Aspen-Semaglutide: Uses, Side Effects and Dosage

Possible Risk of thyroid tumours, including cancer

As part of drug testing, semaglutide, the active ingredient in Aspen-Semaglutide was given to rats and mice in long term studies. In these studies, semaglutide caused both rats and mice to develop medullary thyroid tumours, some of which were cancer. It is not known if semaglutide will cause thyroid tumours or a rare type of thyroid cancer called medullary thyroid cancer in people. Do not use Aspen-Semaglutide if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC), or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

While taking Aspen-Semaglutide, tell your doctor if you get a lump or swelling in your neck, hoarseness, trouble swallowing or shortness of breath. These may be symptoms of thyroid cancer. You should discuss any safety concerns you have about the use of Aspen-Semaglutide with your doctor.

Frequency/Side

Effect/Symptom

Common

Diabetic retinopathy complications – complications of diabetic eye disease/diabetic eye problems

Uncommon

Pancreatitis (severe and ongoing pain in the stomach area which could be a sign of inflamed pancreas)

Rare

Severe allergic reaction (anaphylactic reaction, angioedema) symptoms: breathing problems, swelling of face, lips, tongue and/or throat with difficulty swallowing and a fast heartbeat

Very Rare

Non-arteritic anterior ischemic optic neuropathy (sudden vision loss, may be painless, from swelling of eye nerves): blurring or cloudiness of vision, headaches

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 (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

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

Instructions on how to use Aspen-Semaglutide solution for injection in pre-filled pen

0.25 mg or 0.5 mg doses (1.5 mL)

Please read these instructions carefully before using your Aspen-Semaglutide pre-filled pen.

Talk to your doctor, nurse or pharmacist about how to inject Aspen-Semaglutide correctly.

Start by checking your pen to make sure that it contains Aspen-Semaglutide 0.25 mg or 0.5 mg doses, then look at the illustrations below to get to know the different parts of your pen and needle.

If you are blind or have poor eyesight and cannot read the dose counter on the pen, do not use this pen without help. Get help from a person with good eyesight who is trained to use the Aspen-Semaglutide pre-filled pen.

Your pen is a pre-filled dial-a-dose pen. It contains 2 mg of semaglutide, and you can select doses of 0.25 mg or 0.5 mg.

One unused pen contains:

• 4 doses of 0.25 mg (starting dose) and 2 doses of 0.5 mg
• or 4 doses of 0.5 mg.

Your pen is designed to be used with Unifine^® Pentips 4 mm, 32G (0.23 mm) disposable needles. Disposable needles are included in the pack.

Important information

Pay special attention to these notes, as they are important for safe use of the pen.

1. 1. Prepare your pen with a new needle

• Check the name and coloured label of your pen to make sure that it contains Aspen-Semaglutide 0.25 or 0.5 mg doses. This is especially important if you take more than one type of injectable medicine. Using the wrong medicine could be harmful to your health.
• Pull off the pen cap.

• Check that the solution in your pen is clear and colourless. Look through the pen window. If the solution looks cloudy or coloured, do not use the pen.

• Take a new needle and tear off the paper tab.

  If the paper tab is broken, do not use the needle, as sterility is not guaranteed.

Make sure to attach the needle correctly.

• Push the needle straight onto the pen.
• Turn until it is on tight.

The needle is covered by two caps. You must remove both caps. If you forget to remove both caps, you will not inject any solution.

• Pull off the outer needle cap and keep it for later. You will need it after the injection, to safely remove the needle from the pen.

• Pull off the inner needle cap and throw it away. If you try to put it back on, you may accidentally stick yourself with the needle.

A drop of solution may appear at the needle tip. This is normal, but you must still check the flow if you use a new pen for the first time.

Do not attach a new needle to your pen until you are ready to take your injection.

Always use a new needle for each injection.

This may prevent blocked needles, contamination, infection and inaccurate dosing.

1. 2. Check the flow with each new pen

• If your pen is already in use, go to step 3 ‘Select your dose’. Only check the flow before your first injection with each new pen.
• Turn the dose selector to the flow check symbol

right past ‘0’. Make sure the flow check symbol lines up with the pointer.

• Hold the pen with the needle pointing up.

  Press and hold in the dose button until the dose counter returns to 0. The 0 must line up with the dose pointer.

  A drop of solution should appear at the needle tip.

A small drop may remain at the needle tip, but it will not be injected.

If no drop appears, repeat step 2 ‘Check the flow with each new pen’ up to 6 times. If there is still no drop, change the needle and repeat step 2 ‘Check the flow with each new pen’ once more.

Dispose of the pen and use a new one if a drop of solution still does not appear.

Always make sure that a drop appears at the needle tip before you use a new pen for the first time. This makes sure that the solution flows.

If no drop appears, you will not inject any medicine even though the dose counter may move. This may indicate a blocked or damaged needle.

If you do not check the flow before your first injection with each new pen, you may not get the prescribed dose and the intended effect of Aspen-Semaglutide.

1. 3. Select your dose

• Turn the dose selector until the dose counter shows your dose (0.25 mg or 0.5 mg).

  If you select the wrong dose, you can turn the dose selector forwards or backwards to the correct dose.

  The pen can dial up to a maximum of 0.5 mg. Note: The dose selector will extend as the dose is selected.

The dose selector changes the dose. Only the dose counter and dose pointer will show how many mg you select per dose.

You can select up to 0.5 mg per dose. When your pen contains less than 0.5 mg, the dose counter stops before 0.5 is shown.

The dose selector clicks differently when turned forwards, backwards or past the number of mg left. Do not count the pen clicks.

Always use the dose counter and the dose pointer to see how many mg you have selected before injecting this medicine.

Do not count the pen clicks.

Only doses of 0.25 mg or 0.5 mg must be selected with the dose selector. The selected dose must line up precisely with the dose pointer to ensure that you get a correct dose.

• To see how much solution is left, use the dose counter: Turn the dose selector until the dose counter stops.

  If it shows 0.5, at least 0.5 mg is left in your pen.

  If the dose counter stops before 0.5 mg, there is not enough solution left for a full dose of 0.5 mg.

1. 4. Inject your dose

• Insert the needle into your skin as your doctor or nurse has shown you.
• Make sure you can see the dose counter. Do not cover it with your fingers. This could interrupt the injection.

• Continue pressing the dose button while keeping the needle in your skin. Count slowly to 6 while keeping the dose button pressed.
• If the needle is removed earlier, you may see a stream of solution coming from the needle tip. If so, the full dose will not be delivered. If this occurs, contact your doctor or nurse for further guidance.

• Remove the needle from your skin. You can then release the dose button. If blood appears at the injection site, press lightly.

Always watch the dose counter to know how many mg you inject. Hold the dose button down until the dose counter shows 0.

How to identify a blocked or damaged needle

• If 0 does not appear in the dose counter after continuously pressing the dose button, you may have used a blocked or damaged needle.

• In this case, you have not received any medicine even though the dose counter has moved from the original dose that you have set.

  How to handle a blocked needle

  Change the needle as described in step 5 ‘After your injection’ and repeat all steps starting with step 1 ‘Prepare your pen with a new needle’. Make sure you select the full dose you need.

  Never touch the dose counter when you inject. This can interrupt the injection.

1. 5. After your injection

Always dispose of the needle after each injection to ensure convenient injections and prevent blocked needles. If the needle is blocked, you will not inject any medicine.

Unscrew the needle and dispose of it carefully as instructed by your doctor, nurse, pharmacist or local authorities.

• Lead the needle tip into the outer needle cap on a flat surface without touching the needle or the outer needle cap.

• Once the needle is covered, carefully push the outer needle cap completely on.
• Unscrew the needle and dispose of it carefully.

• Put the pen cap on your pen after each use to protect the solution from light.

Always dispose of the needle after each injection to ensure convenient injections and prevent blocked needles. If the needle is blocked, you will not inject any medicine.

When the pen is empty, throw it away without a needle on as instructed by your doctor, nurse, pharmacist or local authorities.

Never try to put the inner needle cap back on the needle. You may stick yourself with the needle.

Always remove the needle from your pen immediately after each injection.

This may prevent blocked needles, contamination, infection, leakage of solution and inaccurate dosing.

• Always keep your pen and needles out of the sight and reach of others, especially children.
• Never share your pen or your needles with other people.
• Caregivers must be very careful when handling used needles to prevent needle injury and cross-infection.
• Use the table inside the lid of the carton to keep track of how many injections you have taken and when you took the injections.

