Somatrogon is an active pharmaceutical ingredient in the Somatropin and Somatropin Agonists group (H01AC). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
GBOfficial regulatory label· revised January 30, 2026[1]
Ngenla is indicated for the treatment of children and adolescents from 3 years of age with growth disturbance due to insufficient secretion of growth hormone.
How to take
GB
CACanada· Health Canada
2 products
Uses
CAOfficial regulatory label· revised September 23, 2025[2]
NGENLA (somatrogon) is indicated for: • the long-term treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone (growth hormone deficiency). 1 Pediatrics Pediatrics (3 years old to epiphyseal fusion): The efficacy and safety of Ngenla in pediatric patients 3 to 11 years of age with growth failure due to growth hormone deficiency have been established in clinical trials.
The efficacy and safety of Ngenla have not been established in patients under 3 years of age. Data on the efficacy and safety of Ngenla in patients 12 to under 18 years of age are limited. Pediatric patients with growth failure due to acquired growth hormone deficiency caused by a malignancy were not studied in clinical trials.
See 14 CLINICAL TRIALS. 2 Geriatrics Geriatrics: Ngenla is not indicated for use in adults. No data are available to Health Canada; therefore, Health Canada has not authorized an indication for geriatric use.
USUnited States· FDA
1 product
Uses
USOfficial regulatory label· revised May 7, 2026[3]
1 INDICATIONS AND USAGE NGENLA is indicated for the treatment of pediatric patients aged 3 years and older who have growth failure due to an inadequate secretion of endogenous growth hormone. NGENLA is a human growth hormone analog indicated for treatment of pediatric patients aged 3 years and older who have growth failure due to inadequate secretion of endogenous growth hormone ( 1 ).
How to take
EUEuropean Union· EMA
1 product
Uses
EUOfficial regulatory label· revised December 16, 2025[4]
Ngenla is indicated for the treatment of children and adolescents from 3 years of age with growth disturbance due to insufficient secretion of growth hormone.
[1]MHRA (UK) · PLGB000571712 · revised January 30, 2026
[2]Health Canada (DPD) · 02521679 · revised September 23, 2025
[3]FDA DailyMed · 06dce529-b741-4a… · revised May 7, 2026 [PDF]
[4]European Medicines Agency · EMEA/H/C/005633 · revised December 16, 2025
[5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
Treatment should be initiated and monitored by physicians who are qualified and experienced in the diagnosis and management of paediatric patients with growth hormone deficiency (GHD). 66 mg/kg body weight administered once weekly by subcutaneous injection.
Each pre-filled pen is capable of setting and delivering the dose prescribed by the physician. Dose may be rounded up or down based on the physician’s expert knowledge of the individual patient needs. e. bodyweight > 45 kg), two injections have to be administered.
66 mg/kg/week on the day following their last daily injection. Dose titration Somatrogon dose may be adjusted as necessary, based on growth velocity, adverse reactions, body weight and serum insulin-like growth factor 1 (IGF-1) concentrations.
When monitoring for IGF-1, samples should always be drawn 4 days after the prior dose. e. between -2 and +2 (preferably close to 0 SDS). In patients whose serum IGF-1 concentrations exceed the mean reference value for their age and sex by more than 2 SDS, the dose of somatrogon should be reduced by 15%.
More than one dose reduction may be required in some patients. Treatment evaluation and discontinuation Evaluation of efficacy and safety should be considered at approximately 6 to 12 month intervals and may be assessed by evaluating auxological parameters, biochemistry (IGF-1, hormones, glucose levels) and pubertal status.
Routine monitoring of serum IGF-1 SDS levels throughout the course of treatment is recommended. More frequent evaluations should be considered during puberty. 3). e. an annualised height velocity < 2 cm/year or a bone age > 14 years in girls or > 16 years in boys.
Missed dose Patients should maintain their regular dosing day. If a dose is missed, somatrogon should be administered as soon as possible within 3 days after the missed dose, and then the usual once weekly dosing schedule should be resumed.
If more than 3 days have passed, the missed dose should be skipped and the next dose should be administered on the regularly scheduled day. In each case, patients can then resume their regular once weekly dosing schedule. Changing the dosing day The day of weekly administration can be changed if necessary as long as the time between two doses is at least 3 days.
After selecting a new dosing day, the once weekly dosing should be continued. Special populations Elderly The safety and efficacy of somatrogon in patients over the age of 65 years have not been established. No data are available. Renal impairment Somatrogon has not been studied in patients with renal impairment.
No dose recommendation can be made. Hepatic impairment Somatrogon has not been studied in patients with hepatic impairment. No dose recommendation can be made. Paediatric population The safety and efficacy of somatrogon in neonates, infants and children less than 3 years of age have not yet been established.
No data are available. Method of administration Somatrogon is administered by subcutaneous injection. Somatrogon is to be injected in the abdomen, thighs, buttocks or upper arms. 8). Injections to the upper arms and buttocks should be given by the caregiver.
The patient and caregiver should receive training to ensure understanding of the administration procedure to support self-administration. If more than one injection is required to deliver a complete dose, each injection should be administered at a different injection site to prevent lipoatrophy.
