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GlucaGen®
(glucagon) for Injection
GlucaGen (glucagon) for injection is an antihypoglycemic agent and a gastrointestinal motility inhibitor for subcutaneous, intramuscular or intravenous use. It is produced by expression of recombinant DNA in a Saccharomyces cerevisiae vector with subsequent purification. The chemical structure of the glucagon in GlucaGen is identical to human glucagon and to glucagon extracted from beef and pork pancreas. Glucagon with the empirical formula of C153H225N43O49S, and a molecular weight of 3483, is a single-chain polypeptide containing 29 amino acid residues. The structure of glucagon is:
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GlucaGen is a sterile, lyophilized white powder in a 2 mL vial (appearance of the powder may vary, and occasionally the powder may appear compacted). The reconstituted solution contains glucagon as hydrochloride 1 mg/mL and lactose monohydrate (107 mg). GlucaGen is supplied at pH 2.5-3.5 and is soluble in water.
GlucaGen is used to treat severe hypoglycemic (low blood sugar) reactions which may occur in patients with diabetes mellitus treated with insulin. Because GlucaGen depletes glycogen stores, the patient should be given supplemental carbohydrates as soon as he/she awakens and is able to swallow, especially children or adolescents. Medical evaluation is recommended for all patients who experience severe hypoglycemia.
GlucaGen is indicated for use during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract. GlucaGen is not recommended in combination with anticholinergic agents due to the possibility of increased side effects. After the end of the diagnostic procedure, give oral carbohydrates to patients who have been fasting, if this is compatible with the diagnostic procedure applied.
For GlucaGen HypoKit:
For GlucaGen Diagnostic Kit and the GlucaGen 10-pack:
The GlucaGen Diagnostic Kit and the GlucaGen 10-pack presentations are intended only for use by healthcare providers as a diagnostic aid. The GlucaGen Diagnostic Kit and the GlucaGen 10-pack presentations are not intended for use by patients to treat severe hypoglycemia because they are not packaged with a syringe and diluent necessary for rapid preparation and administration during an emergency outside of a healthcare facility.
GlucaGen is supplied in a vial, alone, or accompanied by Sterile Water for Reconstitution (1 mL) also in a vial (10 pack or diagnostic kit). It is also supplied as GlucaGen HypoKit®, a presentation with a disposable prefilled syringe containing 1 mL Sterile Water for Reconstitution. When the glucagon powder is reconstituted with Sterile Water for Reconstitution (if supplied) or with Sterile Water for Injection, USP, it forms a solution of 1 mg/mL glucagon for subcutaneous, intramuscular, or intravenous injection (appearance of the powder may vary, and occasionally the powder may appear compacted).
GlucaGen (glucagon) for injection is supplied as a sterile, lyophilized white powder.
The GlucaGen package may be stored up to 24 months at controlled room temperature 20° to 25° C (68° to 77° F) prior to reconstitution. Do not freeze. Keep in the original package to protect from light. GlucaGen should not be used after the expiry date on the vials.
Reconstituted GlucaGen should be used immediately. Discard any unused portion. If the solution shows any sign of gel formation or particles, it should be discarded.
Manufactured by: Novo Nordisk A/S, 2880 Bagsvaerd, Denmark. Revised: April 2018
Side effects may include nausea and vomiting at doses above 1 mg or with rapid injection. Hypotension has been reported up to 2 hours after administration in patients receiving GlucaGen as premedication for upper GI endoscopy procedures. GlucaGen exerts positive inotropic and chronotropic effects and may, therefore, cause tachycardia and hypertension. Adverse reactions indicating toxicity of GlucaGen have not been reported. A temporary increase in both blood pressure and pulse rate may occur following the administration of GlucaGen. Patients taking beta-blockers might be expected to have a greater increase in both pulse and blood pressure, an increase of which will be temporary because of GlucaGen’s short half-life [see DRUG INTERACTIONS]. The increase in blood pressure and pulse rate may require therapy in patients with pheochromocytoma or coronary artery disease [see WARNINGS AND PRECAUTIONS]. Anaphylactic reactions may occur in some cases [see WARNINGS AND PRECAUTIONS].
