Baqsimi

Last updated on RxList: 11/4/2020
Baqsimi Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Baqsimi?

Baqsimi (glucagon) Nasal Powder is an antihypoglycemic agent indicated for the treatment of severe hypoglycemia in patients with diabetes ages 4 years and above.

What Are Side Effects of Baqsimi?

Common side effects of Baqsimi Nasal Powder include:

Dosage for Baqsimi

The recommended dose of Baqsimi Nasal Powder is 3 mg administered as one pump spray of the intranasal device into one nostril.

What Drugs, Substances, or Supplements Interact with Baqsimi?

Baqsimi Nasal Powder may interact with beta-blockers, indomethacin, and warfarin. Tell your doctor all medications and supplements you use.

Baqsimi During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Baqsimi Nasal Powder; it is not expected to harm a fetus. It is unknown if Baqsimi Nasal Powder passes into breast milk. Glucagon is a peptide and would be expected to be broken down to its constituent amino acids in an infant's digestive tract and is therefore unlikely to cause harm to an exposed infant. Consult your doctor before breastfeeding.

Additional Information

Our Baqsimi (glucagon) Nasal Powder Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Diabetes: What Raises and Lowers Your Blood Sugar Level? See Slideshow
Baqsimi Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; feeling light-headed; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have symptoms of high blood pressure, such as severe headache, blurred vision, and pounding in your neck or ears.

Common side effects may include:

  • discomfort in your nose, runny or stuffy nose;
  • nosebleed;
  • nausea, vomiting;
  • red or watery eyes;
  • itchy eyes, nose, or throat;
  • cough; or
  • headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Baqsimi (Glucagon Nasal Powder )

QUESTION

Diabetes is defined best as... See Answer
Baqsimi Professional Information

SIDE EFFECTS

The following serious adverse reactions are described below and elsewhere in labeling:

  • Hypersensitivity and Allergic Reactions [see WARNINGS AND PRECAUTIONS].

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].

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 ReactionBAQSIMI 3 mg
(N=153)
%
Nausea26.1
Headache18.3
Vomiting15.0
Upper Respiratory Tract Irritationa12.4
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 ReactionaBAQSIMI 3 mg
(n=153)
%
Any increase in symptom severitya
Watery eyes58.8
Nasal congestion42.5
Nasal itching39.2
Runny nose34.6
Redness of eyes24.8
Itchy eyes21.6
Sneezing19.6
Itching of throat12.4
Itching of ears3.3
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 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].

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 ReactionBAQSIMI 3 mg
(n=36)
%
Vomiting30.6
Headache25.0
Nausea16.7
Upper Respiratory Tract Irritationa16.7
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 ReactionaBAQSIMI 3 mg
(n=36)
%
Any increase in symptom severitya
Watery eyes47.2
Nasal congestion41.7
Nasal itching27.8
Runny nose25.0
Sneezing19.4
Itchy eyes16.7
Redness of eyes13.9
Itching of throat2.8
Itching of ears2.8
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 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).

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.

Read the entire FDA prescribing information for Baqsimi (Glucagon Nasal Powder )

© Baqsimi Patient Information is supplied by Cerner Multum, Inc. and Baqsimi Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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