Somatrogon is to be administered once weekly, on the same day each week, at any time of the day. 01 mL). 01 mL). 6 and at the end of the package leaflet.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised January 30, 2026[1]
2%). 1). 66 mg/kg/week). Table 1 presents the adverse reactions for somatrogon within the system organ class (SOC). The adverse reactions listed in the table below are presented by SOC and frequency categories, defined 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) or frequency not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness. Table 1. 2 a Injection site reactions include the following: injection site pain, erythema, pruritus, swelling, induration, bruising, haemorrhage, warmth, hypertrophy, inflammation, deformation, urticaria.
Description of selected adverse reactions Injection site reaction In the phase 3 clinical study, reporting of ISRs was actively solicited during the course of the study. In the majority of cases, local ISRs tended to be transient, occurred mainly in the first 6 months of treatment and were mild in severity; ISRs had a mean onset on the day of the injection and a mean duration of < 1 day.
2% of patients administered daily injections of somatropin. In the long-term OLE of the clinical phase 3 study, local ISRs were similar in nature and severity, and reported early in subjects switching from somatropin to somatrogon treatment.
3% of patients originally treated with somatrogon in the main study and continuing treatment in the OLE portion of the study, and likewise, 37% were reported among patients originally treated with somatropin that were switched in the OLE portion of the study to treatment with somatrogon.
1%) tested positive for anti-drug antibodies (ADAs). There were no clinical or safety effects observed with the formation of antibodies. 4). 4). 4), paraesthesia. • Musculoskeletal, connective tissue, and bone disorders: myalgia. • Reproductive system and breast disorders: gynaecomastia.
• Skin and subcutaneous tissue disorders: skin rash, urticaria and pruritus. • General disorders and administration site conditions: peripheral oedema, facial oedema. 4). 4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
GBOfficial regulatory label· Warnings and precautions· revised January 30, 2026[1]
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. g. anaphylaxis, angioedema) have been reported with daily growth hormone medicinal products.
3). Hypoadrenalism Based on published data patients receiving daily growth hormone therapy who have or are at risk for pituitary hormone deficiency(s) may be at risk for reduced serum cortisol levels and/or unmasking of central (secondary) hypoadrenalism.
5). 5). Thyroid function impairment Growth hormone increases the extrathyroidal conversion of T4 to T3 and may unmask incipient hypothyroidism. Patients with pre-existing hypothyroidism should be treated accordingly prior to the initiation of treatment with somatrogon as indicated based on clinical evaluation.
8). Prader-Willi syndrome Somatrogon has not been studied in patients with Prader-Willi syndrome. Somatrogon is not indicated for the long-term treatment of paediatric patients who have growth failure due to genetically confirmed Prader-Willi syndrome unless they also have a diagnosis of GHD.
There have been reports of sudden death after initiating therapy with growth hormone in paediatric patients with Prader-Willi syndrome who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnoea, or unidentified respiratory infection.
Glucose metabolism impairment Treatment with growth hormone medicinal products may reduce insulin sensitivity and induce hyperglycaemia. Additional monitoring should be considered in patients treated with somatrogon who have glucose intolerance, or additional risk factors for diabetes.
5). Neoplasm In patients with previous malignant disease, special attention should be given to signs and symptoms of relapse. Patients with pre-existing tumours or growth hormone deficiency secondary to an intracranial lesion should be examined routinely for progression or recurrence of the underlying disease process.
In childhood cancer survivors, an increased risk of a second neoplasm has been reported in patients treated with somatropin after their first neoplasm. Intracranial tumours, in particular meningiomas, in patients treated with radiation to the head for their first neoplasm, were the most common of these second neoplasms.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised January 30, 2026[1]
1. Somatrogon must not be used when there is any evidence of activity of a tumour based on experience with daily growth hormone medicinal products. Intracranial tumours must be inactive and antitumour therapy must be completed prior to starting growth hormone (GH) therapy.
4). Somatrogon must not be used for growth promotion in children with closed epiphyses. 4).
This is not medical advice. Consult a qualified healthcare professional.
How to take
CAOfficial regulatory label· revised September 23, 2025[2]
1 Dosing Considerations • Ngenla treatment should be initiated and supervised by a physician who is experienced in the diagnosis and management of pediatric patients with growth failure due to growth hormone deficiency. • Ngenla has not been studied in patients with renal impairment.
• Ngenla has not been studied in patients with hepatic impairment. • Do not shake; shaking can damage the medicine. 66 mg/kg body weight administered once weekly by subcutaneous (SC) injection. 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. Ngenla dosage may be adjusted as necessary based on growth velocity, body weight, and serum insulin-like growth factor 1 (IGF-1) concentrations.
Dose titration When monitoring for IGF-1, samples should always be drawn 4 days after the prior dose. The target IGF-1 standard deviation score (SDS) should be the upper normal range not exceeding 2 SDS (see 7 WARNINGS AND PRECAUTIONS).
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.
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. 4 Administration Ngenla can be given in the abdomen, thighs, buttocks, or upper arms.
