SUMMARY CMI

NGENLA^®

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

▼ This medicine is new or being used differently. Please report side effects. See the full CMI for further details.

1. Why am I using NGENLA?

NGENLA contains the active ingredient somatrogon. NGENLA is used to improve growth in children who are not growing at the expected rate for their age because they have low levels of growth hormone.

For more information, see Section 1. Why am I using NGENLA? in the full CMI.

2. What should I know before I use NGENLA?

Do not use NGENLA if you have ever had an allergic reaction to somatrogon or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use NGENLA? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with NGENLA and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use NGENLA?

• NGENLA comes in two different dosage strengths. Your doctor will prescribe the dose of medicine and dosage strength that is right for you.
• Your doctor, nurse or pharmacist will show you and/or your caregiver how to inject NGENLA before you use it for the first time.

More instructions can be found in Section 4. How do I use NGENLA? in the full CMI.

5. What should I know while using NGENLA?

For more information, see Section 5. What should I know while using NGENLA? in the full CMI.

6. Are there any side effects?

Common side effects are reactions at the site of the injection, headache, fever, low red blood cell count (anaemia), increased eosinophil (a type of white blood cell) count, underactive thyroid (hypothyroidism), allergic conjunctivitis, joint pain, and pain in the legs and arms. For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems.

FULL CMI

NGENLA^®

Active ingredient: somatrogon

Consumer Medicine Information (CMI)

This leaflet provides important information about using NGENLA. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using NGENLA.

Where to find information in this leaflet:

1. Why am I using NGENLA?
2. What should I know before I use NGENLA?
3. What if I am taking other medicines?
4. How do I use NGENLA?
5. What should I know while using NGENLA?
6. Are there any side effects?
7. Product details

1. Why am I using NGENLA?

NGENLA contains the active ingredient somatrogon. NGENLA is a prescription medicine that contains a modified form of human growth hormone.

NGENLA is used to improve growth in children who are not growing at the expected rate for their age, because they have low levels of growth hormone.

Medicines are sometimes prescribed for purposes other than those listed in this leaflet. Do not use NGENLA for a condition for which it was not prescribed.

2. What should I know before I use NGENLA?

Warnings

Do not use NGENLA if:

• You are allergic to somatrogon, or any of the ingredients listed at the end of this leaflet. Symptoms of an allergic reaction may include chest tightness, shortness of breath, wheezing or difficulty breathing, swelling of the face, lips, tongue, throat or other parts of the body, hives, itching or severe skin rash. Always check the ingredients to make sure you can use this medicine.

Your doctor will not prescribe NGENLA if you:

• have an active tumour or evidence of cancer growth or are currently being treated for cancer.
• have a serious illness following open heart or stomach surgery, or due to multiple injuries or respiratory failure (your lungs can't get enough oxygen into your blood).
• have Prader-Willi syndrome without a diagnosis of growth hormone deficiency.
• are a child and have closed epiphyses (this means that your bones are no longer growing).

Tell your doctor if you:

• have any other medical conditions (diabetes, thyroid disease, adrenocortical insufficiency (also known as ACTH deficiency)).
• take medicines for any other condition.
• your liver or kidneys do not work as well as expected.
• experience muscle pain or disproportionate pain at the injection site.

Your doctor should monitor you for high blood sugar levels (hyperglycaemia) and signs and symptoms of other medical conditions (benign intracranial hypertension, curvature of the spine) during treatment with NGENLA. If you are treated with insulin, your doctor may need to adjust your insulin dose.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with NGENLA and affect how it works.

Tell your doctor if you are taking:

• Any medicine (including insulin) for the treatment of diabetes.
• Glucocorticoids (commonly called steroids) such as cortisone and prednisone

Check with your doctor or pharmacist if you are not sure what medicines, vitamins or supplements you are taking and if these affect NGENLA.

4. How do I use NGENLA?

How much to use

• NGENLA comes in two different dosage strengths. Your doctor will prescribe the dose of medicine and dosage strength that is right for you.
• Your doctor, nurse or pharmacist will show you and/or your caregiver how to inject NGENLA before you use it for the first time. Do not try to inject NGENLA until you and/or your caregiver have been shown the correct way by your doctor, nurse or pharmacist.
• Follow the instructions provided and use NGENLA until your doctor tells you to stop.

When to use NGENLA

• NGENLA should be used once a week, on the same day each week, at any time of the day.
• You should record which day of the week NGENLA is used to help you remember to inject this medicine once a week.
• You may change the day of the week you use NGENLA as long as your last dose was given 3 or more days before.

How to use NGENLA

• NGENLA is given by injection under the skin (subcutaneous) of the abdomen (stomach), thighs, buttocks or upper arms.
• Do not inject NGENLA into a muscle or vein.
• Change the site of injection each week.
• If more than one injection is needed to complete your full dose, each injection should be given at a different injection site.
• You and/or your caregiver should review the detailed Instructions for Use provided in the pack on the correct way to prepare and give an injection of NGENLA.

If you forget to use NGENLA

NGENLA should be used regularly at the same time each week. If you miss your dose at the usual time, give the missed dose as soon as possible within 3 days of the missed dose.

If more than 3 days have passed, skip the dose you missed and give your next dose when you are meant to.

Do not take a double dose to make up for the dose you missed.

If you use too much NGENLA

If you think that you have used too much NGENLA you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using NGENLA?

Things you should do

Call your doctor as soon as possible if you experience any of the following:

• nausea, vomiting, headaches or problems with your vision.
• limping.
• pain in the hips and/or knees.

Remind any doctor or dentist you visit that you are using NGENLA.

Things you should not do

• Do not shake your pen, shaking can damage the medicine.
• Do not share your NGENLA pens and needles with another person, even if the needle has been changed. You may give the other person an infection or you may get an infection from them.
• Do not use NGENLA more than once a week.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how NGENLA affects you.

Looking after your medicine

Follow the instructions on the carton on how to take care of your medicine properly.

Store NGENLA pens in the refrigerator (2°C to 8°C) and away from direct sunlight. Do not freeze your pen or expose it to heat.

Do not store the pen with the needle attached and keep the pen cap on the pen when it is not in use.

Do not use this medicine after the expiry date, or if it has been more than 28 days after first use, or if the same pen has been used 5 times, or if the pen has been exposed to temperatures above 32°C, or if the pen has been left out of the refrigerator for more than two hours with each use.

Keep it where young children cannot reach it.

Travelling with your medicine

When travelling, transport your pen in its original carton in an insulated container with an ice pack. To avoid freezing, make sure your pen does not touch the ice pack. Once you arrive, place your pen in a refrigerator as soon as possible. Do not leave it in a car or other place where it can get too hot or too cold.

When to discard your medicine

If your pen is empty, or it has been more than 28 days after first use, or if the same pen has been used 5 times, or if the pen has been exposed to temperatures above 32°C, or if the pen has been left out of the refrigerator for more than 2 hours with each use, discard it even if it contains unused medicine.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

NGENLA contains a preservative called metacresol. In very rare cases the presence of metacresol can cause inflammation (swelling) in muscles. Tell your doctor if you experience muscle pain or disproportionate pain at the injection site.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration (TGA) online at www.tga.gov.au/safety/reporting-problems. By reporting side effects, you can help provide more information on the safety of NGENLA.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What NGENLA contains

Do not use this medicine if you are allergic to any of these ingredients. Talk to your doctor if you are unsure.

What NGENLA looks like

NGENLA comes as a clear and colourless to slightly light-yellow solution contained in a glass cartridge that is enclosed in a disposable pre-filled pen.

The NGENLA 24 mg pen has a lilac colour cap, injection button and label. The NGENLA 60 mg pen has a blue colour cap, injection button and label.

NGENLA 24 mg Aust R 349990.

NGENLA 60 mg Aust R 350035.

Who distributes NGENLA

Pfizer Australia Pty Ltd
Sydney NSW
Toll free number: 1800 675 229
www.pfizermedicalinformation.com.au

This leaflet was prepared in November 2024.

Published by MIMS January 2025

1 Name of Medicine

Somatrogon.

