Ngenla: detailed information

Package leaflet: Information for the patient

Ngenla 24 mg solution for injection in pre-filled pen

somatrogon

Solid black triangle pointing downward on a white background

This medicinal product is subject to additional monitoring. This will allow for the rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you or for the child you are caring for. Do not give it to others, even if their symptoms are the same as yours or those of the child you are caring for, as it could be harmful.
If you or the child you are caring for experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

What Ngenla is and what it is used for
What you need to know before using Ngenla
How to use Ngenla
Possible side effects
How to store Ngenla
Contents of the pack and other information

1. What Ngenla is and what it is used for

Ngenla contains the active substance somatrogon, a modified form of human growth hormone.
Naturally occurring human growth hormone is necessary for the growth of bones and muscles.
It also helps in the development of fat and muscle tissue in appropriate amounts. Ngenla is used to treat children and adolescents from the age of 3 years who do not have sufficient levels of growth hormone and who are not growing at a normal rate.
The active substance in Ngenla is produced using “recombinant DNA technology”, which means it is manufactured in cells that have been genetically modified in the laboratory to produce it.

2. What you should know before using Ngenla

Do not use Ngenla

if you or the child you are caring for is allergic to somatrogon (see Warnings and precautions) or to any of the other ingredients of this medicine (listed in section 6).
if you or the child you are caring for has an active tumour (cancer). Inform your doctor if you or the child you are caring for has or has had an active tumour. Tumours must be inactive and you or the child must have completed anti-tumour treatment before starting treatment with Ngenla.
if you or the child you are caring for has stopped growing due to epiphyseal fusion, meaning your doctor has informed you or the child that bone growth has ceased.
if you or the child you are caring for is severely ill (e.g., complications following open-heart surgery, abdominal surgery, acute respiratory failure, multiple accidental traumas, or similar conditions). If you or the child you are caring for is about to undergo, or has undergone, major surgery, or is admitted to hospital for any reason, inform your doctor and notify other healthcare providers that you or the child is receiving growth hormone treatment.

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

If you or the child you are caring for develops a severe allergic reaction, stop using Ngenla and contact your doctor immediately. Severe allergic reactions such as hypersensitivity, including anaphylaxis or angioedema (difficulty breathing or swallowing, or swelling of the face, lips, throat, or tongue), have occasionally occurred. If you or the child you are caring for experiences any of the following symptoms indicating a severe allergic reaction:
- breathing difficulties
- swelling of the face, mouth, and tongue
- hives (rash, skin swellings)
- skin rash
- fever
If you or the child you are caring for is receiving corticosteroid (glucocorticoid) replacement therapy, regular medical check-ups are necessary, as the dose of glucocorticoids may need adjustment.
Your doctor should regularly monitor the function of your thyroid gland or that of the child you are caring for. If necessary, your doctor may prescribe treatment or adjust the dose of existing treatment, as this may be required to ensure the effectiveness of Ngenla.
If you or the child you are caring for has Prader-Willi syndrome, Ngenla must not be used unless there is a growth hormone deficiency.
Your doctor should monitor you or the child you are caring for for high blood sugar levels (hyperglycaemia) during treatment with Ngenla. If you or the child you are caring for is being treated with insulin or other diabetes medications, your doctor may need to adjust the insulin dose. If you or the child you are caring for has diabetes and severe or worsening eye disease associated with this condition, treatment with Ngenla must not be initiated.
If you or the child you are caring for has previously had a tumour (cancer).
If you or the child you are caring for experiences changes in vision, severe or frequent headaches associated with feeling unwell (nausea), vomiting, or loss of muscle control or coordination of voluntary movements such as walking or picking up objects, difficulty with speech, eye movements, or swallowing, especially at the beginning of treatment, contact your doctor immediately. These may be signs of a temporary increase in pressure inside the brain (intracranial hypertension).
If you or the child you are caring for is severely ill (e.g., complications following open-heart surgery, abdominal surgery, acute respiratory failure, multiple accidental traumas, or similar conditions). If you or the child you are caring for is about to undergo, or has undergone, major surgery, or is admitted to hospital for any reason, inform your doctor and notify other healthcare providers that you or the child is receiving growth hormone treatment.
If you or the child you are caring for develops severe stomach pain during treatment with Ngenla, as this may be a symptom of pancreatitis.
If you or the child you are caring for develops a sideways curvature of the spine (scoliosis), frequent medical check-ups will be required.
If you or the child you are caring for develops a limp or pain in the hip or knee during growth, consult your doctor immediately. As this may occur during periods of rapid growth, these could be symptoms of bone disorders affecting the hip.
If you or the child you are caring for starts or stops taking oral contraceptives or estrogen hormone replacement therapy, your doctor may recommend adjusting the dose of Ngenla.

Other medicines and Ngenla
Inform your doctor, pharmacist, or nurse if you or the child you are caring for is taking, has recently taken, or might take any other medicines.

