAQSIMI.
Common cold with use of decongestant did not impact the pharmacokinetics of BAQSIMI.
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 intramuscular 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.
Table 5: Adult Patients with Type 1 Diabetes Meeting
Treatment Success and Other Glucose Criteria in Study 1
| Type 1 Diabetes (N=66)a |
||
| 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 | 66 (100%) | 66 (100%) |
| (ii) Increase by ≥20 mg/dL from nadir | 66 (100%) | 66 (100%) |
| Both (i) and (ii) | 66 (100%) | 66 (100%) |
| a The Efficacy Analysis Population consisted
of all patients who received both doses of the Study Drug with evaluable
primary outcome. b Difference calculated as (percentage with success in BAQSIMI) – (percentage with success in IMG). c 2-sided 95% confidence interval (CI) of paired differences using a Wald-Min correction; non-inferiority margin = -10%. |
||
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.
Table 6: Adult Patients with Type 1 and Type 2
Diabetes Meeting Treatment Success and Other Glucose Criteria in Study 2
| 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%) |
| a The Efficacy Analysis Population consisted
of all patients who received both doses of the Study Drug with evaluable
primary outcome. b Difference calculated as (percentage with success in BAQSIMI) – (percentage with success in IMG). c2-sided 95% confidence interval (CI) of paired differences using a Wald-Min correction; non-inferiority margin = -10%. d Percentage based on number of patients. |
||
Study 3 (NCT01997411) was a randomized, multicenter, clinical study that assessed BAQSIMI compared to intramuscular 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.
Table 7: Mean Time to Reach Glucose Increase of
≥20 mg/dL from Nadir in Pediatric Patients with Type 1 Diabetes in Study
3
| 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 |
|
| ≥20 mg/dL | 10.8 | 10.8 | 12.5 | 11.3 | 12.5 | 14.2 |
BAQSIMI™
(BAK-see-mee)
(glucagon) nasal powder
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.
Do not use BAQSIMI if you:
Before using BAQSIMI, tell your healthcare provider about all of your medical conditions, including if you:
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?
What are the possible side effects of BAQSIMI?
BAQSIMI may cause serious side effects, including:
The most common side effects of BAQSIMI include:
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.
How should I store BAQSIMI?
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.
What are the ingredients in BAQSIMI?
Active Ingredient: glucagon
Inactive Ingredients: betadex and dodecylphosphocholine
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.
Tube and Device Parts
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Important Information to Know
BAQSIMI will work even if you have a cold or are taking cold medicine.
Preparing the Dose
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Caution: Do not press the Plunger until ready to give the dose.
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Giving the Dose
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After giving BAQSIMI
Storage and Handling
Expiration Date
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Other Information
For Questions or More Information about BAQSIMI
This Instructions for Use has been approved by the U.S. Food and Drug Adminstration
