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Ngenla 60 mg solution for injection in Pre-filled pen – patient leaflet, side effects, dosage

Updated:
Key facts
Status:
Prescription only (POM) Controlled drug (Schedule 4) ▼ Additional monitoring
Medicine strength:
60 mg (50 mg/ml)
Contains active substance:

Patient leaflet - Ngenla 60 mg solution for injection in Pre-filled pen

1. What Ngenla is and what it is used for

Ngenla contains the active substance somatrogon, a modified form of human growth hormone. Natural human growth hormone is needed for bones and muscles to grow. It also helps your fat and muscle tissues to develop in the right amounts. Ngenla is used to treat children and adolescents from 3 years of age who do not have enough growth hormone and are not growing at the normal rate. The active substance in Ngenla is made by ‘recombinant DNA technology’. This means that it is grown in cells that have been modified in the laboratory so that they can produce it.

2. What you need to know before you use Ngenla

Do not use Ngenla

  • If you or the child in your care are allergic to somatrogon (see Warnings and precautions) or any of the other ingredients of this medicine

    (listed in section 6).

  • If you or the child in your care have an active tumour (cancer). Tell your doctor if you or the child in your care have or have had an active

    tumour. Tumours must be inactive, and you or the child in your care must have finished your anti-tumour treatment before starting treatment with Ngenla.

  • If you or the child in your care have stopped growing because of closure of the growth plates (closed epiphyses) meaning that you or the

    child in your care have been told by your doctor that your bones have stopped growing.

  • If you or the child in your care are seriously ill (for example, complications following open heart surgery, abdominal surgery, acute

    respiratory failure, multiple accidental trauma or similar conditions). If you or the child in your care are about to have, or have had, a major operation, or go into hospital for any reason, tell your doctor and remind the other doctors you are seeing that you use growth hormone. Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Ngenla:

  • If you or the child in your care develop a serious allergic reaction, stop using Ngenla, talk to your doctor right away. Sometimes serious

    allergic reactions such as hypersensitivity, including anaphylaxis or angioedema (difficulties breathing or swallowing, or swelling of the face, lips, throat or tongue) have occurred. If you or the child in your care have any of the following symptoms of a serious allergic reaction:

    • breathing problems
    • swelling of your face, mouth, and tongue
    • hives (nettle rash, lumps rising under the skin)
    • rash
    • fever
  • If you or the child in your care have replacement therapy with corticosteroid medicines (glucocorticoids) you or the child in your care

    should consult your doctor regularly as you or the child in your care may need adjustment of your glucocorticoid dose.

  • Your doctor should check at intervals how well the thyroid gland is working in you or the child in your care and if necessary may prescribe

    treatment or adjust the dose of existing treatment as this may be needed for Ngenla to work properly.

  • If you or the child in your care have Prader-Willi syndrome, you or the child should not be treated with Ngenla unless you or the child in

    your care has growth hormone deficiency.

  • Your doctor should monitor you or the child in your care for high blood sugar levels (hyperglycaemia) during treatment with Ngenla. If

    you or the child in your care are treated with insulin or other diabetes medicines, your doctor may need to adjust the insulin dose. If you or the child in your care have diabetes and associated severe/worsening eye disease you or the child in your care should not be treated with Ngenla.

  • If you or the child in your care have ever had any kind of tumour (cancer).
  • If you or the child in your care experience changes in vision, severe or frequent headaches, associated with feeling sick (nausea),

    vomiting, or experience lack of muscle control or coordination of voluntary movements, such as walking or picking up objects, difficulty with speech, eye movement or swallowing, especially at the start of treatment, tell your doctor immediately. These could be signs of a temporary increase in pressure within the brain (intracranial hypertension).

  • If you or the child in your care are seriously ill (for example, complications following open heart surgery, abdominal surgery, acute

    respiratory failure, multiple accidental trauma or similar conditions). If you or the child in your care are about to have, or have had, a major operation, or go into hospital for any reason, tell your doctor and remind the other doctors you are seeing that you or the child in your care use growth hormone.

  • If you or the child in your care develop a severe stomach ache during treatment with Ngenla as this could be a symptom of inflammation

    of the pancreas.

  • If you or the child in your care notice a sideways curvature in your spine (scoliosis), you or the child in your care will need to be checked

    often by your doctor.

  • If during growing you or the child in your care develop a limp or hip or knee pain, you or the child in your care should consult your doctor

    right away. These could be symptoms of bone disorders in your hip as this may happen during periods of rapid growth.