If you or the child you are caring for is receiving corticosteroid (glucocorticoid) replacement therapy, as this may reduce the growth-promoting effect of Ngenla. You or the child should consult your doctor regularly, as the dose of glucocorticoids may need adjustment.
If you or the child you are caring for is taking insulin or other diabetes medications, consult your doctor, as the dose may need adjustment.
If you or the child you are caring for is receiving thyroid hormone treatment, your doctor may need to adjust the dose.
If you or the child you are caring for is taking oral estrogens, consult your doctor, as the dose of Ngenla may need to be adjusted. If you or the child you are caring for is taking cyclosporine (a medicine that suppresses the immune system after transplantation), consult your doctor, as the dose may need adjustment.
If you or the child you are caring for is taking antiepileptic medicines (anticonvulsants), consult your doctor, as the dose may need adjustment.

Pregnancy and breastfeeding
If you or the child you are caring for is pregnant, suspects or is planning a pregnancy, or is breastfeeding, consult your doctor or pharmacist before taking this medicine.
Ngenla has not been studied in pregnant women, and it is unknown whether this medicine could harm the unborn baby. Therefore, Ngenla should preferably be avoided during pregnancy. If you are of childbearing age, you must not use Ngenla unless you are also using a reliable method of contraception.
It is unknown whether somatrogon passes into breast milk. Inform your doctor or the child's doctor if you or the child is breastfeeding or planning to breastfeed. Your doctor will help you or the child decide whether to discontinue breastfeeding or Ngenla treatment, considering the benefits of breastfeeding for the infant and the benefits of Ngenla for you or the child.

Driving and using machines
Ngenla does not affect the ability to drive or operate machinery.

Ngenla contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially "sodium-free".

Ngenla contains metacresol
Ngenla contains a preservative called metacresol. Very rarely, metacresol may cause muscle inflammation (swelling). If you or the child you are caring for experiences muscle pain or injection site pain, inform your doctor.

3. How to use Ngenla

This medicine will only be prescribed by a physician experienced in growth hormone treatment and who has confirmed your diagnosis or that of the child under your care.
Always use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor, pharmacist, or nurse.
Your doctor will determine the dose of Ngenla to be injected.

How much medicine to use
Your doctor will calculate your dose of Ngenla based on your body weight in kilograms. The recommended dose is 0.66 mg per kg of body weight, administered once weekly. If you or the child under your care has previously been treated with daily growth hormone injections, your doctor will instruct you to wait before taking the first dose of Ngenla until the day after the last daily injection, then continue with Ngenla once weekly.
Do not change the dose unless your doctor has instructed you to do so.

How Ngenla is administered
Ngenla is available as a pre-filled pen in two different strengths (Ngenla 24 mg and Ngenla 60 mg). Based on the recommended dose, your doctor or the child’s doctor will prescribe the most appropriate pen strength (see section 6 “Contents of the pack and other information”).

Before using the pen for the first time, your doctor or nurse will show you how to use it. Ngenla is administered by subcutaneous injection (injection under the skin) using a pre-filled pen. Do not inject it into a vein or muscle.
The best sites for injecting Ngenla are the abdomen (stomach), thighs, buttocks, or upper arms. Injections in the upper arms and buttocks should be administered by a caregiver.
Each time a dose is given, change the injection site on your body or on the body of the child under your care.
If more than one injection is needed to deliver a full dose, each injection must be given at a different injection site.

Detailed instructions for using the pre-filled pen are provided at the end of this leaflet.

When to use Ngenla
You or the child under your care should use this medicine once a week, on the same day each week.
You or the caregiver should record which day of the week Ngenla is used, to help remember or remind the child to inject the medicine once weekly.
If necessary, you or the child under your care may change the day of the weekly injection, provided at least 3 days have passed since the last injection. Once you have chosen the new administration day, continue to administer the injection on that day every week.

If you use more Ngenla than you should
If you or the child under your care has injected more Ngenla than prescribed, contact your doctor immediately, as blood sugar levels may need to be monitored.

If you forget to use Ngenla
If you or the child under your care has forgotten to inject a dose:

If 3 days or less have passed since the missed dose, administer Ngenla as soon as you remember. Then give the next dose on the usual scheduled day.
If more than 3 days have passed since the missed dose, skip the missed dose and administer the next dose as usual on the next scheduled day. Maintain a regular dosing schedule.

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 first consulting your doctor.
If you have any questions about how to use this medicine, speak with your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Very common: may affect more than 1 in 10 people

Headache
Bleeding, inflammation, itching, pain, redness, sensitivity, burning, 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 level of thyroid hormone in the blood (hypothyroidism)
Allergic inflammation of the conjunctiva, the transparent layer on the outer part of the eye (allergic conjunctivitis)
Joint pain (arthralgia)
Pain in the arms or legs

Uncommon: may affect up to 1 in 100 people

Adrenal glands do not produce enough steroid hormones (adrenal insufficiency)
Skin rash

Other possible side effects not observed with Ngenla, but reported during treatment with other
growth hormone medicines may include the following:

Growth of tissues (non-cancerous or cancerous)
Type 2 diabetes mellitus
Increased intracranial pressure (causing symptoms such as severe headache, vision disturbances, or vomiting)
Numbness or tingling
Joint or muscle pain
Breast enlargement in boys and men
Skin rash, redness, and itching
Fluid retention (manifesting as swollen fingers or ankles)
Facial swelling
Pancreatitis (causing symptoms such as stomach pain, nausea, vomiting, or diarrhoea)

In very rare cases, the presence of m-cresol may cause inflammation (swelling) of the muscles. If you or
the child you are caring for experiences muscle pain or pain at the injection site, inform your doctor.
Reporting of side effects
If you or the child you are caring for experiences any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system listed in Annex V. 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 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 must not be used for more than 28 days after first use.

