Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - skytrofa

Document Subject

Generated Narrative: MedicinalProductDefinition mp274e38fd037e90bae4b20ed78bb2e359

identifier: http://ema.europa.eu/identifier/EU/1/21/1607/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Skytrofa 3 mg powder and solvent for solution for injection in cartridge

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

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part: nan

type: Strength part

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-274e38fd037e90bae4b20ed78bb2e359

identifier: http://ema.europa.eu/identifier/EU/1/21/1607/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - skytrofa

Attesters

What is in this leaflet

1. What Skytrofa is and what it is used for
2. What you or your child need to know before you or your child use Skytrofa
3. How to use Skytrofa
4. Possible side effects
5. How to store Skytrofa
6. Contents of the pack and other information

Skytrofa 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.

Skytrofa 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, Skytrofa is slowly converted into somatropin, supplying the missing growth hormone.

Do not use Skytrofa

• 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 Skytrofa

• 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 Skytrofa. 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 signs and symptoms of a sudden serious allergic reaction (e.g. breathing difficulty, swelling of your face, mouth, or tongue, fast heartbeat, hives, rash, fever), you should promptly seek medical attention.
• If you have Prader-Willi syndrome, you should not be treated with Skytrofa unless you also have GHD. Skytrofa 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 Skytrofa may need to be higher. If you or your child stop using oral oestrogen, your dose of Skytrofa may need to be reduced.

Other medicines and Skytrofa
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 Skytrofa.

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 Skytrofa unless you are also using reliable contraception. There are no data from the use of Skytrofa in pregnant women. Skytrofa 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 Skytrofa 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 Skytrofa. Skytrofa can be used during breastfeeding on strict indication.

Driving and using machines Skytrofa does not affect the ability to drive or to use machines.

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 Skytrofa.

Skytrofa 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 Skytrofa from your body weight in kilograms. Because lonapegsomatropin is converted into somatropin in the body, doses of Skytrofa are described in terms of the amount of somatropin it produces. The recommended dose of Skytrofa is 0.24 mg somatropin per kilogram of body weight, given once a week.

If changing from daily somatropin therapy to once-weekly Skytrofa, your doctor will tell you to wait at least 8 hours between the final dose of once-daily somatropin and the first dose of Skytrofa. The recommended dose may be reduced according to previous daily dose of somatropin.

When to use Skytrofa
You need to inject Skytrofa 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. Skytrofa 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.

Skytrofa 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 Skytrofa Auto-Injector. The Skytrofa Auto-Injector is supplied separately.

The powder and solvent will be mixed together into a solution for injection by the Skytrofa Auto-Injector. After mixing, the solution is ready for use and the medicine can be injected under the skin using the Skytrofa Auto-Injector.

Read the instructions for use provided with the Skytrofa Auto-Injector.

If you or your child use more than you should If you have injected more Skytrofa than you should have, contact your doctor for advice. If you inject too much Skytrofa, 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 Skytrofa
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 Skytrofa
Do not stop using Skytrofa without talking to your doctor. If you stop taking Skytrofa 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.

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)

• Sudden serious allergic reactions, including angioedema (rapid swelling of the mucous membranes or the skin that may occur in the face, mouth, tongue, abdomen, or arms and legs)

• 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 in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

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.

Skytrofa 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 Skytrofa 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 Skytrofa 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.

What Skytrofa contains

The active substance is lonapegsomatropin. Cartridges come in 9 different strengths:

Skytrofa 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.

Skytrofa 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.

Skytrofa 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.

Skytrofa 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.

Skytrofa 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.

Skytrofa 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.

Skytrofa 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.

Skytrofa 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.

Skytrofa 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.

• The other ingredients in this medicine (for all strengths) are:

Powder: succinic acid, trehalose dihydrate, trometamol

Solvent: water for injections

What Skytrofa looks like and contents of the pack

Skytrofa 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 Skytrofa 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 Skytrofa 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 Skytrofa 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 Golden brown 9.1 mg Pink/yellow Dark blue 11 mg Pink/green Dark red 13.3 mg
Pink/cyan

Skytrofa is designed for use with the injection needles supplied and the Skytrofa Auto-Injector. The Skytrofa Auto-Injector is not included in this pack and is supplied separately. The instructions for use for the Skytrofa Auto-Injector comes with your Skytrofa Auto-Injector box.

Marketing Authorisation Holder

Ascendis Pharma Endocrinology Division A/S Tuborg Boulevard DK-2900 Hellerup Denmark

Manufacturer Ascendis Pharma A/S Tuborg Boulevard DK-2900 Hellerup Denmark

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: