Sogroya - patient leaflet, side effects, dosage

1. What Sogroya is and what it is used for

Sogroya contains the active substance somapacitan: a long acting version of the natural growth hormone produced by the body with a single amino acid substitution. Growth hormone regulates the composition of fat, muscle and bone in adults.

he active substance in Sogroya is made by ‚recombinant DNA technology‘, meaning from cells that have received a gene (DNA) that makes them produce growth hormone. In Sogroya, a small sidechain has been attached to the growth hormone which links Sogroya to the protein (albumin) naturally found in the blood to slow down its removal from the body, allowing the medicine to be given less often.

Sogroya is used to treat adults who have growth hormone deficiency.

Your doctor will evaluate based on your response to Sogroya, if you should continue your treatment with Sogroya a year after starting with Sogroya.

2. What you need to know before you use Sogroya

Do not use Sogroya if

• you are allergic to somapacitan or any of the other ingredients of this medicine (listed in section 6).
• you have a benign or malignant tumour which is growing. You must have completed your antitumour treatment before you start your Sogroya treatment. Sogroya must be stopped if the tumour grows.
• you have recently had open heart surgery or abdominal surgery or multiple accidental injury, severe breathing problems or similar condition.

If you are not sure talk to your doctor, pharmacist or nurse.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Sogroya if:

• you have ever had any kind of tumour
• you have high blood sugar (hyperglycaemia) as your blood sugar may need to be checked regularly and the dose of your diabetes medicine may need to be adjusted
• you have a replacement therapy with corticosteroids, because you have been told your body does not produce enough (adrenocortical insufficiency). Speak to your doctor, as your dose may need regular adjustment
• you have severe headaches, eyesight problems, nausea, or vomiting as these could be symptoms of increased pressure in the brain (benign intracranial hypertension) as your treatment may need to be stopped
• you have thyroid problems, your thyroid hormones need to be checked regularly and your dose of thyroid hormone may need to be adjusted
• you are a woman taking oral contraception or hormonal replacement therapy with oestrogen, your dose of somapacitan may need to be higher. If you stop using oral oestrogen, your dose of somapacitan may need to be reduced.Your doctor may recommend you to change the route of oestrogen administration (e.g transdermal, vaginal) or use another form of contraception.
• you are seriously ill (for example, complications following open heart surgery, abdominal surgery, accidental trauma, acute respiratory failure, or similar conditions). If you are about to have, or have had, a major operation, or go into hospital for the above reasons, tell your doctor and remind the other doctors you are seeing that you use growth hormone.

Thickening of skin

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

Antibodies

You are not expected to get antibodies against somapacitan. Antibodies may occur as it happens with other growth hormone treatments. If your Sogroya treatment does not work, your doctor may test you for antibodies to somapacitan.

Children and adolescents

Do not use Sogroya in children and young people aged under 18 years. This is because it has not been fully studied how Sogroya works in this age group.

Other medicines and Sogroya

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. In particular, tell your doctor if you are taking or have recently taken any of the following medicines. This is because your doctor may have to adjust the doses of your medicines:

• Corticosteroids such as hydrocortisone, dexamethasone and prednisolone
• Oestrogen as part of oral contraception or hormonal replacement therapy with oestrogen
• Male sex hormones (androgen medicines) such as testosterone
• Gonadotropin medicines (gonad stimulating hormones such as luteinising hormone and folliclestimulating hormone) 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
• Cyclosporine (immunosuppressive drug) – a medicine to suppress your immune system.

Pregnancy

• If you are able to get pregnant, you should not use Sogroya unless you are also using reliable

contraception. This is because it is not known if it could harm your unborn child. If you become pregnant while you are using Sogroya, speak to your doctor immediately. If you wish to become pregnant, discuss it with your doctor, as you may need to stop using the medicine.

Breast-feeding

• It is not known whether Sogroya can pass into breast milk. Tell your doctor if you are breastfeeding or plan to do so. Your doctor will then help you decide whether to stop breast-feeding, or whether to stop taking Sogroya, considering the benefit of breast-feeding to the baby and the benefit of Sogroya to the mother.

Driving and using machines

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

Sodium content

This medicine contains less than 1 mmol sodium (23 mg) per dose that is to say essentially ‘sodium-free’.

3. How to use Sogroya

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Sogroya is given as an injection under the skin (subcutaneous injection) from a pen injector. You can give the injection yourself. Your doctor or nurse will tell you the right dose and show you how to give the injection when you start treatment.

When to use Sogroya

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

If necessary you can change the day of your weekly injection of Sogroya as long as it has been at least 4 days since you had your last injection of it. After selecting a new dosing day, continue giving yourself the injection on that day each week.

How much to use

The usual starting dose is 1.5 mg once a week if you are having growth hormone treatment for the first time. If you have been previously treated with daily growth hormone medicine (somatropin) the usual starting dose is 2.0 mg once a week.