Before first use of Ngenla

Store in a refrigerator (2-8 °C).
Keep Ngenla in its outer packaging to protect the medicine from light.
Remove Ngenla from the refrigerator before use. Ngenla may be kept at room temperature (up to 32 °C) for a maximum of 4 hours.
Do not use this medicine if you notice that the solution is cloudy or dark yellow. Do not use the medicine if flakes or particles are present.
Do not shake the pen, as this may damage the medicine.

After first use of Ngenla

Use the medicine within 28 days of first use. Store in a refrigerator (2-8 °C). Do not freeze.
Keep Ngenla with the pen cap attached to protect the medicine from light.
Do not leave the pre-filled pen with a needle attached.
Dispose of the pen after the last dose, even if there is unused medicine remaining.
Ngenla may be kept at room temperature (up to 32 °C) for a maximum of 4 hours per injection, for up to 5 times. Return Ngenla to the refrigerator after each use.
Do not leave the medicine at room temperature for more than 4 hours at each use.
Do not place the pen in a location where the temperature exceeds 32 °C.
If more than 28 days have passed since first use of the pen, dispose of it even if there is unused medicine remaining. If your pen or the pen of the child/adolescent under your care has been exposed to temperatures above 32 °C, has been removed from the refrigerator for more than 4 hours at each use, or has been used a total of 5 times, dispose of it even if there is unused medicine remaining.

To help you remember when to dispose of the pen, you may write the date of first use on the label.
After all doses have been correctly administered, a small amount of medicine may remain in the pen. Do not attempt to use the remaining medicine. After administration of the last dose, the pen must be properly disposed of.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Ngenla contains

The active substance is somatrogon.

Ngenla 24 mg solution for injection in a pre-filled pen
One mL of solution contains 20 mg of somatrogon.
Each pre-filled pen contains 24 mg of somatrogon in 1.2 mL of solution. Each pre-filled pen delivers doses from 0.2 mg to 12 mg in a single injection with increments of 0.2 mg.
Ngenla 60 mg solution for injection in a pre-filled pen
One mL of solution contains 50 mg of somatrogon.
Each pre-filled pen contains 60 mg of somatrogon in 1.2 mL of solution. Each pre-filled pen delivers doses from 0.5 mg to 30 mg in a single injection with increments of 0.5 mg.

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

Description of the appearance of Ngenla and contents of the pack
Ngenla is a clear, colourless to slightly yellowish injectable solution (for injection), contained in a pre-filled pen.
Ngenla 24 mg solution for injection is available in a pack containing 1 pre-filled pen. The pen cap, dose button, and pen label are lilac in colour.
Ngenla 60 mg solution for injection is available in a pack containing 1 pre-filled pen. The pen cap, dose button, and pen label are blue in colour.

Marketing Authorisation Holder
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium

Manufacturer
Pfizer Manufacturing Belgium NV
Rijksweg 12
2870 Puurs-Sint-Amands
Belgium

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Luxembourg/Luxemburg Pfizer Luxembourg SARL filialas Lietuvoje
Pfizer NV/SA Tel: + 370 5 251 4000
Tél/Tel: +32 (0)2 554 62 11

България Magyarország
Пфайзер Люксембург САРЛ, Клон България Pfizer Kft.
Тел.: +359 2 970 4333 Tel.: +36 1 488 37 00

Česká republika Malta
Pfizer, spol. s r.o. Vivian Corporation Ltd.
Tel.: +420 283 004 111 Tel. +356 21344610

Danmark Nederland
Pfizer ApS Pfizer bv
Tlf: +45 44 20 11 00 Tel: +31 (0)800 63 34 636

Deutschland Norge
PFIZER PHARMA GmbH Pfizer AS
Tel: +49 (0)30 550055 51000 Tlf: +47 67 52 61 00

Eesti Österreich
Pfizer Luxembourg SARL Eesti filiaal Pfizer Corporation Austria Ges.m.b.H.
Tel.: +372 666 7500 Tel: +43 (0)1 521 15-0

Ελλάδα Polska
Pfizer Ελλάς Α.Ε. Pfizer Polska Sp. z o.o.
Τηλ.: +30 210 6785800 Tel.: +48 22 335 61 00

España Portugal
Pfizer S.L. Laboratórios Pfizer, Lda.
Tel: +34 91 490 99 00 Tel: +351 21 423 5500

France România
Pfizer Pfizer România S.R.L.
Tél: +33 (0)1 58 07 34 40 Tel: +40 (0)21 207 28 00

