Help ensure patients are ready to treat a severe low with Gvoke HypoPen®
Discover the Benefits of Gvoke HypoPen®
Well studied1
Efficacious and safe1,2,5
Works quickly1,3
Anyone can administer4
Gvoke HypoPen Is Well Studied in Patients
Gvoke Was Evaluated in 2 Phase 3 Trials of Adults With T1D1,2
154 subjects received an injection of Gvoke and 157 subjects received an injection of GEK. A total of 152 subjects received both Gvoke and GEK.
In study A, mean plasma glucose at time of administration was 44.8 mg/dL for Gvoke and 45.2 mg/dL for GEK. In Study B, mean plasma glucose at time of administration was 47.7 mg/dL for Gvoke and 48.7 mg/dL for GEK.
The Safety and Efficacy of Gvoke® for Children and Adolescents Was Evaluated in a Phase 3, Open-label Study1,5
Demonstrated Safety and Efficacy
99% (152/154) of adult patients achieved plasma glucose > 70 mg/dL or an increase ≥ 20 mg/dL from baseline in a pooled analysis of Study A and Study B.1
The most common adverse reactions in adults (N=154) were1: nausea (30%), vomiting (16%), injection site edema (7%), and headache (5%).
The mean time to treatment success was 13.8 minutes in the Gvoke group.
Patients experienced initial blood glucose increases in less than 2 minutes3
Post-hoc analysis in adults revealed the median time to initial blood glucose increase was less than 2 minutes.3†
~176 mg/dL mean maximum increase in plasma glucose from an average baseline of 44 mg/dL (insulin-induced severe hypoglycemia), following administration of Gvoke HypoPen.1
† Estimations yielding times earlier than the initial post dose (PD) collection at 5 minutes assume an immediate increase from baseline and cannot account for a potentially delayed onset from time of injection to initial PD response.
100% (30/30) of pediatric patients achieved a target glucose increase of ≥25 mg/dL.1,5
The most common adverse reactions in pediatric patients (N=31) were1: nausea (45%), hypoglycemia (39%), vomiting (19%), headache (7%), hyperglycemia (7%), abdominal pain (3%), injection site discomfort (3%), injection site reaction (3%), and urticaria (3%).
Adverse reactions occur within 12 hours.
Patients experienced initial blood glucose increases in less than 2 minutes3
Patients experienced initial blood glucose increases in less than 2 minutes with Gvoke HypoPen, and no overcorrection.2
~176 mg/dL mean maximum increase in plasma glucose from an average baseline of 44 mg/dL (insulin-induced severe hypoglycemia), following administration of Gvoke HypoPen.
In a human-factors study with simulated emergency conditions, 99% of people were able to give Gvoke HypoPen correctly4
How To Use Gvoke HypoPen in 2 Simple Steps6
Understanding Dosages
Gvoke HypoPen comes in two premeasured dosing options.1
1 mg per 0.2 mL
- For patients ages 12 and older, or children under 12 years old who weigh ≥ 100 lbs
- Lasts 30 months from date of manufacture when stored at room temperature3
0.5 mg per 0.1 mL
- For patients between the ages 2 and 11 who weigh less than 100 lbs
- Lasts 24 months from date of manufacture when stored at room temperature3
Where Patients Can Keep Gvoke HypoPen
Home
School or work
On the go
Help Patients Save Money on Gvoke HypoPen
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* In a pooled analysis of 2 clinical studies in adults, mean time to treatment success was 13.8 minutes with treatment success defined as plasma glucose increase from mean value (< 50 mg/dL) at time of glucagon administration to absolute value greater than 70 mg/dL or relative increase of 20 mg/dL or greater.
† Offer not valid for prescriptions reimbursed under Medicaid, a Medicare drug benefit plan, TRICARE, or other federal or state health programs (such as medical assistance programs).
REFERENCES:
- Gvoke [prescribing information]. Chicago, IL: Xeris Pharmaceuticals, Inc.
- Christiansen MP, Cummins M, Prestrelski S, Close NC, Nguyen A, Junaidi K. Comparison of a ready-to-use liquid glucagon injection administered by autoinjector to glucagon emergency kit for the symptomatic relief of severe hypoglycemia: two randomized crossover non-inferiority studies. BMJ Open Diabetes Res Care. 2021;9(1):e002137. doi:10.1136/bmjdrc-2021-002137
- Data on file. Xeris Pharmaceuticals, Inc
- Valentine V, Newswanger B, Prestrelski S, Andre AD, Garibaldi M. Human Factors Usability and Validation Studies of a Glucagon Autoinjector in a Simulated Severe Hypoglycemia Rescue Situation. Diabetes Technol Ther. 2019;21(9):522-530. doi:10.1089/dia.2019.0148
- Buckingham B, Sherr J, Prestrelski SJ, Conoscenti V. Pharmacodynamics, pharmacokinetics, safety, and tolerability of a ready-to-use, room temperature, liquid stable glucagon administered via an autoinjector pen to youth with type 1 diabetes. Pediatr Diabetes. 2022;23(6):754-762. doi:10.1111/pedi.13360
- Gvoke HypoPen [instructions for use]. Chicago, IL: Xeris Pharmaceuticals, Inc.
Indication
GVOKE (glucagon) is an antihypoglycemic agent indicated for subcutaneous use for the treatment of severe hypoglycemia in adult and pediatric patients aged 2 years and older with diabetes.
Important Safety Information
- GVOKE is contraindicated in patients with:
-
- Pheochromocytoma because of the risk of substantial increase in blood pressure
- lnsulinoma because of the risk of hypoglycemia
- Prior hypersensitivity reaction to glucagon or to any of the excipients. Serious hypersensitivity reactions have been reported with glucagon, including generalized rash, and anaphylactic shock with breathing difficulties and hypotension
- GVOKE may stimulate the release of catecholamines from the tumor. If patient develops a substantial increase in blood pressure and a previously undiagnosed pheochromocytoma is suspected, 5 to 10 mg of phentolamine mesylate 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, administration may stimulate exaggerated insulin release from an insulinoma and cause hypoglycemia. If a patient develops symptoms of hypoglycemia after a dose of GVOKE, give glucose orally or intravenously
- Patients with insufficient hepatic stores of glycogen may not respond to GVOKE for treatment of severe hypoglycemia. Insufficient hepatic stores of glycogen may be present in conditions such as states of starvation, or in patients with adrenal insufficiency or chronic hypoglycemia
- A skin rash called necrolytic migratory erythema (NME), has been reported post-marketing following continuous glucagon infusion and resolved with discontinuation of the glucagon. GVOKE is not approved for continuous infusion. Should NME occur, consider whether the benefits of continuous glucagon infusion outweigh the risks
- Most common adverse reactions reported in adult patients were nausea, vomiting, injection site edema raised 1 mm or greater, and headache
- Most common adverse reactions reported in pediatric patients were nausea, hypoglycemia, vomiting, headache, abdominal pain, hyperglycemia, injection site discomfort and reaction, and urticaria
- Patients taking concomitant beta-blockers may have a transient increase in pulse and blood pressure. In patients taking concomitant indomethacin, GVOKE may lose its ability to raise glucose or may produce hypoglycemia. GVOKE may increase the anticoagulant effect of warfarin
Please see full Prescribing Information for GVOKE.