SOGROYA 15 MG/1.5 ML INJECTABLE SOLUTION IN PRE-FILLED PEN

2. What you need to know before you use Sogroya

Do not use Sogroya

• if you or a child in your care is allergic to somapacitan or any of the other ingredients of this medicine (listed in section 6).
• if you or a child in your care has a benign or malignant tumor in development. You must have completed anti-tumor treatment before starting treatment with Sogroya. If the tumor grows, you must stop receiving Sogroya.

• if you or a child in your care has recently undergone open-heart or abdominal surgery or has suffered multiple accidental trauma or has severe respiratory problems or similar conditions.
• in children and adolescents who have stopped growing due to the closure of their growth plates (closed epiphyses), which means that your doctor has indicated to you or the child in your care that their bones have stopped growing.

In case of doubt, consult your doctor, pharmacist, or nurse.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before using Sogroya if:

• you or a child in your care has ever had any type of tumor
• you or a child in your care has a high blood sugar level (hyperglycemia), as you may need to regularly check your blood sugar level and adjust the dose of your diabetes medicine
• you or a child in your care is receiving corticosteroid replacement therapy because your body does not produce enough (adrenal insufficiency). Talk to your doctor, as you may need regular adjustments
• you or a child in your care experiences severe headache, vision problems, nausea, or vomiting, as these may be symptoms of increased pressure in the brain (benign intracranial hypertension), and you may need to interrupt treatment
• you or a child in your care has thyroid problems, you should periodically check your thyroid hormones and may need to adjust the dose of thyroid hormones
• you are a woman taking oral contraceptives or hormone replacement therapy with estrogens, you may need a higher dose of Sogroya. If you stop taking oral estrogens, you may need a lower dose of somapacitan. Your doctor may recommend that you change the way you take estrogens (e.g., transdermal, vaginal) or use another contraceptive method
• you or a child in your care is seriously ill (e.g., complications from open-heart surgery, abdominal surgery, accidental trauma, acute respiratory failure, or similar diseases). If you have undergone or are going to undergo major surgery, or are going to be hospitalized for any of the above reasons, inform your doctor and remind other doctors who may treat you that you are being treated with growth hormone
• you or a child in your care suffers from severe stomach pain during treatment with Sogroya, as this could be a symptom of pancreatitis observed in treatments with other growth hormone medicines
• you or a child in your care suffers from persistent hip or knee pain when walking, or if you or a child in your care starts to limp during growth hormone treatment. These could be symptoms of a disease that affects the femur where it inserts into the hip (slipped capital femoral epiphysis) and occurs more frequently in children with rapid growth and children with endocrine disorders, including growth hormone deficiency. Inform your doctor if you experience persistent pain in any joint.

Changes in the skin at the injection site

The injection site of Sogroya should be rotated to prevent changes in the fatty tissue under the skin, such as thickening of the skin, shrinkage of the skin, or lumps under the skin. Change the injection site on your body every week.

Antibodies

It is not expected that you will develop antibodies against somapacitan. However, in very rare cases, the child may develop antibodies. If your treatment with Sogroya does not work, your doctor will need to check if you have developed antibodies to somapacitan.

Other medicines and Sogroya

Tell your doctor or pharmacist if you or a child in your care is using, has recently used, or might use any other medicines.

In particular, tell your doctor if you or a child in your care is taking or has recently taken any of the following medicines.

The reason is that your doctor may need to adjust the doses of your medicines:

• Corticosteroids such as hydrocortisone, dexamethasone, and prednisolone
• Estrogens as part of oral contraception or hormone replacement therapy with estrogens
• Male sex hormones (androgens) such as testosterone

• Gonadotropins (gonad-stimulating hormones, such as luteinizing hormone and follicle-stimulating hormone), which stimulate the production of sex hormones
• Insulin or other diabetes medicines
• Thyroid hormone medicines such as levothyroxine
• Medicines for treating epilepsy or seizures (epileptic fits) such as carbamazepine
• Cyclosporins (immunosuppressant), a medicine that suppresses the immune system's response.

Pregnancy

• If you can become pregnant, you must not use Sogroya unless you are using a reliable method of contraception. This is because it is not known whether it could harm the fetus. If you become pregnant during treatment with Sogroya, inform your doctor immediately. If you wish to become pregnant, talk to your doctor, as you may need to stop using the medicine.

Breast-feeding

• It is not known whether Sogroya is excreted in breast milk. Inform your doctor if you are breast-feeding or plan to breast-feed. Your doctor will help you decide whether to stop breast-feeding or stop using 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 the ability to drive and use machines.

Sodium content

This medicine contains less than 1 mmol of sodium (23 mg) per dose; this is essentially "sodium-free".

3. How to use Sogroya

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Sogroya is injected under the skin (subcutaneous injection) with a pre-filled pen. You can administer the injection yourself. Your doctor or nurse will show you how to inject Sogroya when you or a child in your care starts treatment.

When to use Sogroya

• You or a child in your care should use Sogroya once a week, on the same day of the week if possible.
• The injection can be administered at any time of day.

If you or a child in your care changes from another weekly growth hormone treatment to Sogroya, it is recommended to continue injecting on the same day of the week.

If you or a child in your care changes from daily growth hormone treatment to Sogroya, choose the preferred day for weekly administration and inject the last dose of daily treatment the day before (or at least 8 hours before) the first dose of Sogroya.

