Sogroya® is used for the long-term treatment of children and adolescents who are not growing because of low growth hormone levels. 

 

Sogroya® also replaces growth hormone in adults with growth hormone deficiency. 

Sogroya® contains the active substance somapacitan, a long-acting version of the natural growth hormone produced by the body. Somapacitan is made by recombinant DNA technology, using cells that have received a gene that makes them produce growth hormone. 

 

The growth hormone in Sogroya® is attached to a small side-chain that links it to albumin, a protein naturally found in the blood. This slows down removal from the blood, allowing Sogroya® to be given less often. 

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.

 

See detailed instructions on how to use Sogroya®. 

 

Changing from another weekly growth hormone therapy to Sogroya® 

Continue your usual once-weekly dosing schedule. 

 

Changing from daily growth hormone therapy to Sogroya® 

Choose your preferred day for a weekly dose, then stop the final dose of daily treatment the day before (or at least 8 hours before) taking the first dose of Sogroya®

 

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

 

What happens if I can’t take Sogroya® on my scheduled dosing day?

Take Sogroya® up to 2 days before or 3 days after your scheduled dosing day. Take your next dose as usual the week after. 

 

Can I change my scheduled dosing day?

If necessary, you can change your scheduled dosing day as long as it has been at least 4 days since your last injection of Sogroya®. After choosing a new preferred day for a weekly dose, continue with once-weekly dosing. 

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

  • If you are taking 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. Treatment continuation should be decided by your doctor.
  • Do not stop using Sogroya® without discussing this with your healthcare professional first.

Always use Sogroya® exactly as your healthcare professional has told you. Check with them if you are not sure about how to use your medication.

 

See detailed instructions on how to use Sogroya®

 

 

 

If you think you (or a person you are caring for) have taken too much Sogroya®, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.

Do not use Sogroya® if:

 

 

 

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Sogroya®.

 

Talk about any health conditions or problems you may have, including if:

 

 

 

 

Other considerations:

 

 

 

 

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements, or alternative medicines.

 

The following may interact with Sogroya®:

  • Glucocorticoids such as hydrocortisone, dexamethasone, and prednisolone
  • Estrogen as part of oral hormonal replacement therapy
  • Male sex hormones (androgen medicines) such as testosterone
  • Gonadotropin medicines (gonad stimulating hormone) which stimulate the production of sex hormones
  • Insulin or other diabetes medicines
  • Thyroid hormone medicines such as thyroxine and levothyroxine
  • Anticonvulsants such as carbamazepine and diazepam
  • Cyclosporine (immunosuppressive)—a medicine to suppress your immune system

Has it been ≤ 3 days since you should have used Sogroya®?
Use it as soon as you remember. Then inject your next dose as usual the following week.

 

Has it been > 3 days since you should have used Sogroya®? 
Skip the missed dose. Then inject your next dose as usual on your next scheduled dosing day. 

 

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

These are not all the possible side effects you may have when taking Sogroya®. If you experience any side effects not listed here, tell your healthcare professional.

 

Side effects seen in children and adolescents

 

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

  • Headache

 

Common side effects (may affect up to 1 in 10 people) 

 

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

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

  • Headache

 

Common side effects (may affect up to 1 in 10 people)

  • 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 (hyperglycemia)
  • Joint pain
  • Feeling of "pins and needles" mainly in fingers

 

Uncommon side effects (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)

 

Talk to your healthcare professional if any of the above symptoms are severe.

 

Please consult the Sogroya® Patient Medication Information brochure for complete safety information.

 

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.

 

Before opening 

 

  • Keep unused (unopened) Sogroya® in the carton so that it stays clean and protected from light

 

  • Keep away from the cooling element inside the fridge
  • Do not freeze
  • Keep Sogroya® as cool as possible and away from direct heat and light
  • Place Sogroya® in the refrigerator after keeping it at room temperature

 

During use*

  • 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 Sogroya® as cool as possible and away from direct heat and light
  • Place Sogroya® in the refrigerator after keeping it at room temperature

 

  • When you are not using the pen, 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 Sogroya® if the solution does not appear clear to slightly opalescent, colourless to slightly yellow, and free from visible particles

 

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

 

 

If you still have questions and can’t find the answers on this website, be sure to ask your healthcare professional.