Sogroya ® 5 mg/1,5 ml Solution

Sogroya ® contains the active substance somapacitan. Somapacitan a long-acting version of the natural growth hormone produced by the body with a single amino acid substitution. 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 side-chain 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 growth failure in children and adolescents if they have no or very low production of growth hormone (growth hormone deficiency). It replaces the growth hormone in adults with growth hormone deficiency and regulates the composition of fat, muscle and bone.

Do not use Sogroya ® if:

• you are allergic to somapacitan or phenol any of the other ingredients of this medicine (listed in section 6).
• you have a tumour which is growing. You must have completed your anti-tumour treatment before you start your Sogroya ® treatment. Sogroya ® must be stopped if the tumour grows.
• (Adults only) you have recently had open heart surgery or abdominal surgery or multiple accidental injury, severe breathing problems or similar conditions.
• (Children and adolescents only) your bones have already stopped growing (closure of the growth plates).
• your healthcare provider tells you that you have certain types of eye problems caused by diabetes (diabetic retinopathy).

If you are not sure talk to your doctor, pharmacist or other health care professional.

Warnings and precautions

Tell your doctor or health care provider before using Sogroya ® if:

• you have ever had any kind of cancer or another 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 glucocorticoids, because you have been told your body does not produce enough (adrenocortical insufficiency). You should consult your doctor regularly, as you may need adjustment of your glucocorticoid dose.
• 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 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 change to a vaginal hormone medicine or a hormone patch.
• you have liver problems.

Tell your doctor, pharmacist or health care provider if any of these applies to you as Sogroya ® may not be suitable.

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.

Other medicines and Sogroya ®

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional 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:

• Glucocorticoids such as hydrocortisone, dexamethasone and prednisolone.
• Oestrogen as part of oral hormonal replacement therapy.
• Male sex hormones (androgen medicines) such as testosterone.
• Gonadotropin medicines (gonad stimulating hormones such as luteinising hormone and follicle-stimulating hormone) which stimulate the production of sex hormones.
• Insulin or other diabetes medicines.
• Thyroid hormone medicines such as thyroxine and levothyroxine.
• Medicines to treat epilepsy or fits (seizures) such as carbamazepine and diazepam.
• Ciclosporin (immunosuppressive medicine) – a medicine to suppress your immune system.

Do not share medicines prescribed for you with any other person. Always use Sogroya ® exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.

How much to use

Children and adolescents

The dose for children and adolescents depends on the body weight. The recommended dose of Sogroya ® is 0,16 mg per kg body weight given once a week.

Adults

The usual starting dose of Sogroya ® is 1,5 mg once a week if you are receiving growth hormone treatment for the first time. The usual starting dose of Sogroya ® is 2,0 mg per week if you are already in treatment with a daily growth hormone (somatropin).

If you are a woman taking oral oestrogen (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 18 to less than 60 years 1,5 mg/week
• You are woman on oral oestrogen therapy regardless of age 2 mg/week
• You are 60 years or above 1 mg/week

You have previously received daily growth hormone medicine

• You are 18 to less than 60 years 2 mg/week
• You are woman on oral oestrogen therapy regardless of age 4 mg/week
• You are 60 years or above 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 given

Sogroya ® is given as an injection under the skin (subcutaneous injection). Do not inject it into a vein or muscle. Before you use the pen for the first time, your doctor or nurse will show you how to use it.

The best places to give the injection are:

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

Change the place on your body where you inject into every week.

Detailed instructions on how to inject Sogroya ® , the Instructions for Use , are included at the end of the Patient Information Leaflet.

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 you are changing from another weekly growth hormone therapy to Sogroya ® , you are advised to continue injecting on the same day of the week.

If you are changing from daily growth hormone therapy to Sogroya ® choose the preferred day for the weekly dose and stop the final dose of daily treatment the day before (or at least 8 hours before) injecting the first dose of Sogroya ®.

Changing from another type or brand of growth hormone should be done by your doctor.

On occasions when administration at the scheduled dosing day is not possible, you can use Sogroya ® up to 2 days before or 3 days after your scheduled dosing day. The next dose you can inject as usual the following week.

If necessary, you can change the day of your weekly injection of Sogroya ® as long as it has been at least 4 days (96 hours) since you had your last injection of it. After selecting a new dosing day, continue with once a week dosing.

How long you will need treatment for

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

• If you are using Sogroya ® for growth failure you will continue using Sogroya ® until you stop growing.
• If you still lack growth hormone after you stop growing, you may need to continue using Sogroya ® into adulthood.
• Do not stop using Sogroya ® without discussing this with your doctor first.

If you use more Sogroya ® than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

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.

Sogroya ® can have side effects. Not all side effects reported for Sogroya ® medicine are included in this leaflet. Should your general health worsen or if you experience any untoward effects while using Sogroya ® , please consult your health care provider for advice.

If any of the following happens, stop using Sogroya ® and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing, wheezing.
• Rash or itching, flushing and hives.
• Fainting, or dizziness.

These are all very serious side effects. If you have them, you may have had a serious reaction to Sogroya ®. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

Side effects seen in children and adolescents

Side effects occurring frequently:

• Headache.
• Swollen hands and feet due to a fluid retention.
• Decreased thyroid hormone (hypothyroidism).
• Redness and pain in the area of injection.
• Joint pain.
• High blood sugar (hyperglycaemia).
• Feeling very tired (fatigue).
• The adrenal glands do not make enough steroid hormones (adrenocortical insufficiency).

Side effects seen in adults

Side effects occurring frequently:

• Headache.
• Swollen hands and feet due to fluid retention.
• Decreased thyroid hormone (hypothyroidism).
• The adrenal glands do not make enough steroid hormones (adrenocortical insufficiency).
• Feeling very tired or weak (fatigue or asthenia).
• Redness and pain in the area of injection.
• High blood sugar (hyperglycaemia).
• Joint pain.
• Feeling of ‘pins and needles’ mainly in the fingers.

Side effects occurring less frequently:

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

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects via the 6.04 Adverse Drug Reaction Reporting Form, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of Sogroya ®.

Store all medicines out of reach of children.

Before opening *

• Store in refrigerator (2 °C – 8 °C).
• Do not freeze or expose to heat.
• Keep away from the cooling element inside the fridge.
• Do not use Sogroya ® if it has been frozen.
• Keep unused (unopened) Sogroya ® in the carton so that it stays clean and protected from light.
• If you are not able to store in a refrigerator before opening Sogroya ®: you can keep it at room temperature, 30 °C and below for a maximum of 72 hours (3 days). This is as long as you keep Sogroya ® as cool as possible and away from direct heat and light. place Sogroya ® in the refrigerator after this period of keeping it at room temperature.

During use *

• You can keep the pen for 6 weeks when stored in a refrigerator (2 °C – 8 °C).
• Keep away from the cooling element.
• Do not freeze.
• If you are not able to store the opened Sogroya ® in a refrigerator: it can be kept at room temperature, 30 °C and below for a maximum of 72 hours (3 days). This is as long you keep as cool as possible and away from direct heat and light.
• -return Sogroya ® in the refrigerator after period of use at room temperature.
• When you are not using the pen, keep the Sogroya ® in the outer carton with pen cap on to protect from light.
• Always remove the injection needle after each injection and store the pen without a needle attached.

* The total time allowed at room temperature, 30 °C and below is 72 hours (3 days). This is regardless of whether the product is in-use (opened) or not in-use (unopened).

Do not use this medicine if the solution does not appear clear to slightly opalescent, colourless to slightly yellow and free from 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.

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.