Lupin-Glucagon: Uses, Side Effects and Dosage

What LUPIN-GLUCAGON is used for:

• LUPIN-GLUCAGON (glucagon for injection) is used:

  • for emergency treatment of severe hypoglycemia (low blood sugar). It is used in adults and children with diabetes mellitus, who are unconscious or unable to swallow any type of sugar by mouth.
  • as diagnostic aid for adults during medical examinations to slow down the movement of digestive organs.

  • LUPIN-GLUCAGON should only be given if the patient is unconscious or unable to swallow any type of sugar by mouth.

    • Patients usually awaken within 15 minutes after glucagon injection into the muscle (intramuscular injection) or under the skin (subcutaneous).
    • After giving LUPIN-GLUCAGON, call for medical help right away. Patients may need additional treatment with glucose given by healthcare professional by injection into the veins (intravenous injection).
    • When the patient has responded to the treatment, get them to eat as soon as they are able to safely swallow. This is to prevent relapse of severe low blood sugar levels again.

  • LUPIN-GLUCAGON will not work well if the patient does not have enough glucose stored in the liver. This may occur if they:

    • are fasting or have not been eating for a longtime
    • have a condition where the adrenal glands do not make enough hormones (adrenal insufficiency)
    • have chronic low blood sugar

In such cases, glucose must be given by injection into the veins (intravenous injection) by a healthcare professional.

How LUPIN-GLUCAGON works

LUPIN-GLUCAGON causes an increase in blood sugar levels. It works by causing the liver to convert glycogen into glucose and releasing it into the blood.

The ingredients in LUPIN-GLUCAGON are:

Medicinal ingredient: Glucagon (synthetic)

Non-medicinal ingredients:

Powder (in vial): hydrochloric acid (pH adjuster) and lactose monohydrate.

Diluent (in prefilled syringe): glycerin, water for injection

LUPIN-GLUCAGON comes in the following dosage form:

Powder for solution: 1 mg glucagon per vial (1 unit)

The LUPIN GLUCAGON kit contains:

• LUPIN-GLUCAGON powder in vial, and
• diluting solution (1 mL) in syringe

Do not use LUPIN-GLUCAGON if:

• you are allergic to glucagon or any other ingredients in LUPIN-GLUCAGON or its container.
• you have a type of adrenal gland tumor called pheochromocytoma.
• you have a type of pancreas tumor called insulinoma.
• you have a type of pancreas tumor called glucagonoma and are using LUPIN-GLUCAGON as a diagnostic aid.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take LUPIN-GLUCAGON. Talk about any health conditions or problems you may have, including if you:

• are fasting
• have low levels of adrenaline
• have chronic low blood sugar (hypoglycemia)

• have low levels of liver glycogen due to excessive consumption of alcohol

• are pregnant or breastfeeding

• have heart problems

Other warnings you should know about:

• Make sure your friends, family, caregivers or co-workers are aware of signs and symptoms of low blood sugar. Symptoms of low blood sugar may include:

  • sweating
  • drowsiness
  • dizziness, light-headedness, unsteady movement
  • sleep disturbances
  • palpitations
  • anxiety, restlessness, irritability
  • tremor
  • blurred vision

  • hunger

    • slurred speech
    • depressive mood
    • tingling in the hands, feet, lips, or tongue
    • abnormal behaviour
    • inability to concentrate
    • headache
    • personality changes

If not treated, you may progress to severely low blood sugar, which can cause:

• disorientation
• death
• unconsciousness
• palpitations
• seizures
• convulsions

• Driving and using machines

• before you drive or do tasks that require special attention, wait until you know how you respond to LUPIN-GLUCAGON. Low blood sugar (hypoglycemia) may affect your ability to concentrate and react.
• Check-ups and testing
• After treatment with LUPIN-GLUCAGON for low blood sugar, your healthcare professional will do blood tests to follow your blood glucose levels.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with LUPIN-GLUCAGON:

• Anticholinergic medicines, used to stop involuntary muscle movements in various conditions
• beta-blockers, medicines used to treat heart and blood vessel problems
• insulin and sulfonylurea, medicines used to treat diabetes
• indomethacin, medicine used to treat arthritis
• warfarin, medicine used to treat blood clots
• alcohol

How to take LUPIN-GLUCAGON:

Emergency treatment of low blood sugar (hypoglycemia)

LUPIN-GLUCAGON is an emergency drug to be used only under the direction of healthcare professional. It should only be given only if the patient is unconscious or unresponsive and unable to swallow any type of sugar by mouth.