Use a different site of injection each week. If more than one injection is required to deliver a complete dose, administer each injection at a different injection site. Administer Ngenla once weekly, on the same day each week, at any time of the day.
The designated injection site should be prepared as instructed in the instructions for use. Always use a new sterile needle for each injection. The pre-filled pen may be used straight from the refrigerator. For a more comfortable injection, allow up to 30 minutes for the pre-filled pen to reach room temperature (20° to 25°C).
The day of weekly administration can be changed if necessary as long as the time between 2 doses is at least 3 days (>72 hours). After selecting a new dosing day, the once weekly dosing should be continued. If deemed appropriate, caregivers/parents can administer Ngenla to a person in their care/their child, or patients can self-inject (with caregiver/parental supervision), once they have been adequately trained by a health care professional on the use of proper subcutaneous injection technique and on the determination of the correct dose.
5 Missed Dose 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.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
CAOfficial regulatory label· Adverse reactions· revised September 23, 2025[2]
). Continuous rotation of the injection site may help reduce or prevent these reactions. On rare occasions, injection site reactions may require discontinuation of therapy. g. anaphylaxis, angioedema) have been reported with daily growth hormone products.
If a serious hypersensitivity reaction occurs, immediately discontinue use of Ngenla and treat promptly per standard of care and monitor until signs and symptoms resolve. Do not use in patients with previous hypersensitivity to Ngenla (see 2 CONTRAINDICATIONS).
Monitoring and Laboratory Tests Ngenla dosage may be adjusted as necessary, based on growth velocity, body weight, and serum insulin-like growth factor 1 (IGF-1) concentrations. When monitoring for IGF-1, samples should always be drawn 4 days after the prior dose.
2 Recommend Dose and Dosage Adjustment). 7 Drug- Laboratory Test Interactions). Musculoskeletal Epiphyseal disorders No epiphyseal disorders were reported with the administration of Ngenla in clinical trials. Based on the experience with daily growth hormone products, epiphyseal disorders, including slipped capital femoral epiphysis, may occur more frequently in patients with endocrine disorders or in Product Monograph Page 11 of 60 NGENLA (somatrogon) Unclassified / Non classifié patients undergoing rapid growth.
Any pediatric patient with the onset of a limp or complaints of hip or knee pain during treatment should be carefully evaluated. Scoliosis Progression of scoliosis can occur in pediatric patients who experience rapid growth. Because somatrogon increases growth rate, signs of development or progression of scoliosis should be monitored during treatment with Ngenla.
Reproductive Health:
Female and Male Potential • Fertility The risk of infertility in males and females of reproductive potential has not been studied in humans. Animal data from a fertility and early embryonic development study conducted in rats demonstrated that somatrogon administration resulted in an increase in estrous cycle length coupled with a decrease in the number of estrous cycles and an increase in the copulatory interval.
, an increase in the number of corpora lutea) and increases in the number of implantations and the percentage of pre -implantation loss were also observed. The effects were observed at doses of 3, 10, and/or 30 mg/kg body weight administered by SC injection once every two days.
However, there were no effects on mating, fertility, and pregnancy indices or on early embryonic development in rats (see 16 NON-CLINICAL TOXICOLOGY). 1 Pregnant Women There are no studies of Ngenla use by pregnant women. Animal data from a pre- and post-natal development study conducted in rats demonstrated an increase in post-natal body weight in offspring of maternal animals administered somatrogon at doses of 10 and 30 mg/kg body weight once every two days.
Reproductive assessment in the offspring also demonstrated an increase in time to mating at a maternal dose of 30 mg/kg body weight once every two days. The effects were related to maternal somatrogon administration but were considered non- adverse (see 16 NON-CLINICAL TOXICOLOGY).
Animal reproduction studies are not always predictive of human response; therefore, it is unknown whether Ngenla can cause fetal harm when administered to a pregnant woman. Ngenla should be used during pregnancy only if clearly needed.
7 Drug- Laboratory Test Interactions). 2 Breast-feeding It is unknown if somatrogon is excreted in human milk. Precaution should be exercised because many drugs can be excreted in human milk. 3 Pediatrics The efficacy and safety of Ngenla have been evaluated in pediatric patients aged 3 to 11 years with growth failure due to growth hormone deficiency (see 1 INDICATIONS).
4 Geriatrics Ngenla is not indicated for use in adults. The efficacy and safety of Ngenla in geriatric patients aged 65 years of age and older have not been established (see 1 INDICATIONS). 1 Adverse Reaction Overview The description of adverse reactions in this section is based on clinical experience with somatrogon in a Phase 3 study (CP-4-006) in pediatric patients with GHD.
9%, respectively) (see 7 WARNINGS AND PRECAUTIONS). Most events of injection site pain were mild or moderate in severity for both treatment groups. 6%]). The anatomical injection site that was most frequently associated with injection site pain for both treatment groups was the arm (left and right), and this was the site most frequently associated with severe pain events.
