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GlucaGen (Novo Nordisk)

GlucaGen (Novo Nordisk) - General Information

29 residue peptide hormone. Glucagon is synthesized in a special non- pathogenic laboratory strain of Escherichia coli bacteria that has been genetically altered by the addition of the gene for glucagons

 

Pharmacology of GlucaGen (Novo Nordisk)

Used in the treatment of hypoglycemia and in gastric imaging, glucagon increases blood glucose concentration and is used in the treatment of hypoglycemia. Glucagon acts only on liver glycogen, converting it to glucose through the release of insulin. It also relaxes the smooth muscles of the gastrointestinal tract.

 

GlucaGen (Novo Nordisk) for patients

Refer patients and family members to the attached Information for the User for instructions describing the method of preparing and injecting glucagon. 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 (1 unit) for adults and 1/ 2 the adult dose (0.5 mg) [0.5 unit] for pediatric patients weighing less than 44 lb (20 kg).

Patients and family members should be informed of the following measures to prevent hypoglycemic reactions due to insulin:

  1. Reasonable uniformity from day to day with regard to diet, insulin, and exercise.
  2. Careful adjustment of the insulin program so that the type (or types) of insulin, dose, and time (or times) of administration are suited to the individual patient.
  3. Frequent testing of the blood or urine for glucose so that a change in insulin requirements can be foreseen.
  4. Routine carrying of sugar, candy, or other readily absorbable carbohydrate by the patient so that it may be taken at the first warning of an oncoming reaction.

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. Glucagon or intravenous glucose should awaken the patient sufficiently so that oral carbohydrates may be taken.

Patients should be advised to inform their physician when hypoglycemic reactions occur so that the treatment regimen may be adjusted if necessary.

INFORMATION FOR THE USER

FOR INJECTION

(rDNA ORIGIN)

BECOME FAMILIAR WITH THE FOLLOWING INSTRUCTIONS BEFORE AN EMERGENCY ARISES. DO NOT USE THIS KIT AFTER DATE STAMPED ON THE BOTTLE LABEL. IF YOU HAVE QUESTIONS CONCERNING THE USE OF THIS PRODUCT, CONSULT A DOCTOR, NURSE OR PHARMACIST.

Make sure that your relatives or close friends know that if you become unconscious, medical assistance must always be sought. Glucagon may have been prescribed so that members of your household can give the injection if you become hypoglycemic and are unable to take sugar by mouth. If you are unconscious, glucagon can be given while awaiting medical assistance.

Show your family members and others where you keep this kit and how to use it. They need to know how to use it before you need it. They can practice giving a shot by giving you your normal insulin shots. It is important that they practice. A person who has never given a shot probably will not be able to do it in an emergency.

IMPORTANT
  • Act quickly. Prolonged unconsciousness may be harmful.
  • These simple instructions will help you give glucagon successfully.
  • Turn patient on his/her side to prevent patient from choking.
  • The contents of the syringe are inactive. You must mix the contents of the syringe with the glucagon in the accompanying bottle before giving injection.
  • Do not prepare Glucagon for Injection until you are ready to use it. WARNING: THE PATIENT MAY BE IN A COMA FROM SEVERE HYPERGLYCEMIA (HIGH BLOOD GLUCOSE) RATHER THAN HYPOGLYCEMIA. IN SUCH A CASE, THE PATIENT WILL NOT RESPOND TO GLUCAGON AND REQUIRES IMMEDIATE MEDICAL ATTENTION.

INDICATIONS FOR USE

Use glucagon to treat insulin coma or insulin reaction resulting from severe hypoglycemia (low blood sugar). Symptoms of severe hypoglycemia include disorientation, unconsciousness, and seizures or convulsions. Give glucagon if (1) the patient is unconscious (2) the patient is unable to eat sugar or a sugar-sweetened product (3) the patient is having a seizure, or (4) repeated administration of sugar or a sugar-sweetened product such as a regular soft drink or fruit juice does not improve the patient's condition. Milder cases of hypoglycemia should be treated promptly by eating sugar or a sugar-sweetened product. Glucagon is not active when taken orally.

DIRECTIONS FOR USE

TO PREPARE GLUCAGON FOR INJECTION

1. Remove the flip-off seal from the bottle of glucagon. Wipe rubber stopper on bottle with alcohol swab.

2. Remove the needle protector from the syringe, and inject the entire contents of the syringe into the bottle of glucagon. DO NOT REMOVE THE PLASTIC CLIP FROM THE SYRINGE. Remove syringe from the bottle.

3. Swirl bottle gently until glucagon dissolves completely. GLUCAGON SHOULD NOT BE USED UNLESS THE SOLUTION IS CLEAR AND OF A WATER-LIKE CONSISTENCY.

TO INJECT GLUCAGON

Use Same Technique as for Injecting Insulin

1. Using the same syringe, hold bottle upside down and, making sure the needle tip remains in solution, gently withdraw all of the solution (1 mg mark on syringe) from bottle. The plastic clip on the syringe will prevent the rubber stopper from being pulled out of the syringe; however, if the plastic plunger rod separates from the rubber stopper, simply reinsert the rod by turning it clockwise. The usual adult dose is 1 mg (1 unit). For children weighing less than 44 lb (20 kg), give 1/2 adult dose (0.5 mg). For children, withdraw 1/2 of the solution from the bottle (0.5 mg mark on syringe). DISCARD UNUSED PORTION.