  • If you or the child in your care are taking or stop taking oral contraception or hormonal replacement therapy with oestrogen, your doctor

    may recommend the dose of Ngenla to be adjusted.

Other medicines and Ngenla

Tell your doctor, pharmacist or nurse if you or the child in your care are using, have recently used or might use any other medicines.

  • If you or the child in your care take replacement therapy with corticosteroid medicines (glucocorticoids), as these may reduce the

    effect of Ngenla on growth. You or the child in your care should consult your doctor regularly, as you or the child in your care may need adjustment of your glucocorticoid dose.

  • If you or the child in your care are treated with insulin or other diabetes medicines, you should consult with your doctor as you or your

    doctor may need to adjust the dose.

  • If you or the child in your care are receiving treatment with thyroid hormones, your doctor may need to adjust the dose.
  • If you or the child in your care are receiving oestrogen taken orally, you should consult your doctor as you or the child may need to adjust

    your dose of Ngenla.

  • If you or the child in your care are receiving ciclosporin (a medicine that weakens the immune system after transplantation), you should

    consult your doctor as your doctor may need to adjust the dose.

    • If you or the child in your care are receiving medicines to control epilepsy (anticonvulsants), you should consult your doctor as your doctor

      may need to adjust the dose.

Pregnancy and breast-feeding

If you or the child in your care are pregnant or breast-feeding, think you or the child in your care may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Ngenla has not been tested in pregnant women and it is not known if this medicine can harm your unborn baby. It is therefore preferable to avoid Ngenla during pregnancy. If you are able to get pregnant, you should not use Ngenla unless you are also using reliable contraception. It is not known whether somatrogon can pass into breast milk. Tell your doctor or the doctor of the child in your care, if you or the child in your care are breast-feeding or plan to do so. Your doctor will then help you or the child in your care decide whether to stop breast-feeding, or whether to stop taking Ngenla, considering the benefit of breast-feeding to the baby and the benefit of Ngenla to you or the child in your care.

Driving and using machines

Ngenla does not affect the ability to drive and use machines.

Ngenla contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

Ngenla contains metacresol

Ngenla contains a preservative called metacresol. In very rare cases the presence of metacresol can cause inflammation (swelling) in muscles. If you or the child in your care experience muscle pain or pain at the injection site, inform your doctor.

3. How to use Ngenla

This medicine will only be prescribed by a doctor who has experience with growth hormone treatment and who has confirmed your diagnosis or that of the child in your care.

Always use this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure. The dose of Ngenla to be injected will be decided by your doctor.

How much to use

Your doctor will work out your dose of Ngenla from your body weight in kilograms. The recommended dose is 0.66 mg per kg body weight and is given once weekly. If you or the child in your care have been previously treated with daily growth hormone injections, your doctor will tell you to wait before taking the first dose of Ngenla until the day after your last daily injection and then continue with Ngenla once each week.

Do not change your dose unless your doctor has told you to.

How Ngenla is given

  • Ngenla is available as a pre-filled pen in 2 different sizes (Ngenla 24 mg and Ngenla 60 mg). Based on the recommended dose your

    doctor or the doctor of the child in your care will prescribe the most appropriate pen size (see section 6 “Contents of the pack and other information”).

  • Before you or the child in your care use the pen for the first time, your/their doctor or nurse will show you how to use it. Ngenla is given as

    an injection under the skin (subcutaneous injection) using a pre-filled pen. Do not inject it into a vein or muscle.

  • The best place to give Ngenla is in the abdomen (belly), thighs, buttocks or upper arms. Injections to the upper arms and buttocks should

    be given by the caregiver.

  • Fatty tissue below the skin can shrink at the site of injection (see section 4). To avoid this, use a different injection site each time.
  • If more than one injection is required to deliver a complete dose, each should be administered at a different injection site. Detailed instructions for use of the pre-filled pen are at the end of this leaflet.

When to use Ngenla

You or the child in your care should use this medicine once a week on the same day each week.

You or the child in your care should record which day of the week you use Ngenla to help you or the child in your care remember to inject this medicine once a week.

If necessary you or the child in your care can change the day of your/their weekly injection as long as it has been at least 3 days since you or the child in your care had your/their last injection. After selecting a new dosing day, continue giving yourself or the child in your care the injection on that day each week.

