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Glucagon

Gvoke Hypopen

0.5MG/0.1ML, 1MG/0.2ML solutionEstados UnidosComercializadoAutorizado el 10 sept 2019

Contenido en inglés

Indicaciones

GVOKE is an antihypoglycemic agent indicated for subcutaneous use for the treatment of severe hypoglycemia in adult and pediatric patients aged two years and older with diabetes ( 1.1 ) GVOKE VialDx is a gastrointestinal motility inhibitor indicated for intravenous use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients ( 1.2 )

1.1Severe Hypoglycemia in Adult and Pediatric Patients Aged 2 Years and Older with Diabetes

GVOKE is indicated for subcutaneous use for the treatment of severe hypoglycemia in adult and pediatric patients aged two and older with diabetes.

1.2Diagnostic Aid in Adults

GVOKE VialDx is indicated for intravenous use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients.

Contraindicaciones

GVOKE and GVOKE VialDx are 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 )] Prior hypersensitivity reaction to glucagon or to any of the excipients in GVOKE or GVOKE VialDx. Serious hypersensitivity reactions have been reported with glucagon and include anaphylactic shock with breathing difficulties and hypotension [see Warnings and Precautions ( 5.3 )] .

GVOKE VialDx for use as a diagnostic aid is also contraindicated in patients with glucagonoma because of risk of hypoglycemia [see Warnings and Precautions ( 5.8 )] Pheochromocytoma ( 4 ) Insulinoma ( 4 ) Prior hypersensitivity reaction to glucagon or to any of the excipients ( 4 ) Glucagonoma when used as a diagnostic aid ( 4 )

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Glucagon

Gvoke Hypopen

0.5MG/0.1ML, 1MG/0.2ML solutionEstados UnidosComercializadoAutorizado el 10 sept 2019

Contenido en inglés

Abrir en el registroPregúntale a Osler

Indicaciones

1.1Severe Hypoglycemia in Adult and Pediatric Patients Aged 2 Years and Older with Diabetes

GVOKE is indicated for subcutaneous use for the treatment of severe hypoglycemia in adult and pediatric patients aged two and older with diabetes.

1.2Diagnostic Aid in Adults

GVOKE VialDx is indicated for intravenous use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients.

Contraindicaciones

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Substantial Increase in Blood Pressure in Patients with Pheochromocytoma: Contraindicated in patients with pheochromocytoma because glucagon may stimulate the release of catecholamines from the tumor. ( 5.1 ) Hypoglycemia in Patients with Insulinoma: In patients with insulinoma, administration may produce an initial increase in blood glucose; however, glucagon may stimulate exaggerated insulin release from an insulinoma and cause hypoglycemia.

If a patient develops symptoms of hypoglycemia after a dose of GVOKE or GVOKE VialDx, give glucose orally or intravenously. ( 5.2 ) Serious Hypersensitivity Reactions: Serious hypersensitivity reactions have been reported with glucagon products, including generalized rash, and in some cases anaphylactic shock with breathing difficulties, and hypotension.( 5.3 ) Lack of Efficacy with Subcutaneous Use for Severe Hypoglycemia in Patients with Decreased Hepatic Glycogen: Patients with insufficient hepatic stores of glycogen may not respond to GVOKE for subcutaneous use for the 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. ( 5.4 ) Necrolytic Migratory Erythema (NME): a skin rash, has been reported postmarketing following continuous glucagon infusion and resolved with discontinuation of the glucagon. GVOKE and GVOKE VialDx are not approved for continuous infusion. Should NME occur, consider whether the benefits of continuous glucagon infusion outweigh the risks.

( 5.5 ) Hyperglycemia with Intravenous Use as a Diagnostic Aid in Patients with Diabetes Mellitus: GVOKE VialDx in patients with diabetes mellitus may cause hyperglycemia. Monitor patients with diabetes for changes in blood glucose levels during treatment and treat hyperglycemia if indicated. ( 5.6 ) Blood Pressure and Heart Rate Increases with Intravenous Use as a Diagnostic Aid in Patients with Cardiac Disease: GVOKE VialDx may increase myocardial oxygen demand, blood pressure, and pulse rate.

Cardiac monitoring is recommended in patients with cardiac disease during use of GVOKE VialDx as a diagnostic aid, and an increase in blood pressure and pulse rate may require therapy. ( 5.7 ) Hypoglycemia in Patients with Glucagonoma with Intravenous Use as a Diagnostic Aid: GVOKE VialDx administered to patients with glucagonoma may cause secondary hypoglycemia. Test patients suspected of having glucagonoma for blood levels of glucagon prior to treatment and monitor for changes in blood glucose levels during treatment.