Hrvatska Slovenija
Pfizer Croatia d.o.o. Pfizer Luxembourg SARL,
Tel: + 385 1 3908 777 Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana
Tel: + 386 (0)1 52 11 400

Ireland Slovenská republika
Pfizer Healthcare Ireland Pfizer Luxembourg SARL, organizačná zložka
Tel: 1800 633 363 (toll free) Tel: + 421 2 3355 5500
Tel: +44 (0)1304 616161

Ísland Suomi/Finland
Icepharma hf. Pfizer Oy
Sími: +354 540 8000 Puh/Tel: +358 (0)9 430 040

Italia Sverige
Pfizer S.r.l. Pfizer AB
Tel: +39 06 33 18 21 Tel: +46 (0)8 550 520 00

Κύπρος United Kingdom (Northern Ireland)
Pfizer Ελλάς Α.Ε. (Cyprus Branch) Pfizer Limited
Τηλ: +357 22817690 Tel: +44 (0)1304 616161

Latvija
Pfizer Luxembourg SARL filiāle Latvijā
Tel. +371 670 35 775

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu .

Instructions for Use

Ngenla 24 mg Pen
For subcutaneous injection only (under the skin)
Keep this leaflet. These instructions contain detailed information
on how to prepare and administer an injection of Ngenla.
Important information about the Ngenla pen

Ngenla for injection is a multidose pre-filled pen containing 24 mg of medicine.
Ngenla for injection may be administered by a patient, caregiver, doctor, nurse, or pharmacist. Do not attempt to inject Ngenla on your own until you have been shown the correct way to give injections and until you have read and understood the Instructions for Use. If your doctor, nurse, or pharmacist determines that you or a caregiver may be able to administer Ngenla injections at home, you must receive adequate training on the correct way to prepare and inject Ngenla. It is important to read, understand, and follow these instructions so that you administer Ngenla correctly. It is important that you speak with your doctor, nurse, or pharmacist to ensure you understand the instructions for administering Ngenla.
To help you remember when to inject Ngenla, you may mark the administration dates in advance on your calendar. Contact your doctor, nurse, or pharmacist if you or your caregiver have any questions about the correct way to inject Ngenla.
Each turn (click) of the dose knob increases the dose by 0.2 mg of medicine. You may administer from 0.2 mg to 12 mg in a single injection. If your prescribed dose is greater than 12 mg, you will need to administer more than one injection.
After correctly administering all doses, a small amount of medicine may remain in the pen. This is normal. Patients must not attempt to use the remaining solution but must dispose of the pen properly.
Do not share the pen with other people, even if the needle has been changed. This could transmit a serious infection to others or cause you to acquire a serious infection.
Always use a new sterile needle for each injection. This reduces the risk of contamination, infection, medicine leakage, and blocked needles, which could lead to incorrect dosing.
Do not shake the pen. Shaking may damage the medicine.
It is not recommended that visually impaired or blind individuals use the pen without the assistance of a trained person.

Materials needed for each injection
Included in the package:

1 Ngenla 24 mg pen. Not included in the package:
1 new sterile needle for each injection.
Alcohol swabs.
Cotton balls or gauze.
Adhesive bandage.
A proper sharps disposal container for used needles and pens.

Ngenla 24 mg Pen:

Diagram of an injection pen with labels indicating cap, needle attachment

Needles to use
Pen needles are not included with the Ngenla pen. You may use pen needles
with a length from 4 mm to 8 mm and gauge from 30G to 32G.

The following needles have been shown to be compatible with the Ngenla pen:
o 32G (Novo Nordisk®, NovoFine® Plus)
o 31G (Novo Nordisk®, NovoFine®)
o 31G (Becton Dickinson and Company, BD Ultra-Fine™ or BD Micro-Fine™)
The following safety-protected needles have been shown to be compatible with the Ngenla pen:
o 30G (Becton Dickinson and Company, AutoShield Duo™)
o 30G (Novo Nordisk®, NovoFine® AutoCover®)
Consult your doctor, nurse, or pharmacist about the correct needle to use.

Sterile needle (example), not supplied:

Diagram showing a sterile needle, outer cover, inner cap, needle, and protective paper with descriptive labels on a white background

Note: safety-protected needles do not have an inner needle cap. Steps 5, 6, and
11 of these instructions regarding the inner needle cap may not apply when
using a safety-protected needle. For further information, refer to the manufacturer’s instructions
for use of the needle.
Caution: never use a bent or damaged needle. Always handle pen needles carefully
to avoid accidental needlestick injuries (to yourself or others). Do not attach a new needle to the pen until you are ready to inject.
Preparation for injection
Step 1 Preparation

Wash and dry your hands.
You may use the pen immediately after removing it from the refrigerator. For a more comfortable injection, you may allow the pen to reach room temperature for up to 30 minutes (refer to section 5 “How to store Ngenla” in the package leaflet of the Ngenla 24 mg pre-filled pen).
Check the name, dosage, and label of the pen to ensure it is the medicine prescribed by your doctor.
Check the expiration date on the pen label. Do not use the product if the expiration date has passed.
Do not use the pen if:
o it has been frozen or exposed to heat (above 32°C)
o more than 28 days have passed since first use of the pen (refer to section 5 “How to store Ngenla” in the package leaflet of the Ngenla 24 mg pre-filled pen)
o it has been dropped
o it appears broken or damaged.
Do not remove the pen cap until you are ready to perform the injection.

Step 2 Selection and cleaning of the injection site

Human body diagram indicating injection sites: back of arms, buttocks, abdomen away from the navel

Ngenla may be administered in the abdomen (stomach), thighs, buttocks, or upper arms.
Choose the best site for injection as recommended by your doctor, nurse, or pharmacist.
If more than one injection is needed to administer the full dose, each injection must be given at a different injection site.
Do not inject into bony areas, bruised, red, tender, or hardened skin, or areas with scars or skin conditions.
Clean the injection site with an alcohol swab.
Allow the injection site to dry.
Do not touch the injection site after cleaning.

Step 3 Check the medicine

Two hands holding and connecting two parts of a medical device for administration

Remove the pen cap and keep it to replace after the injection.
Inspect the medicine inside the cartridge holder.
Ensure the medicine is clear and colorless to slightly yellowish. Do not inject the medicine if it is cloudy or dark yellow.
Ensure the medicine is free of flakes or particles. Do not inject the medicine if flakes or particles are present. Note: It is normal to see one or more bubbles in the medicine.

Step 4 Attach the needle

Two hands attaching a cap to an injection pen with an orange arrow and a prohibition symbol on a white background

Take a new needle and remove the protective paper.
Align the needle with the pen, holding both straight.
Gently push and then screw the needle onto the pen. Do not overtighten. Note: Be careful not to attach the needle at an angle. This may cause leakage from the pen. Caution: needles have sharp tips at both ends. Handle carefully to avoid needlestick injury (to yourself or others).

Step 5 Remove the outer needle cap

Two-part illustration showing hands removing the cap from a syringe and placing it on a flat surface

Remove the outer needle cap.
Be sure to keep the outer needle cap. You will need it later to remove the needle. Note: after removing the outer cap, you should see the inner needle cap. If you do not, try reattaching the needle. Note: if you are using a safety-protected needle, refer to the manufacturer’s instructions for use.

Step 6 Remove the inner needle cap

Two hands separating the plunger from a purple syringe and inserting it into the white drug container with an orange arrow indicating the action

Carefully remove the inner needle cap to expose the needle.
Dispose of the inner needle cap in a sharps disposal container. It is no longer needed. Note: if you are using a safety-protected needle, refer to the manufacturer’s instructions for use.

Flowchart with a gray arrow pointing to a box with the question Is this a new pen? with Yes and No options and separate paths

(“Yes: Go to new pen setup” has an arrow pointing to “New pen setup (priming)” and “No” has an arrow pointing to “Setting the prescribed dose”)
New pen setup (priming) – Only for first use of a new pen
Each new pen must be set up (primed) before first use

The new pen setup is performed before each new pen is used for the first time.
The purpose of this procedure is to remove air bubbles and ensure the correct dose is delivered. Important: skip from Step A to Step C if the pen has already been primed.

Step A: Set the dose knob to 0.4

Two hands holding a medical device with a window displaying the number 0.4 and an orange arrow indicating rotational movement

Rotate the dose knob to 0.4. Note: if you rotate the dose knob too far, you may rotate it back.

Step B: Tap the cartridge holder

One hand holding a purple injection pen while the other prepares for use

Hold the pen with the needle pointing upward so that air bubbles can rise.
Gently tap the cartridge holder to move any air bubbles upward. Important: follow Step B even if you do not see air bubbles.

Step C: Press the injection button and check for liquid

Diagram showing hands holding an injection pen with magnified details of the dosage window and needle tip on a vial

Press the injection button fully: the dose window will show “0”.
Check for liquid at the needle tip. If liquid appears, the pen is primed.
Always ensure a drop of liquid appears before injecting. If no liquid appears, repeat Steps A to C.
o If no liquid appears after repeating Steps A to C five (5) times, attach a new needle and try one (1) more time. Do not use the pen if no drop of liquid appears. Contact your doctor, nurse, or pharmacist and use a new pen.

Setting the prescribed dose
Step 7 Setting the dose

Illustration of a medical device with two dosage examples showing 3.8 mg and 12.0 mg through a small transparent window

Rotate the dose knob to set the dose.
o The dose can be increased or decreased by rotating the knob in either direction.
o The dose knob increments by 0.2 mg per click.
o The pen contains 24 mg of medicine, but you can set a maximum of 12 mg per single injection.
o The dose window displays the dose in mg. See Examples A and B.
Always check the dose window to ensure you have set the correct dose. Important: do not press the injection button while setting the dose.

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

If your dose is greater than 12 mg, you will need more than one injection.
You may administer from 0.2 mg to 12 mg in a single injection.
o If you need help dividing the dose correctly, consult your doctor, nurse, or pharmacist.
o Use a new needle for each injection (see Step 4: Attach the needle).
o If you normally give two injections to administer the full dose, make sure to administer the second dose.

What should I do if there is not enough medicine left in the pen?

If the pen contains less than 12 mg of medicine, the dose knob will stop, and the remaining amount will be displayed in the dose window.
If there is not enough medicine in the pen for the full dose, you may:
o inject the remaining amount in the pen and then prepare a new pen to complete the dose. Remember to subtract the dose already administered. For example, if the dose is 3.8 mg and you can only set the dose knob to 1.8 mg, you must inject an additional 2.0 mg with a new pen.
o or take a new pen and administer the full dose.

Administering the dose
Step 8 Insert the needle

One hand holding an injection pen and pressing it vertically downward onto the skin following the direction of the orange arrow

Hold the pen so you can see the numbers in the dose window.
Insert the needle into the skin straight.

Step 9 Inject the medicine

One hand holding an injection pen with a magnification showing the digital display with the number 0 highlighted

Keep the needle in the same position in the skin.
Press the injection button fully: the dose window will show “0”.

Step 10 Count to 10

One hand holding an injection pen on a skin surface next to a clock with the text Count to 10

Continue pressing the injection button while counting to 10. Counting to 10 ensures the full dose of medicine is delivered.
After counting to 10, release the injection button and slowly remove the pen from the injection site by pulling the needle out straight. Note: you may see a drop of medicine at the needle tip. This is normal and does not affect the dose received.

Step 11 Replace the outer needle cap

Technical illustration showing the internal mechanism of a medical device

Carefully replace the outer needle cap.
Press the cap until it is securely in place. Caution: never attempt to reinsert the inner needle cap, as this may result in a needlestick injury. Note: if you are using a safety-protected needle, refer to the manufacturer’s instructions for use.

Step 12 Remove the needle

Two hands holding an injection pen while an orange arrow indicates rotating the upper part for preparation

Unscrew the needle from the pen.
Gently pull until the needle detaches. Note: if the needle remains attached, replace the outer needle cap and try again. Ensure you apply pressure when unscrewing the needle.
Dispose of used pen needles in a sharps disposal container according to instructions from your doctor, nurse, or pharmacist and in compliance with local health and safety regulations. Keep the sharps container out of reach of children. Do not reuse needles.

Step 13 Replace the pen cap

Two hands bringing together two parts of a medical device with orange arrows indicating inward movement toward the center

Replace the cap on the pen.
Do not store the pen with a needle attached.
If medicine remains in the pen, store it in the refrigerator between uses (refer to section 5 “How to store Ngenla” in the package leaflet of the Ngenla 24 mg pre-filled pen).

Step 14 After the injection

Gently press on the injection site with a clean cotton ball or gauze and hold for a few seconds.
Do not rub the injection site. Mild bleeding may occur. This is normal.
If needed, you may cover the injection site with a small adhesive bandage.
If the pen is empty or more than 28 days have passed since first use, discard it even if medicine remains. Dispose of the pen in a sharps disposal container.
To help you remember when to discard the pen, you may write the date of first use on the pen label and record it below:

Date of first use ______ / ______ / ______

Patient information leaflet

Ngenla 60 mg solution for injection in a pre-filled pen

somatrogon

This medicinal product is under additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this entire leaflet carefully before using this medicine, as it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for you or for the child you are caring for. Do not give it to others, even if their symptoms seem identical to yours or to those of the child you are caring for, as it could be harmful.
If you or the child you are caring for experiences any side effects, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

What Ngenla is and what it is used for
What you need to know before using Ngenla
How to use Ngenla
Possible side effects
How to store Ngenla
Contents of the pack and other information

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 necessary for the growth of bones and muscles.
It also helps in the development of fat and muscle tissue in appropriate amounts. Ngenla is used to treat children and adolescents from the age of 3 years who do not have sufficient growth hormone and who are not growing at a normal rate.
The active substance in Ngenla is produced using "recombinant DNA technology", which means 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 using Ngenla

Do not use Ngenla

if you or the child under your care are allergic to somatrogon (see Warnings and precautions) or to any of the other ingredients of this medicine (listed in section 6).
if you or the child under your care has active cancer (tumour). Inform your doctor if you or the child under your care has or has had an active tumour. Tumours must be inactive and you or the child under your care must have completed anti-tumour treatment before starting treatment with Ngenla.
if you or the child under your care has stopped growing due to epiphyseal fusion, meaning that your doctor has informed you or the child that their bones have stopped growing.
if you or the child under your care is seriously ill (e.g. complications following open-heart surgery, abdominal surgery, acute respiratory failure, multiple accidental traumas, or similar conditions). If you or the child under your care is about to undergo or has recently undergone major surgery, or is admitted to hospital for any reason, inform your doctor and inform other healthcare providers that you or the child under your care is receiving growth hormone treatment.

