July 27, 2016
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GlucaGen

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GlucaGen




Indications
Dosage
How Supplied

INDICATIONS

Treatment Of Severe Hypoglycemia

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.

Use As A Diagnostic Aid

GlucaGen® is indicated for use during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract. Glucagon is as effective for this examination as are the anticholinergic drugs. However, the addition of the anticholinergic agent may result in 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.

DOSAGE AND ADMINISTRATION

For GlucaGen® HypoKit

Treatment Of Severe Hypoglycemia
  1. Using the supplied prefilled syringe, carefully insert the needle through the rubber stopper of the vial containing GlucaGen® powder and inject all the liquid from the syringe into the vial.
  2. Shake the vial gently until the powder is completely dissolved and no particles remain in the fluid. The reconstituted fluid should be clear and of water-like consistency.
  3. The reconstituted GlucaGen® gives a concentration of approximately 1 mg/mL glucagon.
  4. The reconstituted GlucaGen® should be used immediately after reconstitution.
  5. Inject 1 mL (adults and children, weighing more than 55 lbs (25 kg)) or 0.5 mL (children weighing less than 55 lbs (25 kg)) subcutaneously, intramuscularly, or intravenously. Common injection sites for GlucaGen® are upper arms, thighs, or buttocks. If the weight is not known: children younger than 6 years should be given a 0.5 mL and children 6 years and older should be given 1 mL.
  6. Discard any unused portion.
  7. Emergency assistance should be sought immediately after subcutaneous or intramuscular injection of glucagon.
  8. The glucagon injection may be repeated using a new kit while waiting for emergency assistance.
  9. Intravenous glucose MUST be administered if the patient fails to respond to glucagon.
  10. When the patient has responded to the treatment, give fast-acting and long-acting oral carbohydrates to restore the liver glycogen and prevent recurrence of hypoglycemia.

For GlucaGen® Diagnostic Kit and the GlucaGen® 10-pack

Use As A Diagnostic Aid
  1. GlucaGen® should be reconstituted with 1 mL of Sterile Water for Reconstitution (if supplied) or 1 mL of Sterile Water for Injection, USP. Using a syringe, withdraw all of the Sterile Water for Reconstitution (if supplied) or 1 mL Sterile Water for Injection, USP and inject into the GlucaGen® vial.
  2. Shake the vial gently until the powder is completely dissolved and no particles remain in the fluid. The reconstituted fluid should be clear and of water-like consistency.
  3. The reconstituted GlucaGen® gives a concentration of approximately 1 mg/mL glucagon.
  4. The reconstituted GlucaGen® should be used immediately after reconstitution.
  5. GlucaGen® must be administered by medical personnel.
  6. Discard any unused portion.
  7. Onset of action after an injection will depend on the organ under examination and route of administration [see Pharmacodynamics].
  8. The usual diagnostic dose for relaxation of the stomach, duodenal bulb, duodenum, and small bowel is 0.2 mg to 0.5 mg given intravenously or 1 mg given intramuscularly; the usual dose to relax the colon is 0.5 mg to 0.75 mg intravenously and 1 mg to 2 mg intramuscularly [see Pharmacodynamics].
  9. 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.

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.

HOW SUPPLIED

Dosage Forms And Strengths

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 (1 unit/mL) glucagon for subcutaneous, intramuscular, or intravenous injection (appearance of the powder may vary, and occasionally the powder may appear compacted).

Storage And Handling

GlucaGen® is supplied as a sterile, lyophilized white powder in a vial, alone, or accompanied by Sterile Water for Reconstitution also in a vial (Diagnostic Kit or 10-pack). It is also supplied as GlucaGen® HypoKit® with a disposable prefilled syringe containing Sterile Water for Reconstitution.

GlucaGen® HypoKit® includes:

1 vial containing 1 mg (1 unit) GlucaGen® (glucagon [rDNA origin] for injection)
1 disposable syringe containing 1 mL Sterile Water for Reconstitution

NDC 0169-7065-15

GlucaGen® Diagnostic Kit (NDC 0597-0260-10) includes:

1 vial containing 1 mg (1 unit) GlucaGen® (glucagon [rDNA origin] for injection)

NDC 0597-0053-01

1 vial containing 1 mL Sterile Water for Reconstitution

NDC 0597-0265-94

GlucaGen® Diagnostic Kit is also available as NDC 55390-004-01 and includes:

1 vial containing 1 mg (1 unit) GlucaGen® (glucagon [rDNA origin] for injection)

NDC 55390-004-01

1 vial containing 1 mL Sterile Water for Reconstitution

The GlucaGen® 10-pack includes:

10 vials, each containing 1 mg (1 unit) GlucaGen® (glucagon [rDNA origin] for injection)

NDC 55390-004-10
NDC
0597-0053-45

Recommended Storage

Before Reconstitution

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.

After Reconstitution

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.

Revised: Dec 2015. Manufactured by: Novo Nordisk A/S 2880 Bagsvaerd, Denmark. For information contact: Novo Nordisk Inc. 800 Scudders Mill Road Plainsboro, New Jersey 08536 1-800-727-6500 www.novonordisk-us.com.

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 2/16/2016

Indications
Dosage
How Supplied

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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