"SILVER SPRING, MD â€” A US Food and Drug Administration (FDA) advisory committee has given its blessing to a new injectable that combines fixed doses of a long-acting basal insulin with a glucagonlike peptide 1 (GLP-1) receptor agonist for diabetes"...
Glucagon is contraindicated in patients with pheochromocytoma because Glucagon may stimulate the release of catecholamines from the tumor. If the patient develops a dramatic increase in blood pressure, 5 to 10 mg of phentolamine mesylate has been shown to be effective in lowering blood pressure for the short time that control would be needed.
Insulinoma And Glucagonoma
GlucaGen® should not be administered to patients suspected of having insulinoma. In patients with insulinoma, intravenous 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. A patient developing symptoms of hypoglycemia after a dose of glucagon should be given glucose orally or intravenously, whichever is most appropriate. Caution should be observed in administering GlucaGen® to patients with glucagonoma.
Hypersensitivity And Allergic Reactions
Allergic reactions may occur and include generalized rash, and in some cases anaphylactic shock with breathing difficulties, and hypotension. The anaphylactic reactions have generally occurred in association with endoscopic examination during which patients often received other agents including contrast media and local anesthetics. The patients should be given standard treatment for anaphylaxis including an injection of epinephrine if they encounter respiratory difficulties after GlucaGen® injection.
Glycogen Stores And Hypoglycemia
In order for GlucaGen® treatment to reverse hypoglycemia, adequate amounts of glucose must be stored in the liver (as glycogen). Therefore, GlucaGen® should be used with caution in patients with conditions such as prolonged fasting, starvation, adrenal insufficiency, or chronic hypoglycemia because these conditions result in low levels of releasable glucose in the liver and an inadequate reversal of hypoglycemia by GlucaGen® treatment.
Caution should be observed when glucagon is used as an adjunct in endoscopic or radiographic procedures to inhibit gastrointestinal motility in patients with known cardiac disease.
Blood glucose measurements may be considered to monitor the patient's response.
Patient Counseling Information
[See FDA-Approved Patient Information and Instructions for Use.]
Refer patients and family members to the FDA-approved patient labeling for instructions describing the method of preparing and injecting GlucaGen®. Advise the patient and family members to become familiar with the technique of preparing glucagon before an emergency arises. Instruct patients to use 1 mg for adults or ½ the adult dose (0.5 mg) for children weighing less than 55 lb (25 kg). To prevent severe hypoglycemia, patients and family members should be informed of the symptoms of mild hypoglycemia and how to treat it appropriately. Family members should be informed to arouse the patient as quickly as possible because prolonged hypoglycemia may result in damage to the central nervous system. Patients should be advised to inform their physician each time a hypoglycemic reaction occurs so that the treatment regimen may be adjusted if necessary.
No studies on the effects on the ability to drive and use machines have been performed. After diagnostic procedures, hypoglycemia has been reported infrequently. The patient's ability to concentrate and react may be impaired as a result of hypoglycemia. This may present a risk in situations where these abilities are especially important, such as driving or operating machinery. Therefore, these activities should be avoided until the patient has had intake of oral carbohydrates.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Long term studies in animals to evaluate carcinogenic potential have not been performed. Several studies have been conducted to evaluate the mutagenic potential of glucagon. The mutagenic potential tested in the Ames and human lymphocyte assays, was borderline positive under certain conditions for both glucagon (pancreatic) and glucagon (rDNA) origin. In vivo, very high doses (100 and 200 mg/kg) of glucagon (both origins) gave a slightly higher incidence of micronucleus formation in male mice but there was no effect in females. The weight of evidence indicates that GlucaGen® is not different from glucagon pancreatic origin and does not pose a genotoxic risk to humans. GlucaGen® (rDNA origin) was not tested in animal fertility studies. Studies in rats have shown that pancreatic glucagon does not cause impaired fertility.
Use In Specific Populations
Pregnancy Category B. Reproduction studies were performed in rats and rabbits at GlucaGen® doses of 0.4, 2.0, and 10 mg/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. Glucagon does not cross the human placenta barrier.
It is not known whether this drug 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 glucagon is not absorbed from the GI tract. Therefore, even if the infant ingested glucagon 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.
For the treatment of severe hypoglycemia: The use of glucagon in pediatric patients has been reported to be safe and effective.
For use as a diagnostic aid: Safety and effectiveness in pediatric patients have not been established.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 2/16/2016
Additional GlucaGen Information
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