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. 1 Clinical Trial Adverse Reactions – Pediatrics The main safety data are derived from a Phase 3 safety and efficacy study (CP-4-006) in pediatric patients with growth failure due to GHD (see 14 […]
CAOfficial regulatory label· Warnings and precautions· revised September 23, 2025[2]
). • 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 7 WARNINGS AND PRECAUTIONS). • Ngenla is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. 1 Dosing Considerations • Ngenla treatment should be initiated and supervised by a physician who is experienced in the diagnosis and management of pediatric patients with growth failure due to growth hormone deficiency.
• Ngenla has not been studied in patients with renal impairment. • Ngenla has not been studied in patients with hepatic impairment. • Do not shake; shaking can damage the medicine. 66 mg/kg body weight administered once weekly by subcutaneous (SC) injection.
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. Ngenla dosage may be adjusted as necessary based on growth velocity, body weight, and serum insulin-like growth factor 1 (IGF-1) concentrations.
Dose titration When monitoring for IGF-1, samples should always be drawn 4 days after the prior dose. The target IGF-1 standard deviation score (SDS) should be the upper normal range not exceeding 2 SDS (see 7 WARNINGS AND PRECAUTIONS).
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.
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. 4 Administration Ngenla can be given in the abdomen, thighs, buttocks, or upper arms.
Use a different site of injection each week. If more than one injection is required to deliver a complete dose, administer each injection at a different injection site. Administer Ngenla once weekly, on the same day each week, at any time of the day.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
CAOfficial regulatory label· Contraindications· revised September 23, 2025[2]
• Ngenla is contraindicated in patients with closed/fused epiphyses. • Ngenla is contraindicated in patients with active tumours and/or malignancy (see 7 WARNINGS AND PRECAUTIONS). • 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 7 WARNINGS AND PRECAUTIONS).
• Ngenla is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Product Monograph Page 5 of 60 NGENLA (somatrogon) Unclassified / Non classifié
This is not medical advice. Consult a qualified healthcare professional.
1 ). 1 ). 3 ). 3 ). 3 ). 3 ). 1 Important Dosing and Administration Information • NGENLA treatment should be supervised by a healthcare provider who is experienced in the diagnosis and management of pediatric patients aged 3 years and older with growth failure due to growth hormone deficiency (GHD) [see Indications and Usage (1) ] .
• Refer patient to the Instructions for Use for complete administration instructions. • Administer NGENLA by subcutaneous injection, once weekly, on the same day each week, at any time of the day in the abdomen, thighs, buttocks, or upper arms.
Rotate the injection site weekly. • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If flakes, particles or discoloration are observed, do not use the pen.
Do not shake; shaking can damage the product. 5 mg increments. 2 Perform Fundoscopic Examination Prior to Initiation of NGENLA • Perform fundoscopic examination before initiating treatment with NGENLA to exclude preexisting papilledema.
5) ] . 66 mg/kg based on actual body weight administered once weekly by subcutaneous (SC) injection. • Individualize dosage for each patient based on the growth response. • The day of weekly administration can be changed if necessary as long as the time between 2 doses is at least 3 days.
After selecting a new dosing day, the once weekly dosing should be continued. • When switching from daily growth hormone, the once-weekly NGENLA may be initiated on the day following their last daily injection. • If more than one injection is required to deliver a complete dose, each injection should be administered at a different injection site.
4 Missed Dose • 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.
This is not medical advice. Consult a qualified healthcare professional.
Most-reported reactions to the US regulator (12 mo to June 4, 2026): 181 reports total. [5]
Injection Site Pain 73
Drug Dose Omission By Device 11
Device Mechanical Issue 10
Incorrect Dose Administered By Device 9
Headache 8
Wrong Technique In Device Usage Process 7
Injection Site Erythema 6
Injection Site Haemorrhage 6
Injection Site Mass 6
Nausea 6
Device Defective 5
Device Leakage 5
Side effects & warnings
USOfficial regulatory label· Adverse reactions· revised May 7, 2026[3]
1 ). To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. gov/medwatch . 1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
1) ]. 034 mg/kg/day). 1% were female. 7% of patients identified as Hispanic or Latino. Baseline disease characteristics were balanced across treatment groups. Table 1 shows the adverse reactions that occurred in ≥5% of patients treated with NGENLA or daily somatropin during the 12-month main study period.
Reporting of injection site reactions was solicited through the use of a patient diary after each weekly injection for patients administered NGENLA and once weekly for patients administered daily injections of somatropin. Table 1 Adverse Reactions Occurring in ≥5% of NGENLA- or Somatropin-Treated Pediatric Patients (52 Weeks of Treatment) Adverse reactions that are medically related were grouped to a single preferred term.
Adverse Drug Reactions Daily Somatropin (N=115) n (%) NGENLA (N=109) n (%) Injection site reactions Injection site reactions included: injection site pain (39% somatrogon-ghla vs 25% daily somatropin), injection site swelling/induration/hypertrophy/inflammation (10% somatrogon-ghla vs 1% daily somatropin), injection site erythema (8% somatrogon-ghla vs none daily somatropin), injection site pruritus (5% somatrogon-ghla vs none daily somatropin), injection site hemorrhage (5% somatrogon-ghla vs none daily somatropin).
