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GVOKE contains glucagon, an antihypoglycemic agent used to treat severe hypoglycemia. Glucagon is a single chain containing 29 amino acid residues and has a molecular weight of 3483 and is identical to human glucagon. Glucagon is produced by solid phase synthesis with subsequent purification.
Its molecular formula is C153H225N43O49S with the following structure:
 |
GVOKE is a clear, colorless to pale yellow, sterile solution for subcutaneous injection available in 0.5 mg per 0.1 mL or 1 mg per 0.2 mL auto-injector or pre-filled syringe.
Each 0.2 mL of GVOKE contains 1 mg of glucagon, 11.1 mg of trehalose dihydrate USP and 1.2 mg of 1N sulfuric acid, NF in dimethyl sulfoxide diluent.
Each 0.1 mL of GVOKE contains 0.5 mg of glucagon, 5.6 mg of trehalose dihydrate USP and 0.6 mg of 1N sulfuric acid, NF in dimethyl sulfoxide diluent.
GVOKE is indicated for subcutaneous use for the treatment of severe hypoglycemia in adult and pediatric patients aged 2 years and older with diabetes.
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.
To treat severe hypoglycemia in adult and pediatric patients aged 2 years and older with diabetes, administer GVOKE HypoPen, GVOKE PFS, or GVOKE Kit subcutaneously. These three presentations are only for subcutaneous use and are referred to as GVOKE in this labeling.
Instruct patients and their caregivers on the signs and symptoms of severe hypoglycemia. Because severe hypoglycemia requires the help of others to recover, instruct the patient to inform those around them about GVOKE and its Instructions for Use. Administer GVOKE subcutaneously 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 GVOKE.
To treat severe hypoglycemia in patients 12 years of age and older with diabetes, use GVOKE HypoPen, GVOKE PFS, or GVOKE Kit:
To treat severe hypoglycemia in pediatric patients aged 2 to less than 12 years of age with diabetes, use GVOKE HypoPen, GVOKE PFS, or GVOKE Kit.
For use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract, use GVOKE VialDx. GVOKE VialDx is only for intravenous use under medical supervision.
For use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract, use GVOKE VialDx. The recommended intravenous dose for relaxation of the [see CLINICAL PHARMACOLOGY]:
The onset of action after an injection will depend on the organ under examination [see CLINICAL PHARMACOLOGY].
GVOKE HypoPen, GVOKE PFS, GVOKE Kit (these three presentations are also referred to as GVOKE in this labeling) , and GVOKE VialDx are clear, colorless to pale yellow solutions.
GVOKE (glucagon) injection is supplied as a clear, colorless to pale yellow solution in the following configurations:
| Strength | Package Size | NDC number |
| For Subcutaneous Use | ||
| 0.5 mg per 0.1 mL | 1 single-dose GVOKE HypoPen auto-injector | 72065-120-11 |
| 0.5 mg per 0.1 mL | 2 single-dose GVOKE HypoPen auto-injectors | 72065-120-12 |
| 1 mg per 0.2 mL | 1 single-dose GVOKE HypoPen auto-injector | 72065-121-11 |
| 1 mg per 0.2 mL | 2 single-dose GVOKE HypoPen auto-injectors | 72065-121-12 |
| 1 mg per 0.2 mL | 1 single-dose GVOKE PFS prefilled syringe | 72065-131-11 |
| 1 mg per 0.2 mL | 2 single-dose GVOKE PFS prefilled syringes | 72065-131-12 |
| 1 mg per 0.2 mL | 1 single-dose GVOKE Kit vial and syringe kit | 72065-140-11 |
| For Intravenous Use | ||
| 1 mg per 0.2 mL | 1 single-dose GVOKE VialDx vial | 0517-2901-01 |
| 1 mg per 0.2 mL | 10 single-dose GVOKE VialDx vials | 0517-2901-10 |
Store GVOKE HypoPen, GVOKE PFS, and GVOKE Kit (these three presentations are referred to as GVOKE in this labeling), and GVOKE VialDx at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). Do not refrigerate or freeze. Do not expose to extreme temperatures.
Distributed by: Xeris Pharmaceuticals, Inc., Chicago, IL. Revised: Mar 2025
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 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.
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].
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 GVOKEa
| GVOKE 1 mg dose (N = 154) |
|
| Nausea | 30% |
| Vomiting | 16% |
| Injection site edema raised 1 mm or greater | 7% |
| Headache | 5% |
| a Adverse Reactions that occurred within 12 hours. | |
Injection site pain was reported by 1% of GVOKE-treated patients.
Hypertension and tachycardia have occurred with glucagon treatment.
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].
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 Mellitusa
| 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% |
| a Adverse Reactions that occurred within 12 hours | ||||
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% |
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.
