Note: This document contains side effect information about glucagon. Some dosage forms listed on this page may not apply to the brand name Gvoke.

Applies to glucagon: injection powder for solution. Other dosage forms:

• nasal powder, powder nasal

Serious side effects of Gvoke

Along with its needed effects, glucagon (the active ingredient contained in Gvoke) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking glucagon:

Rare

• Anxiety
• blurred vision
• chills
• cold sweats
• coma
• confusion
• cool, pale skin
• depression
• dizziness
• dry mouth
• fast heartbeat
• flushed, dry skin
• fruit-like breath odor
• headache
• increased hunger
• increased thirst
• increased urination
• nausea
• nervousness
• nightmares
• seizures
• shakiness
• slurred speech
• sweating
• trouble breathing
• unexplained weight loss
• unusual tiredness or weakness
• vomiting

Incidence not known

• Chest tightness
• cough
• diarrhea
• difficulty with swallowing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fast, pounding, or irregular heartbeat or pulse
• hives, itching, or skin rash
• lack or loss of strength
• paleness of the skin
• pounding in the ears
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• sleepiness or unusual drowsiness
• slow or fast heartbeat

Other side effects of Gvoke

Some side effects of glucagon may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

For Healthcare Professionals

Applies to glucagon: injectable powder for injection, nasal powder, subcutaneous solution.

General

The more commonly reported adverse reactions have included nausea, vomiting, and headache; nasal and ocular symptoms including watery eyes and nasal congestion and itching have been reported with nasal administration.^[Ref]

Hypersensitivity

Very rare (less than 0.01%): Anaphylactic reactions

Frequency not reported: Generalized allergic reactions^[Ref]

Nervous system

Very common (10% or more): Headache (up to 18.3%)

Frequency not reported: Dysgeusia (nasal), parosmia (nasal)

Metabolic

Hypoglycemia/hypoglycemia coma have been reported in patients using this drug as a diagnostic aid, especially among those patients who have fasted.

Uncommon (0.1% to 1%): Hypoglycemia

Very rare (less than 0.01%): Hypoglycemia coma

Ocular

Frequency not reported: Watery eyes, itchy eyes, redness of eyes

Watery eyes, itchy eyes, and eye redness were reported when adult patients were specifically questioned if these symptoms were present; some increase in symptom severity was reported by 58.8%, 21.6%, 24.8%, respectively. Symptom worsening of watery eyes, itchy eyes, and eye redness were reported by 47.2%, 16.7%, 13.9%, of pediatric patients, respectively.

Gastrointestinal

Very common (10% or more): Nausea (up to 26.1%), vomiting (up to 15%)

Rare (less than 0.1%): Abdominal pain

Frequency not reported: Throat irritation (nasal)^[Ref]

Dermatologic

Frequency not reported: Pruritus

Postmarketing reports: Necrolytic migratory erythema (with continuous glucagon (the active ingredient contained in Gvoke) infusions)

Cardiovascular

Very rare (less than 0.01%): Bradycardia, tachycardia, hypotension, hypertension

Respiratory

Upper respiratory tract irritation including rhinorrhea, nasal discomfort, nasal congestion, cough, and epistaxis were reported in 12.4% of adult patients in pooled studies of IM and nasal glucagon (the active ingredient contained in Gvoke) In pediatric studies, upper respiratory tract irritation including nasal discomfort, nasal congestion, and sneezing were reported in up to 16.7% of patients. When adult patients were questioned specifically if symptoms of nasal congestion, nasal itchiness, runny nose, sneezing, or itchy throat were present and worsened 42.5%, 39.2%, 34.6%, 19.6%, and 12.4% reported some increase in symptom severity, respectively; 41.7%, 27.8%, and 25% of pediatric patients reported some increase in symptom severity of nasal congestion, nasal itchiness, and runny nose, respectively.

Very common (10% or more): Upper respiratory tract irritation (up to 16.7%)

Frequency not reported: Nasal pruritus (nasal)

Other

Frequency not reported: Itching of ears