USING THE FOLLOWING DIRECTIONS, INJECT GLUCAGON IMMEDIATELY AFTER MIXING.

  • Cleanse injection site on buttock, arm, or thigh with alcohol swab.
  • Insert the needle into the loose tissue under the cleansed injection site, and inject all (or � for children weighing less than 44 lb) of the glucagon solution. THERE IS NO DANGER OF OVERDOSE. Apply light pressure at the injection site, and withdraw the needle. Press an alcohol swab against the injection site.
  • Turn the patient on his/her side. When an unconscious person awakens, he/she may vomit. Turning the patient on his/her side will prevent him/her from choking.
  • FEED THE PATIENT AS SOON AS HE/SHE AWAKENS AND IS ABLE TO SWALLOW. Give the patient 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). If the patient does not awaken within 15 minutes, give another dose of glucagon and INFORM A DOCTOR OR EMERGENCY SERVICES IMMEDIATELY.
  • Even if the glucagon revives the patient, his/her doctor should be promptly notified. A doctor should be notified whenever severe hypoglycemic reactions occur.

INFORMATION ON HYPOGLYCEMIA

Early symptoms of hypoglycemia (low blood glucose) include:

  • sweating
  • dizziness
  • palpitation
  • tremor
  • hunger
  • restlessness
  • tingling in the hands, feet, lips, or tongue
  • lightheadedness
  • inability to concentrate
  • headache
  • drowsiness
  • sleep disturbances
  • anxiety
  • blurred vision
  • slurred speech
  • depressed mood
  • irritability
  • abnormal behavior
  • unsteady movement
  • personality changes

If not treated, the patient may progress to severe hypoglycemia that can include:

  • disorientation
  • unconsciousness
  • seizures
  • death

The occurrence of early symptoms calls for prompt and, if necessary, repeated administration of some form of carbohydrate. Patients should always carry a quick source of sugar, such as candy mints or glucose tablets. The prompt treatment of mild hypoglycemic symptoms can prevent severe hypoglycemic reactions. If the patient does not improve or if administration of carbohydrate is impossible, glucagon should be given or the patient should be treated with intravenous glucose at a medical facility. Glucagon, a naturally occurring substance produced by the pancreas, is helpful because it enables the patient to produce his/her own blood glucose to correct the hypoglycemia.

POSSIBLE PROBLEMS WITH GLUCAGON TREATMENT

Severe side effects are very rare, although nausea and vomiting may occur occasionally.

A few people may be allergic to glucagon or to one of the inactive ingredients in glucagon, or may experience rapid heart beat for a short while.

If you experience any other reactions which are likely to have been caused by glucagon, please contact your doctor.

STORAGE

Before dissolving glucagon with diluting solution--Store the kit at controlled room temperature between 20� to 25�C (68� to 77�F).

After dissolving glucagon with diluting solution--Should be used immediately. Discard any unused portion. Solutions should be clear and of a water-like consistency at time of use.

 

GlucaGen (Novo Nordisk) Interactions

 

GlucaGen (Novo Nordisk) Contraindications

Glucagon is contraindicated in patients with known hypersensitivity to it or in patients with known pheochromocytoma.

 

Additional information about GlucaGen (Novo Nordisk)

GlucaGen (Novo Nordisk) Indication: For treatment of severe hypoglycemia, also used in gastrointestinal imaging
Mechanism Of Action: Glucagon binds the glucagon receptor which then initiates a dual signaling pathway using both adenylate cyclase activation and increased intracellular calcium. Glucagon receptors are found in the liver, kidney, brain and pancreatic islet cells. The glucagon mediated signals lead to an increase in insulin excretion
Drug Interactions: Not Available
Food Interactions: Not Available
Generic Name: Glucagon recombinant
Synonyms: Fragment; Glucagon precursor [Contains: Glicentin, Glicentin-related polypeptide,GRPP, Oxyntomodulin,OXY,OXM, Glucagon, Glucagon-like peptide 1,GLP-1, Glucagon-like peptide 1(7-37),GLP-1(7-37), Glucagon-like peptide 1(7-36),GLP-1(7-36), Glucagon-like peptide 2,GLP-2]
Drug Category: Antihypoglycemic Agents
Drug Type: Biotech; Approved

Other Brand Names containing Glucagon recombinant: GlucaGen (Novo Nordisk); Glucagon (Eli Lilly);
Absorption: Not Available
Toxicity (Overdose): Not Available
Protein Binding: Not Available
Biotransformation: Not Available
Half Life: Not Available
Dosage Forms of GlucaGen (Novo Nordisk): Kit Subcutaneous
Chemical IUPAC Name: Human Glucagon
Chemical Formula: C165H249N49O51S1
Glucagon recombinant on Wikipedia: https://en.wikipedia.org/wiki/Glucagon_recombinant
Organisms Affected: Humans and other mammals