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

If you or the child under your care develops a severe allergic reaction, stop using Ngenla and contact your doctor immediately. Severe allergic reactions such as hypersensitivity, including anaphylaxis or angioedema (difficulty breathing or swallowing, or swelling of the face, lips, throat, or tongue), have occasionally occurred. If you or the child under your care experiences any of the following symptoms indicating a severe allergic reaction:
- breathing difficulties
- swelling of the face, mouth, and tongue
- hives (rash, skin swelling)
- skin rash
- fever
If you or the child under your care is receiving corticosteroid (glucocorticoid) replacement therapy, you or the child should consult your doctor regularly, as dose adjustments of glucocorticoids may be necessary.
Your doctor should regularly monitor the function of your thyroid gland or that of the child under your care, and may prescribe treatment or adjust the dose of existing treatment if needed, as this may be required to ensure the effectiveness of Ngenla.
If you or the child under your care has Prader-Willi syndrome, you or the child must not use Ngenla unless a growth hormone deficiency is also present.
Your doctor should monitor you or the child under your care for high blood sugar levels (hyperglycaemia) during treatment with Ngenla. If you or the child under your care is being treated with insulin or other diabetes medications, your doctor may need to adjust the insulin dose. If you or the child under your care has diabetes and severe or worsening eye disease related to this condition, treatment with Ngenla must not be used.
If you or the child under your care has previously had a tumour (cancer).
If you or the child under your care experiences changes in vision, severe or frequent headaches associated with feeling unwell (nausea), vomiting, or loss of muscle control or coordination of voluntary movements such as walking or picking up objects, difficulty with speech, eye movements, or swallowing, especially at the beginning of treatment, contact your doctor immediately. These may be signs of a temporary increase in pressure within the brain (intracranial hypertension).
If you or the child under your care is seriously ill (e.g. complications following open-heart surgery, abdominal surgery, acute respiratory failure, multiple accidental traumas, or similar conditions). If you or the child under your care is about to undergo or has recently undergone major surgery, or is admitted to hospital for any reason, inform your doctor and inform other healthcare providers that you or the child under your care is receiving growth hormone treatment.
If you or the child under your care develops severe stomach pain during treatment with Ngenla, as this may be a symptom of pancreatitis.
If you or the child under your care develops a sideways curvature of the spine (scoliosis), frequent monitoring by your doctor will be required.
If during growth you or the child under your care develops a limp or pain in the hip or knee, you must consult your doctor immediately. As this may occur during periods of rapid growth, these may be symptoms of bone disorders in the hip.
If you or the child under your care is starting or stopping oral contraceptives or estrogen replacement therapy, your doctor may recommend adjusting the dose of Ngenla.

Other medicines and Ngenla
Inform your doctor, pharmacist, or nurse if you or the child under your care is taking, has recently taken, or might take any other medicines.

If you or the child under your care is receiving corticosteroid (glucocorticoid) replacement therapy, as these may reduce the growth-promoting effect of Ngenla. You or the child under your care should consult your doctor regularly, as dose adjustments of glucocorticoids may be necessary.
If you or the child under your care is taking insulin or other diabetes medications, consult your doctor, as dose adjustments may be needed.
If you or the child under your care is receiving treatment with thyroid hormones, your doctor may need to adjust the dose.
If you or the child under your care is taking oral estrogens, consult your doctor, as the dose of Ngenla may need to be adjusted. If you or the child under your care is taking cyclosporine (a medicine that suppresses the immune system after transplantation), consult your doctor, as dose adjustments may be necessary.
If you or the child under your care is taking antiepileptic medicines (anticonvulsants), consult your doctor, as dose adjustments may be necessary.

Pregnancy and breastfeeding
If you or the child under your care is pregnant, suspect you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Ngenla has not been studied in pregnant women and it is unknown whether this medicine may harm the unborn baby. Therefore, it is preferable to avoid using Ngenla during pregnancy. If you are of childbearing age, you must not use Ngenla unless you are also using a reliable method of contraception.
It is not known whether somatrogon passes into breast milk. Inform your doctor or the child’s doctor if you or the child under your care is breastfeeding or planning to breastfeed. Your doctor will help you or the child under your care decide whether to discontinue breastfeeding or Ngenla treatment, taking into account the benefits of breastfeeding for the infant and the benefits of Ngenla for you or the child under your care.

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

Ngenla contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially “sodium-free”.

Ngenla contains metacresol
Ngenla contains a preservative called metacresol. In very rare cases, metacresol may cause inflammation (swelling) of the muscles. If you or the child under your care experiences 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 experienced in treating with growth hormone and who has confirmed your diagnosis or that of the child for whom you are caring.
Always use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor, pharmacist, or nurse.
The dose of Ngenla to be injected will be determined by your doctor.

How much medicine to use
Your doctor will calculate your dose of Ngenla based on your body weight in kilograms. The recommended dose is 0.66 mg per kg of body weight, administered once weekly. If you or the child under your care has previously been treated with daily injections of growth hormone, your doctor will instruct you to wait before taking the first dose of Ngenla until the day after the last daily injection, then continue with Ngenla once weekly.
Do not change the dose unless your doctor has told you to do so.

How Ngenla is administered
Ngenla is available in two different sizes of prefilled pen (Ngenla 24 mg and Ngenla 60 mg). Based on the recommended dose, your doctor or the child's doctor will prescribe the most appropriate pen size (see section 6 “Contents of the pack and other information”).

