Package leaflet: Information for the user

Sogroya 5 mg/1.5 mL solution for injection in a pre-filled pen

somapacitan
Read this entire leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, as it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

What Sogroya is and what it is used for
What you need to know before using Sogroya
How to use Sogroya
Possible side effects
How to store Sogroya
Contents of the pack and other information

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 fat, muscle, and bone composition in adults.
The active substance in Sogroya is produced using "recombinant DNA technology", meaning it is made by cells that have been given a gene (DNA) enabling them to produce growth hormone. In Sogroya, a small side chain has been attached to the growth hormone, which binds Sogroya to a protein (albumin) naturally present in the blood, thereby slowing its removal from the body and allowing less frequent administration of the medicine.
Sogroya is used to treat growth hormone deficiency in children and adolescents aged 3 years and older when growth hormone production is absent or very low (growth hormone deficiency), and in adults with growth hormone deficiency.
Your doctor will assess whether continued treatment with Sogroya is necessary one year after starting therapy, based on your response to this medicine.

2. What you need to know before using Sogroya

Do not use Sogroya

if you or the child under your care is allergic to somapacitan or to any of the other ingredients of this medicine (listed in section 6).
if you or the child under your care has a benign or malignant tumour that is growing. Anti-tumour treatment must be completed before starting treatment with Sogroya. Sogroya must be discontinued if tumour growth occurs.
if you or the child under your care has recently undergone open-heart surgery, abdominal surgery, or has sustained multiple accidental injuries, severe respiratory problems, or similar conditions.
for children and adolescents who have stopped growing due to closure of growth plates (closed epiphyses), meaning that you or the child in your care has been informed by a doctor that their bones have stopped growing.

If you are unsure, consult your doctor, pharmacist, or nurse.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Sogroya if:

you or the child under your care has ever had any type of tumour
you or the child under your care has high blood sugar levels (hyperglycaemia), as regular blood glucose monitoring may be required and the dose of your diabetes medications may need to be adjusted
you or the child under your care is receiving corticosteroid replacement therapy because you have been diagnosed with insufficient corticosteroid production (adrenal insufficiency). Speak with your doctor, as regular dose adjustments may be necessary
you or the child under your care experiences severe headaches, vision problems, nausea, or vomiting, as these could be symptoms of increased pressure in the brain (benign intracranial hypertension), which may require discontinuation of treatment
you or the child under your care has thyroid problems; thyroid hormones should be monitored regularly and the dose of thyroid hormone may need to be adjusted
you are a woman taking oral contraceptives or estrogen-based hormone replacement therapy, as the dose of Sogroya may need to be increased. If you stop taking oral estrogens, the dose of somapacitan may need to be reduced. Your doctor may advise you to change the route of estrogen administration (e.g. transdermal, vaginal) or to use another form of contraception
you or the child under your care is seriously ill (e.g. complications following open-heart surgery, abdominal surgery, accidental trauma, acute respiratory failure, or similar conditions). If you are about to undergo or have undergone major surgery or are admitted to hospital for any of the reasons listed above, inform your doctor and remind other physicians treating you that you are using growth hormone
you or the child under your care develops severe stomach pain during treatment with Sogroya, as this could be a symptom of pancreatitis, which has been observed with other growth hormone products.
you or the child experiences persistent hip or knee pain when walking, or if limping develops during growth hormone treatment. These could be symptoms of a condition affecting the femur where it joins the hip (slipped capital femoral epiphysis), which occurs more frequently in rapidly growing children and children with endocrine disorders, including growth hormone deficiency. Speak with your doctor if persistent joint pain occurs.

Skin changes at the injection site
The injection site for Sogroya should be rotated to avoid changes in the fatty tissue under the skin, such as thickening of the skin, skin tightening, or lumps under the skin. Change the injection site on your body from week to week.
Antibodies
It is not expected that you will develop antibodies against somapacitan. However, very rarely, your child may develop antibodies. If treatment with Sogroya is not effective, your doctor may test you for antibodies against somapacitan.
Other medicines and Sogroya
Tell your doctor or pharmacist if you or the child under your care is taking, has recently taken, or might take any other medicines.
In particular, inform your doctor if you or the child under your care is taking or has recently taken any of the following medicines, as your doctor may need to adjust the dose:

corticosteroids such as hydrocortisone, dexamethasone, and prednisolone
estrogens, as part of oral contraception or estrogen-based hormone replacement therapy
male sex hormones (androgenic drugs), such as testosterone
gonadotropin-containing medicines (gonad-stimulating hormones such as luteinizing hormone and follicle-stimulating hormone) that stimulate the production of sex hormones
insulin or other medicines for diabetes
thyroid hormones, such as levothyroxine
medicines for the treatment of epilepsy or seizures, such as carbamazepine
cyclosporine (an immunosuppressant), a medicine used to suppress the immune system.

Pregnancy

If there is a possibility you could become pregnant, you must not use Sogroya unless you are also using an effective method of contraception. This is because it is not known whether the medicine could harm the unborn baby. If you become pregnant while using Sogroya, contact your doctor immediately. If you wish to become pregnant, discuss this with your doctor, as it may be necessary to stop using the medicine.

Breast-feeding

It is not known whether Sogroya passes into breast milk. Inform your doctor if you are breast-feeding or plan to breast-feed. Your doctor will help you decide whether to discontinue breast-feeding or to discontinue Sogroya treatment, taking into account the benefits of breast-feeding for the newborn and the benefits of Sogroya for the mother.

Driving and using machines
Sogroya has no influence on the ability to drive vehicles or use machinery.
Sodium content
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially “sodium-free”.

3. How to use Sogroya

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Sogroya is administered by subcutaneous injection (injection under the skin) using a pre-filled pen.
You may self-administer the injection. Your doctor or nurse will inform you of the correct dose and
will show you how to perform the injection when you or the child under your care starts
treatment.

When to use Sogroya

You or the child under your care must use Sogroya once a week, preferably on the same day each week.
You may administer the injection at any time of day.

If you or the child under your care is switching from another weekly growth hormone therapy to Sogroya,
it is recommended to continue the injection on the same day of the week.
If you or the child under your care is switching from daily growth hormone therapy to Sogroya,
choose a preferred day for the weekly dose and administer the last dose of the daily treatment the day before (or at least 8 hours before) injecting the first dose of Sogroya.
Switching from another type or brand of growth hormone should be managed by your doctor.
If it is not possible for you or the child under your care to inject Sogroya on the usual day of the week,
you may inject Sogroya up to 2 days before or 3 days after the scheduled administration day.
The next dose can then be administered as usual the following week.
If necessary, you may change the weekly injection day of Sogroya, provided at least 4 days have passed since the last injection of the medicine. Once you have selected a new administration day, continue administering the injection on that day every week.

How long you will need treatment
You may need Sogroya until your body produces sufficient growth hormone.

If you or the child under your care is using Sogroya for growth problems, treatment will continue until growth stops.
If you or the child under your care still lacks growth hormone after growth has stopped, Sogroya may need to be continued into adulthood.

Do not stop using Sogroya without first discussing it with your doctor.

How much medicine to use

Children and adolescents
The dose for children and adolescents depends on body weight. The recommended dose of Sogroya is
0.16 mg per kg of body weight administered once weekly.

Adults
If you are receiving growth hormone treatment for the first time, the usual starting dose is
1.5 mg once a week. If you have previously been treated with daily growth hormone (somatropin),
the usual starting dose is 2 mg once a week.
If you are a woman taking oral estrogens (contraceptive or hormone replacement therapy),
a higher dose of somapacitan may be required. If you are over 60 years of age, you may require a lower dose. See Table 1 below.
Your doctor may gradually increase or decrease the dose and adjust it until the optimal dose for your individual needs is reached, based on clinical response and occurrence of side effects.

Do not use more than a maximum of 8 mg once a week.
Do not change the dose unless instructed by your doctor.

Table 1 Dose recommendation

Adults with growth hormone deficiency	Recommended initial dose
Has not previously been treated with daily growth hormone Is aged ≥18 to <60 years Is a woman receiving oral estrogen therapy regardless of age Is 60 years of age or older	1.5 mg/week 2 mg/week 1 mg/week
Has previously been treated with daily growth hormone Is aged ≥18 to <60 years Is a woman receiving oral estrogen therapy regardless of age Is 60 years of age or older	2 mg/week 4 mg/week 1.5 mg/week

After reaching the correct dose, your doctor will review your treatment every 6–12 months. It may be necessary to monitor your body mass index and take blood samples.

How to use Sogroya
Your doctor or nurse will show you how to inject Sogroya under the skin.
The best injection sites are:

the front of the thighs
the front of the waist (abdomen)
the buttocks
the upper arms

Change the injection site each week.
Detailed instructions on how to inject Sogroya, including the instructions for use, are included at the end of this leaflet.

If you use more Sogroya than you should
If you or the child in your care accidentally uses more Sogroya than prescribed, speak to your doctor, as it may be necessary to monitor blood glucose levels.

If you forget to use Sogroya
If you or the child in your care forgets to inject a dose and:

it has been 3 days or less since the missed dose, inject it as soon as you remember. Then continue with the next dose on your usual injection day
it has been more than 3 days since the missed dose, skip the missed dose. Then inject the next dose as usual on the next scheduled day

Do not inject a double dose or a higher dose to make up for the missed dose.

If you stop using Sogroya
Do not stop treatment with Sogroya without first discussing it with your doctor.

If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

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

Side effects observed in children and adolescents

Very common (may affect more than 1 in 10 people)

Headache

Common (may affect up to 1 in 10 people)

Swollen hands and feet due to fluid accumulation under the skin (peripheral oedema)
Adrenal glands do not produce enough steroid hormones (adrenal insufficiency)
Reduced thyroid hormone levels (hypothyroidism)
Redness and pain at the injection site (injection site reactions)
Joint pain (arthralgia)
Pain in arms or legs (pain in extremities)
High blood sugar levels (hyperglycaemia)
Severe tiredness (fatigue)

Side effects observed in adults

Very common (may affect more than 1 in 10 people)

Headache

Common (may affect up to 1 in 10 people)

Adrenal glands do not produce enough steroid hormones (adrenal insufficiency)
Reduced thyroid hormone levels (hypothyroidism)
High blood sugar levels (hyperglycaemia)
Tingling sensation, mainly in the fingers (paraesthesia)
Skin rash
Hives (urticaria)
Joint pain (arthralgia), muscle pain (myalgia), muscle stiffness
Swollen hands and feet due to fluid accumulation under the skin (peripheral oedema)
Severe feeling of tiredness or weakness (fatigue or asthenia)
Redness and pain at the injection site (injection site reactions)

Uncommon (may affect up to 1 in 100 people)

Thickening of the skin at the injection site (lipohypertrophy)
Numbness and tingling sensation in the hand(s) (carpal tunnel syndrome)
Itching (pruritus)
Joint stiffness

Reporting of side effects

If you get any side effects, including any that are not listed in this leaflet, 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 in Annex V. By 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 stated on the pen label and on the
packaging after "Exp.". The expiry date refers to the last day of that month.
Store in the refrigerator (2 °C - 8 °C). Do not freeze. Keep away from refrigerating elements.
After first opening
Use within 6 weeks of first use. Store in the refrigerator (2 °C - 8 °C).
Before and after first opening
If refrigeration is not possible (e.g. during travel), Sogroya may be
temporarily stored at temperatures up to 30 °C for a total of 72 hours (3 days). Return
Sogroya to the refrigerator after storage at this temperature. If stored outside the
refrigerator and then returned, the total combined time outside the refrigerator must not
exceed 3 days; monitor carefully. Discard the Sogroya pen if it has been stored at 30 °C
for more than 72 hours or above 30 °C for any period of time.
Record time spent outside the refrigerator: ________________
Keep Sogroya in the outer carton with the pen cap in place to protect it from light.
Always remove the injection needle after each injection and store the pen without the needle attached.
Do not use the medicine if the solution does not appear clear to slightly opalescent, colourless to slightly yellow, and free of visible particles.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Sogroya contains

The active substance is somapacitan. One mL of solution contains 3.3 mg of somapacitan. Each pre-filled pen contains 5 mg of somapacitan in 1.5 mL of 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 “What you need to know before using Sogroya” for information on sodium.

Description of the appearance of Sogroya and contents of the pack
Sogroya is a clear or slightly opalescent, colourless to slightly yellowish injectable liquid solution, free from visible particles.
Sogroya 5 mg/1.5 mL solution for injection in pre-filled pen with injection button in titanium colour is available in the following pack sizes: one pack containing 1 pre-filled pen or a multiple pack 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

Other sources of information
More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.

Instructions for use

Cylindrical medical device with a gray and blue body, a transparent window on the left, and a numbered dosage display with mg on the right

Overview of the Sogroya 5 mg/1.5 mL pen
Sogroya

A cylindrical medical device in light blue color with a thin vertical metal needle protruding from the top

Sequence of four white and blue components of a medical device arranged horizontally on a white background

Needle (example)
How to use the Sogroya pen
5 steps to follow when injecting Sogroya:
For further information about the pen, see sections : Checking how much Sogroya is left,
Caring for the pen, Important information.
Read the package leaflet and these instructions carefully before using the pre-filled pen

Sogroya.

Pay particular attention to these notes because they are important for the safe use of the
pen.

Additional information
Sogroya contains 5 mg of somapacitan and can be used to inject doses from 0.025 mg to 2 mg, in
increments of 0.025 mg. Sogroya is for subcutaneous (under the skin) use only. Needles are not
included and must be purchased separately. The Sogroya pre-filled pen is designed to be used
with disposable needles 4 mm to 8 mm in length and 30 G to 32 G in thickness.
Do not share the Sogroya pen or needles with another person. You could transmit an infection to
another person or acquire an infection from them.
Do not use the pen without first receiving adequate instructions from your doctor or nurse. Before
starting treatment, ensure you are able to self-administer an injection. If you are blind or have severe
vision problems and cannot read the dose counter, do not use this pen without assistance. Have a
person with good eyesight who has been trained to use the pen assist you.
Step 1. Preparing the Sogroya pen

A hand holds horizontally a medical device in blue and gray with a central transparent window for monitoring

Wash your hands with soap and water.
Check the name, dosage, and colored label on the pen to make sure it contains Sogroya and the correct dosage.
Remove the pen cap.
Turn the pen upside down one or two times to check that the Sogroya medicine in the pen appears clear to slightly opalescent or colorless to slightly yellow. See Figure A.
If Sogroya contains visible particles, do not use the pen.

Make sure you are using the correct pen. Especially if
you use more than one type of injectable medication. Using
the wrong medicine can be harmful to your health.

Medical illustration showing two hands removing the protective cap from a pre-filled syringe, with a blue arrow pointing to the left

When ready to inject, take a new disposable needle. First, remove the protective seal.
Then push the needle straight onto the pen. Screw the needle clockwise until it is firmly secure. See Figure B.
Remove 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. Both must be removed. If you forget to remove both caps, you will not inject the medicine. See Figures C and D.

Line drawing of a hand pushing a syringe forward

A hand holds a green and white medical device, pushing it forward to the right as indicated by a blue arrow

Remove the inner needle cap and dispose of it. Do not attempt to reinsert it, as you may accidentally prick yourself with the needle. See Figure D.

A drop of Sogroya may appear at the tip of the needle. 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, loss of Sogroya, and blocked needles leading to incorrect dosing.