• Read the “Instructions for use of LUPIN-GLUCAGON” for full administration instructions.
• Show your friends and family where you keep LUPIN-GLUCAGON and the package leaflets. Explain how to use it by sharing these instructions. Make sure they know how to use LUPIN-GLUCAGON and where it is kept before an emergency arises.
• Act quickly. Having very low blood sugar for a period of time may be harmful.
• Call for emergency help right away after giving the dose.
• If the patient does not respond in 15 minutes, a second dose of LUPIN-GLUCAGON may be given.

• When you are able to safely swallow food or drink, your caregiver should give you both:

  • a fast-acting source of sugar (such as regular soft drink or sweetened orange juice) and
  • a long-acting source of sugar (such as crackers and cheese or a meat sandwich).
• Tell your healthcare professional each time after using LUPIN-GLUCAGON. You need to find out why you had severe low blood sugar and how to avoid it happening again.

Diagnostic aid

• Your healthcare professional will give you LUPIN-GLUCAGON in a healthcare setting.

Usual dose:

Emergency treatment of low blood sugar (Adults and Children)

The dose depends on the patients age and weight.

• Adults: 1 mg/1 mL (1 unit)

• Children weighing more than 20 kg: 1 mg/mL (1 unit)

• Children weighing less than 20 kg: 0.5 mg/1 mL (0.5 unit). This is half the adult dose.

Doses must be given by injection subcutaneously (under the skin) or intramuscularly (into a muscle).

Diagnostic aid (Adults)

Adults: Your dose will depend on what organ will be examined. Your healthcare professional will decide on the best dosage for you.

Overdose:

Giving too much LUPIN-GLUCAGON may cause nausea, vomiting, stomach relaxation and diarrhea.

If you think you, or a person you are caring for, have been given too much LUPIN-GLUCAGON, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Possible side effects from using LUPIN-GLUCAGON:

These are not all the possible side effects you may have when taking LUPIN-GLUCAGON. If you experience any side effects not listed here, tell your healthcare professional.

• Reaction at the injection site
• Nausea
• Vomiting
• Headache, dizziness, weakness
• Diarrhea
• Drowsiness
• Low potassium levels in the blood (as seen on blood tests)

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html) for information on how to report online, by mail or by fax;

  or

• Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Ensure that friends or relatives know where LUPIN-GLUCAGON is stored.

• Keep out of reach and sight of children.

• Before reconstitution (mixing LUPIN-GLUCAGON powder and diluting solution):

  • Store at room temperature (15° to 30°C).
  • Do NOT refrigerate or freeze LUPIN-GLUCAGON.
  • Keep in its original package and away from light.

• Reconstituted solution:

  • LUPIN-GLUCAGON should be used immediately after reconstitution. Discard any unused portion.
  • Do NOT use if reconstituted solution looks cloudy or has particles. If this happens, discard it right away.
• The expiry date of this medicine is printed on the package label. Do not use past expiry date.

If you want more information about LUPIN-GLUCAGON:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website https://www.lupinpharma.ca/, or by calling 1-844-587-4623.

Date of Authorization: XXXX

Instruction for use of LUPIN-GLUCAGON (for emergency treatment of low blood sugar):

What to tell your friends, family, caregiver or co-workers:

Your doctor has given you LUPIN-GLUCAGON so that your friends or relatives can give you the injection if you become severely hypoglycemic (unconscious due to low blood sugar) and cannot take sugar by mouth. Ensure that friends or relatives know where LUPIN-GLUCAGON is stored. Note: LUPIN-GLUCAGON should not be prepared for injection until emergency arises.

• Check the expiry date regularly. When approaching the expiry date, you should get a new LUPIN-GLUCAGON. Do not use this LUPIN-GLUCAGON after the date stamped on the outside of the box.
• Use LUPIN-GLUCAGON immediately after mixing with diluent.
• Do not share your LUPIN-GLUCAGON syringes or needles with another person. You may give other people a serious infection or get a serious infection from them.
• The prefilled syringe (diluent) in the package is for use with LUPIN-GLUCAGON only. Do NOT use this syringe to inject other medicines.
• Alcohol swabs are not included in the LUPIN-GLUCAGON kit. You should store alcohol swabs with the kit so it can be used in emergencies.