Before using the pen for the first time, your doctor or nurse will show you how to use it. Ngenla is administered by subcutaneous injection (under the skin) using a prefilled pen. Do not inject it into a vein or muscle.
The best sites for injecting Ngenla are the abdomen (stomach), thighs, buttocks, or upper arms. Injections in the upper arms and buttocks must be given by a caregiver.
Each time a dose is administered, change the injection site on your body or on the body of the child under your care.
If more than one injection is needed to deliver a full dose, each injection must be given at a different injection site.

Detailed instructions for using the prefilled pen are provided at the end of this leaflet.

When to use Ngenla
You or the child under your care should use this medicine once a week, on the same day each week.
You or the caregiver should record which day of the week Ngenla is used, to help remember or remind the child to inject the medicine once weekly.
If necessary, you or the child under your care may change the day of the weekly injection, provided at least 3 days have passed since the last injection. After choosing the new administration day, continue to give the injection to yourself or to the child on that day every week.

If you use more Ngenla than you should
If you or the child under your care has injected more Ngenla than intended, contact your doctor immediately, as blood sugar levels may need to be monitored.

If you forget to use Ngenla
If you or the child under your care forgets to inject a dose and:

Less than or equal to 3 days have passed since the missed dose, administer the dose as soon as you remember. Then give the next dose on the usual scheduled day.
More than 3 days have passed since the missed dose, skip the missed dose. Then administer the next dose as usual on the next scheduled day. Maintain a regular dosing schedule.

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 speaking to your doctor.
If you have any questions about how to use this medicine, consult 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, tenderness, burning, soreness, 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 level of thyroid hormone in the blood (hypothyroidism)
Allergic inflammation of the conjunctiva, the transparent layer on the outer part of the eye (allergic conjunctivitis)
Joint pain (arthralgia)
Pain in the arms or legs

Uncommon: may affect up to 1 in 100 people

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

Other possible side effects not observed with Ngenla, but reported during treatment with other
growth hormone medicines may include the following:

Growth of tissues (non-cancerous or cancerous)
Type 2 diabetes mellitus
Increased intracranial pressure (causing symptoms such as severe headache, vision problems, or vomiting)
Numbness or tingling
Joint or muscle pain
Breast enlargement in boys and men
Rash, redness, and itching of the skin
Fluid retention (which may appear as swollen fingers or ankles)
Facial swelling
Pancreatitis (causing symptoms such as stomach pain, nausea, vomiting, or diarrhoea)

In very rare cases, the presence of m-cresol may cause inflammation (swelling) of the muscles. If you or
the child under your care experiences muscle pain or pain at the injection site, inform your doctor.
Reporting of side effects
If you or the child under your care experiences any side effect, including those not listed in this leaflet,
talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system listed in Annex V. 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 sight and reach of children.
Do not use this medicine after the expiry date 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 must not be used for more than 28 days after first use.

Before first use of Ngenla

Store in a refrigerator (2-8 °C).
Keep Ngenla in its outer packaging to protect the medicine from light.
Remove Ngenla from the refrigerator before use. Ngenla may be kept at room temperature (up to 32 °C) for a maximum of 4 hours.
Do not use this medicine if you notice the solution is cloudy or dark yellow. Do not use the medicine if flakes or particles are present.
Do not shake the pen, as this may damage the medicine.

After first use of Ngenla

Use the medicine within 28 days of first use. Store in a refrigerator (2-8 °C). Do not freeze.
Keep Ngenla with the pen cap on to protect the medicine from light.
Do not leave the pre-filled pen with a needle attached.
Dispose of the pen after the last dose, even if there is unused medicine remaining.
Ngenla may be kept at room temperature (up to 32 °C) for a maximum of 4 hours per injection, up to a maximum of 5 times. Return Ngenla to the refrigerator after each use.
Do not leave the medicine at room temperature for more than 4 hours with each use.
Do not place the pen in locations where the temperature exceeds 32 °C.
If more than 28 days have passed since first use of the pen, dispose of it even if there is unused medicine remaining. If your pen or the pen of the child you are caring for has been exposed to temperatures above 32 °C, or has been removed from the refrigerator for more than 4 hours with each use, or has been used a total of 5 times, dispose of it even if there is unused medicine remaining.

To help you remember when to dispose of the pen, you may write the date of first use on the label.
After correctly administering all doses, a small amount of medicine may remain in the pen. Do not attempt to use the remaining medicine. After administering the last dose, the pen must be properly disposed of.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Ngenla contains

The active substance is somatrogon.

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

Description of the appearance of Ngenla and contents of the pack
Ngenla is a clear, colourless to slightly yellowish injectable solution (for injection), contained in a pre-filled pen.
Ngenla 24 mg solution for injection is available in a pack containing 1 pre-filled pen. The pen cap, dose button, and label on the pen are lilac in colour.
Ngenla 60 mg solution for injection is available in a pack containing 1 pre-filled pen. The pen cap, dose button, and label on the pen are blue in colour.

Marketing Authorisation Holder
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium

Manufacturer
Pfizer Manufacturing Belgium NV
Rijksweg 12
2870 Puurs-Sint-Amands,
Belgium

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder: