Patient leaflet - Lonapegsomatropin Ascendis Pharma
1. What Lonapegsomatropin Ascendis Pharma is and what it is used for
Lonapegsomatropin Ascendis Pharma is a medicine that contains the active substance lonapegsomatropin. This is a substance that the body can convert into somatropin, also called human growth hormone (hGH). Somatropin is needed for bones and muscles to grow and helps your body to develop the right amount of fat and muscle tissues.
Lonapegsomatropin Ascendis Pharma is used to treat children and adolescents, aged 3 up to 18 years, who have failed to grow because their body produces no growth hormone or not enough. Doctors call this growth hormone deficiency (GHD). After injection, Lonapegsomatropin Ascendis Pharma is slowly converted into somatropin, supplying the missing growth hormone.
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2. What you or your child need to know before you or your child use Lonapegsomatropin Ascendis Pharma
Do not use Lonapegsomatropin Ascendis Pharma
- If you are allergic to lonapegsomatropin or any of the other ingredients of this medicine (listed in section 6)
- If you have a tumour (cancer) which is growing. You must have finished your anti-tumour treatment, and tumours must be inactive before you start your treatment with Lonapegsomatropin Ascendis Pharma
- If you have recently had an open heart surgery, abdominal surgery, multiple accidental trauma or acute respiratory failure
- If you have been told by your doctor that the parts of your bones that grow and increase height (growth plates or epiphyses) have closed and stopped growing
Tell your doctor before starting the treatment if any of these apply to you.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Lonapegsomatropin Ascendis Pharma. It is especially important to talk about anything mentioned below:
If you previously had an intracranial tumour , a doctor will examine you regularly during your treatment for recurrence of the tumour or any other cancer.
If you develop a strong headache, disturbed vision, vomiting or inability to coordinate voluntary muscle movements (ataxia) , especially in the first few weeks of treatment, tell your doctor straight away. These may be signs of raised pressure in the skull (intracranial pressure). See section 4, possible side effects.
If you have diabetes mellitus, high blood sugar (glucose intolerance), or additional risk factors for diabetes, your blood sugar may need to be checked regularly and the dose of your diabetes medicine may need to be adjusted.
If you are being treated for adrenal insufficiency with corticosteroids, talk to your doctor, as your steroid dose may need regular adjustment.
If you are being treated with thyroid hormones or you need to start thyroid hormone replacement, your doctor will test your thyroid function regularly and the dose may need to be adjusted.
If you have persistent hip or knee pain when walking, or if you start to limp during your growth hormone treatment, tell your doctor. These could be symptoms of a condition that affects the thighbone (femur) where it inserts into the hip (slipped capital femoral epiphysis) and that occurs with greater frequency in children on growth hormone therapy.
If you notice a sideways curve in your spine (scoliosis), you will need to be checked often by your doctor.
If you get a stomach ache (pain in your tummy) that gets worse, tell your doctor. Your doctor may test for pancreatitis, which is when an organ called the pancreas becomes inflamed. See section 4, possible side effects.
If you have Prader-Willi syndrome , you should not be treated with Lonapegsomatropin Ascendis Pharma unless you also have GHD. Lonapegsomatropin Ascendis Pharma has not been studied in individuals with Prader-Willi syndrome and therefore its effectiveness as a treatment for this condition is unknown.
A small number of patients given growth hormone replacement have developed a type of cancer of the blood and bone marrow (leukaemia). However, it has not been proven that growth hormone treatment caused the cancer.
If you have immediate complications following open heart surgery, abdominal surgery, a bad accident (trauma), or an acute critical illness like acute respiratory failure.
- If you are a female taking oral contraception or hormonal replacement therapy with oestrogen, your dose of Lonapegsomatropin Ascendis Pharma may need to be higher. If you or your child stop using oral oestrogen, your dose of Lonapegsomatropin Ascendis Pharma may need to be reduced.
Other medicines and Lonapegsomatropin Ascendis Pharma
Tell your doctor, pharmacist, or nurse 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:
- Insulin or any other medicines to treat diabetes mellitus
- Thyroid hormone treatments such as levothyroxine
- Tablets containing oestrogen, including tablets for oestrogen replacement therapy or for contraception
- Steroids or synthetic adrenal hormones (corticosteroids or glucocorticoids)
- Medicines to treat epilepsy or fits (seizures) – antiseizure medicines (anticonvulsants) such as carbamazepine
- Ciclosporin (immunosuppressive medicine) – a medicine to suppress your immune system
- Theophylline, a medicine used to treat asthma and other chronic lung diseases
Your doctor may need to adjust the dose of these medicines or the dose of Lonapegsomatropin Ascendis Pharma.
Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor before taking this medicine.
Pregnancy
If you are able to get pregnant, you should not use Lonapegsomatropin Ascendis Pharma unless you are also using reliable contraception. There are no data from the use of Lonapegsomatropin Ascendis Pharma in pregnant women. Lonapegsomatropin Ascendis Pharma is not to be used during pregnancy. This is because it is not known if it could harm your unborn child. If you are pregnant, think you may be pregnant or are planning to have a baby, talk to your doctor. If you become pregnant during treatment, tell your doctor immediately.
Breastfeeding
It is not known whether Lonapegsomatropin Ascendis Pharma can pass into breast milk. However, as lonapegsomatropin is not absorbed by mouth, it is unlikely to adversely affect the breastfed infant. If you are breast-feeding or intend to breast-feed, ask your doctor for advice before using Lonapegsomatropin Ascendis Pharma. Lonapegsomatropin Ascendis Pharma can be used during breastfeeding on strict indication.
Driving and using machines
Lonapegsomatropin Ascendis Pharma does not affect the ability to drive or to use machines.
3. How to use Lonapegsomatropin Ascendis Pharma
This medicine will only be prescribed by a doctor who has experience with growth hormone treatment and who has confirmed your diagnosis.
Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. Your doctor will show you how to use Lonapegsomatropin Ascendis Pharma.
Lonapegsomatropin Ascendis Pharma is given as an injection under the skin (subcutaneous injection). This means that it is injected with a short needle into fatty tissue under the skin of the abdomen, buttock or thigh. It is important to change the place where you have your injection every week to avoid damaging your skin. Your doctor or nurse will tell you the right dose and show you how to give the injection when you start treatment.
Recommended dose
Your doctor will work out your dose of Lonapegsomatropin Ascendis Pharma from your body weight in kilograms. Because lonapegsomatropin is converted into somatropin in the body, doses of Lonapegsomatropin Ascendis Pharma are described in terms of the amount of somatropin it produces. The recommended dose of Lonapegsomatropin Ascendis Pharma is 0.24 mg somatropin per kilogram of body weight, given once a week.
If changing from daily somatropin therapy to once-weekly Lonapegsomatropin Ascendis Pharma, your doctor will tell you to wait at least 8 hours between the final dose of once-daily somatropin and the first dose of Lonapegsomatropin Ascendis Pharma. The recommended dose may be reduced according to previous daily dose of somatropin.
When to use Lonapegsomatropin Ascendis Pharma
You need to inject Lonapegsomatropin Ascendis Pharma once a week, on the same day each week, at any time during the day.
If necessary, you can change the day of your weekly injection. Lonapegsomatropin Ascendis Pharma can be administered 2 days before or 2 days after the scheduled dosing day. There should be at least 5 days since your last injection, on the old day and the first dose on the new day. After selecting a new dosing day, continue giving yourself the injection on that day each week. Ask your doctor if you are not sure how to do this.
Preparation and administration
Read “Instructions for use” at the end of this leaflet before you start using this medicine.
Lonapegsomatropin Ascendis Pharma comes in a two-chamber cartridge containing both medicine (powder) and a solvent (liquid). It is to be used with the needles supplied. To give injections, you also need a GH Auto-Injector. The GH Auto-Injector is supplied separately.
The powder and solvent will be mixed together into a solution for injection by the GH Auto-Injector. After mixing, the solution is ready for use and the medicine can be injected under the skin using the GH Auto-Injector.
Read the instructions for use provided with the GH Auto-Injector.
If you or your child use more than you should
If you have injected more Lonapegsomatropin Ascendis Pharma than you should have, contact your doctor for advice. If you inject too much Lonapegsomatropin Ascendis Pharma, your blood sugar level may fall too low and later rise too high. Long-term overdose could cause irregular growth.
If you or your child forget to use Lonapegsomatropin Ascendis Pharma
If you miss your weekly dose and you are 1 or 2 days late: inject today, then on your usual day next week. If you are 3 days late or more: skip the missed dose and then resume injections on your next usual dosing day. Leave at least 5 clear days between injections.