If you are a woman taking oral oestrogen (contraception or hormonal replacement therapy) you may need a higher dose of somapacitan. If you are above 60 years, you may need a lower dose. See Table 1 below.

Your doctor may increase or decrease your dose step by step and regularly until you are on the right dose based on your individual needs and your 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.

Table 1 Starting dose recommendation

Adult growth hormone deficiency	Recommended starting dose
You have not received daily growth hormone medicine before You are between 18–60 years You are woman on oral oestrogen (contraception or hormonal therapy) regardless of age You are 60 years or above	1.5 mg/week 2 mg/week 1 mg/week
You have previously received daily growth hormone medicine You are between 18–60 years You are woman on oral oestrogen (contraception or hormonal therapy) regardless of age You are 60 years or above	2 mg/week 4 mg/week 1.5 mg/week

After you have reached your right dose, your doctor will evaluate your treatment every 6 to 12 months.

You may need to have your body mass index checked and blood samples taken.

How Sogroya is used

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.

Detailed instructions on how to inject Sogroya, the instructions for use, are included at the end of this booklet.

If you use more Sogroya than you should

If you accidentally use more Sogroya than you should, talk to your doctor as your blood sugar levels may need to be checked.

If you forget to use Sogroya

If you forget to inject a dose:

• 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.
• and 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 inject an extra dose or increase the dose to make up for a missed dose.

If you stop using Sogroya

Do not stop using Sogroya without talking to your doctor.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common: may affect more than 1 in 10 people

• Headache.

Common: may affect up to 1 in 10 people

• The adrenal glands do not make enough steroid hormones (adrenocortical insufficiency)
• Decreased thyroid hormone (hypothyroidism)
• High blood sugar (hyperglycaemia)
• Feeling of ‘pins and needles’ mainly in fingers (paraesthesia)
• Rash
• Hives (urticaria)
• Joint pain (arthralgia), muscle pain (myalgia), muscle stiffness
• Swollen hands and feet due to a build-up of fluid under the skin (peripheral oedema)
• Feeling very tired or weak (fatigue or asthenia)
• Redness and pain in the area of injection (injection site reactions).

Uncommon: may affect up to 1 in 100 people

• Thickening of skin where you inject your medicine (lipohypertrophy)
• Numb feeling and tingling in your hand(s) (carpal tunnel syndrome)
• Itching (pruritus)
• Joint stiffness.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed inBy reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Sogroya

Keep this medicine out of the sight and reach of children.

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.

Store in a refrigerator (2° – 8°C). Do not freeze. Keep away from the freezing element.

After first opening

Use within 6 weeks after first use. Store in a refrigerator (2° – 8°C).

Before and after first opening

If you cannot refrigerate (for example during travelling), Sogroya may be kept temporarily at temperatures up to 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. Discard the Sogroya pen, if you have kept it at 30°C for more than 72 hours, or for any period of time above 30°C.

Record the time outside the refrigerator:________­________

Keep Sogroya in the outer carton with the pen cap on to protect from light.

Always remove the injection needle after each injection and store the pen without a needle attached.

Do not use this medicine if the solution is not clear and colourless or there are visible particles.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Sogroya contains

• The active substance is somapacitan. One mL of solution contains 6.7 mg of somapacitan. Each pre-filled pen contains 10 mg of somapacitan in 1.5 mL solution.
• The other ingredients are: histidine, mannitol, poloxamer 188, phenol, water for injections,

hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment). See also section 2 ‘Important information about some of the ingredients of Sogroya’ for information on sodium.

What Sogroya looks like and contents of the pack

Sogroya is a clear to slightly opalescent, colourless to slightly yellow and free from visible particles for injection in a pre-filled pen.

Sogroya 10 mg/1.5 mL solution for injection in pre-filled pen is available in the following pack sizes: a 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.

Marketing Authorisation Holder and Manufacturer

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd Denmark

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

Instructions for use

Overview Sogroya pen

Needle (example)

How to use your Sogroya pen 5 Steps you should follow for a Sogroya 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 package leaflet 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 31 Gx6 mm and

32 Gx5 mm disposable needles. Sogroya pre-filled pen is for use with disposable needles up to a length of 8 mm and as thin as 32 G.

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 figure 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 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.

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.	(m)---------
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, your needle or pen may be blocked or damaged.	te——------ -
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).	Count slowly: (O-l__v2.3.4.5.6j-
In this case the needle or pen may be blocked or damaged Sogroya – even though the dose counter has moved from Remove the needle as described in Step 5 and repeat Step	, and you have not received any the original dose that you have set. s 1 to 4.
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.	t p}——

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.	(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.	(T)---------	------73
To store your pen, see How to store in the package leaflet.		7"~ —■
		“Q/
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.		® M Example: 1 / . | Approx. —■—1— 2 2 mg left 1 1 1 ji___ Pen scale Bi
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.		<V> Example: 2.8 mg left
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.
I * 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 How to store in the package leaflet.

42