Any change from another type or brand of growth hormone should be made by your doctor.

If it is not possible for you or a child in your care to inject Sogroya on the usual day of the week, you can administer Sogroya up to 2 days before or 3 days after the scheduled day. The next week, you can inject the next dose as usual.

If necessary, you can change the day of the weekly Sogroya injection, as long as at least 4 days have passed since the last injection. Once the new administration day is selected, you should continue injecting the dose on the same day every week.

For how long you will need treatment

You may need Sogroya as long as your body does not produce enough growth hormone

• If you or a child in your care is using Sogroya for growth retardation, you will continue using Sogroya until you stop growing
• If you or a child in your care still has a growth hormone deficiency after stopping growth, you may need to continue treatment with Sogroya until adulthood

Do not stop your treatment with Sogroya without talking to your doctor first.

How much 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 a week.

Adults

The usual initial dose is 1.5 mg once a week if you are receiving growth hormone treatment for the first time. The usual initial dose is 2 mg once a week if you have previously received daily growth hormone treatment (somatropin).

If you are a woman taking oral estrogens (contraceptives or hormone replacement therapy), you may need a higher dose of somapacitan. If you are over 60 years old, you may need a lower dose. See Table 1 below.

Your doctor may gradually increase or decrease the dose until you find the right dose according to your individual needs and the side effects experienced.

• Do not use more than 8 mg once a week.
• Do not change the dose unless your doctor tells you to.

Table 1 Recommended dose

After reaching the correct dose, your doctor will assess your treatment every 6 to 12 months. You may need to review your body mass index and have blood samples taken.

How to use Sogroya

Your doctor or nurse will show you how to inject Sogroya under the skin.

The best places to inject are:

• the front of the thigh
• the front of the waist (abdomen)
• the buttocks
• the upper arms.

Change the injection site on your body every week.

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

If you use more Sogroya than you should

If you or a child in your care accidentally uses more Sogroya than you should, consult your doctor, as you may need to check your blood sugar levels.

If you forget to use Sogroya

If you or a child in your care forgets to inject a dose:

• and it has been 3 days or less since you should have used Sogroya, administer it as soon as you remember. Then, inject the next dose on the usual injection day
• and it has been more than 3 days since you should have used Sogroya, skip the missed dose. Then, inject the next dose as usual, on the next scheduled day.

Do not inject an extra dose or increase the dose to make up for the missed dose.

If you stop treatment with Sogroya

Do not stop your treatment with Sogroya without consulting your doctor.

If you have any other questions about 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.

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)

• Swelling in hands and feet due to fluid accumulation under the skin (peripheral edema)
• The adrenal glands do not produce enough steroid hormones (adrenal insufficiency)
• Decreased thyroid hormone (hypothyroidism)
• Redness and pain at the injection site (injection site reactions)
• Joint pain (arthralgia)
• Pain in arms or legs (pain in the limbs)
• High blood sugar level (hyperglycemia)
• Feeling very tired (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)

• The adrenal glands do not produce enough steroid hormones (adrenal insufficiency)
• Decreased thyroid hormone (hypothyroidism)
• High blood sugar level (hyperglycemia)
• Feeling of "tingling", especially in the fingers (paresthesia)
• Rash
• Hives
• Joint pain (arthralgia), muscle pain (myalgia), muscle stiffness
• Swelling in hands and feet due to fluid accumulation under the skin (peripheral edema)
• Feeling very tired or weak (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 (lipoatrophy)
• Feeling of numbness and tingling in the hands (carpal tunnel syndrome)
• Itching (pruritus)
• Joint stiffness.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible that they are not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sogroya

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and on the carton of the pen after “EXP”. The expiry date is the last day of the month indicated.

Store in a refrigerator (between 2 °C and 8 °C). Do not freeze. Keep away from the cooling element of the refrigerator.

After first use

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

Before and after first use

If you cannot refrigerate it (for example, during travel), Sogroya can be temporarily stored at temperatures below 30 °C for a maximum total of 72 hours (3 days). Return Sogroya to the refrigerator after storing it at this temperature. If you have stored it out of the refrigerator and then put it back in the refrigerator, the total time out of refrigeration must not exceed 3 days; keep track of this 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 the time out of refrigerator:_____________

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

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

Do not use this medicine if you notice that the solution is not transparent or slightly opalescent, colorless to slightly yellow, and is not free of visible particles.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medicines that are no longer needed. This will help protect the environment.

6. Container Contents and Additional Information

Composition of Sogroya

• The active substance is somapacitan. One ml of solution contains 10 mg of somapacitan. Each pre-filled pen contains 15 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). Also, refer to section 2 "What you need to know before you start using Sogroya" for more information on sodium.

Appearance and Container Contents of the Product

Sogroya is an injectable liquid in a pre-filled pen with a transparent or slightly opalescent appearance, colorless or slightly yellow, and free of visible particles.

Sogroya 15 mg/1.5 ml solution for injection in a pre-filled pen with a ruby red push button is available in the following pack sizes: one pack containing 1 pre-filled pen or a multipack containing 5 packs, each with 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

Date of Last Revision of this Leaflet:06/2025

Other Sources of Information

Detailed information on this medicinal product is available on the European Medicines Agency web site: http://www.ema.europa.eu.