Never use a bent or damaged needle.
Step 2. Checking the flow with each new pen

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

Two hands hold an injection pen with a display indicating 0 mg and a blue arrow pointing to the dosage counter

Before using a new pen, check the flow to ensure that Sogroya flows through the pen and needle.
Rotate the dose selector clockwise by one increment to select 0.025 mg. You may hear a soft click. See Figure E.
One increment equals 0.025 mg on the dose counter. See Figure F.

Detail of a medical device with a digital display showing a dose of 0.05 mg next to the abbreviation mg on a blue and gray background

Hold the pen with the needle pointing upward. Press and

A hand holds a dark cylindrical medical device with a blue arrow pointing to the left

keep pressing the injection button until the dose counter returns to “0” (zero). The “0” (zero) must align with the dose indicator. See Figure G.

White vial with a green screw cap positioned at the center of a blue rectangular frame with a circle in the center

Check that a drop of Sogroya appears at the tip of the needle. See Figure H.

If no drop of Sogroya appears, repeat Step 2 up to 6 times.
If still no drop appears, change the needle once as described in Step 5 and repeat Steps 1 and 2.

If no drop of Sogroya appears when checking flow, the needle may be blocked or damaged. If no drop appears even after changing the needle, do not use the pen. The pen may be defective.
Step 3. Selecting the dose

Two hands hold a cylindrical medical device with a display indicating 0 mg and a curved blue arrow pointing to the center of the device

To begin, check that the dose counter is set to “0” (zero).
Rotate the dose selector clockwise to select the required dose. See Figure I.

After selecting the dose, proceed to Step 4.

If there is not enough Sogroya remaining to select a full dose, see Checking how much Sogroya is left.

The dose counter displays the dose in mg. See Figures J and K. Always use the dose indicator to select the exact dose.
Do not count pen clicks. Do not use the pen scale (see Sogroya Pen Overview) to measure the amount of growth hormone to inject. Only the dose indicator shows the exact number of mg.

Detail of a dosage indicator on a medical device showing values 1.8 and 1.85 mg with an arrow

Detail of a medical device with a display showing the selected dose of 1.85 mg next to the label mg and the word 'example' below

Two hands hold an injection pen with a display showing 1.8 mg and a blue arrow indicating rotation of the device

If you select the wrong dose, you can correct it by rotating the dose selector clockwise or counterclockwise. See Figure L.
The pen clicks may feel and sound different when rotating the dose selector clockwise or counterclockwise, or if accidentally forced beyond the remaining mg amount.
Step 4. Injecting the dose
Insert the needle into the skin as shown to you by your doctor or nurse. 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 each week.

A hand holds an injection pen ready to be pressed downward toward the skin as indicated by the blue arrow

Press and keep pressing the injection button until the dose counter shows “0” (zero) (see Figure N). The “0” (zero) must align with the dose indicator. You may hear or feel a click.
Continue holding the injection button down while the needle is in the skin.

Continue holding the injection button down with the needle in the skin and count slowly to 6 to ensure the full dose has been delivered (see Figure O).
If “0” does not appear on the dose counter after continuously pressing the injection button, the needle or pen may be blocked or damaged, meaning you have not received Sogroya—even if the dose counter has moved from the original dose you selected.
Remove the needle as described in Step 5 and repeat Steps 1 to 4.

Illustration of a hand pressing a medical device downward with a blue arrow and a close-up detail of the display showing zero

Carefully withdraw the needle from the skin. See Figure P. If bleeding occurs at the injection site, apply gentle pressure. Do not rub the area.

After the injection, you may see a drop of Sogroya at the tip of the needle. This is normal and does not affect the administered dose.
Step 5. After the injection

Insert the needle tip into the outer needle cap placed on a flat surface, without touching the needle or cap. See Figure Q.

Blue drawing of a hand holding an auto-injector on the skin with the text 'Count slowly' and a numerical sequence from 1 to 6

Diagram with a blue arrow pointing to the left

Once the needle is covered, firmly push the outer cap all the way on. See Figure R.

Unscrew the needle and dispose of it carefully according to instructions from 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 shown above and discard the pen separately as instructed by your doctor, nurse, pharmacist, or local authorities.
The pen cap and empty box can be disposed of in household waste.