If you or your child stop using Lonapegsomatropin Ascendis Pharma
Do not stop using Lonapegsomatropin Ascendis Pharma without talking to your doctor. If you stop taking Lonapegsomatropin Ascendis Pharma prematurely, your growth rate may decline, and your final height may be less than if you had completed the full course of treatment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common side effects (may affect more than 1 in 10 people)
- Headache
Common side effects (may affect up to 1 in 10 people)
- Low levels of the hormone thyroxine seen in blood tests (secondary hypothyroidism)
- Joint pain (arthralgia)
- Injection site reactions. The skin around the injection area can get uneven or lumpy, but this
should not happen if you inject in a different place each time.
Uncommon side effects (may affect up to 1 in 100 people)
- A decrease in the levels of the hormone cortisol seen in blood tests
- Stiffness of the joints (arthritis)
- An increased sideways curve of the spine (scoliosis)
- Growing pains
- Breast enlargement affecting males
Not known (frequency cannot be estimated from the available data)
Below side effects have been seen with other growth hormone-containing medicine.
- Leukaemia
- Type 2 diabetes mellitus
- Increased pressure of the fluid surrounding the brain (which causes symptoms such as strong headache, visual disturbances and vomiting)
- Numbness/tingling
- Muscle pain
- Swelling of the lower legs and feet and/or arms and hands
- Swelling of the face
- Rash
- Itching
- Hives
If any of the side effects gets severe, tell your doctor or pharmacist.
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 Lonapegsomatropin Ascendis Pharma
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 carton after EXP.
Store in a refrigerator (2°C – 8°C). Do not freeze. Store in the original package in order to protect from light.
Lonapegsomatropin Ascendis Pharma may be taken out of the refrigerator for a maximum period of 6 months and stored at temperatures up to 30°C. During these 6 months this medicine can be returned to refrigeration (2°C – 8°C). Record on the carton the date Lonapegsomatropin Ascendis Pharma is first removed from the refrigerator. Discard this medicine 6 months after the date this medicine was first stored outside the refrigerator.
The powder is white to off-white, and the solvent is a clear colourless solution.
The mixed solution is colourless and clear. The solution may occasionally contain air bubbles, these are okay. Do not use this medicine if you notice visible particles in the mixed solution.
Inject immediately after the powder and solvent has been mixed together by using the GH Auto-Injector. If you cannot use the mixed solution immediately, it should be used within 4 hours.
When you have finished with a cartridge with needle, you must dispose of it carefully in a suitable container.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicine you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Lonapegsomatropin Ascendis Pharma contains
The active substance is lonapegsomatropin.
Cartridges come in 9 different strengths:
Lonapegsomatropin Ascendis Pharma 3 mg powder and solvent for solution for injection (injection) in cartridge
Each two-chamber cartridge contains 3 mg of somatropin (equivalent to 8.6 mg of lonapegsomatropin [powder]) and 0.279 mL of solvent (liquid). After mixing the somatropin concentration is 11 mg/mL.
Lonapegsomatropin Ascendis Pharma 3.6 mg powder and solvent for solution for injection (injection) in cartridge
Each two-chamber cartridge contains 3.6 mg of somatropin (equivalent to 10.3 mg of lonapegsomatropin [powder]) and 0.329 mL of solvent (liquid). After mixing the somatropin concentration is 11 mg/mL.
Lonapegsomatropin Ascendis Pharma 4.3 mg powder and solvent for solution for injection (injection) in cartridge
Each two-chamber cartridge contains 4.3 mg of somatropin (equivalent to 12.3 mg of lonapegsomatropin [powder]) and 0.388 mL of solvent (liquid). After mixing the somatropin concentration is 11 mg/mL.
Lonapegsomatropin Ascendis Pharma 5.2 mg powder and solvent for solution for injection (injection) in cartridge
Each two-chamber cartridge contains 5.2 mg of somatropin (equivalent to 14.8 mg of lonapegsomatropin [powder]) and 0.464 mL of solvent (liquid). After mixing the somatropin concentration is 11 mg/mL.
Lonapegsomatropin Ascendis Pharma 6.3 mg powder and solvent for solution for injection (injection) in cartridge
Each two-chamber cartridge contains 6.3 mg of somatropin (equivalent to 18 mg of lonapegsomatropin [powder]) and 0.285 mL of solvent (liquid). After mixing the somatropin concentration is 22 mg/mL.
Lonapegsomatropin Ascendis Pharma 7.6 mg powder and solvent for solution for injection (injection) in cartridge
Each two-chamber cartridge contains 7.6 mg of somatropin (equivalent to 21.7 mg of lonapegsomatropin [powder]) and 0.338 mL of solvent (liquid). After mixing the somatropin concentration is 22 mg/mL.
Lonapegsomatropin Ascendis Pharma 9.1 mg powder and solvent for solution for injection (injection) in cartridge
Each two-chamber cartridge contains 9.1 mg of somatropin (equivalent to 25.9 mg of lonapegsomatropin [powder]) and 0.4 mL of solvent (liquid). After mixing the somatropin concentration is 22 mg/mL.
Lonapegsomatropin Ascendis Pharma 11 mg powder and solvent for solution for injection (injection) in cartridge
Each two-chamber cartridge contains 11 mg of somatropin (equivalent to 31.4 mg of lonapegsomatropin [powder]) and 0.479 mL of solvent (liquid). After mixing the somatropin concentration is 22 mg/mL.
Lonapegsomatropin Ascendis Pharma 13.3 mg powder and solvent for solution for injection (injection) in cartridge
Each two-chamber cartridge contains 13.3 mg of somatropin (equivalent to 37.9 mg of lonapegsomatropin [powder]) and 0.574 mL of solvent (liquid). After mixing the somatropin concentration is 22 mg/mL.
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– The other ingredients in this medicine (for all strengths) are:
Powder: succinic acid, trehalose dihydrate, trometamol
Solvent: water for injections
What Lonapegsomatropin Ascendis Pharma looks like and contents of the pack
Lonapegsomatropin Ascendis Pharma contains medicine as a powder together with a solvent to make a solution for injection, in a two-chamber cartridge, containing powder in one chamber and the solvent in the other.
The powder is white to off-white, and the solvent is a clear colourless solution. When the powder and solvent has been mixed together into a solution for injection, the solution is colourless and clear.
Each pack of Lonapegsomatropin Ascendis Pharma contains 4 single-use two-chamber cartridges packed in individual blisters and 6 disposable injection needles (two spare needles). Each cartridge has a specific label with assigned two-colour coding ribbons only for use by the GH Auto-Injector to select the correct mixing settings. Strength colours are indicated on the carton and blister foil and should be used to differentiate the individual strengths.
The strength colours on the carton and blister indicate the strength of your Lonapegsomatropin Ascendis Pharma medicine:
| Carton/blister strength colours | Strength | Cartridge two-colour label (bottom/top) |
| Light Apricot | 3 mg | Yellow/green |
| Cyan | 3.6 mg | Yellow/cyan |
| Dark grey | 4.3 mg | Yellow/pink |
| Yellow | 5.2 mg | Green/pink |
| Orange | 6.3 mg | Cyan/yellow |
| Dark purple | 7.6 mg | Cyan/pink |
| Carton/blister strength colours | Strength | Cartridge two-colour label (bottom/top) |
| Golden brown | 9.1 mg | Pink/yellow |
| Dark blue | 11 mg | Pink/green |
| Dark red | 13.3 mg | Pink/cyan |
Lonapegsomatropin Ascendis Pharma is designed for use with the injection needles supplied and the GH Auto-Injector. The GH Auto-Injector is not included in this pack and is supplied separately. The instructions for use for the GH Auto-Injector comes with your GH Auto-Injector box.
Marketing Authorisation Holder
Ascendis Pharma Endocrinology Division A/S
Tuborg Boulevard 12
DK-2900 Hellerup
Denmark
Manufacturer
Ascendis Pharma A/S
Tuborg Boulevard 12
DK-2900 Hellerup
Denmark
This leaflet was last revised in
Detailed information on this medicine is available on the European Medicines Agency web site:
Instructions for use
This guide is designed to help you prepare, mix, and inject your Lonapegsomatropin Ascendis Pharma medicine.
These instructions are divided into 5 stages
Getting to know the parts of your or your child’s medicine
Preparing your or your child’s medicine
Mixing your or your child’s medicine
Injecting your or your child’s medicine
After injecting your or your child’s medicine
If you or your child need help at any time, contact your doctor, pharmacist or nurse.
What you need to know before getting started
- Always read the package leaflet before use.
- Always wash and dry your hands.
- A new cartridge should be used for every injection.
- A new needle must be used for every injection. Do not re-use needle.
- Do not use this medicine beyond the expiry date printed after ‘EXP’ on the outer carton and on
the cartridge pack or 6 months after the date it was first removed from refrigeration (whichever is earlier).
- Do not use this medicine if you notice that it contains visible particles.
- The cartridge and needle are for single-use and designed for use only with the GH Auto-Injector
[hereafter referenced as the auto-injector].
Getting to know the parts of your or your child’s Lonapegsomatropin Ascendis Pharma medicine
Lonapegsomatropin Ascendis Pharma is a powder and solvent for solution for injection in a cartridge. Each package contains 4 single-use cartridges and 6 disposable injection needles. Your cartridge contains medicine powder and solvent to mix the powder with.
Two-chamber cartridge
To give injections, you also need the GH Auto-Injector. This is not included in the
Lonapegsomatropin Ascendis Pharma package but comes in a separate box. Read also the instructions
for use provided with the GH Auto-Injector. _____________________________________________________
Preparing your or your child’s medicine
If you keep your medicine in a refrigerator, take it out 15 minutes before use.
1. Check and assemble cartridge and needle
on the cartridge pack.
‘EXP’ has passed. | en^me 3mg : Expiry date Strength | ||
STOP sign. This will ensure that the orange plug remains in the cartridge pack. In order to secure the cartridge stopper position during transportation an orange plug is affixed to the cartridge in the blister.
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cartridge, remove the orange plug by pulling it straight off and throw it away. | r | ||
paper is not fully sealed or if it is broken, do not use.
| |||
| | Do not remove the plastic needle cover. |
| 2. | Turn on the auto-injector | |||
| | Press and release the green button to turn on the auto-injector. You will hear 2 loud beeps ® , the battery icon lights up and green top will start flashing. | E il I… | ........> |
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3. Insert cartridge
| | Insert cartridge into flashing green top. | |
| | Click cartridge into place. The green top will stop flashing, the green mixing icon will light up and the battery icon will switch off. | k / ♦ U G\'c^ <- Q |
remove finger from cartridge. | r a |
Mixing your or your child’s medicine
4. Wait while mixing
| | Wait 4 to 8 minutes for the auto-injector to mix your medicine. | Wait 4 to 8 minutes – | |
| | Watch the progress bar gradually light | I |
|
| up. | | ||
5. Turn the auto-injector up and down
Turn the auto-injector up and down. A tick sound confirms you are turning correctly.
Turn 5 to 10 times until you hear 2 loud beeps and the progress bar, except the top element, lights up.
6. Finish mixing
| | Keep the auto-injector upright until you hear 2 loud beeps and the entire progress bar lights up. | ■0 |
(Green eye icon <2> will light up) | i | |
Injecting your or your child’s medicine
7. Check mixed solution
| | Solution is OK if it is colourless and clear (some air bubbles are OK). | |
| | Do not use solution if it has visible | |
| particles. If visible particles press the |
| |
| green button for 3 seconds and remove | ||
| cartridge. | J u' ok x |
| | Wash and dry your hands. | |
| | Clean injection site with alcohol wipe. | |
| | Do not inject through clothes. |
9. Inject medicine
site for 10 to 15 seconds until you hear 2 loud beeps. (Green top will flash twice and the green check mark icon will light up). | J |
wait until you hear 2 loud beeps. (Green top will start flashing). |
11 t J |
After injecting your or your child’s medicine
10. Remove cartridge
| | Press needle cover into flashing green top. | ||
| | Press needle cover down to release cartridge. | w | i / |
| * ■ | 'oV\c^ | ||
| I | ' \ | ||
| in | |||
| | Remove used cartridge. |
| |
| 7 | |||
11. Dispose cartridge and needle
use the auto-injector if there is medicine left in the cartridge after injection.
needle as instructed by your pharmacist.
household waste. | r |
| Does your weekly dose require 2 cartridges?
| |
12. Store the auto-injector
| |
| room temperature ready for use next time. | I |
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