Table 4: Clinically Significant Drug Interaction with GVOKE and GVOKE VialDx.
| Beta-Blockers | |
| Clinical 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 | |
| Clinical Impact: | Insulin acts antagonistically to glucagon. |
| Intervention: | Monitor blood glucose when GVOKE VialDx is used as a diagnostic aid in patients receiving insulin. |
| Indomethacin | |
| Clinical 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 | |
| Clinical 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 | |
| Clinical 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. |
Included as part of the "PRECAUTIONS" Section
GVOKE and GVOKE VialDx are contraindicated in patients with pheochromocytoma because glucagon may stimulate the release of catecholamines from the tumor [see CONTRAINDICATIONS]. If the patient develops a substantial 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, glucagon administration may directly or indirectly (through an initial rise in blood glucose) stimulate exaggerated insulin release from an insulinoma and cause hypoglycemia. GVOKE and GVOKE VialDx are contraindicated in patients with insulinoma [see CONTRAINDICATIONS]. If a patient develops symptoms of hypoglycemia after a dose of GVOKE or GVOKE VialDx, give glucose orally or intravenously.
Serious hypersensitivity reactions have been reported with glucagon products, including generalized rash, and in some cases anaphylactic shock with breathing difficulties and hypotension. Discontinue GVOKE or GVOKE VialDx if symptoms of serious hypersensitivity reactions occur. Advise patients and/or caregivers to seek immediate medical attention if the patient experiences any symptoms of serious hypersensitivity reactions. GVOKE and GVOKE VialDx are contraindicated in patients with a prior hypersensitivity reaction to glucagon, or any of the excipients in GVOKE and GVOKE VialDx[see CONTRAINDICATIONS].
Patients with insufficient hepatic stores of glycogen may not respond to GVOKE for the treatment of severe hypoglycemia [see CLINICAL PHARMACOLOGY]. Insufficient hepatic stores of glycogen may be present in conditions such as states of starvation, or in patients with adrenal insufficiency or chronic hypoglycemia.
Necrolytic migratory erythema (NME), a skin rash commonly associated with glucagonomas (glucagon-producing tumors) and characterized by scaly, pruritic erythematous plaques, bullae, and erosions, has been reported postmarketing following continuous glucagon infusion. GVOKE and GVOKE VialDx are not approved for continuous infusion. NME lesions may affect the face, groin, perineum and legs or be more widespread. In the reported cases NME resolved with discontinuation of the glucagon, and treatment with corticosteroids was not effective. Should NME occur, consider whether the benefits of continuous glucagon infusion outweigh the risks.
GVOKE VialDx in patients with diabetes mellitus may cause hyperglycemia. Monitor patients with diabetes for changes in blood glucose levels during treatment with GVOKE VialDx and treat hyperglycemia, if indicated.
GVOKE VialDx may increase myocardial oxygen demand, blood pressure, and pulse rate which may be life threatening in patients with cardiac disease. 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.
Use of GVOKE VialDx in patients with glucagonoma may cause secondary hypoglycemia. GVOKE VialDx is contraindicated in patients with glucagonoma when used as a diagnostic aid [see CONTRAINDICATIONS]. Test patients suspected of having glucagonoma for blood levels of glucagon prior to administration of GVOKE VialDx, and monitor for changes in blood glucose levels during treatment. If a patient develops symptoms of hypoglycemia after administration of GVOKE VialDx, administer glucose orally or intravenously.
Advise the patient and family members or caregivers to read the GVOKE FDA-approved patient labeling (PATIENT INFORMATION and Instructions for Use).
Inform patients with diabetes mellitus and family members or caregivers on how to recognize the signs and symptoms of severe hypoglycemia and the risks of prolonged hypoglycemia.
Inform patients that serious hypersensitivity reactions can occur with GVOKE and GVOKE VialDx. Advise patients to seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions [see WARNINGS AND PRECAUTIONS].
Inform patients with diabetes mellitus that treatment with GVOKE VialDx may increase their risk of hyperglycemia [see WARNINGS AND PRECAUTIONS].
Inform patients with cardiac disease that intravenous treatment with GVOKE VialDx may increase their risk of a transient increase in blood pressure and heart rate [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 GVOKE for subcutaneous use for the treatment of severe hypoglycemia in patients with diabetes have been established in pediatric patients aged 2 years and older. Use of GVOKE for this indication is supported by evidence from two adequate and well-controlled studies in adults with type 1 diabetes mellitus [see Clinical Studies] and from a study in 31 pediatric patients ages 2 and older with type 1 diabetes mellitus [see Clinical Studies].
The safety and effectiveness of GVOKE for subcutaneous use for the treatment of severe hypoglycemia in patients with diabetes have not been established in pediatric patients younger than 2 years of age.
Safety and effectiveness of GVOKE VialDx for intravenous use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in pediatric patients have not been established.
