If overdosage occurs, the patient may experience nausea, vomiting, inhibition of GI tract motility, increase in blood pressure and heart rate, and decrease in serum potassium. In case of suspected overdosage, monitor and correct hypokalemia. If the patient develops a severe increase in blood pressure, phentolamine mesylate may be effective in lowering blood pressure for the short time that control would be needed.
GlucaGen for Injection is contraindicated in patients with:
The following serious adverse reactions are described below and elsewhere in the labeling:
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in clinical trials of another drug and may not reflect the rates observed in practice.
In an open-label clinical study of GlucaGen for Injection, 29 healthy volunteers received a single dose of 1 mg GlucaGen for Injection intramuscularly. Table 1 shows the most common adverse reactions that were not present at baseline and occurred in at least 5% of patients.
Table 1: Adverse Reactions in Healthy Volunteers Who Received GlucaGen for Injection, 1 mg Administered Intramuscularly
| (N=29) % of Patients | |
| Vomiting | 17 |
| Nausea | 7 |
The following adverse reactions have been identified from the literature and clinical studies with the use of GlucaGen. Therefore, it is not possible to reliably estimate their frequency.
GlucaGen for Injection is indicated for use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract.
Limitations of UseGlucaGen for Injection is not indicated for the emergency treatment of hypoglycemia because it is not packaged with a syringe and diluent necessary for rapid preparation and administration during an emergency outside of a healthcare facility.
Table 3 displays the pharmacodynamics properties of GlucaGen for Injection as a diagnostic aid during radiologic examination.
Table 3: Pharmacodynamic Properties of GlucaGen for Injection as a Diagnostic Aid
| Route of Administration | Dosea | Time of Onset of Action for GI Smooth Muscle Relaxation | Duration of Smooth Muscle Relaxation |
| Intravenous | 0.25 to 0.5 mg | 45 seconds | 9 to 17 minutes |
| Intramuscular | 1 mg | 8 to 10 minutes | 12 to 27 minutes |
| 2 mg | 4 to 7 minutes | 21 to 32 minutes | |
| a Select from these doses based on type of diagnostic procedure, route of administration and procedure duration. |
Included as part of the PRECAUTIONS section.
PRECAUTIONS Hypertension In Patients With PheochromocytomaGlucaGen for Injection is contraindicated in patients with pheochromocytoma because GlucaGen may stimulate the release of catecholamines from the tumor, which may result in a sudden and marked increase in blood pressure.
Hypoglycemia In Patients With Insulinoma Or GlucaGenomaGlucaGen for Injection is contraindicated in patients with insulinoma or GlucaGenoma as it may cause secondary hypoglycemia. Test patients suspected of having GlucaGenoma for blood levels of GlucaGen prior to treatment, and monitor for changes in blood glucose levels during treatment. If a patient develops symptoms of hypoglycemia after a dose of GlucaGen for Injection, administer glucose orally or intravenously.
Hyperglycemia In Patients With Diabetes MellitusTreatment with GlucaGen for Injection in patients with diabetes mellitus may cause hyperglycemia. Monitor diabetic patients for changes in blood glucose levels during treatment. If patients develop symptoms of hyperglycemia after a dose of GlucaGen for Injection, administer insulin.
Blood Pressure And Heart Rate Increase In Patients With Cardiac DiseaseGlucaGen for Injection 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 GlucaGen treatment, and an increase in blood pressure and pulse rate may require therapy.
Hypersensitivity And Allergic ReactionsGeneralized allergic reactions and hypersensitivity, including generalized rash, and anaphylactic shock with breathing difficulties, and hypotension, have been reported with GlucaGen treatment or lactose. Discontinue GlucaGen for Injection and administer standard treatment for anaphylaxis if needed.
Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment Of Fertility CarcinogenesisLong term studies in animals to evaluate carcinogenic potential have not been performed.
MutagenesisSynthetic GlucaGen was negative in the bacterial reverse mutation assay (Ames test). The clastogenic potential of synthetic GlucaGen in the Chinese Hamster Ovary (CHO) assay was positive in the absence of metabolic activation. Doses of 100 and 200 mg/kg of GlucaGen of both pancreatic and recombinant origins gave slightly higher incidences of micronucleus formation in male mice but there was no effect in females. The weight of evidence indicates that synthetic and recombinant GlucaGen are not different and do not pose a genotoxic risk to humans.
Impairment of FertilityGlucaGen (rDNA and synthetic origin) was not tested in animal fertility studies. Studies in rats have shown that pancreatic GlucaGen does not cause impaired fertility.
Use In Specific Populations Pregnancy Pregnancy Category BReproduction studies were performed in rats and rabbits with another GlucaGen product at doses of 0.4, 2, and 10 mg per kg. These doses represent exposures of up to 100 and 200 times the human dose based on mg/m² for rats and rabbits, respectively, and revealed no evidence of harm to the fetus. There are, however, no adequate and well-controlled studies in pregnant women. GlucaGen does not cross the human placental barrier.
Nursing MothersIt is not known whether GlucaGen is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when GlucaGen is administered to a nursing woman. No clinical studies have been performed in nursing mothers, however, GlucaGen is a peptide and intact GlucaGen is not absorbed from the GI tract. Therefore, even if the infant ingested GlucaGen it would be unlikely to have any effect on the infant. Additionally, GlucaGen has a short plasma half-life thus limiting amounts available to the child.
Pediatric UseSafety and effectiveness of GlucaGen for Injection have not been established in pediatric patients for use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract.
Determine the dose based on the type of diagnostic procedure, the route of administration and expected procedure duration.
The usual dose to inhibit movement of the:
Bolus doses above 1 mg administered intravenously have caused nausea and vomiting and are not recommended.
Reconstitution Of The Lyophilized PowderGlucaGen for Injection is a lyophilized powder, which requires reconstitution with Sterile Water for Injection prior to intravenous or intramuscular use.