( 5.8 )

Interacciones

Table 4: Clinically Significant Drug Interaction with GVOKE and GVOKE VialDx Beta-Blockers Clincial Impact: Patients taking beta-blockers may have a transient increase in pulse and blood pressure when given GVOKE or GVOKE VialDx. Intervention The increase in blood pressure and heart rate may require therapy in patients with coronary artery disease. Insulin Clincial Impact: Insulin acts antagonistically to glucagon. Intervention Monitor blood glucose when GVOKE VialDx is used as a diagnostic aid in patients receiving insulin.

Indomethacin Clincial Impact: In patients taking indomethacin, GVOKE may lose its ability to raise blood glucose or may even produce hypoglycemia. Intervention Monitor blood glucose levels during glucagon treatment of patients taking indomethacin. Anticholinergic Drugs Clincial Impact: The concomitant use of anticholinergic drugs and GVOKE VialDx increases the risk of gastrointestinal adverse reactions due to additive effects on inhibition of gastrointestinal motility.

Intervention Concomitant use of anticholinergic drugs with GVOKE VialDx is not recommended. Warfarin Clincial Impact: GVOKE and GVOKE Vial Dx may increase the anticoagulant effect of warfarin. Intervention Monitor patients for unusual bruising or bleeding, as adjustments in warfarin dosage may be required. Beta-blockers: GVOKE- or GVOKE VialDx-treated patients taking concomitant beta-blockers may have a transient increase in pulse and blood pressure.

( 7 ) Indomethacin: In patients taking concomitant indomethacin, GVOKE may lose its ability to raise glucose or may produce hypoglycemia. ( 7 ) Anticholinergic drugs: Concomitant use of anticholinergic drugs with GVOKE VialDx for use as a diagnostic aid is not recommended. ( 7 ) Warfarin: GVOKE and GVOKE VialDx may increase the anticoagulant effect of warfarin. ( 7 ) Insulin: Monitor blood glucose when GVOKE VialDx is used as a diagnostic aid in patients receiving insulin.

( 7 ) See 17 for PATIENT COUNSELING INFORMATION and FDA ‑ approved patient labeling for GVOKE.

Reacciones adversas

The following serious adverse reactions are described below and elsewhere in labeling: Substantial Increase in Blood Pressure in Patients with Pheochromocytoma [see Warnings and Precautions ( 5.1 )] . Hypoglycemia in Patients with Insulinoma [see Warnings and Precautions ( 5.2 )] . Serious Hypersensitivity Reactions [see Warnings and Precautions (5.3)] Lack of Efficacy With Subcutaneous Use for Severe Hypoglycemia in Patients with Decreased Hepatic Glycogen [see Warnings and Precautions ( 5.4 )] Necrolytic Migratory Erythema [see Warnings and Precautions ( 5.5 )] .

Hyperglycemia with Intravenous Use as a Diagnostic Aid in Patients with Diabetes Mellitus [see Warnings and Precautions ( 5.6 )] Blood Pressure and Heart Rate Increases with Intravenous Use as a Diagnostic Aid in Patients with Cardiac Disease [see Warnings and Precautions ( 5.7 )] Hypoglycemia in Patients with Glucagonoma with Intravenous Use as a Diagnostic Aid [see Warnings and Precautions ( 5.8 )] Most common adverse reactions (incidence 2% or greater) reported for GVOKE were: Adults—nausea, vomiting, injection site edema raised 1 mm or greater, and headache ( 6.1 ) Pediatric Patients—nausea, hypoglycemia, vomiting, headache, abdominal pain, hyperglycemia, injection site discomfort and reaction, and urticaria ( 6.1 ) Most common adverse reactions (incidence 5 % or greater) reported for GVOKE VialDx were nausea, dysgeusia, headache, dizziness and hot flush ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Xeris Pharmaceuticals, Inc. at toll-free 1-877-937-4737 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

6.1Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of GVOKE and GVOKE VialDx cannot be directly compared to rates in the clinical trials of other drugs and may not reflect the rates observed in practice. GVOKE for Subcutaneous Use for the Treatment of Severe Hypoglycemia in Adult and Pediatric Patients 2 Aged Years and Older with Type 1 Diabetes Mellitus Adverse Reactions in Adult Patients The safety of GVOKE for subcutaneous use for the treatment of severe hypoglycemia in adults with diabetes was evaluated in two randomized, blinded, 2-way crossover studies conducted in adults with type 1 diabetes mellitus.

In total, 154 patients received a subcutaneous injection of GVOKE [see Clinical Studies ( 14.1 )] . The most common adverse reactions that occurred in 2% or more of adults treated with GVOKE during these two clinical trials are listed in Table 1. Table 1: Adverse Reactions that occurred ≥ 2% in Adult Patients with Type 1 Diabetes Mellitus Treated with GVOKE a a Adverse Reactions that occurred within 12 hours. GVOKE 1 mg dose (N = 154) Nausea 30% Vomiting 16% Injection site edema raised 1 mm or greater 7% Headache 5% Injection site pain was reported by 1% of GVOKE-treated patients.

Hypertension and tachycardia have occurred with glucagon treatment. Adverse Reactions in Pediatric Patients Aged 2 Years and Older The safety of GVOKE for the treatment of severe hypoglycemia in patients with diabetes was evaluated in one single-arm, open-label, study in 31 pediatric patients with type 1 diabetes mellitus [see Clinical Studies ( 14.2 )] . The data in Table 2 reflect the exposure of 31 pediatric patients to 0.5 mg or 1 mg of GVOKE given subcutaneously.

The most common adverse reactions that occurred in ≥2% of GVOKE-treated pediatric patients aged 2 years and older are listed in Table 2. Table 2: Adverse Reactions That Occurred ≥ 2% in GVOKE-treated Pediatric Patients Aged 2 Years and Older with Type 1 Diabetes Mellitus a a Adverse Reactions that occurred within 12 hours. 2 to 6 years of age (0.5 mg dose) N =7 6 to 12 years of age (0.5 mg dose) N = 13 12 to 18 years of age (1 mg dose) N = 11 Total N = 31 Nausea 43% 54% 36% 45% Hypoglycemia 29% 54% 27% 39% Vomiting 14% 23% 18% 19% Headache 0% 15% 0% 7% Abdominal pain 0% 8% 0% 3% Hyperglycemia 14% 8% 0% 7% Injection site discomfort 0% 8% 0% 3% Injection site reaction 0% 0% 9% 3% Urticaria 0% 8% 0% 3% GVOKE VialDx for Intravenous Use As a Diagnostic Aid in Adults The safety of GVOKE VialDx for intravenous use as a diagnostic aid in adults was evaluated in an open-label single-dose study in 83 adult healthy volunteers.

Table 3 displays the most common adverse reactions that occurred in 5% or greater in healthy volunteers who received 0.75 mg of GVOKE VialDx intravenously. Table 3: Adverse Reactions that Occurred ≥ 5 % in Adult Healthy Volunteers Who Received 0.75 mg of GVOKE VialDx for Intravenous Use as a Diagnostic Aid N=83 Nausea 37.3% Dysgeusia 18.1% Headache 10.8% Hot Flush 9.6% Dizziness 8.4%

6.2Postmarketing Experience

Additional adverse reactions have been identified during post-approval use of glucagon. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Necrolytic migratory erythema (NME) cases have been reported postmarketing in patients receiving continuous infusion of glucagon.

Hypoglycemia and hypoglycemic coma. Patients taking indomethacin may be more likely to experience hypoglycemia following glucagon administration [see Drug Interactions ( 7 )] .

Presentación	Código	Estado
GLUCAGON 0.5MG/0.1ML (0.5MG/0.1ML)	NDA212097-003	Prescription
GLUCAGON 1MG/0.2ML (1MG/0.2ML)	NDA212097-004	Prescription

Gvoke Hypopen

Indicaciones

1.1Severe Hypoglycemia in Adult and Pediatric Patients Aged 2 Years and Older with Diabetes

1.2Diagnostic Aid in Adults

Contraindicaciones

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Gvoke Hypopen

Indicaciones

1.1Severe Hypoglycemia in Adult and Pediatric Patients Aged 2 Years and Older with Diabetes

1.2Diagnostic Aid in Adults

Contraindicaciones

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Advertencias y precauciones

5.1Substantial Increase in Blood Pressure in Patients with Pheochromocytoma

5.2Hypoglycemia in Patients with Insulinoma

5.3Serious Hypersensitivity Reactions

5.5Necrolytic Migratory Erythema

5.6Hyperglycemia with Intravenous Use as a Diagnostic Aid in Patients with Diabetes Mellitus

5.8Hypoglycemia in Patients with Glucagonoma with Intravenous Use as a Diagnostic Aid Use of

Interacciones

Embarazo y lactancia

8.1Pregnancy Risk Summary

Reacciones adversas

6.1Clinical Trials Experience

6.2Postmarketing Experience

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