• Do not leave the pen in a car or another place where it can get too hot or too cold.
• Do not inject Aspen-Semaglutide which has been frozen. If you do that, your blood sugar level may get too high or you might feel abdominal discomfort such as nausea or vomiting.
• Do not inject Aspen-Semaglutide which has been exposed to direct sunlight. If you do that, your blood sugar level may get too high.
• Do not expose your pen to dust, dirt or liquid.
• Do not wash, soak or lubricate your pen. It may be cleaned with a mild detergent on a moistened cloth.
• Do not drop your pen or knock it against hard surfaces. If you drop it or suspect a problem, attach a new needle and check the flow before you inject.
• Do not try to refill your pen. Once empty, it must be disposed of.
• Do not try to repair your pen or pull it apart.

Instructions on how to use Aspen-Semaglutide solution for injection in pre-filled pen

1 mg doses

Please read these instructions carefully before using your Aspen-Semaglutide pre-filled pen.

Talk to your doctor, nurse or pharmacist about how to inject Aspen-Semaglutide correctly.

Start by checking your pen to make sure that it contains Aspen-Semaglutide 1 mg doses, then look at the illustrations below to get to know the different parts of your pen and needle.

If you are blind or have poor eyesight and cannot read the dose counter on the pen, do not use this pen without help. Get help from a person with good eyesight who is trained to use the Aspen-Semaglutide pre-filled pen.

Your pen is a pre-filled dial-a-dose pen. It contains 4 mg of semaglutide, and you can only select doses of 1 mg. Your pen is designed to be used with Unifine^® Pentips 4 mm, 32G (0.23 mm) disposable needles.

Disposable needles are included in the pack.

Important information

Pay special attention to these notes, as they are important for safe use of the pen.

1. 1. Prepare your pen with a new needle

• Check the name and coloured label of your pen, to make sure that it contains Aspen-Semaglutide 1 mg doses. This is especially important if you take more than one type of injectable medicine. Using the wrong medicine could be harmful to your health.
• Pull off the pen cap.

• Check that the solution in your pen is clear and colourless. Look through the pen window. If the solution looks cloudy or coloured, do not use the pen.

• Take a new needle and tear off the paper tab.

  If the paper tab is broken, do not use the needle, as sterility is not guaranteed.

Make sure to attach the needle correctly.

• Push the needle straight onto the pen.
• Turn until it is on tight.

The needle is covered by two caps. You must remove both caps. If you forget to remove both caps, you will not inject any solution.

• Pull off the outer needle cap and keep it for later. You will need it after the injection, to safely remove the needle from the pen.

• Pull off the inner needle cap and throw it away. If you try to put it back on, you may accidentally stick yourself with the needle.

A drop of solution may appear at the needle tip. This is normal, but you must still check the flow, if you use a new pen for the first time.

Do not attach a new needle to your pen until you are ready to take your injection.

Always use a new needle for each injection.

This may prevent blocked needles, contamination, infection and inaccurate dosing.

1. 2. Check the flow with each new pen

• If your pen is already in use, go to step 3 ‘Select your dose’. Only check the flow before your first injection with each new pen.
• Turn the dose selector to the flow check symbol

right past ‘0’. Make sure the flow check symbol lines up with the pointer.

• Hold the pen with the needle pointing up.

  Press and hold in the dose button until the dose counter returns to 0. The 0 must line up with the dose pointer.

  A drop of solution should appear at the needle tip.

A small drop may remain at the needle tip, but it will not be injected.

If no drop appears, repeat step 2 ‘Check the flow with each new pen’ up to 6 times. If there is still no drop, change the needle and repeat step 2 ‘Check the flow’ once more with each new pen.

Dispose of the pen and use a new one if a drop still does not appear.

Always make sure that a drop appears at the needle tip before you use a new pen for the first time. This makes sure that the solution flows.

If no drop appears, you will not inject any medicine, even though the dose counter may move. This may indicate a blocked or damaged needle.

If you do not check the flow before your first injection with each new pen, you may not get the prescribed dose and the intended effect of Aspen-Semaglutide.

1. 3. Select your dose

• Turn the dose selector to select 1 mg.

  Keep turning until the dose counter stops and shows 1 mg. Note: The dose selector will extend as the dose is selected.

Only the dose counter and dose pointer will show that 1 mg has been selected.

You can only select 1 mg per dose. When your pen contains less than 1 mg, the dose counter stops before 1 is shown.

The dose selector clicks differently when turned forwards, backwards or past 1 mg. Do not count the pen clicks.

Always use the dose counter and the dose pointer to see that 1 mg has been selected before injecting this medicine.

Do not count the pen clicks.

Only doses of 1 mg must be selected with the dose selector. 1 mg must line up precisely with the dose pointer to ensure that you get a correct dose.

• To see how much solution is left, use the dose counter: Turn the dose selector until the dose counter stops.

  If it shows 1, at least 1 mg is left in your pen.

  If the dose counter stops before 1 mg, there is not enough solution left for a full dose of 1 mg.

1. 4. Inject your dose

• Insert the needle into your skin as your doctor or nurse has shown you.
• Make sure you can see the dose counter. Do not cover it with your fingers. This could interrupt the injection.

• Press the button until the dose counter shows 0. The 0 must line up with the dose pointer. The dose button will retract into the device body, and the injection will be completed once the dose selector stops moving. An audible clicking sound will be emitted throughout the injection and will stop once the injection is fully delivered.

• Continue pressing the dose button while keeping the needle in your skin. Count slowly to 6.
• If the needle is removed earlier, you may see a stream of solution coming from the needle tip. If so, the full dose will not be delivered. If you notice this, contact your doctor or nurse for further guidance.

• Remove the needle from your skin. You can then release the dose button. If blood appears at the injection site, press lightly. .

Always watch the dose counter to know how many mg you inject. Hold the dose button down until the dose counter shows 0.

How to identify a blocked or damaged needle

• If 0 does not appear in the dose counter after continuously pressing the dose button, you may have used a blocked or damaged needle.
• In this case, you have not received any medicine – even though the dose counter has moved from the original dose that you have set.

How to handle a blocked needle

Change the needle as described in step 5 ‘After your injection’ and repeat all steps starting with step 1 ‘Prepare your pen with a new needle’. Make sure you select the full dose you need.

Never touch the dose counter when you inject. This can interrupt the injection.

1. 5. After your injection

Always dispose of the needle after each injection to ensure convenient injections and prevent blocked needles. If the needle is blocked, you will not inject any medicine.

Unscrew the needle and dispose of it carefully as instructed by your doctor, nurse, pharmacist or local authorities.

• Lead the needle tip into the outer needle cap on a flat surface without touching the needle or the outer needle cap.

• Once the needle is covered, carefully push the outer needle cap completely on.
• Unscrew the needle and dispose of it carefully.

• Put the pen cap on your pen after each use to protect the solution from light.

Always dispose of the needle after each injection to ensure convenient injections and prevent blocked needles. If the needle is blocked, you will not inject any medicine.

When the pen is empty, throw it away without a needle on as instructed by your doctor, nurse, pharmacist or local authorities.

Never try to put the inner needle cap back on the needle. You may stick yourself with the needle.

Always remove the needle from your pen immediately after each injection.

This may prevent blocked needles, contamination, infection, leakage of solution and inaccurate dosing.

• Always keep your pen and needles out of the sight and reach of others, especially children.
• Never share your pen or your needles with other people.
• Caregivers must be very careful when handling used needles to prevent needle injury and cross-infection.
• Use the table inside the lid of the carton to keep track of how many injections you have taken and when you took the injections.

• Do not leave the pen in a car or another place where it can get too hot or too cold.
• Do not inject Aspen-Semaglutide which has been frozen. If you do that, your blood sugar level may get too high or you might feel abdominal discomfort such as nausea or vomiting.
• Do not inject Aspen-Semaglutide which has been exposed to direct sunlight. If you do that, your blood sugar level may get too high.
• Do not expose your pen to dust, dirt or liquid.
• Do not wash, soak or lubricate your pen. It may be cleaned with a mild detergent on a moistened cloth.
• Do not drop your pen or knock it against hard surfaces. If you drop it or suspect a problem, attach a new needle and check the flow before you inject.
• Do not try to refill your pen. Once empty, it must be disposed of.
• Do not try to repair your pen or pull it apart.