The following adverse reactions have been identified during postapproval use of GlucaGen. 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 1 Frequency of Adverse Reactions
| Treatment of severe hypoglycemia | |
| Frequency (%) | Adverse Reaction |
| < 10 | Nausea |
| < 1 | Vomiting |
| Use as a diagnostic aid | |
| < 10 | Nausea |
| < 1 | Vomiting |
| < 1 | Hypoglycemia |
| < 1 | Hypoglycemic coma |
Patients taking beta-blockers might be expected to have a greater increase in both pulse and blood pressure, an increase of which will be temporary because of glucagon’s short half-life. The increase in blood pressure and pulse rate may require therapy in patients with pheochromocytoma or coronary artery disease.
When used with indomethacin, glucagon may lose its ability to raise blood glucose or may even produce hypoglycemia. Therefore, caution should be exercised for patients taking indomethacin when glucagon will be administered.
Coadministration with an anticholinergic drug is not recommended due to increased gastrointestinal side effects.
Glucagon may increase the anticoagulant effect of warfarin. Therefore, caution should be exercised for patients taking warfarin when glucagon will be administered.
Insulin reacts antagonistically towards glucagon. Therefore, caution should be exercised when glucagon is used as a diagnostic aid in diabetes patients.
Included as part of the "PRECAUTIONS" Section
GlucaGen is contraindicated in patients with pheochromocytoma because GlucaGen 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.
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, GlucaGen 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 GlucaGen should be given glucose orally or intravenously, whichever is most appropriate. Caution should be observed in administering GlucaGen to patients with glucagonoma.
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.
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 GlucaGen 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.
[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 GlucaGen 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.
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 was not tested in animal fertility studies. Studies in rats have shown that pancreatic glucagon does not cause impaired fertility.
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.
No reports of overdosage with GlucaGen have been reported. 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, the 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.
GlucaGen is contraindicated in patients with:
Glucagon induces liver glycogen breakdown, releasing glucose from the liver. Hepatic stores of glycogen are necessary for glucagon to produce an antihypoglycemic effect.
Extra hepatic effects of glucagon include relaxation of the smooth muscle of the stomach, duodenum, small bowel, and colon.
Blood glucose concentration rises within 10 minutes of injection and maximal concentrations are attained at approximately 30 minutes after injection (see Figure 1). The duration of hyperglycemic action after intravenous or intramuscular injection is 60 – 90 minutes.
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Figure 1. Recovery from Insulin Induced Hypoglycemia (mean blood glucose) After Intramuscular Injection of 1 mg GlucaGen in Type I Diabetic Men
Table 2 Pharmacodynamic Properties of Glucagon
| Route of Administration | Dose* | Time of Maximal Glucose Concentration | Time of Onset of Action for GI Smooth Muscle Relaxation | Duration of Smooth Muscle Relaxation1 |
| IV | 0.25-0.5 mg | 5-20 minutes | 45 seconds | 9-17 minutes |
| 2 mg | 5-20 minutes | 45 seconds | 22-25 minutes | |
| IM | 1 mg | 30 minutes | 8-10 minutes | 12-27 minutes |
| 2 mg | 30 minutes | 4-7 minutes | 21-32 minutes | |
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*The usual diagnostic dose for relaxation of the stomach, duodenal bulb, duodenum, and small bowel is 0.2 – 0.5 mg given intravenously or 1 mg given intramuscularly; the usual dose to relax the colon is 0.5 – 0.75 mg intravenously and 1 – 2 mg intramuscularly. 1 Note: The time of maximal glucose concentration for GlucaGen administered subcutaneously is 30-45 minutes. |
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Intramuscular injection of 1 mg GlucaGen resulted in a mean Cmax (CV%) of 1686 pg/mL (43%) and median Tmax of 12.5 minutes. The mean apparent half-life of 45 minutes after intramuscular injection probably reflects prolonged absorption from the injection site. Glucagon is degraded in the liver, kidney, and plasma.
GlucaGen®
(Glū-ka-Gen)
(glucagon) for injection
HypoKit®
What is GlucaGen?
GlucaGen is a prescription medicine used:
Who should not use GlucaGen?
Do not use GlucaGen if:
What should I tell my doctor before using GlucaGen?
Before using GlucaGen, tell your doctor about all of your medical conditions, including if you:
Tell your doctor about all the medicines you take, including prescription and over the counter medicines, vitamins and herbal supplements. GlucaGen may affect the way other medicines work, and other medicines may affect how GlucaGen works. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
How should I use GlucaGen?
What should I avoid while using GlucaGen?
While using GlucaGen do not:
What are the possible side effects of GlucaGen?
GlucaGen may cause serious side effects, including:
The most common side effects of GlucaGen include:
Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of GlucaGen. For more information, ask your doctor or pharmacist. 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 GlucaGen?
Before you mix the GlucaGen powder and liquid:
After you mix the GlucaGen powder and liquid:
Keep GlucaGen and all medicines out of the reach of children.
General information about the safe and effective use of GlucaGen.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use GlucaGen for a condition for which it was not prescribed. Do not give GlucaGen 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 GlucaGen that is written for health professionals.
What are the ingredients in the GlucaGen?
Active Ingredient: glucagon
Inactive ingredients: lactose monohydrate and sterile water for reconstitution
Instructions For Use
GlucaGen®
(Gl-ka-Gen)
(glucagon)
for injection
HypoKit®
Read this Instructions for Use before you start using GlucaGen and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment. Talk to your doctor or pharmacist if you have any questions about how to use GlucaGen.
Important:How should I store GlucaGen?
Before you mix the GlucaGen powder and liquid:
After you mix the GlucaGen powder and liquid:
Supplies you will need for your GlucaGen injection (See Figure A):
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Figure A
Preparing the GlucaGen dose:
Step 1. Using your thumb, flip the orange plastic cap off the GlucaGen vial (See Figure B).
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Figure B
Step 2. Pick up the prefilled syringe containing sterile water. Hold the syringe with 1 hand and with your other hand; pull the needle cover off the syringe (See Figure C).
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Figure C
Step 3. Pick up the GlucaGen vial. Hold the vial of dry powder with 1 hand and with your other hand; push the needle of the prefilled syringe through the center of the rubber stopper (See Figure D).
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Figure D
Step 4. Hold the vial and syringe together, with the needle still inserted into the vial. Carefully turn the vial and syringe together right side up. Slowly push the plunger down until the syringe is empty (See Figure E).
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Figure E
Step 5. Hold the entire unit (the vial and syringe) in one hand and gently shake the vial until the powder is completely dissolved (See Figure F).
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Figure F
Step 6. Firmly hold the vial and syringe together, with the needle still inserted into the vial. Carefully turn the vial and syringe together upside down. Gently pull down on the plunger and slowly withdraw all of the liquid into the syringe (See Figure G).
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Figure G
Step 7. Keep the needle inside the vial. Check the syringe for air bubbles. If you see bubbles, tap the syringe until the bubbles rise to the top of the syringe (See Figure H). Gently push on the plunger to move only the air bubbles back into the vial.
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Figure H
Step 8. Hold the vial and syringe as shown (See Figure I).
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Figure I
Take the syringe and needle out of the vial when the correct dose of GlucaGen is in the syringe.
If you do not know how much the child weighs:
Giving the GlucaGen injection:
Step 9. Choose the injection site (See Figure J). Common injection sites for GlucaGen are upper arms, thighs, or buttocks.
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Figure J
Step 10. With one hand gently pinch the skin at the injection site. With your other hand insert the needle into the skin and push the syringe plunger down until the syringe is empty (See Figure K).
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Figure K
After Giving the GlucaGen injection:
Step 11. Pull the needle out of the skin and press on the injection site (See Figure L).
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Figure L
Throw away your used syringe with the needle attached and any GlucaGen you did not use. See "How should I dispose of (throw away) used GlucaGen prefilled syringes" at the end of these instructions.
Step 12. Turn the person on their side. When an unconscious person awakens, they may vomit. Turning the person on their side will lessen the chance of choking.
Step 13. Call for emergency medical help right away.
Step 14. Feed the person as soon as they are awake and able to swallow.
Give the person a fast-acting source of sugar (such as a regular soft drink or fruit juice) and a long-acting source of sugar (such as crackers and cheese or a meat sandwich).
Step 15. Even if the GlucaGen treatment wakes the person, tell their doctor right away. The doctor should be told whenever a severe drop in blood sugar (hypoglycemia reaction) happens. The person’s dose of diabetes medicine may need to be changed.
Hypoglycemia may happen again after receiving GlucaGen treatment.
Early symptoms of hypoglycemia may include:
If not treated early, hypoglycemia may worsen and the person may have severe hypoglycemia. Signs of severe hypoglycemia include:
How should I dispose of (throw away) GlucaGen pre-filled syringes?
Keep GlucaGen and all medicines out of the reach of children.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
