Somatropin 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 June 17, 2024[1]
Paediatric Patients Humatrope is indicated for the long-term treatment of children who have growth failure due to an inadequate secretion of normal endogenous growth hormone. Humatrope is also indicated for the treatment of short stature in children with Turner Syndrome, confirmed by chromosome analysis.
Humatrope is also indicated for the treatment of patients who have growth failure associated with SHOX deficiency, as confirmed by DNA analysis. Humatrope is also indicated for the treatment of growth retardation in prepubertal children with chronic renal insufficiency.
5 and parental adjusted height SDS < - 1) in short children born small for gestational age (SGA), with a birth weight and/or length below – 2 SD, who failed to show catch up growth (height velocity SDS < 0 during the last year) by 4 years of age or later.
Adult Patients Humatrope is indicated for replacement therapy in adults with pronounced growth hormone deficiency. Patients with severe growth hormone deficiency in adulthood are defined as patients with known hypothalamic-pituitary pathology and at least one known deficiency of a pituitary hormone not being prolactin.
CACanada· Health Canada
24 products
Uses
CAOfficial regulatory label· revised March 22, 2025[2]
Omnitrope (somatropin for injection) is indicated for:
Children The long-term treatment of children, who have growth failure due to an inadequate secretion of endogenous growth hormone (growth hormone deficiency [GHD]). Other causes of short stature should be excluded. SGA Indication Omnitrope is indicated for the treatment of growth failure (current height standard deviation score [SDS] < - 2) in short children born SGA (birth weight and/or length below -2 SD) and who fail to achieve catch-up growth (height velocity SDS < 0 during the last year) by 2 to 4 years or later.
TS Indication The treatment of short stature associated with Turner syndrome in patients whose epiphyses are not closed. 25, and associated with growth rates unlikely to permit attainment of adult height in the normal range, in pediatric patients for whom diagnostic evaluation excludes other causes associated with short stature that should be observed or treated by other means.
USUnited States· FDA
2 products
Uses
USOfficial regulatory label· revised July 7, 2025[3]
25, and associated with growth rates unlikely to permit attainment of adult height in the normal range, • growth failure due to Prader-Willi syndrome (PWS). 2 Adult Patients NORDITROPIN is indicated for the replacement of endogenous GH in adults with growth hormone deficiency (GHD)
How to take
US
EUEuropean Union· EMA
2 products
Uses
EUOfficial regulatory label· revised August 5, 2025[4]
Infants, children and adolescents - Growth disturbance due to insufficient secretion of growth hormone (growth hormone deficiency, GHD). - Growth disturbance associated with Turner syndrome. - Growth disturbance associated with chronic renal insufficiency.
5 and parental adjusted height SDS < -1) in short children/adolescents born small for gestational age (SGA), with a birth weight and/or length below -2 standard deviation (SD), who failed to show catch-up growth (height velocity (HV) SDS < 0 during the last year) by 4 years of age or later.
- Prader-Willi syndrome (PWS), for improvement of growth and body composition. The diagnosis of PWS should be confirmed by appropriate genetic testing. Adults - Replacement therapy in adults with pronounced growth hormone deficiency.
- Adult onset: Patients who have severe growth hormone deficiency associated with multiple hormone deficiencies as a result of known hypothalamic or pituitary pathology, and who have at least one known deficiency of a pituitary hormone not being prolactin.
Drug interactions
Known interactions involving Somatropin. Select one for details. This list is informational and not a complete interaction checker.
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Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
[1]MHRA (UK) · PL148950290 · revised June 17, 2024
[2]Health Canada (DPD) · 02325063 · revised March 22, 2025
[3]FDA DailyMed · 1058e17c-9261-45… · revised July 7, 2025 [PDF]
[4]European Medicines Agency · EMEA/H/C/000607 · revised August 5, 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.
These patients should undergo a single dynamic test in order to diagnose or exclude a growth deficiency. In patients with childhood onset isolated GH deficiency (no evidence of hypothalamic-pituitary disease or cranial irradiation), two dynamic tests should be recommended, except for those having low IGF-I concentrations (<2SDS) who may be considered for one test.
The cut-off point of the dynamic test should be strict.