If you use more Ngenla than you should

If you or the child in your care have injected more Ngenla than you should have been given, contact your doctor straight away as your/their blood sugar levels may need to be checked.

If you forget to use Ngenla

If you or the child in your care forgot to inject a dose and:

  • It is 3 days or less since you or the child in your care should have used Ngenla, use it as soon as you remember. Then inject your/their next

    dose on your/their usual injection day.

  • It is more than 3 days since you or the child in your care should have used Ngenla, skip the missed dose. Then inject your/their next dose

    as usual on your/their next scheduled day. A regular dosing day should be maintained.

Do not use a double dose to make up for a forgotten dose.

If you stop using Ngenla

Do not stop using this medicine without talking to your doctor.

If you have any further questions on 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.

Very common: may affect more than 1 in 10 people

  • Headache
  • Bleeding, inflammation, itching, pain, redness, soreness, stinging, tenderness, or warmth at the injection site (injection site reactions)
  • Fever (pyrexia)

Common: may affect up to 1 in 10 people

  • Decrease in the number of red blood cells in the blood (anaemia)
  • Increase in the number of eosinophils in the blood (eosinophilia)
  • Decrease in the blood level of thyroid hormone (hypothyroidism)
  • Allergic inflammation of the conjunctiva, the clear layer over the outside of the eye (allergic conjunctivitis)
  • Joint pain (arthralgia)
  • Pain in arms or legs

Uncommon: may affect up to 1 in 100 people

  • The adrenal glands do not make enough steroid hormones (adrenal insufficiency)
  • Rash

Not known: frequency cannot be estimated from the available data

  • Localised loss of fat below the skin (lipoatrophy)
  • Problems with hip joint which may cause hip or knee pain or limp (epiphysiolysis, including slipped capital femoral epiphysis) Other possible side effects not seen with Ngenla but which have been reported in other growth hormone medicines treatment may include the following:
  • Tissue growth (non cancerous or cancer)
  • Type 2 diabetes
  • Increased intracranial pressure (which causes symptoms such as strong headache, visual disturbances or vomiting)
  • Numbness or tingling
  • Joint or muscle pain
  • Breast enlargement in boys and men
  • Skin rash, reddening and itching
  • Water retention (which shows as puffy fingers or swollen ankles)
  • Facial swelling
  • Pancreatitis (which causes symptoms of stomach pain, nausea, vomiting or diarrhoea)

    In very rare cases the presence of metacresol can cause inflammation (swelling) in muscles. If you or the child in your care experience muscle pain or pain at the injection site, inform your doctor.

    Reporting of side effects

    If you or the child in your care 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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Ngenla

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 pen label and on the carton after ‘EXP’. The expiry date refers to the last day of that month.

The pre-filled pen should not be used more than 28 days after first use.

Before first use of Ngenla

  • Store in a refrigerator (2 °C - 8 °C).
  • Keep Ngenla in the outer carton in order to protect from light.
  • Remove Ngenla from the refrigerator prior to use. Ngenla may be held at room temperature (up to 32 °C) for up to 4 hours.
  • Do not use this medicine if you notice that the solution is cloudy or dark yellow. Do not use the medicine if it has flakes or particles.
  • Do not shake the pen. Shaking can damage the medicine.

After first use of Ngenla

  • Use within 28 days after first use. Store in a refrigerator (2 °C - 8 °C). Do not freeze.
  • Keep Ngenla with the pen cap on in order to protect from light.
  • Do not store the pre-filled pen with a needle attached.
  • Discard the pen after last dose, even if it contains unused medicine.
  • Ngenla may be held at room temperature (up to 32 °C) for up to 4 hours with each injection for a maximum of 5 times. Return Ngenla to the refrigerator again after each use.
  • Do not leave at room temperature for more than 4 hours with each use.
  • Do not put the pen anywhere that the temperature goes above 32 °C.
  • If it has been more than 28 days after first use of your pen, get rid of it even if it contains unused medicine. If your pen or the pen of the child in your care has been exposed to temperatures higher than 32 °C, or has been removed from the refrigerator for more than 4 hours with each use or if it has been used a total of 5 times, get rid of it even if it contains unused medicine.

To help you remember when to dispose of your pen you can write the date of first use on the pen label.

A small amount of medicine may remain in the pen after all doses have been correctly given. Do not try to use any remaining medicine. After the last dose is given, the pen must be properly thrown away.

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.

6. Contents of the pack and other information

What Ngenla contains

  • The active substance is somatrogon.

Ngenla 24 mg solution for injection in pre-filled pen

One mL of solution contains 20 mg of somatrogon.

Each pre-filled pen contains 24 mg somatrogon in 1.2 mL of solution. Each pre-filled pen delivers doses from 0.2 mg to 12 mg in a single injection in 0.2 mg increments.

Ngenla 60 mg solution for injection in pre-filled pen

One mL of solution contains 50 mg of somatrogon.

Each pre-filled pen contains 60 mg somatrogon in 1.2 mL solution. Each pre-filled pen delivers doses from 0.5 mg to 30 mg in a single injection in 0.5 mg increments.

  • The other ingredients are: trisodium citrate dihydrate, citric acid monohydrate, L-Histidine, sodium chloride (see section 2 “Ngenla contains sodium”), poloxamer 188, m-Cresol, water for injections.

What Ngenla looks like and contents of the pack

Ngenla is a clear and colourless to slightly light yellow solution for injection (injection) in a pre-filled pen. Ngenla 24 mg solution for injection is available in a pack size containing 1 pre-filled pen. The pen cap, dose button, and label on the pen are coloured lilac.

Ngenla 60 mg solution for injection is available in a pack size containing 1 pre-filled pen. The pen cap, dose button, and label on the pen are coloured blue.

Marketing Authorisation Holder

Pfizer Limited,

Ramsgate Road,

Sandwich,

Kent CT13 9NJ,

United Kingdom

Manufacturer

Pfizer Manufacturing Belgium NV

Rijksweg 12

2870 Puurs-Sint-Amands

Belgium

For any information about this medicine, please contact:

Medical Information, Pfizer Ltd, Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS.

Telephone 01304 616161.

This leaflet was last revised in 06/2026

Ref: NL 6_0

PAA247570

232

PUURS Time:

PAR Number

ITF / DM

Source Code

Market Layout

Description

11:03

22 Apr 2026

PAA247570 02 N/A

10 pt

PAR-2026-1000912

N/A

N/A

N/A

T_I145/D_01_1

840 x 450 mm

PUURS

Cyan

Magenta

Yellow

UNITED KINGDOM

A C

30.0

29.0

21.0

22.0

Sterile needle Needle Protective

paper

Inner needle cap

Outer needle

cover

Sterile needle (example) not supplied:

Injection for subcutaneous (under the skin) use only Keep this leaflet. These instructions show step-by-step

directions on how to prepare and give a Ngenla

injection.

Ngenla 60 mg Pen

Instructions for use

Important information about your Ngenla pen

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Ngenla for injection is a multi-dose pre-filled pen containing 60 mg of medicine.

Ngenla for injection can be given by a patient, caregiver, doctor, nurse or pharmacist. Do not try to inject Ngenla yourself until you are shown the right way to give the injections and read and understand the Instructions for Use. If your doctor, nurse or pharmacist decides that you or a caregiver may be able to give your injections of Ngenla at home, you should receive training on the right way to prepare and inject Ngenla. It is important that you read, understand, and follow these instructions so that you inject Ngenla the right way.

It is important to talk to your doctor, nurse or pharmacist to be sure you understand your Ngenla dosing instructions. To help you remember when to inject Ngenla, you can mark your calendar ahead of time. Call your doctor, nurse or pharmacist if you or your caregiver have any questions about the right way to inject Ngenla. Each turn (click) of the dose knob increases the dose by 0.5 mg of medicine. You can give from 0.5 mg to 30 mg in a single injection. If your dose is more than 30 mg, you will need to give more than 1 injection. Each injection should be given at a different injection site. A small amount of the medicine may remain in the pen after all doses have been correctly given. This is normal. Patients should not try to use the remaining solution but get rid of the pen in the correct way.

Do not share your pen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.

Always use a new sterile needle for each injection. This will reduce the risk of contamination, infection, leakage of medicine, and blocked needles leading to the wrong dose.

Do not shake your pen. Shaking can damage the medicine. The pen is not recommended for use by the blind or visually impaired without the assistance of a person trained in the proper use of the product.

Supplies you will need each time you inject Included in the carton:

  • 1 Ngenla 60 mg pen.

Not included in the carton:

  • 1 new sterile needle for each injection.

    Alcohol swabs.

    Cotton balls or gauze pads.

    Adhesive bandage.

    A suitable sharps disposal container for disposal of pen needles and pens.

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Needles to use

Pen needles are not included with your Ngenla pen. You can use pen needles from 4 mm to 8 mm and between 30G and 32G.

32G (Novo Nordisk®, NovoFine® Plus)

31G (Novo Nordisk®, NovoFine®)

31G (Becton, Dickinson and Company, BD Ultra-Fine™ or BD Micro-Fine™)

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30G (Becton, Dickinson and Company, AutoShield Duo™) 30G (Novo Nordisk®, NovoFine® AutoCover®)

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Caution: Never use a bent or damaged needle. Always handle pen needles with care to make sure you do not prick yourself (or anyone else) with the needle. Do not attach a new needle to your pen until you are ready for your injection.

Note: Needles with safety shield do not have an inner needle cap. Steps 5, 6 and 11 within these instructions relating to the inner needle cap may not apply when using a needle with safety shield. Refer to the needle manufacturer’s instructions for use for more information.

  • New pen set up is done

    before each new pen is used

    for the first time.

  • The purpose of setting up a

    new pen is to remove air

    bubbles and make sure you

    get the correct dose.

    Important: Skip Step-A

    through to Step-C if you have

    already set up your pen.

    • Hold the pen with the needle

      pointing up so that the air bubbles can rise.

    • Tap the cartridge holder gently to

      float any air bubbles to the top. Important: Follow Step-B even if you do not see air bubbles. ● Turn the dose knob to1.0.

Note: If you turn the dose knob

too far, you can turn it back.

  • Press the injection button until it cannot go any further and “0” is

    shown in the dose window.

  • Check for liquid at the needle tip. If liquid appears, your pen is set up. ● Always make sure that adrop of liquid appears before you inject.

    If liquid has not appeared, repeat Step-A through to Step-C.

    • If liquid does not appear after you have repeated Step-A through

      Step-C five (5) times, attach a new needle and try one (1) more time. Do not use the pen if a drop of liquid still does not appear. Contact your doctor, nurse or pharmacist, and use a new pen.

      • Turn the dose knob to set your dose.

        • The dose can be increased or decreased by turning the dose knob in either direction.
        • The dose knob turns 0.5 mg at a time.
        • Your pen contains 60 mg of medicine but you can only set adose of up to 30 mg for a single injection.
        • The dose window shows the dose in mg. See Examples A and B. ● Always check the dose window to make sure you have set the correct dose.

Important: Do not press the injection button while setting your dose.

What should I do if I cannot set the dose Ineed?

  • If your dose is more than 30 mg you will need more than 1 injection.
  • You can give from 0.5 mg to 30 mg in asingle injection.

    • If you need help dividing up your dose the right way, ask your doctor, nurse or pharmacist.
    • Use anew needle for each injection (See Step 4:

      Attach needle).

    • If you normally need to give 2injections for your full dose, be sure to give your second dose.

What should Ido if Ido not have enough medicine left in my pen?

  • If your pen contains less than 30 mg of medicine, the dose knob will stop with the remaining amount of medicine shown in the dose window.
  • If there is not enough medicine left in your pen for your full dose, you may either:

    • inject the amount left in your pen, then prepare a new pen to complete your dose in full.

      Remember to subtract the dose you have already received. For example, if the dose is 21.5 mg and you can only set the dose knob to 17 mg, you should inject another 4.5 mg with anew pen.

    • or get anew pen and inject the full dose.
  • Hold your pen so you can see the

    numbers in the dose window.

  • Insert the needle straight into

    your skin.

  • Keepholding theneedle in thesameposition in your skin.
  • Press the injection button until it cannot go any

    further and “0” is shown in the dose window.

  • Continue to press the injection button while

    counting to 10. Counting to 10 will allow the full

    dose of medicine to be given.

  • After counting to 10, let go of the injection button

    and slowly remove the pen from the injection site by

    pulling the needle straight out.

    Note: You may see a drop of medicine at the needle

    tip. This is normal and does not affect the dose you

    just received.

  • Carefully place the outer needle cover back on

    the needle.

    Press on the outer needle cover until it is

    secure.

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Caution: Never try to put the inner needle cap

back on the needle. You may prick yourself

with the needle.

Note: If using needle with safety shield, refer to

manufacturer’s instructions for use.

  • Unscrew the needle from the pen.

    Gently pull until the needle comes off.

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Note: If the needle is still on, replace the outer

needle cover and try again. Be sure to apply pressure

when unscrewing the needle.

  • Dispose of your used pen needles in a sharps container as

    instructed by your doctor, nurse or pharmacist and in

    accordance with local health and safety laws. Keep the sharps

    container out of the reach of children. Do not reuse needles.

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    • If there is any medicine left in your pen, store in the refrigerator between uses. (See section 5 “How to store Ngenla” of the Ngenla 60 mg pre-filled pen Package Leaflet).

      • Press lightly on the injection site with aclean cotton ball or gauze pad, and hold for afew seconds.
      • Do not rub the injection site. You may have slight bleeding. This is normal.
      • You may cover the injection site with asmall adhesive bandage, if needed.
      • If your pen is empty or it has been more than 28 days after first use, throw it away even if it contains unused medicine. Throw away your pen in the sharps container.

        To help you remember when to dispose of your pen you can write the date of first use on the pen label and below:

You must set up each new pen (priming) before using it for the first time New pen set up (priming) – for the first use of a new pen only

Set knob to 1.0 Tap cartridge holder Press button and check for liquid Set your dose

Setting your prescribed dose

Step

7

Step

8

Step

9

Step

10 11 13 14

Step Step Step Injecting your dose

Insert the needle Attach outer needle cover After your injection

Inject your medicine Count to 10 Replace the pen cap

Count to

10

Example B:

Example A:

21.5 mg shown in the dose window

30.0 mg shown in the dose window

  • Wash and dry your hands.
  • You can use your pen straight from the refrigerator. For a more comfortable injection, leave your pen at room temperature for up to 30 minutes. (See section 5 “How to store Ngenla” of the Ngenla 60 mg pre-filled pen Package Leaflet).

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Check the name, strength, and label of your pen to make sure it is the medicine your doctor has prescribed for you. Check the expiry date on the pen label. Do not use if the expiry date has passed.

Do not

  • Do not remove the pen cap from your pen - until you

    are ready to inject.

    use your pen if:

    • it has been frozen or exposed to heat (above 32 °C) or it has been more than 28 days after first use of the pen. (See section 5 “How to store Ngenla” of the Ngenla 60 mg pre-filled pen Package Leaflet).
    • it has been dropped
    • it looks broken or damaged

      • Ngenla can be given in the abdomen (belly), thighs, buttocks,

        or upper arms.

      • Choose the best place to inject, as recommended by your doctor,

        nurse or pharmacist. Choose a different injection site for each injection.

      • If more than 1 injection is needed to complete your full dose, each

        injection should be given in a different injection site.

      • Do not inject into bony areas, areas that are bruised, red, sore or hard,

        and areas that have scars or skin conditions.

      • Clean the injection site with an alcohol swab.
      • Allow the injection site to dry.
      • Do not touch injection site after cleaning.

        ●

        • Check the medicine inside the cartridge holder.

          Pull off the pen cap and keep it for after your injection.

          Make sure the medicine is free of flakes or particles.

        • Make sure the medicine is clear and colourless to slightly

          light yellow. Do not inject the medicine if it is cloudy or dark yellow.

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Do not inject the medicine if it has flakes or particles.

Note: It is normal to see one or more bubbles in

the medicine.

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  • Line the needle up with your pen keeping them both straight.

    Take a new needle and pull off the protective paper.

  • Gently push and then screw the needle onto your pen.

    Do not over tighten.

    Note: Be careful not to attach the needle at an angle. This may cause the pen to leak.

    Caution: Needles havesharptips at bothends. Handle withcare to makesure you donot prick yourself(or anyone else) with the needle.

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    • Make sure you keep the outer needle cover.

      You will need it later to remove the needle.

      Note: You should see an inner needle cap

      after you have removed the outer cover. If you

      do not see this, try to attach the needle again.

      Note: If using needle with safety shield, refer

      to the manufacturer’s instructions for use.

      Pull off the outer needle cover. ● Pull off the inner needle cap carefully to show the needle.

      • Throw away the inner needle cap in a sharps container. It is not needed again.

        Note: If using needle with safety shield, refer to the manufacturer’s instructions for use.

        Is this pen new?

        Yes:

        Go to new pen set up

        No

Preparing for your injection

Step

1 Getting ready Step

3 Check medicine Step

5 Pull off outer needle cover Step

6 Pull off inner needle cap Step

2 Choose and clean your injection site

Abdomen sites :

Keep at least 5 cm awayfrombellybutton

Buttocks:

Caregiver administration only

Thighs (front upper) Arms (rear upper):

Caregiver administration only

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Step- Step- Step-

B

Replace the pen cap back onto your pen. Do not recap the pen with a needle attached. 12

Step Remove the needle

Pen cap Cartridge holder

Needle attachment

Medicine

Injection button

Dose knob Dose window Expiration date (EXP.) Ngenla 60 mg pen:

Step

4 Attach needle

Date of first use ______ / ______ / ______

The following needles have been shown to be compatible with your Ngenla pen:

The following needles with safety shield have been shown to be compatible with your Ngenla pen:

Talk with your doctor, nurse or pharmacist about the right needle for you.

PAA247570

About this document

Source: MHRA - Medicines and Healthcare products Regulatory Agency (products.mhra.gov.uk) · Marketing authorisation: PLGB 00057/1713

Last revision stated in the text: June 2026 · MHRA data as of 13 October 2026

What the sections and the side effect frequencies mean: How to read a patient leaflet

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The information on this site does not replace the advice of a doctor or pharmacist.

Facts about Ngenla 60 mg solution for injection in Pre-filled pen

What these facts mean

Prescription needed?? Yes, prescription-only medicine (POM)
Controlled drug?
Yes, Schedule 4 of the Misuse of Drugs Regulations?
  • Controlled drugs are medicines that UK law controls more strictly because they can be misused or cause dependence. The Misuse of Drugs Regulations 2001 divide them into 5 schedules: schedule 1 has the strictest rules and schedule 5 the least strict.
  • Schedule 4 has lighter rules. Its part II covers anabolic steroids and hormones such as growth hormone.
  • A prescription is valid for 28 days and usually covers up to 30 days of treatment.
  • Travelling abroad: carry it in your hand luggage, take your prescription or a letter from your doctor to show it is yours, and check the rules of the country you are going to with its embassy before you travel (GOV.UK).
Active substance? Somatrogon
Strength? 60 mg (50 mg/ml)
Pharmaceutical form? Solution for injection
The solution is a clear and colourless to slightly light yellow solution with a pH of 6.6.
How is it taken? Subcutaneous
Excipients? Trisodium citrate dihydrate, Citric acid monohydrate, L-Histidine, Sodium chloride, m-Cresol, Poloxamer 188, Water for injections
Pack sizes 1 pre-filled disposable injection
Is it available?? Listed as available (NHS Dictionary of Medicines and Devices – not a record of current supplies)
Shelf life? Before first use
3 years at 2 °C to 8 °C.
Prior to the first use store Ngenla in a refrigerator. The unopened pre-filled pen may temporarily be held for up to 4 hours at temperatures up to 32 °C.
After first use
28 days.
Store in a refrigerator (2 °C – 8 °C).
Do not freeze.
Keep Ngenla with the pen cap attached in order to protect from light.
Ngenla may be held at room temperature (up to 32 °C) for up to 4 hours with each injection for a maximum of 5 times. Return Ngenla to the refrigerator again after each use. Do not expose Ngenla to temperatures above 32 °C or leave at room temperature for more than 4 hours with each use. The Ngenla pen should be discarded if it has been used 5 times, if it has been exposed to temperatures higher than 32 °C or if it has been removed from the refrigerator for more than 4 hours with each use.
Chemical and physical in-use stability has been demonstrated for 28 days from the date of first use of the pre-filled pen, when the pre-filled pen has been stored at 2 °C to 8 °C in between each use.
Storage Store in a refrigerator (2 °C to 8 °C). Do not freeze. Keep Ngenla in the outer carton in order to protect from light.
For storage conditions after first use of the medicinal product, see section 6.3.
Drug group (ATC)? Pituitary and hypothalamic hormones and analogues, somatropin and somatropin agonists
Additional monitoring? Yes ▼ – it is being monitored particularly closely for safety. Report any side effect to the Yellow Card scheme.
Marketing authorisation? PLGB 00057/1713 (first authorised 25 March 2022)
Marketing authorisation holder? Pfizer Limited
Codes? GTIN 5415062384695, 5415062386866 · BNF 06050100

Sources: the MHRA product information (products.mhra.gov.uk) and the NHS Dictionary of Medicines and Devices (dm+d), release 11.1.0 of 9 November 2026, NHS Business Services Authority. Contains public sector information licensed under the Open Government Licence v3.0.