2 Qualitative and Quantitative Composition

Each pre-filled pen contains 24 mg or 60 mg somatrogon.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

A clear and colourless to slightly light-yellow solution for injection available as:
Single-patient-use disposable pre-filled pen containing 24 mg/1.2 mL that delivers a dose in 0.2 mg increments.
Single-patient-use disposable pre-filled pen containing 60 mg/1.2 mL that delivers a dose in 0.5 mg increments.
The pre-filled pen is capable of setting and delivering a dose, which is variable, and is determined based on patient body weight.
Ngenla has a pH of approximately 6.6.

4 Clinical Particulars

4.1 Therapeutic Indications

Ngenla is indicated for the long-term treatment of paediatric patients with growth disturbance due to insufficient secretion of growth hormone (GH).

4.2 Dose and Method of Administration

The recommended dose is 0.66 mg/kg body weight administered once weekly by subcutaneous (SC) injection. For patients switching from daily growth hormone products, weekly therapy with Ngenla may be initiated at a dose of 0.66 mg/kg/week on the day following their last daily injection.
Regular monitoring of Insulin-like Growth Factor-1 (IGF-1) concentrations is recommended during treatment with Ngenla. When monitoring for IGF-1, samples should always be drawn 4 days after the prior dose.
Ngenla dosage may be adjusted as necessary, based on growth velocity, body weight and serum insulin-like growth factor 1 (IGF-1) concentration. In patients whose blood IGF-1 concentrations exceed the mean reference value for their age and sex by more than 2 SDS, the dose of Ngenla should be reduced by 15%. More than one dose reduction may be required in some patients.
Monitor growth rate closely during the first year of Ngenla treatment. If a patient's growth rate fails to increase in the first year, assess for treatment adherence and other causes of growth failure (e.g. hypothyroidism, undernutrition, advanced bone age) and consider discontinuation of Ngenla treatment.
Treatment should be discontinued when there is evidence of closure of the epiphyseal growth plates.
There is no clinical trial experience with doses of Ngenla above a dose of 0.66 mg/kg/week.
Ngenla must not be given by any other route of administration including intravenous (IV) or intramuscular (IM) injection.
Ngenla can be given in the abdomen, thighs, buttocks, or upper arms. The injection site should be rotated weekly. If more than one injection is required to deliver a complete dose, each injection should be administered at a different injection site.
Administer Ngenla once weekly, on the same day each week, at any time of the day. The day of weekly administration can be changed if necessary, as long as the time between the two doses is at least 3 days (> 72 hours). After selecting a new dosing day, the once weekly dosing should be continued.
If a dose is missed, administer Ngenla as soon as possible within 3 days after the missed dose. If more than 3 days have passed, skip the missed dose and administer the next dose on the regularly scheduled day. In each case, patients can then resume their regular once weekly dosing schedule.
Refer to the Instructions for Use leaflet for complete administration instructions.

4.3 Contraindications

Based on experience with daily growth hormone products, Ngenla is contraindicated in patients with active tumours and/or malignancy.
Based on experience with pharmacologic amounts of daily growth hormone products, Ngenla is contraindicated in patients with acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma, or acute respiratory failure (see Section 4.4).
Ngenla is contraindicated in patients with known hypersensitivity to somatrogon (see Section 4.4) or any of its excipients (see Section 6.1).

4.4 Special Warnings and Precautions for Use

Ngenla should be administered by physicians who are experienced in the diagnosis and management of patients with growth hormone deficiency.

Acute critical illness.

Hypersensitivity reactions.

Hypoadrenalism.

Neoplasm.

Benign intracranial hypertension.

Glucose metabolism impairment.

Scoliosis.

Closed epiphyses.

Thyroid function impairment.

Prader-Willi syndrome.

Epiphyseal disorders.

Myositis.

Immunogenicity.

Use in hepatic impairment.

Use in renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Drugs metabolised by CYP3A4.

Glucocorticoids.

Insulin and/or oral/injectable hypoglycaemic agents.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

No effects on the ability to drive and use machines have been observed.