How to take
GBOfficial regulatory label· revised June 17, 2024[1]
035 mg/kg of body weight per day by subcutaneous injection. 0 mg/m2 body surface area per day. 30 mg/day. A lower starting dose may be necessary in older and obese patients. This dose should be gradually increased according to individual patient requirements based on the clinical response and serum IGF-I concentrations.
Total daily dose usually does not exceed 1 mg. IGF-I concentrations should be maintained below the upper limit of the age-specific normal range. The minimum effective dose should be used and dose requirements may decline with increasing age.
Women may require higher doses than men, with men showing an increasing IGF-I sensitivity over time. This means that there is a risk that women, especially those on oral oestrogen therapy are under-treated while men are over-treated.
8). 050 mg/kg of body weight per day given as a subcutaneous injection to be administered preferably in the evening. 4 mg/m2 per day. 050 mg/kg of body weight per day given as a subcutaneous injection. 050 mg/kg of body weight per day given as subcutaneous injection.
1). 0 SDS. Treatment should be discontinued if height velocity is <2cm/year and, if confirmation is required, bone age is >14 years (girls) or >16 years (boys), corresponding to closure of epiphyseal growth plates. Method of administration Humatrope is administered by subcutaneous injection after reconstitution The subcutaneous injection sites should be varied in order to avoid lipoatrophy.
6.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised June 17, 2024[1]
The following table of undesirable effects and frequencies is based on clinical trial and post- marketing spontaneous reports. 1 % adults Paediatric patients In clinical trials with growth hormone deficient patients approximately 2 % of the patients developed antibodies to growth hormone.
In trials in Turner Syndrome where higher doses were used, up to 8 % of patients developed antibodies to growth hormone. The binding capacity of these antibodies was low and growth rate was not affected adversely. Testing for antibodies to growth hormone should be carried out in any patient who fails to respond to therapy.
A mild and transient oedema was observed early during the course of treatment. Leukaemia has been reported in a small number of children who have been treated with growth hormone. However there is no evidence that leukaemia incidence is increased in growth hormone recipients without predisposing factors.
Adult patients In patients with adult onset growth hormone deficiency, oedema, muscle pain and joint pain and disorder, were reported early in therapy and tended to be transient. Adult patients treated with growth hormone, following diagnosis of growth hormone deficiency in childhood, reported side effects less frequently than those with adult onset growth hormone deficiency.
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 June 17, 2024[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. 2). Previous paediatric subjects, who had been treated with growth hormone during childhood until final height was attained, should be re-evaluated for growth hormone deficiency after epiphyseal closure, before replacement therapy is commenced at the doses recommended for adults.
Diagnosis and therapy with Humatrope should be initiated and monitored by physicians who are appropriately qualified and experienced in the diagnosis and management of patients with growth hormone deficiency. There is so far no evidence to suspect that growth hormone replacement influences the recurrence rate or regrowth of intracranial neoplasms, but standard clinical practice requires regular pituitary imaging in patients with a history of pituitary pathology.
A baseline scan is recommended in these patients before instituting growth hormone replacement therapy. In childhood cancer survivors, a higher risk of a second neoplasm (benign or malignant) has been reported in patients treated with somatropin.
Intracranial tumours, in particular, were the most common of these second neoplasms. In cases of severe or recurrent headache, visual problems, nausea and/or vomiting, a fundoscopy for papilloedema is recommended. If papilloedema is confirmed a diagnosis of benign intracranial hypertension should be considered and, if appropriate, the growth hormone treatment should be discontinued.
At present there is insufficient evidence to guide clinical decision making in patients with resolved intracranial hypertension. If growth hormone treatment is restarted, careful monitoring for symptoms of intracranial hypertension is necessary.
Patients with endocrine disorders, including growth hormone deficiency, may develop slipped capital epiphyses more frequently. Any child with the onset of a limp during growth hormone therapy should be evaluated. Growth hormone increases the extrathyroidal conversion of T4 to T3 and may as such unmask incipient hypothyroidism.
Monitoring of thyroid function should therefore be conducted in all patients. In patients with hypopituitarism, standard replacement therapy must be closely monitored when somatropin therapy is administered. For paediatric patients, the treatment should be continued until the end of the growth has been reached.
It is advisable not to exceed the recommended dosage in view of the potential risks of acromegaly, hyperglycaemia and glucosuria. Before instituting treatment with somatropin for growth retardation secondary to chronic renal insufficiency, patients should have been followed for one year to verify growth disturbance.