GATHER SUPPLIES AND PREPARE TO USE LUPIN-GLUCAGON

Gather the following supplies to give the injection:

• LUPIN-GLUCAGON kit: 1 Product vial and 1 Diluent Prefilled syringe with Backstop (Plastic clip) - to facilitate the syringe grip.
• 1 alcohol swab (not included)
• Clean surface

LUPIN-GLUCAGON kit contents:

Before you give the injection:

• Wash your hands thoroughly with soap and water
• Check the expiration date on the LUPIN-GLUCAGON kit. Do NOT use if expired. If you do not have another LUPIN-GLUCAGON kit, call for emergency help right away.

PREPARING LUPIN-GLUCAGON

Step 1: Remove the flip-off seal from the LUPIN-GLUCAGON vial Wipe rubber stopper on vial with alcohol swab.
Step 2: Remove the needle protector from the syringe. Do NOT remove the plastic clip from the syringe. Insert needle through the rubber stopper of the vial and inject the entire contents of the syringe into the LUPIN-GLUCAGON vial. Remove syringe from the bottle. Place the syringe on a clean surface. Do NOT let the syringe touch anything else to keep the needle clean.
Step 3: Swirl bottle gently until LUPIN-GLUCAGON powder dissolves completely. The solution should be clear and of a water-like consistency. Do NOT use LUPIN-GLUCAGON if it looks cloudy, or has particles. If you do not have another LUPIN-GLUCAGON kit, call for emergency help right away.

PREPARING THE DOSE FOR LUPIN-GLUCAGON:

Step 4: Using the same syringe, place needle tip inside the vial. Hold both the vial and syringe together and carefully turn it upside down. Make sure the needle tip remains in solution. Prepare the dose. The dose depends on the patient’s age and weight. Adults and children weighing 20 kgs or more: Usual adult dose is 1 mg (1 unit) Withdraw all of the solution (1 mg mark on syringe) from the vial by pulling the plunger down. Children weighing less than 20kg: Give half of the adult dose (0.5 mg) Withdraw the solution up to the 0.5 mg mark on the syringe by pulling the plunger down. Throw away the unused solution in vial.

Note: The plastic clip on the syringe will prevent the plunger being pulled from the syringe. However, if it separates from the rubber stopper, reinsert the plastic rod by turning it clockwise.

INJECTING LUPIN-GLUCAGON

Step 5: Immediately after mixing, get ready to inject LUPIN-GLUCAGON LUPIN-GLUCAGON should be given by injection under the skin (subcutaneously) or into the muscle (intramuscularly). Choose an injection site. It may be the buttocks, arms or thigh. Clean the injection site with an alcohol swab.
Step 6 With one hand, gently pinch the skin at the injection site. With the other hand, insert the needle into the skin. Push the plunger down to inject the correct dose (1 mg for adults; 0.5 mg for children weighing less than 20 kg). Make sure to inject all of the LUPIN-GLUCAGON solution in the syringe. Apply light pressure at the injection site and withdraw the needle. Place an alcohol swab against the injection site. Throw away your used syringe.
Step 7 Turn the patient on their side. When an unconscious person awakens, they may vomit. Turning them on their side will prevent them from choking. Note the time. The patient will usually wake up within 15 minutes.

AFTER GIVING THE DOSE

• Call for emergency medical help right away after giving the dose.
• If the patient does not awaken within 15 minutes, give another dose of LUPIN-GLUCAGON while waiting for medical help to arrive.

• Feed the patient as soon as they awaken and are able to swallow. Give the patient both:

  • a fast-acting source of sugar (such as regular soft drink or sweetened orange juice) and
  • a long-acting source of sugar (such as crackers and cheese or a meat sandwich).

The high sugar snack will prevent low blood sugar from happening again.

• After using LUPIN-GLUCAGON, you or someone else must contact the patient’s doctor. The patient will need to find out why they had severe blood sugar and how to avoid it happening again.

Remember to replace your dose of LUPIN-GLUCAGON once it has been used, in case you need it in the future.