Clinical studies of GVOKE and GVOKE VialDx did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger adult 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 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. In the event of an overdose of GVOKE, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendation.
GVOKE and GVOKE VialDx are contraindicated in patients with:
GVOKE VialDx for use as a diagnostic aid is also contraindicated in patients with glucagonoma because of risk of hypoglycemia [see WARNINGS AND PRECAUTIONS].
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. Extrahepatic effects of glucagon include relaxation of the smooth muscle of the stomach, duodenum, small bowel, and colon.
After subcutaneous administration of 1 mg GVOKE in adult patients with type 1 diabetes, the mean maximum glucose increase from baseline was 176 mg/dL (see Figure 1).
Figure 1: Plasma Glucose (mean ± standard error of the mean) vs. Time After Subcutaneous Administration of 1 mg of GVOKE in Adult Patients with Type 1 Diabetes Mellitus
 |
In pediatric patients with type 1 diabetes mellitus (2 to less than 18 years), the mean maximum glucose increase from baseline was 134 mg/dL (2 to less than 6 years), 145 mg/dL (6 to less than 12 years), and 123 mg/dL (12 to less than 18 years) (see Figure 2).
Figure 2: Plasma Glucose (mean ± standard error of the mean) vs. Time After Subcutaneous Administration of GVOKE in Pediatric Patients with Type 1 Diabetes Mellitus
 |
GVOKE VialDx Table 5 presents the pharmacodynamic properties of another glucagon product after intravenous administration.
Table 5: Pharmacodynamic Properties of Another Glucagon Product After Intravenous Administration
| Route of Administration | Dosea | Time of Maximal Glucose Concentration | Time of Onset of Action for GI Smooth Muscle Relaxation | Duration of Smooth Muscle Relaxation |
| Intravenous | 0.25 to 0.5 mg | 5 to 20 minutes | 45 seconds | 9 to 17 minutes |
| aDose is determined based on the length of the procedure | ||||
Subcutaneous injection of 1 mg GVOKE in adult type 1 diabetes mellitus patients resulted in a mean glucagon Cmax of 2481.3 pg/mL, tmax of 50 minutes and AUC0-240min of 3454.6 pg*min/mL (see Figure 3).
Figure 3: Plasma Glucagon Concentration (mean ± standard error of the mean) vs. Time After Subcutaneous Administration of 1 mg of GVOKE in Adults with Type 1 Diabetes Mellitus
 |
The apparent volume of distribution was in the range of 137-2425 L.
The half-life of GVOKE was determined to be 32 minutes.
Metabolism
Glucagon is extensively degraded in liver, kidney, and plasma.
Excretion
Urinary excretion of intact glucagon has not been measured.
Subcutaneous injection of 0.5 mg GVOKE in patients with type 1 diabetes mellitus ages 2 to under 6 years resulted in a mean glucagon Cmax of 2300 pg/mL, tmax of 41 minutes, and AUC0-180min of 138900 pg/mL*min. Subcutaneous injection of 0.5 mg GVOKE in patients with type 1 diabetes ages 6 to under 12 years resulted in a mean Cmax of 1600 pg/mL, median tmax of 34 minutes and AUC0-180min of 104700 pg/mL*min. Subcutaneous injection of 1 mg GVOKE in patients with type 1 diabetes ages 12 to less than 18 years resulted in a mean Cmax of 1900 pg/mL, tmax of 51 minutes AUC0-180min of 134300 pg/mL*min. Mean plasma glucagon levels were similar across the age groups following age appropriate doses of GVOKE (see Figure 4).
Figure 4: Plasma Glucagon Concentration (mean ± standard error of the mean) vs. Time After Subcutaneous Administration of GVOKE in Pediatric Patients with Type 1 Diabetes Mellitus
 |
GVOKE was evaluated in adult patients aged 18 to 74 years with type 1 diabetes mellitus in two multi-center 2-way crossover studies: Study A was double-blinded with 80 patients, and Study B was single-blinded with 81 patients. Both studies involved 2 clinic visits 7 to 28 days apart, with random assignment to receive GVOKE 1 mg subcutaneous injection during one session and glucagon 1 mg subcutaneous injection (subcutaneous glucagon) during the other. In these studies, 154 patients received GVOKE and 157 patients received subcutaneous glucagon. A total of 152 patients received both GVOKE and subcutaneous glucagon.
The efficacy of GVOKE was compared to subcutaneous glucagon in patients who were in a state of insulin--induced hypoglycemia via insulin infusion with target plasma glucose less than 50 mg/dL. In Study A, mean plasma glucose at time of glucagon administration was 44.8 mg/dL and 45.2 mg/dL for the GVOKE and subcutaneous glucagon groups, respectively. In Study B, mean plasma glucose at time of glucagon administration was 47.7 mg/dL and 48.7 mg/dL for the GVOKE and subcutaneous glucagon groups, respectively.
Treatment “success” was defined as plasma glucose increase from mean value at time of glucagon administration to absolute value greater than 70 mg/dL or relative increase of 20 mg/dL or greater, at 30 minutes after glucagon administration. In a pooled analysis of Study A and Study B, the proportion of patients who achieved treatment “success” was 98.7 % in the GVOKE group and 100% in the subcutaneous glucagon group and the comparison between groups met the pre-specified non-inferiority margin. A summary of treatment “success” rates is shown in Table 6.
The mean time to treatment “success” was 13.8 minutes in the GVOKE group and 10 minutes in the subcutaneous glucagon group.
Table 6: Adult Patients with Type 1 Diabetes Mellitus Treatment “Success” in Studies A and B
| Study A (n=80) | Study B (n=81) | |||
| GVOKE | subcutaneous glucagon | GVOKE | subcutaneous glucagon | |
| Treatment Success-n (%)a | 76 (97 %) | 79 (100%) | 76 (100%) | 78 (100%) |
|
Glucose criteria met- n (%) |
74 (95%) 76 (97%) |
79 (100%) 79 (100%) |
76 (100%) 76 (100%) |
78 (100%) 78 (100%) |
| a Treatment success was defined as blood glucose greater than 70 mg/dL or an increase of blood glucose by 20 mg/dL or greater from baseline. The efficacy analysis population consisted of all patients who received both doses of the study drug. b Percentage based on number of patients from both studies. |
||||
GVOKE was evaluated in a study in 31 pediatric patients with type 1 diabetes mellitus. Pediatric patients were administered insulin to induce a plasma glucose of less than 80 mg/dL, following which patients ages 2 to under 12 years of age received a 0.5 mg subcutaneous dose of GVOKE and patients ages 12 and older received a 0.5 mg or 1 mg subcutaneous dose of GVOKE.
All evaluable pediatric patients (30/30) achieved a target glucose increase of at least 25 mg/dL. Following administration, plasma glucose levels over time showed similar glucose responses for patients in each age group. A summary of plasma glucose results is shown in Table 7.
Table 7: Pediatric Patients with Type 1 Diabetes Mellitus Plasma Glucose by Age Group
| Age Group | GVOKE Dose | Plasma Glucose (mg/dL) Mean (SD) |
||
| Baseline | 30 minutes | Change | ||
| 2 to under 6 years (n=7) |
0.5 mg | 68.1 (8.3) | 149.6 (15.2) | 81.4 (18.3) |
| 6 to under 12 years (n=13) |
0.5 mg | 71.6 (7.6) | 155.8 (26.5) | 84.2 (25.3) |
| 12 to under 18 years (n=11) |
0.5 mg | 75.2(2.1) | 128.1(20.46) | 52.9(19.88) |
| 1 mg | 74.5(4.84) | 129.5 (29.5) | 55 (27.3) | |
| SD=standard deviation | ||||
GVOKE®
(Gee-voke)
(glucagon) injection, for subcutaneous use
GVOKE
(Gee-voke)
VIALDXTM
(glucagon) injection, for intravenous use
What is GVOKE?
GVOKE is a prescription medicine used:
It is not known if GVOKE is safe and effective in children under 2 years of age.
What is GVOKE VialDx?
GVOKE VialDx is a prescription medicine used:
It is not known if GVOKE VialDx is safe and effective in children.
Do not use GVOKE or receive GVOKE VialDx if you:
Do not receive GVOKE VialDx if you:
Before using GVOKE or receiving GVOKE VialDx, 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. GVOKE and GVOKE VialDx may affect the way other medicines work, and other medicines may affect how GVOKE and GVOKE VialDx works. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I use GVOKE?
Tell your healthcare provider each time you use GVOKE. Low blood sugar may happen again after receiving an injection of GVOKE. Your diabetes medicine may need to be changed.
How will I receive GVOKE VialDx?
What are the possible side effects of GVOKE and GVOKE VialDx?
GVOKE and GVOKE VialDx may cause serious side effects, including:
The most common side effects of GVOKE in adults include:
The most common side effects of GVOKE in children include:
The most common side effects of GVOKE VialDx include:
These are not all the possible side effects of GVOKE and GVOKE VialDx. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store GVOKE?
Keep GVOKE and all medicines out of the reach of children.
General information about the safe and effective use of GVOKE.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use GVOKE for a condition for which it was not prescribed. Do not give GVOKE 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 GVOKE that is written for health professionals.
What are the ingredients in GVOKE and GVOKE VialDx?
Active ingredient: glucagon.
Inactive ingredients: trehalose dihydrate NF, sulfuric acid NF, mannitol USP (kit only), and dimethyl sulfoxide.
This Patient Information has been approved by the U.S. Food and Drug Administration.