Replace the pen cap on the pen after each use to protect Sogroya from direct light. See Figure T.
For pen storage, see How to store in the leaflet.

Do not attempt to reinsert the inner needle cap.
You may accidentally prick yourself with the needle.

Always remove the needle from the pen immediately after each injection. This reduces the risk of contamination, infection, loss of Sogroya, and blocked needles leading to incorrect dosing.
Checking how much Sogroya is left
The pen scale shows approximately how much Sogroya remains in the pen. See Figure U.
To check how much Sogroya is left, use the dose counter. Rotate the dose selector clockwise until the dose counter stops. A maximum dose of 2 mg can be selected. If it shows “2”, at least 2 mg remains in the pen.
If the dose counter stops at “1.2”, only 1.2 mg remains in the pen. See Figure V.
What if I need a dose larger than what is left in my pen? You cannot select a dose greater than the amount of mg remaining in the pen.
If you need more Sogroya than remains in the pen, you may use a new pen or split the dose between the current pen and a new pen. The dose may only be split if you have been trained to do so or advised by your doctor or nurse. Use a calculator to plan doses as instructed by your doctor or nurse.
Calculate very carefully, otherwise medication administration errors may occur. If you are unsure how to split the dose between two pens, select and inject the required dose using a new pen.
How to care for the pen
How do I care for the pen? Be careful not to drop the pen or hit it against hard surfaces. Do not expose the pen to dust, dirt, liquids, or direct light.
Do not attempt to refill the pen, as it is pre-filled and must be discarded once empty.
What if the pen is dropped? If the pen is dropped or you suspect something is wrong, attach a new disposable needle and check the flow before injection—see Steps 1 and 2. If the pen has been dropped,

	check the cartridge; if the cartridge is cracked, do not use the pen.
How to clean the pen?	Do not wash, immerse or lubricate the pen. It may be cleaned with a neutral detergent on a damp cloth.
Important information • Anyone assisting the patient must pay close attention when handling needles, to reduce the risk of needlestick injuries and cross-infections. • Always keep the pen and needles out of reach of others, especially children. • Do not use the pen if it is damaged. Do not attempt to repair or disassemble the pen. • For storage of the pen, see How to store in the leaflet.

Patient Information Leaflet: information for the user

Sogroya 10 mg/1.5 mL solution for injection in a pre-filled pen

somapacitan
Please read this leaflet carefully before using this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

What Sogroya is and what it is used for
What you need to know before using Sogroya
How to use Sogroya
Possible side effects
How to store Sogroya
Contents of the pack and other information

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 fat, muscle, and bone composition in adults.
The active substance in Sogroya is produced using "recombinant DNA technology", meaning cells have been given a gene (DNA) that causes them to produce growth hormone. In Sogroya, a small side chain has been attached to the growth hormone, enabling Sogroya to bind to the protein (albumin) naturally present in the blood, thereby slowing its removal from the body and allowing less frequent administration of the medicine.
Sogroya is used to treat growth hormone deficiency in children and adolescents aged 3 years and older when growth hormone production is absent or very low (growth hormone deficiency), and in adults with growth hormone deficiency.
Your doctor will assess whether treatment with Sogroya should continue one year after starting therapy, based on your response to this medicine.

2. What you should know before using Sogroya

Do not use Sogroya

if you or the child under your care are allergic to somapacitan or any of the other ingredients of this medicine (listed in section 6)
if you or the child under your care has a benign or malignant tumour that is currently growing. Anti-tumour treatment must be completed before starting treatment with Sogroya. Sogroya must be discontinued if tumour growth occurs
if you or the child under your care has recently undergone open-heart surgery, abdominal surgery, or suffered multiple accidental injuries, severe respiratory problems, or similar conditions
for children and adolescents who have stopped growing due to closure of the growth plates (closed epiphyses), meaning that a doctor has informed you or the child in your care that their bones have stopped growing.