4.8 Adverse Effects (Undesirable Effects)

The most frequently occurring adverse reactions after treatment with Ngenla are injection site reactions (ISRs) (25.1%), headache (10.7%), and pyrexia (10.2%).
Safety data are derived from the phase 2, multi-centre safety and dose finding study, and the pivotal phase 3, multi-centre non-inferiority study in paediatric GHD patients (see Section 5.1). The data reflect exposure of 265 patients to Ngenla administered once weekly (0.66 mg/kg/week).
Adverse drug reactions (ADRs) for Ngenla are presented in Table 1 within the system organ class (SOC) and CIOMS frequency using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
The most frequently reported all-causality adverse events that occurred in ≥ 5% of subjects in any treatment group were injection site pain, nasopharyngitis, headache, pyrexia, cough, injection site erythema, vomiting, bronchitis, arthralgia, blood creatinine phosphokinase increased, anaemia, pharyngitis, hypothyroidism, otitis media, ear pain, oropharyngeal pain, rhinitis, arthropod bite, injection site pruritus, abdominal pain upper, and tonsillitis.

Long-term exposure.

Reporting suspected adverse effects.

4.9 Overdose

Single doses of Ngenla higher than 0.66 mg/kg/wk have not been studied.
Based on experience with daily growth hormone products, short-term overdosage could lead initially to hypoglycaemia and subsequently to hyperglycaemia. Long-term overdosage could result in signs and symptoms of gigantism and/or acromegaly consistent with the effects of growth hormone excess.
There is no experience of overdose with Ngenla. Treatment of overdose with Ngenla should consist of general supportive measures.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Pharmacodynamics.

Clinical trials.

5.2 Pharmacokinetic Properties

Somatrogon pharmacokinetics (pK) was assessed using a population pK approach for Ngenla in 42 paediatric patients (age range 3-15.5 years) with GHD.

Absorption.

Distribution.

Metabolism.

Elimination.

Excretion.

Special populations.

Age, race, gender, body weight.

Patients with renal impairment.

Patients with hepatic impairment.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Citric acid monohydrate, histidine, metacresol, poloxamer, sodium citrate dihydrate, sodium chloride, water for injections.

6.2 Incompatibilities

In the absence of compatibilities studies, this medicinal product must not be mixed with other medicinal products.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.
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.

6.4 Special Precautions for Storage

Before first use store Ngenla at 2°C to 8°C (refrigerate, do not freeze). Store in the original carton and away from direct sunlight. Do not freeze Ngenla or expose Ngenla to heat. Do not use Ngenla if it has been frozen. Unused pre-filled pens may be used until the expiration date printed on the carton, only if the pen has been kept in the refrigerator.
After first use of Ngenla, the pen can be stored for up to 28 days of use in a refrigerator (2°C to 8°C). Store away from direct sunlight. Always remove and safely discard the needle after each injection and store the Ngenla pre-filled pen without an injection needle attached. Always use a new needle for each injection. Replace the cap on the pre-filled pen when it is not in use. Store the pre-filled pen at 2°C to 8°C in between each use. Do not expose the Ngenla to temperatures above 32°C, or leave it at room temperature for more than two hours with each use. The pre-filled pen should not be used more than 28 days after first use and should not be used beyond the expiration date. The same pre-filled pen should not be used more than 5 times.
The Ngenla pen should be discarded if it has been more than 28 days after first use or it has been used 5 times, or if it has been exposed to temperatures above 32°C, or left out of the refrigerator for more than two hours with each use.

6.5 Nature and Contents of Container

Cartridge with 1.2 mL preserved solution for injection contained in a single-patient-use disposable pre-filled pen: 1s.
The medicinal product, the primary container (cartridge, bilayer disc seal, plunger stopper) and the pre-filled pen are not made with natural rubber latex.
Ngenla pre-filled pen is available in the following packages (see Table 3):
Sterile needles are required for administration but are not included. Consult the Instruction for Use leaflet for needles that can be used.

6.6 Special Precautions for Disposal

Special precautions for disposal and other handling.

Dose preparation.

Administration.

Disposal.

6.7 Physicochemical Properties

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes