SOGROYA®

▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems.

SOGROYA®(suh-GROY-uh)

Active ingredient(s): somapacitan

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Consumer Medicine Information (CMI)

This leaflet provides important information about using Sogroya^®. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Sogroya^®.

Where to find information in this leaflet:

1. Why am I using Sogroya^®?
2. What should I know before I use Sogroya^®?
3. What if I am taking other medicines?
4. How do I use Sogroya^®?
5. What should I know while using Sogroya^®?
6. Are there any side effects?
7. Product details

1. Why am I using Sogroya^®?

Sogroya^® contains the active ingredient somapacitan, a long acting version of the natural growth hormone produced by the body.

Sogroya^® is used to treat adults who do not make enough growth hormone.

2. What should I know before I use Sogroya^®?

Warnings

Do not use Sogroya^® if:

• you are allergic to growth hormone, or any of the ingredients listed at the end of this leaflet.
  Always check the ingredients to make sure you can use this medicine.
• you have cancer or other tumours which are growing.
  You must have completed anti-tumour treatment before you start to use Sogroya^®.
• you have a critical illness due to complications after open heart or stomach surgery, trauma, or serious breathing problems.

Check with your doctor if you:

• have diabetes or high blood sugar
• have had cancer or tumours
• have severe or recurring headaches, eyesight problems, nausea (feeling sick) or vomiting. These could be symptoms of increased pressure in the brain.
• have thyroid problems
• have a condition where your body is not making enough steroid hormones and have replacement therapy with corticosteroids
• have had heart or stomach surgery, trauma or serious breathing problems
• are a woman taking oral contraception or hormonal replacement therapy with estrogen, as your dose of Sogroya^® may need to be higher. If you stop using oral estrogen, your dose of Sogroya^® may need to be reduced. Your doctor may recommend you change the route of estrogen administration (e.g transdermal, vaginal) or use another form of contraception.
• take any medicines for any other condition.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant. It is not known if Sogroya^® may harm your unborn baby.

Talk to your doctor if you are breastfeeding or intend to breastfeed. It is not known if Sogroya^® passes into breast milk.

Children and adolescents

Do not use Sogroya^® in children or young people aged under 18 years. It is not yet known how Sogroya^® works in this age group.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

This includes the following medicines:

• corticosteroids such as hydrocortisone, dexamethasone and prednisolone, medicines that can be used to replace low levels of steroid hormones
• estrogen as part of oral contraception, or hormonal replacement therapy with estrogen
• male sex hormones (androgen medicines) such as testosterone
• gonadotropin medicines which stimulate the production of sex hormones
• insulin or other diabetes medicines
• thyroid hormone medicines such as levothyroxine
• medicines to treat epilepsy or fits (seizures) – such as carbamazepine
• medicines to suppress your immune system, such as cyclosporine, which can be used to treat severe skin disease (e.g., psoriasis), rheumatoid arthritis or after transplant surgery.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Sogroya^®.

4. How do I use Sogroya^®?

How much to use

• The Sogroya^® dose is calculated by your doctor based on your individual needs.
• Your doctor may increase or decrease your dose step by step and regularly until you are on the right dose based on your need and experience of side effects.
• Do not use more than a maximum of 8 mg once a week.
• Do not change your dose unless your doctor has told you to.

When to use Sogroya^®

• Sogroya^® should be used once a week on the same day each week if possible.
• You can give yourself the injection at any time of the day.

How to use Sogroya^®

Your doctor or nurse will show you how to inject Sogroya^® under your skin.

The best places to give the injection are:

• the front of your thighs
• the front of your waist (abdomen).

Change the place of injection on your body from one week to the next. If you inject Sogroya^® at the same site for a long period, thickened skin may appear where you inject your medicine.

Follow the detailed instructions on how to inject Sogroya^® in the instructions for use included at the end of this leaflet.

If you forget to use Sogroya^®

Sogroya^® should be used regularly at the same time each week.

If you miss your dose at the usual time, and:

• it is 3 days or less after you should have used Sogroya^®, use it as soon as you remember. Then inject your next dose on your usual injection day.
• it is more than 3 days since you should have used Sogroya^®, skip the missed dose. Then inject your next dose as usual on your next scheduled day.

Do not take a double dose to make up for the dose you missed.

If you use too much Sogroya^®

If you think that you have used too much Sogroya^®, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using Sogroya^®?

Things you should do

Call your doctor straight away if you become pregnant.

Keep all your doctor’s appointments so that your progress may be checked.

Your doctor may recommend some tests to monitor your levels of blood sugar and certain hormones (e.g., thyroid hormone).

Remind any doctor, dentist, pharmacist or nurse you visit that you are using Sogroya^®.

Things you should not do

• Do not stop using this medicine without talking to your doctor.
• Do not use Sogroya^® every day.

Driving or using machines

Sogroya^® does not affect your ability to drive and use machines.

Looking after your medicine

• Store Sogroya^® in the refrigerator (between 2°C and 8°C). Do not allow the medicine to freeze.
• Always remove the injection needle after each injection and store the pen without a needle attached.
• Keep Sogroya^® in the outer carton with the pen cap on to protect from light.

If you cannot refrigerate (for example during travelling):

• Sogroya^® may be kept temporarily at temperatures below 30°C for up to a total of 72 hours (3 days).
• Return Sogroya^® to the refrigerator again after storage at this temperature.
• If you store out of the refrigerator and then return to the refrigerator, the total combined time out of the refrigerator is 3 days. Monitor this carefully.
• Record the time outside the refrigerator: ____________

Keep it where young children cannot reach it.

Follow the instructions on the carton on how to take care of your medicine properly.

When to discard your medicine (as relevant)

Use within 6 weeks after first use.

Discard the Sogroya^® pen if you have kept it outside the refrigerator for more than 72 hours, or for any period of time above 30°C.

Do not use this medicine after the expiry date which is stated on the pen label and carton after ‘EXP’. The expiry date refers to the last day of that month.

Getting rid of any unwanted medicines

If you no longer need to use this medicine or it is out of date, check with your pharmacy about options for safe disposal.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effects

What to do

Brain and nerves: headache feeling of ‘pins and needles’, tingling or numbness in your fingers, hands or feet Food and energy: increased thirst, urination and fatigue, which could be signs of high blood sugar (hyperglycaemia) Skin: thickening of skin where you inject your medicine Muscles and joints: joint and/or muscle pain joint and/or muscle stiffness General conditions: feeling very tired or weak redness and pain in the area of injection (injection site reactions) swollen hands or feet due to fluid retention. Hormone-related: Feeling tired, weight gain, sensitive to cold. These could be signs of decreased thyroid hormone

Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects	What to do
Brain and nerves: severe or recurring headaches, eyesight problems, nausea (feeling sick) or vomiting. These could be symptoms of increased pressure in the brain. Hormone-related: Your body is not making enough adrenal steroid hormones, some symptoms of which are severe weakness, confusion, abdominal pain, nausea, vomiting	Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

If you experience any of the following signs of allergic reaction, stop taking Sogroya^® and tell your doctor immediately, or go to the Emergency Department at your nearest hospital:

• swelling of the face, lips, tongue or throat which may cause difficulty in swallowing or breathing
• skin rashes over a large part of the body

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor’s prescription.

What Sogroya^® contains

Active ingredient (main ingredient)	somapacitan
Other ingredients (inactive ingredients)	histidine mannitol poloxamer phenol hydrochloric acid (for pH adjustment) sodium hydroxide (for pH adjustment) water for injections

Do not take this medicine if you are allergic to any of these ingredients.

What Sogroya^® looks like

Sogroya^® is a clear to slightly opalescent, colourless to slightly yellow liquid, essentially free from visible particles. Sogroya^® comes in a disposable multidose pre-filled pen.

It is available in a single pack containing 1 pre-filled pen or a multipack containing 5 packs, each containing 1 pre-filled pen.

Not all pack sizes may be marketed.
(AUST R 363895).

Who distributes Sogroya^®

Novo Nordisk Pharmaceuticals Pty. Ltd.
Level 10, 118 Mount Street,
North Sydney, NSW 2060.

This leaflet was prepared in February 2022.

Sogroya^® is a registered trademark of Novo Nordisk Health Care AG. NovoFine^® is a registered trademark of Novo Nordisk A/S.

© 2022

Novo Nordisk A/S

2880 Bagsvaerd, Denmark

Instructions for use

Overview Sogroya pen

How to use your Sogroya^® pen

Five steps you should follow for a Sogroya^® injection:

Step 1. Prepare your Sogroya^® pen
Step 2. Check the flow with each new pen
Step 3. Select your dose
Step 4. Inject your dose
Step 5. After your injection

For further information about your pen, see sections: Check how much Sogroya^® is left, How to care for your pen, Important information.

Please read the Consumer Medicine Information and these instructions carefully before using your Sogroya^® pre-filled pen.

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

Sogroya^® contains 10 mg of somapacitan and it can be used to inject doses from 0.05 mg to 4 mg, in steps of 0.05 mg. Sogroya^® is for use under the skin only (subcutaneous). Needles are not included and must be obtained separately. Sogroya^® pre-filled pen has been tested with 31G x 6 mm and 32G x 5 mm disposable needles. Sogroya^® pre-filled pen is for use with NovoFine^® disposable needles up to a length of 8 mm and as thin as 32G.

Do not share your Sogroya^® pen and needles with another person. You may give another person an infection or get an infection from them.

Do not use your pen without proper training from your doctor or nurse. Make sure that you are confident giving yourself an injection with the pen before you start your treatment. 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 pen.

Step 1. Prepare your Sogroya^® pen

• Wash your hands with soap and water.
• Check the name and coloured label on your pen to make sure that it contains Sogroya^®.
• Pull off the pen cap.
• Turn the pen upside down once or twice to check that the Sogroya^® in your pen is clear and colourless. See figure A.

• If Sogroya^® looks cloudy or particles are visible, do not use the pen.

  Make sure the right pen is used. Especially if you use more than one type of injectable medicine. Using the the wrong medicine could be harmful to your health.

• When you are ready to inject, take a new disposable needle. Firstly, tear off the paper tab.
• Secondly, push the needle straight onto the pen. Turn the needle clockwise until it is on tight. See figure B.

• 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. See figure C.

  The needle is covered by two caps. You must remove both caps. If you forget to remove both caps you will not inject any medicine. See figures C and D.

• Pull off the inner needle cap and dispose of it. If you try to put it back on, you may accidentally stick yourself with the needle. See figure D.

  A drop of Sogroya^® may appear at the needle tip. This is normal, but you must still check the flow with each new pen. See Step 2.

  Always use a new needle for each injection. This reduces the risk of contamination, infection, leakage of Sogroya^®, and blocked needles leading to incorrect dosing.

  Never use a bent or damaged needle.

Step 2. Check the flow with each new pen

  If your pen is already in use, proceed to Step 3.

• Before using a new pen, check the flow to make sure Sogroya^® can flow through the pen and needle.
• Turn the dose selector clockwise one tick mark to select 0.05 mg. You may hear a faint click. See figure E.

• One tick mark equals 0.05 mg in the dose counter. See figure F.

• 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. See figure G.

• Check that a drop of Sogroya^® appears at the needle tip. See figure H.

  If no Sogroya^® appears, repeat Step 2 up to 6 times.

If you still do not see a drop of Sogroya^®, replace the needle once as described in Step 5 and repeat Step 1 and 2 again.

  If no Sogroya^® appears when you check the flow, your needle may be blocked or damaged. Do not use your pen if Sogroya^® still does not appear after changing the needle. Your pen may be defective.

Step 3. Select your dose

• To start, check that the dose counter is set at ‘0’.
• Turn the dose selector clockwise to select the dose you need. See figure I.

When you have selected your dose, you can proceed to Step 4.

  If there is not enough Sogroya^® left to select a full dose, see Check how much Sogroya^® is left.

  The dose counter shows the dose in mg. See figures J and K. Always use the dose pointer to select the exact dose.

Do not count the pen clicks. Do not use the pen scale (see Overview Sogroya^® pen) to measure how much growth hormone to inject. Only the dose pointer will indicate the exact number of mg.

  If you select the wrong dose, you can turn the dose selector clockwise or counterclockwise to the correct dose. See figure L.

The pen clicks sound and feel differently when the dose selector is turned clockwise, counterclockwise, or if you accidentally force it past the number of mg left.

Step 4. Inject your dose

• Insert the needle into your skin as your doctor or nurse has shown you. See figure M.

Make sure you can see the dose counter. Do not cover it with your fingers. This could block the injection.

  Remember to change the injection site every week.

• Press and hold down the dose button until the dose counter shows ‘0’ (See figure N). The ‘0’must line up with the dose pointer. You may then hear or feel a ‘click’.

  Continue to hold down the dose button with the needle in your skin.

  If “0” does not appear in the dose counter after continuously pressing the dose button, the needle or pen may be blocked or damaged, and you have not received any Sogroya^®, even though the dose counter has moved from the original dose that you have set. Remove the needle as described in step 5 and repeat steps 1 to 4.

• Keep holding down the dose button with the needle in your skin and slowly count to 6 to make sure that the full dose has been delivered (see figure O).

• Carefully remove the needle from your skin. See figure P. If blood appears at the injection site, press lightly. Do not rub the area.

  You may see a drop of Sogroya^® at the needle tip after injecting. This is normal and does not affect your dose.

Step 5. After your injection

• Insert the needle tip into the outer needle cap on a flat surface without touching the needle or the outer needle cap. See figure Q.

• Once the needle is covered, carefully push the outer needle cap completely on. See figure R.

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

When the pen is empty, remove and dispose of the needle as above and throw the pen away separately as instructed by your doctor, nurse, pharmacist or local authorities.

The pen cap and the empty carton can be disposed of in your household waste.

• Put the pen cap on your pen after each use to protect Sogroya^® from direct light. See figure T.

To store your pen, see Looking after your medicine in the consumer medicine information.

  Do not try to put the inner needle cap back on.
You may stick yourself with the needle.

  Always remove the needle from your pen immediately after each injection. This reduces the risk of contamination, infection, leakage of Sogroya^®, and blocked needles leading to incorrect dosing.

Check how much Sogroya^® is left

The pen scale shows you approximately how much Sogroya^® is left in your pen. See figure U.

To see how much Sogroya^® is left, use the dose counter: Turn the dose selector clockwise until the dose counter stops. You can select a maximum dose of 4 mg. If it shows ‘4’ at least 4 mg are left in your pen.

If the dose counter stops at ‘2.8’, only 2.8 mg are left in your pen. See figure V.

What if I need a larger dose than what is left in my pen?

It is not possible to select a larger dose than the amount of mg left in your pen.

If you need more Sogroya^® than you have left in your pen, you can use a new pen or split your dose between your current pen and a new pen. Only if trained or advised by your doctor or nurse, you may split your dose. Use a calculator to plan the doses as instructed by your doctor or nurse.

Be very careful to calculate correctly, otherwise it may lead to medication error. If you are not sure how to split your dose using two pens, then select and inject the dose you need with a new pen.

How to care for your pen

How should I take care of my pen?

Be careful not to drop your pen or knock it against hard surfaces. Do not expose your pen to dust, dirt, liquid, or direct light.

Do not try to refill your pen, it is pre-filled and must be disposed of when empty.

What if I drop my pen?

If you drop your pen or think that something is wrong with it, attach a new disposable needle and check the flow before you inject, see Steps 1 and 2. If your pen has been dropped, check the cartridge. If the cartridge is cracked, do not use the pen.

How do I clean my pen?

Do not wash, soak, or lubricate your pen. If necessary, clean it with mild detergent on a moistened cloth.

  Important information

• Caregivers must be very careful when handling needles – to reduce the risk of needle sticks and cross-infection.
• Always keep your pen and needles out of reach of others, especially children.
• Do not use the pen if it is damaged. Do not try to repair your pen or pull it apart.
• To store your pen, see Looking after your medicine in the Consumer Medicine Information.