If you are unsure, consult your doctor, pharmacist, or nurse.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Sogroya if:

you or the child under your care has had any type of tumour
you or the child under your care has high blood sugar levels (hyperglycaemia), as regular blood glucose monitoring may be required and the dose of your diabetes medications may need adjustment
you or the child under your care is receiving corticosteroid replacement therapy because you have been diagnosed with insufficient corticosteroid production (adrenal insufficiency). Speak with your doctor, as regular dose adjustments may be necessary
you or the child under your care experiences severe headaches, vision problems, nausea, or vomiting, as these may be symptoms of increased pressure in the brain (benign intracranial hypertension), which may require discontinuation of treatment
you or the child under your care has thyroid problems; thyroid hormones must be monitored regularly and the dose of thyroid hormone may need to be adjusted
you are a woman taking oral contraceptives or estrogen-based hormone replacement therapy, as the dose of Sogroya may need to be increased. If you stop taking oral estrogens, the dose of somapacitan may need to be reduced. Your doctor may advise you to change the route of estrogen administration (e.g. transdermal, vaginal) or to use another form of contraception
you or the child under your care is seriously ill (e.g. complications following open-heart surgery, abdominal surgery, accidental trauma, acute respiratory failure, or similar conditions). If you are about to undergo or have recently undergone major surgery or are admitted to hospital for the reasons listed above, inform your doctor and remind other healthcare providers that you are using growth hormone
you or the child under your care develops severe stomach pain during treatment with Sogroya, as this may be a symptom of pancreatitis, which has been observed with other growth hormone products
you or the child experiences persistent hip or knee pain when walking, or if limping develops during treatment with growth hormone. These may be symptoms of a condition affecting the femur where it connects to the hip (slipped capital femoral epiphysis), which occurs more frequently in rapidly growing children and children with endocrine disorders, including growth hormone deficiency. Speak with your doctor if you experience persistent joint pain.

Skin changes at injection site
The injection site for Sogroya should be rotated to avoid changes in the fatty tissue under the skin, such as skin thickening, skin tightening, or lumps under the skin. Change the injection site on your body from week to week.
Antibodies
Antibodies against somapacitan are not expected. However, very rarely, your child may develop antibodies. If treatment with Sogroya is not effective, your doctor may test you for antibodies against somapacitan.
Children and adolescents
Do not use Sogroya in children and adolescents under 18 years of age, as the effectiveness of Sogroya has not been fully studied in this age group.
Other medicines and Sogroya
Inform your doctor or pharmacist if you or the child under your care is taking, has recently taken, or might take any other medicines.
In particular, inform your doctor if you or the child under your care is taking or has recently taken any of the following medicines, as your doctor may need to adjust the dose:

corticosteroids such as hydrocortisone, dexamethasone, and prednisolone
estrogens as part of oral contraception or estrogen replacement therapy
male sex hormones (androgenic drugs) such as testosterone
gonadotropin-containing medicines (gonadotropins such as luteinizing hormone and follicle-stimulating hormone) that stimulate the production of sex hormones
insulin or other diabetes medications
thyroid hormones such as levothyroxine
medicines for epilepsy or seizures – such as carbamazepine
cyclosporine (an immunosuppressant) – a medicine used to suppress the immune system

Pregnancy

If there is a possibility you may become pregnant, you must not use Sogroya unless you are also using an effective method of contraception. This is because it is unknown whether the medicine could harm the foetus. If you become pregnant while using Sogroya, contact your doctor immediately. If you wish to become pregnant, discuss this with your doctor, as you may need to stop taking the medicine.

Breast-feeding

It is unknown whether Sogroya passes into breast milk. Inform your doctor if you are breast-feeding or plan to breast-feed. Your doctor will help you decide whether to discontinue breast-feeding or discontinue Sogroya, taking into account the benefits of breast-feeding for the child and the benefits of Sogroya for the mother.

Driving and using machines
Sogroya does not affect the ability to drive or operate machinery.
Sodium content
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is essentially “sodium-free”.