2) Nasopharyngitis Nasopharyngitis included: rhinitis, pharyngitis, rhinitis allergic, pharyngitis streptococcal, viral pharyngitis, nasopharyngitis. 8) Laboratory Tests More NGENLA-treated patients shifted from normal eosinophil levels at baseline to elevated eosinophil levels at the end of the 12-month study compared to the daily somatropin group (29% vs 12%).
2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of somatropin products or NGENLA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Skin and subcutaneous tissue disorders – lipoatrophy Musculoskeletal and connective tissue disorders – osteonecrosis in pediatric patients, slipped capital femoral epiphysis
USOfficial regulatory label· Warnings and precautions· revised May 7, 2026[3]
5 WARNINGS AND PRECAUTIONS • Severe Hypersensitivity : Severe hypersensitivity reactions may occur. 2 ). • Increased Risk of Neoplasms : Monitor patients with preexisting tumors for progression or recurrence. 3 ). • Glucose Intolerance and Diabetes Mellitus : NGENLA may decrease insulin sensitivity, particularly at higher doses.
4 ). • Intracranial Hypertension : Perform fundoscopic examinations prior to initiation of treatment with NGENLA and periodically thereafter. If preexisting papilledema is identified, evaluate the etiology and treat the underlying cause before initiating.
5 ). • Fluid Retention: May occur and may be dose dependent. 6 ). 7 ). 8 ). • Slipped Capital Femoral Epiphysis : May develop. 9 ). 10 ). 11 ). • Lipoatrophy: May occur if NGENLA is administered in the same location over a long period of time.
12 ). 1 Increased Mortality in Patients with Acute Critical Illness Increased mortality in patients with acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure has been reported with somatropin [see Contraindications (4) ] .
The safety of continuing NGENLA treatment for the approved indication in patients who concurrently develop these illnesses has not been established. 2 Severe Hypersensitivity Severe systemic hypersensitivity reactions including anaphylaxis and angioedema have been reported with somatropin.
Inform patients and/or caregivers that such reactions are possible and that prompt medical attention should be sought if an allergic reaction occurs. NGENLA is contraindicated in patients with known hypersensitivity to somatrogon-ghla or any excipients in NGENLA [see Contraindications (4) ] .
3 Increased Risk of Neoplasms Active Malignancy There is an increased risk of malignancy progression with somatropin treatment in patients with active malignancy [see Contraindications (4) ] . Any preexisting malignancy should be inactive, and its treatment should be completed prior to instituting therapy with NGENLA.
Discontinue NGENLA if there is evidence of recurrent malignancy. Risk of Second Neoplasm in Pediatric Patients In childhood cancer survivors, who were treated with radiation to the brain/head for their first neoplasm and who developed subsequent GHD and were treated with somatropin, an increased risk of a second neoplasm has been reported.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
USOfficial regulatory label· Contraindications· revised May 7, 2026[3]
1) ] . 2) ]. • Closed epiphyses. 3) ] . 4) ] . 13) ] . • Acute critical illness ( 4 ). • Hypersensitivity to somatrogon-ghla or excipients ( 4 ). • Closed epiphyses ( 4 ). • Active malignancy ( 4 ). • Active proliferative or severe non-proliferative diabetic retinopathy ( 4 ).
• Prader-Willi syndrome who are severely obese or have severe respiratory impairment ( 4 ).
This is not medical advice. Consult a qualified healthcare professional.
Treatment should be initiated and monitored by physicians who are qualified and experienced in the diagnosis and management of paediatric patients with growth hormone deficiency (GHD). 66 mg/kg body weight administered once weekly by subcutaneous injection.
3 Each pre-filled pen is capable of setting and delivering the dose prescribed by the physician. Dose may be rounded up or down based on the physician’s expert knowledge of the individual patient needs. e. bodyweight > 45 kg), two injections have to be administered.
66 mg/kg/week on the day following their last daily injection. Dose titration Somatrogon dose may be adjusted as necessary, based on growth velocity, adverse reactions, body weight and serum insulin-like growth factor 1 (IGF-1) concentrations.
When monitoring for IGF-1, samples should always be drawn 4 days after the prior dose. e. between -2 and +2 (preferably close to 0 SDS). In patients whose serum IGF-1 concentrations exceed the mean reference value for their age and sex by more than 2 SDS, the dose of somatrogon should be reduced by 15%.
More than one dose reduction may be required in some patients. Treatment evaluation and discontinuation Evaluation of efficacy and safety should be considered at approximately 6 to 12 month intervals and may be assessed by evaluating auxological parameters, biochemistry (IGF-1, hormones, glucose levels) and pubertal status.
Routine monitoring of serum IGF-1 SDS levels throughout the course of treatment is recommended. More frequent evaluations should be considered during puberty. 3). e. an annualised height velocity < 2 cm/year or a bone age > 14 years in girls or > 16 years in boys.
Missed dose Patients should maintain their regular dosing day. If a dose is missed, somatrogon should be administered as soon as possible within 3 days after the missed dose, and then the usual once weekly dosing schedule should be resumed.
If more than 3 days have passed, the missed dose should be skipped and the next dose should be administered on the regularly scheduled day. In each case, patients can then resume their regular once weekly dosing schedule. Changing the dosing day The day of weekly administration can be changed if necessary as long as the time between two doses is at least 3 days.
After selecting a new dosing day, the once weekly dosing should be continued. Special populations Elderly The safety and efficacy of somatrogon in patients over the age of 65 years have not been established. No data are available. Renal impairment Somatrogon has not been studied in patients with renal impairment.
No dose recommendation can be made. 4 Hepatic impairment Somatrogon has not been studied in patients with hepatic impairment. No dose recommendation can be made. Paediatric population The safety and efficacy of somatrogon in neonates, infants and children less than 3 years of age have not yet been established.
No data are available. Method of administration Somatrogon is administered by subcutaneous injection. Somatrogon is to be injected in the abdomen, thighs, buttocks or upper arms. 8). Injections to the upper arms and buttocks should be given by the caregiver.
The patient and caregiver should receive training to ensure understanding of the administration procedure to support self-administration. If more than one injection is required to deliver a complete dose, each injection should be administered at a different injection site to prevent lipoatrophy.
Somatrogon is to be administered once weekly, on the same day each week, at any time of the day. 01 mL). 01 mL). 6 and at the end of the package leaflet.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
EUOfficial regulatory label· Adverse reactions· revised December 16, 2025[4]
2%). 1). 66 mg/kg/week). Table 1 presents the adverse reactions for somatrogon within the system organ class (SOC). The adverse reactions listed in the table below are presented by SOC and frequency categories, defined 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) or frequency not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness. Table 1. 2 a Injection site reactions include the following: injection site pain, erythema, pruritus, swelling, induration, bruising, haemorrhage, warmth, hypertrophy, inflammation, deformation, urticaria.
Description of selected adverse reactions Injection site reaction In the phase 3 clinical study, reporting of ISRs was actively solicited during the course of the study. In the majority of cases, local ISRs tended to be transient, occurred mainly in the first 6 months of treatment and were mild in severity; ISRs had a mean onset on the day of the injection and a mean duration of < 1 day.
2% of patients administered daily injections of somatropin. In the long-term OLE of the clinical phase 3 study, local ISRs were similar in nature and severity, and reported early in subjects switching from somatropin to somatrogon treatment.
3% of patients originally treated with somatrogon in the main study and continuing treatment in the OLE portion of the study, and likewise, 37% were reported among patients originally treated with somatropin that were switched in the OLE portion of the study to treatment with somatrogon.
1%) tested positive for anti-drug antibodies (ADAs). There were no clinical or safety effects observed with the formation of antibodies. 4). 4). 4), paraesthesia. • Musculoskeletal, connective tissue, and bone disorders: myalgia. • Reproductive system and breast disorders: gynaecomastia.
• Skin and subcutaneous tissue disorders: skin rash, urticaria and pruritus. • General disorders and administration site conditions: peripheral oedema, facial oedema. 4). 4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V. 10
EUOfficial regulatory label· Warnings and precautions· revised December 16, 2025[4]
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. g. anaphylaxis, angioedema) have been reported with daily growth hormone medicinal products.
3). Hypoadrenalism Based on published data patients receiving daily growth hormone therapy who have or are at risk for pituitary hormone deficiency(s) may be at risk for reduced serum cortisol levels and/or unmasking of central (secondary) hypoadrenalism.
5). 5). Thyroid function impairment Growth hormone increases the extrathyroidal conversion of T4 to T3 and may unmask incipient hypothyroidism. Patients with pre-existing hypothyroidism should be treated accordingly prior to the initiation of treatment with somatrogon as indicated based on clinical evaluation.
8). Prader-Willi syndrome Somatrogon has not been studied in patients with Prader-Willi syndrome. Somatrogon is not indicated for the long-term treatment of paediatric patients who have growth failure due to genetically confirmed Prader-Willi syndrome unless they also have a diagnosis of GHD.
There have been reports of sudden death after initiating therapy with growth hormone in paediatric patients with Prader-Willi syndrome who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnoea, or unidentified respiratory infection.
Glucose metabolism impairment Treatment with growth hormone medicinal products may reduce insulin sensitivity and induce hyperglycaemia. Additional monitoring should be considered in patients treated with somatrogon who have glucose intolerance, or additional risk factors for diabetes.
5). Neoplasm In patients with previous malignant disease, special attention should be given to signs and symptoms of relapse. Patients with pre-existing tumours or growth hormone deficiency secondary to an intracranial lesion should be examined routinely for progression or recurrence of the underlying 6 disease process.
In childhood cancer survivors, an increased risk of a second neoplasm has been reported in patients treated with somatropin after their first neoplasm. Intracranial tumours, in particular meningiomas, in patients treated with radiation to the head for their first neoplasm, were the most common of these second neoplasms.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
EUOfficial regulatory label· Contraindications· revised December 16, 2025[4]
1. Somatrogon must not be used when there is any evidence of activity of a tumour based on experience with daily growth hormone medicinal products. Intracranial tumours must be inactive and antitumour therapy must be completed prior to starting growth hormone (GH) therapy.
4). Somatrogon must not be used for growth promotion in children with closed epiphyses. 4). 5
This is not medical advice. Consult a qualified healthcare professional.
Benign intracranial hypertension Intracranial hypertension (IH) with papilledema, ataxia, visual changes, headache, nausea and/or vomiting has been reported in a small number of patients treated with growth hormone medicinal products.
Funduscopic examination is recommended at the initiation of treatment and as clinically warranted. In patients with clinical or funduscopic evidence of IH, somatrogon should be temporarily discontinued. At present there is insufficient evidence to give specific advice on the continuation of growth hormone treatment in patients with resolved IH.
If treatment with somatrogon is restarted, monitoring for signs and symptoms of IH is necessary. e. 1 – 56 mg/week) compared to patients receiving placebo, 42% vs. 19%. Based on this information, these types of patients should not be treated with somatrogon.
As there is no information available on the safety of growth hormone substitution therapy in acutely critically ill patients, the benefits of continued somatrogon treatment in this situation should be weighed against the potential risks involved.
In all patients developing other or similar acute critical illness, the possible benefit of treatment with somatrogon must be weighed against the potential risk involved. Pancreatitis Although rare in patients treated with growth hormone medicinal products, pancreatitis should be considered in somatrogon-treated patients who develop severe abdominal pain during treatment.
Scoliosis Because somatrogon increases growth rate, signs of development or progression of scoliosis should be monitored during treatment. Epiphyseal disorders Epiphyseal disorders, including slipped capital femoral epiphysis may occur more frequently in patients with endocrine disorders or in patients undergoing rapid growth.
Any paediatric patient with the onset of a limp or complaints of hip or knee pain during treatment should be carefully evaluated. Oral oestrogen therapy Oral oestrogen influences the IGF-1 response to growth hormone. 2). In female patients on oral oestrogen-containing therapy, a higher […]
The designated injection site should be prepared as instructed in the instructions for use. Always use a new sterile needle for each injection. The pre-filled pen may be used straight from the refrigerator. For a more comfortable injection, allow up to 30 minutes for the pre-filled pen to reach room temperature (20° to 25°C).
The day of weekly administration can be changed if necessary as long as the time between 2 doses is at least 3 days (>72 hours). After selecting a new dosing day, the once weekly dosing should be continued. If deemed appropriate, caregivers/parents can administer Ngenla to a person in their care/their child, or patients can self-inject (with caregiver/parental supervision), once they have been adequately trained by a health care professional on the use of proper subcutaneous injection technique and on the determination of the correct dose.
5 Missed Dose 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.
66 mg/kg body weight/week have not been studied. Based on experience with daily growth hormone products, short-term overdosage could lead initially to hypoglycemia and subsequently to hyperglycemia. Long-term overdosage could result in signs and symptoms of gigantism and/or acromegaly consistent with the effects of growth hormone excess.
Treatment of overdose with Ngenla should consist of general supportive measures. For management of a suspected drug overdose, contact your regional poison control centre. Product Monograph Page 7 of 60 NGENLA (somatrogon) Unclassified / Non classifié 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING To help ensure the traceability of biologic products, including biosimilars, health professionals should recognize the importance of recording both the brand name and the non-proprietary (active ingredient) name as well as other product-specific identifiers such as the Drug Identification Number (DIN) and the batch/lot number of the product supplied.
6. Each carton contains one single-patient-use, disposable pre-filled pen containing a preserved solution of somatrogon. Each pre-filled pen is capable of setting and delivering a variable dose that is determined based on patient body weight.
The medicinal product, the primary container (cartridge, bilayer disc seal, plunger stopper) and the […]
Intracranial tumors, in particular meningiomas, were the most common of these second neoplasms. Monitor all patients with a history of GHD secondary to an intracranial neoplasm while on NGENLA therapy for progression or recurrence of the tumor.
New Malignancy During Treatment Because children with certain rare genetic causes of short stature have an increased risk of developing malignancies, thoroughly consider the risks and benefits of starting NGENLA in these patients. If treatment with NGENLA is initiated, carefully monitor these patients for development of neoplasms.
Monitor patients on NGENLA therapy carefully for increased growth or potential malignant changes of preexisting nevi. Advise patients and/or caregivers to report marked changes in behavior, onset of headaches, vision disturbances and/or changes in skin pigmentation or changes in the appearance of preexisting nevi.
4 Glucose Intolerance and Diabetes Mellitus Treatment with growth hormone may decrease insulin sensitivity, particularly at higher doses. New onset type 2 diabetes mellitus has been reported in patients receiving growth hormone. Patients with undiagnosed pre-diabetes and diabetes mellitus may experience worsened glycemic control and become symptomatic.
Monitor glucose levels periodically in all patients receiving NGENLA, especially in those with risk factors for diabetes mellitus, such as obesity, Turner syndrome, or a family history of diabetes mellitus. Patients with preexisting type 1 or type 2 diabetes mellitus or pre-diabetes should be monitored closely.
The doses of antidiabetic agents may require adjustment when NGENLA is initiated. 5 Intracranial Hypertension Intracranial hypertension (IH) with papilledema, visual changes, headache, nausea, and/or vomiting has been reported in patients treated with somatropin.
Symptoms usually occurred within the first eight (8) weeks after the initiation of somatropin therapy. In all reported cases, IH-associated signs and symptoms rapidly resolved after cessation of therapy or a reduction of somatropin dose.
Perform fundoscopic examination before initiating treatment with NGENLA to exclude preexisting papilledema and periodically thereafter. If papilledema is identified prior to initiation, evaluate the etiology and treat the underlying cause before initiating NGENLA.
NGENLA should be temporarily discontinued in patients with clinical or fundoscopic evidence of IH. If IH is confirmed, restart treatment with NGENLA at a lower dose after IH-associated signs and symptoms have resolved. 6 Fluid Retention Fluid retention during NGENLA therapy may occur.
g. edema and nerve compression syndromes including carpal tunnel syndrome/paresthesia) are usually transient and dose dependent. 7 Hypoadrenalism Patients receiving growth hormone therapy who have or are at risk for pituitary hormone deficiency(s) may be at risk for reduced serum cortisol levels and/or unmasking of central (secondary) hypoadrenalism.
In addition, patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses following initiation of NGENLA treatment. Monitor patients for reduced serum cortisol levels and/or need for glucocorticoid dose increases in those with known hypoadrenalism [see Drug Interactions (7) ] .
8 Hypothyroidism Undiagnosed/untreated hypothyroidism may prevent an optimal response to NGENLA therapy. In patients with GH deficiency, central (secondary) hypothyroidism may first become evident or worsen during treatment with growth hormone therapy.
Therefore, patients should have periodic thyroid function tests and thyroid hormone replacement therapy should be initiated or appropriately adjusted when indicated. 9 Slipped Capital Femoral Epiphysis Slipped capital femoral epiphysis may occur more frequently in patients undergoing rapid growth.
Slipped capital femoral epiphysis may lead to osteonecrosis. Cases of slipped capital femoral epiphysis with or without osteonecrosis have been reported in pediatric patients with short stature receiving somatropin products or NGENLA .
Evaluate pediatric patients receiving NGENLA with the onset of a limp or complaints of persistent hip or knee pain for slipped capital femoral epiphysis and osteonecrosis and manage accordingly. 10 Progression of Preexisting Scoliosis NGENLA increases growth rate, and progression of preexisting scoliosis can occur in patients who experience rapid growth.
Growth hormone treatment has not been shown to increase the occurrence of scoliosis. Monitor patients with a history of scoliosis for disease progression. 11 Pancreatitis Cases of pancreatitis have been reported in patients receiving somatropin.
The risk may be greater in pediatric patients compared with adults. Consider pancreatitis in patients who develop persistent severe abdominal pain. 12 Lipoatrophy When NGENLA is administered subcutaneously at the same site over a long period of time, lipoatrophy may result.
1) ]. 13 Sudden Death in Pediatric Patients with Prader-Willi Syndrome There have been reports of sudden death after initiating therapy with somatropin in pediatric patients with Prader-Willi syndrome who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnea, or unidentified respiratory infection.
Male patients with one or more of these factors may be at greater risk than females. NGENLA is not indicated for the treatment of pediatric patients who have growth failure due to genetically confirmed Prader-Willi syndrome. 14 Laboratory Tests Serum levels of phosphorus, alkaline phosphatase, and parathyroid hormone may increase with NGENLA therapy.
If a patient is found to have abnormal laboratory tests, monitor as appropriate.
Benign intracranial hypertension Intracranial hypertension (IH) with papilledema, ataxia, visual changes, headache, nausea and/or vomiting has been reported in a small number of patients treated with growth hormone medicinal products.
Funduscopic examination is recommended at the initiation of treatment and as clinically warranted. In patients with clinical or funduscopic evidence of IH, somatrogon should be temporarily discontinued. At present there is insufficient evidence to give specific advice on the continuation of growth hormone treatment in patients with resolved IH.
If treatment with somatrogon is restarted, monitoring for signs and symptoms of IH is necessary. e. 1 – 56 mg/week) compared to patients receiving placebo, 42% vs. 19%. Based on this information, these types of patients should not be treated with somatrogon.
As there is no information available on the safety of growth hormone substitution therapy in acutely critically ill patients, the benefits of continued somatrogon treatment in this situation should be weighed against the potential risks involved.
In all patients developing other or similar acute critical illness, the possible benefit of treatment with somatrogon must be weighed against the potential risk involved. Pancreatitis Although rare in patients treated with growth hormone medicinal products, pancreatitis should be considered in somatrogon-treated patients who develop severe abdominal pain during treatment.
Scoliosis Because somatrogon increases growth rate, signs of development or progression of scoliosis should be monitored during treatment. Epiphyseal disorders Epiphyseal disorders, including slipped capital femoral epiphysis may occur more frequently in patients with endocrine disorders or in patients undergoing rapid growth.
Any paediatric patient with the onset of a limp or complaints of hip or knee pain during treatment should be carefully evaluated. Oral oestrogen therapy Oral oestrogen influences the IGF-1 response to growth hormone. 2). In female patients on oral oestrogen-containing therapy, a higher […]