Conservative treatment for renal insufficiency (which includes control of acidosis, hyperparathyroidism and nutritional status for one year prior to the treatment) should have been established and should be maintained during treatment.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised June 17, 2024[1]
Somatropin must not be used when there is any evidence of activity of a tumour. Intracranial tumours must be inactive and antitumour therapy must be completed prior to starting GH therapy. Treatment should be discontinued if there is evidence of tumour growth.
Humatrope should not be reconstituted with the supplied solvent for patients with a known sensitivity to either metacresol or glycerol. Humatrope should not be used for growth promotion in children with closed epiphyses. 4). 1.
This is not medical advice. Consult a qualified healthcare professional.
Omnitrope treatment for ISS should be prescribed only for those patients whose epiphyses are not closed. Adults Omnitrope (somatropin [rDNA origin] for injection) is indicated for replacement of endogenous growth hormone in adults with growth hormone deficiency who meet either of the following two criteria: Adult Onset (AO): Patients who have growth hormone deficiency, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; or Childhood Onset (CO): Patients who were growth hormone deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes.
Patients who were treated with somatropin for growth hormone deficiency in childhood and whose epiphyses are closed should be re-evaluated before continuation of somatropin therapy at the reduced dose level recommended for growth hormone deficient adults.
According to current standards, confirmation of the diagnosis of adult growth hormone deficiency in both groups involves an appropriate growth hormone provocative test with two exceptions: (1) patients with multiple other pituitary hormone deficiencies due to organic disease; and (2) patients with congenital/genetic growth hormone deficiency.
1 Pediatrics Based on the data submitted and reviewed by Health Canada, the efficacy and safety of Omnitrope in pediatric patients has been established. Therefore Health Canada has authorized indications for pediatric use (see 1 INDICATIONS, 14 CLINICAL TRIALS).
4 Geriatrics).
How to take
CAOfficial regulatory label· revised March 22, 2025[2]
1 Dosing Considerations Therapy with Omnitrope (somatropin for injection) should be supervised by a physician who is experienced in the diagnosis and management of pediatric patients with growth failure associated with growth hormone deficiency (GHD), Turner syndrome (TS), those who were born small for gestational age (SGA) or Idiopathic Short Stature (ISS), and adult patients with either childhood onset or adult onset GHD.
The Omnitrope dosage and administration schedule should be individualized based on the growth response of each patient. Response to somatropin therapy in pediatric patients tends to decrease with time. However, in pediatric patients, the failure to increase growth rate, particularly during the first year of therapy, indicates the need for close assessment of compliance and evaluation for other causes of growth failure, such as hypothyroidism, undernutrition, advanced bone age and antibodies to recombinant human GH (rhGH).
Treatment with Omnitrope for short stature should be discontinued when the epiphyses are fused. 24 mg/kg body weight/week SC Divided into 6-7 doses diagnosis of GHD should be confirmed before Omnitrope is administered. 48 mg/kg body weight per week SC Divided into 6-7 doses 1 Omnitrope dosage must be adjusted for the individual patient.
33 mg. Women may require higher doses than men. This means that there is a risk that women, especially those on oral estrogen replacement may be under-treated. As normal physiological growth hormone production decreases with age, dose requirements may be reduced.
3 Treatment should stop when near adult height is achieved (height velocity < 2 cm/ yr and/or bone age >16 yr in boys and >14 yr in girls) or when height is in the normal adult range (above -2 SDS). 4 Omnitrope may be administered in the thigh, buttocks or abdomen; the site of SC injections (administered preferably in the evenings) should be rotated daily to help prevent lipoatrophy.
OMNITROPE (somatropin for injection) Page 7 of 69 Adults Growth Hormone Deficiency Clinical response, side effects and determination of IGF-1 in serum may be used as guidance for dose titration. The level of IGF-1 should not exceed the upper limit of normal IGF-1 levels matched to age and sex.
It is recommended that IGF-1 concentrations be monitored regularly and GH dose be reduced in children with a plasma IGF-1 above + 2SD. 24 mg/kg/week) should be considered if substantial catch-up growth is observed during the first few years of therapy.
24 mg/kg/week), and titrating the dose as needed over time. In all children, clinicians should carefully monitor the growth response, and adjust the somatropin dose as necessary. Dosing should continue until final height is reached. Treatment should be discontinued after the first year of treatment if the height velocity SDS is below + 1.
Treatment should be discontinued if height velocity is < 2 cm/year and, if confirmation is required, bone age is > 14 years (girls) or > 16 years (boys) corresponding to closure of the epiphyseal growth plates. In short children born SGA, it is recommended that IGF I concentration be measured before initiation of treatment and monitored every 6 months thereafter.
If on repeated measurements IGF-1 concentrations exceed +2 SD compared to references for age and pubertal status, the IGF-1/IGFBP-3 ratio could be taken into account to consider dose adjustment. No studies with somatropin have been carried out in geriatric patients or in patients with hepatic or renal impairment.
5 mL solutions for injection, are sterile, ready-to-use solutions filled in pen cartridges. The presentations are indicated for multiple use. 5 mL respectively. The solutions must be administered using sterile, disposable pen needles.
The solution must be clear prior to insertion of the cartridge into the Pen. Do not inject if the solution is cloudy. Patients and caregivers have to receive appropriate training and instruction on the proper use of the Omnitrope cartridges and pens from the physician or other suitable qualified healthcare professionals.
After the first injection, the content of the cartridge must be used within 28 days. The cartridge should remain in the pen and be refrigerated between 2 and 8°C. Do not freeze. Protect from light (see 11 OMNITROPE (somatropin for injection) Page 8 of 69 STORAGE, STABILITY AND DISPOSAL).
The following is a general description of […]
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
CAOfficial regulatory label· Adverse reactions· revised March 22, 2025[2]
). g. hypertension, stroke, and aortic dilatation, aneurysm and dissection) and these patients should be monitored closely for development or worsening of these conditions before and during treatment with somatropin. Patients with Turner syndrome have an inherently increased risk of developing autoimmune thyroid disease.
Therefore, these patients should have periodic thyroid function tests performed and be OMNITROPE (somatropin for injection) Page 12 of 69 treated appropriately (see 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism).
Note:
Skeletal abnormalities including scoliosis are commonly seen in untreated patients with Turner syndrome. Dependence/ Liability Somatropin is not considered to be a drug that has potential to produce drug dependency. Somatropin does not have stimulant, depressant or hallucinogenic effects on the central nervous system that could be expected to lead to psychological or physical dependency.
Potential for Misuse:
Inappropriate use of somatropin by individuals who do not have indications for which growth hormone is approved, may result in clinically significant negative health consequences Endocrine and Metabolism Patients with diabetes mellitus or glucose intolerance should be monitored closely during therapy with somatropin as an adjustment of their antidiabetic therapy may be required.
Treatment with somatropin may decrease insulin sensitivity, particularly at higher doses in patients with risk factors for diabetes mellitus, such as obesity, Turner syndrome, or a family history of diabetes mellitus, those receiving high dose corticosteroid therapy, and patients with impaired glucose tolerance or pre-existing diabetes mellitus.
As a result, previously undiagnosed impaired glucose tolerance and overt diabetes mellitus may be unmasked during somatropin treatment. Therefore, patients who receive somatropin should be monitored for evidence of abnormal glucose metabolism and/or diabetes mellitus.
New-onset type 2 diabetes mellitus has been reported in children and adults receiving somatropin. In patients with hypopituitarism standard hormonal replacement therapy should be monitored closely when Omnitrope therapy is administered.
Somatropin can increase the extrathyroidal conversion of thyroxine (T4) to triiodothyronine (T3) and may unmask incipient hypothyroidism. Because inadequate treatment of hypothyroidism may prevent optimal response to somatropin, thyroid function should be evaluated before starting somatropin therapy and should be monitored regularly during treatment, not less frequently than annually.
Notes Regarding Potential Effects of Somatropin on Glucocorticoid Metabolism:
The microsomal enzyme 11β-hydroxysteroid dehydrogenase type 1 (11βHSD-1) is required for conversion of cortisone to its active metabolite, cortisol in hepatic and adipose tissue. Endogenous growth hormone and exogenous somatropin inhibit the activity of 11βHSD-1.
Therefore growth hormone deficiency is associated with a relative increase in 11βHSD-1 activity, which in turn results in a relative increase in serum cortisol. Somatropin treatment may inhibit 11βHSD-1, resulting in relative reduction of serum cortisol concentrations.
In addition, somatropin may enhance the activity of CYP3A4, a cytochrome P450 enzyme involved in glucocorticoid catabolism. Therefore, by increasing the activity of CYP3A4, somatropin could potentially decrease serum cortisol concentration.
Because somatropin may both inhibit 11βHSD-1 (an enzyme required for production of cortisol) and induce activity of CYP3A4 (an enzyme involved in cortisol breakdown), careful monitoring of serum cortisol concentrations is required for all patients receiving concomitant glucocorticoid and somatropin therapy.
OMNITROPE (somatropin for injection) Page 13 of 69 As a consequence of its actions on enzymes involved in cortisol metabolism, somatropin treatment may unmask previously undiagnosed central (secondary) hypoadrenalism, and glucocorticoid replacement may be required.
In addition, patients treated with glucocorticoids for previously diagnosed hypoadrenalism (primary or secondary) may require adjustments of their maintenance or stress doses following initiation of somatropin treatment; this may be especially true for patients treated with cortisone acetate and prednisone, because conversion of these drugs to their biologically active metabolites is dependent on the activity of 11βHSD-1 (see 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests).
Fluid Retention Fluid retention during somatropin replacement therapy in adults may occur. Clinical manifestations of fluid retention are usually transient and dose dependent.
Immune Local allergic reactions:
Patients receiving somatropin treatment may experience redness, swelling, pain, inflammation, or itching at the site of injection (see 8 ADVERSE REACTIONS). Most of these minor reactions usually resolve in a few days to a few weeks.
Such reactions may occur if the injection is given incorrectly (irritants in the skin cleansing agent or poor injection technique), or if the patient is allergic to somatropin or any non-medicinal ingredient (see 2 CONTRAINDICATIONS).
Rarely, subcutaneous administration of somatropin can result in lipoatrophy or lipohypertrophy. Regular rotation of the injection site may help reduce or prevent these reactions. Patients should be advised to consult their doctor if they notice any of the conditions described above.
On rare occasion, injection site reactions may require discontinuation of somatropin therapy.
Systemic allergic reactions:
As with any protein, local or systemic allergic reactions may occur. Parents/patients should be informed that such reactions are possible and that prompt medical attention should be sought if allergic reactions occur. These reactions may be characterized by a generalized rash (with pruritus), shortness of breath, wheezing, […]
CAOfficial regulatory label· Warnings and precautions· revised March 22, 2025[2]
4 Geriatrics). 2 CONTRAINDICATIONS Omnitrope (somatropin for injection) should not be used when there is any evidence of neoplastic activity. Intracranial lesions must be inactive and antitumour therapy complete prior to the institution of therapy.
Treatment with Omnitrope should be discontinued if there is evidence of tumour growth. Growth hormone should not be used for growth promotion in children with fused epiphyses. Somatropin is contraindicated in patients with active proliferative or severe non-proliferative diabetic retinopathy.
Omnitrope is contraindicated in patients with acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma, or acute respiratory failure. 5 mL solution which also contains the preservative benzyl alcohol, should not be administered in newborns or in patients with a known sensitivity to benzyl alcohol (see 7 WARNINGS AND PRECAUTIONS).
Omnitrope is contraindicated in patients with a history of hypersensitivity to any of its components. 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions • Therapy with somatropin should be supervised by a physician who is experienced in the diagnosis and management of patients with growth hormone deficiency and that any change in brand of somatropin products should be made cautiously and only under medical supervision.
5 mL solution has been associated with toxicity in newborns. It must not be used in newborns (see 7 WARNINGS AND PRECAUTIONS, Sensitivity/Resistance). 1 Dosing Considerations Therapy with Omnitrope (somatropin for injection) should be supervised by a physician who is experienced in the diagnosis and management of pediatric patients with growth failure associated with growth hormone deficiency (GHD), Turner syndrome (TS), those who were born small for gestational age (SGA) or Idiopathic Short Stature (ISS), and adult patients with either childhood onset or adult onset GHD.
The Omnitrope dosage and administration schedule should be individualized based on the growth response of each patient. Response to somatropin therapy in pediatric patients tends to decrease with time. However, in pediatric patients, the failure to increase growth rate, particularly during the first year of therapy, indicates the need for close assessment of compliance and evaluation for other causes of growth failure, such as hypothyroidism, undernutrition, advanced bone age and antibodies to recombinant human GH (rhGH).
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
CAOfficial regulatory label· Contraindications· revised March 22, 2025[2]
Omnitrope (somatropin for injection) should not be used when there is any evidence of neoplastic activity. Intracranial lesions must be inactive and antitumour therapy complete prior to the institution of therapy. Treatment with Omnitrope should be discontinued if there is evidence of tumour growth.
Growth hormone should not be used for growth promotion in children with fused epiphyses. Somatropin is contraindicated in patients with active proliferative or severe non-proliferative diabetic retinopathy. Omnitrope is contraindicated in patients with acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma, or acute respiratory failure.
5 mL solution which also contains the preservative benzyl alcohol, should not be administered in newborns or in patients with a known sensitivity to benzyl alcohol (see 7 WARNINGS AND PRECAUTIONS). Omnitrope is contraindicated in patients with a history of hypersensitivity to any of its components.
This is not medical advice. Consult a qualified healthcare professional.
1 Administration and Use Instructions • Therapy with NORDITROPIN should be supervised by a physician who is experienced in the diagnosis and management of patients with the conditions for which NORDITROPIN is indicated [see Indications and Usage (1) ].
5) ]. • Administer NORDITROPIN by subcutaneous injection to the back of the upper arm, abdomen, buttocks, or thigh with regular rotation of injection sites to avoid lipoatrophy. • Inspect visually for particulate matter and discoloration.
NORDITROPIN should be clear and colorless. If the solution is cloudy or contains particulate matter do not use. • Instructions for delivering the dosage are provided in the PATIENT INFORMATION and INSTRUCTIONS FOR USE leaflets enclosed with the NORDITROPIN FlexPro prefilled pen.
2 Pediatric Dosage • Individualize dosage for each patient based on the growth response. • Divide the calculated weekly NORDITROPIN dosage into equal doses given either 6, or 7 days per week. 067 mg/kg/day). Consider a gradual reduction in dosage if substantial catch-up growth is observed during the first few years of therapy.
033 mg/kg/day and titrate the dose as needed. 034 mg/kg/day) • Assess compliance and evaluate other causes of poor growth such as hypothyroidism, under-nutrition, advanced bone age and antibodies to recombinant human growth hormone if patients experience failure to increase height velocity, particularly during the first year of treatment.
• Discontinue NORDITROPIN for stimulation of linear growth once epiphyseal fusion has occurred [see Contraindications (4) ]. 3 Adult Dosage • Patients who were treated with somatropin for GH deficiency in childhood and whose epiphyses are closed should be reevaluated before continuation of somatropin for GH deficient adults.
5) ]. • Estrogen-replete women and patients receiving oral estrogen may require higher doses [see Drug Interactions (7) ]. • Administer the prescribed dose daily. 2 mg/day, according to individual patient requirements based on the clinical response and serum insulin-like growth factor 1 (IGF-1) concentrations.
• Decrease the dose as necessary on the basis of adverse reactions and/or serum IGF-1 concentrations above the age- and gender-specific normal range. • Maintenance dosages will vary considerably from person to person, and between male and female patients.
016 mg/kg daily. • Use the patient’s clinical response, adverse reactions, and determination of age- and gender-adjusted serum IGF-1 concentrations as guidance in dose titration. • Not recommended for obese patients as they are more likely to experience adverse reactions with this regimen
This is not medical advice. Consult a qualified healthcare professional.
Most-reported reactions to the US regulator (12 mo to June 4, 2026): 8,499 reports total. [5]
Drug Dose Omission By Device 2,654
Device Breakage 1,949
Device Leakage 1,750
Device Mechanical Issue 1,302
Device Information Output Issue 1,296
Circumstance Or Information Capable Of Leading To Medication Error 704
Device Issue 642
Circumstance Or Information Capable Of Leading To Device Use Error 599
Device Defective 579
Device Use Error 531
Device Delivery System Issue 529
Device Physical Property Issue 523
Side effects & warnings
USOfficial regulatory label· Adverse reactions· revised July 7, 2025[3]
13) ] Common adverse reactions in adult and pediatric patients include: upper respiratory infection, fever, pharyngitis, headache, otitis media, edema, arthralgia, paresthesia, myalgia, peripheral edema, flu syndrome, and impaired glucose tolerance.
gov/medwatch. 1 Clinical Trials Experience Because clinical trials are conducted under varying conditions, adverse reaction rates observed during the clinical trials performed with one somatropin product cannot always be directly compared to the rates observed during the clinical trials performed with another somatropin product, and may not reflect the adverse reaction rates observed in practice.
Pediatric Patients Growth Failure due to Inadequate Secretion of Endogenous Growth Hormone In one randomized, open label, clinical study the most frequent adverse reactions were headache, pharyngitis, otitis media and fever. 1 mg/kg/day).
066 mg/kg/day. After the two-year study, patients continued NORDITROPIN treatment until final height was achieved; randomized dose groups were not maintained. Adverse reactions were later collected retrospectively from 18 pediatric patients; total follow-up was 11 years.
An additional 6 pediatric patients were not randomized, but followed the protocol and are included in this assessment of adverse reactions. The most frequent adverse reactions were upper respiratory infection, gastroenteritis, ear infection, and influenza.
Cardiac disorders was the system organ class with the second most adverse reactions reported. 066 mg/kg/day respectively. 066 mg/kg/day dose group. 066 mg/kg/day dose group. Short Stature Associated with Turner Syndrome In two clinical studies in pediatric patients that were treated until final height with various doses of NORDITROPIN, the most frequently reported adverse reactions were influenza-like illness, otitis media, upper respiratory tract infection, otitis externa, gastroenteritis, eczema and, impaired fasting glucose.
Adverse reactions in study 1 were most frequent in the highest dose groups. Three patients in study 1 had excessive growth of hands and/or feet in the high dose groups. 045 mg/kg/day group. 5 years for girls and boys, respectively). The most frequently reported adverse reactions were influenza-like illness, upper respiratory tract infection, bronchitis, gastroenteritis, abdominal pain, otitis media, pharyngitis, arthralgia, headache, gynecomastia, and increased sweating.
067 mg/kg/day developed a melanocytic nevus. 033 mg/kg/day of NORDITROPIN had increased fasting blood glucose levels after 1 year of treatment. In addition, small increases in mean fasting blood glucose and insulin levels after 1 and 2 years of NORDITROPIN treatment appeared to be dose-dependent.
067 mg/kg/day) for 2 years or were untreated for 1 year. Adverse reactions were otitis media, arthralgia and impaired glucose tolerance. 067 mg/kg/day treatment group. Idiopathic Short Stature In two open-label clinical studies with another somatropin product in pediatric patients, the most common adverse reactions were upper respiratory tract infections, influenza, tonsillitis, nasopharyngitis, gastroenteritis, headaches, increased appetite, pyrexia, fracture, altered mood, and arthralgia.
Growth Failure Due to Prader-Willi Syndrome In two clinical studies in pediatric patients with PWS carried out with another somatropin product, the following adverse reactions were reported: edema, aggressiveness, arthralgia, benign intracranial hypertension, hair loss, headache, and myalgia.
Adult Patients Adults with Growth Hormone Deficiency Adverse reactions with an incidence of ≥5% occurring in patients with AO GHD during the 6 month placebo-controlled portion of a clinical trial for NORDITROPIN are presented in Table 1 .
2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of somatropin or NORDITROPIN. Because these adverse 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 .
10)]. Cases have been reported with NORDITROPIN. Investigations — Increase in blood alkaline phosphatase level — Decrease in serum thyroxin (T4) levels Gastrointestinal — Pancreatitis Neoplasm — Leukemia has been reported in a small number of GH deficient children treated with somatropin, somatrem (methionylated rhGH) and GH of pituitary origin
USOfficial regulatory label· Warnings and precautions· revised July 7, 2025[3]
5 WARNINGS AND PRECAUTIONS • Increased Risk of Neoplasms : Second neoplasms have occurred in childhood cancer survivors. Monitor patients with preexisting tumors for progression or recurrence. 3 ) • Glucose Intolerance and Diabetes Mellitus : NORDITROPIN may decrease insulin sensitivity, particularly at higher doses.
Monitor glucose levels periodically in all patients receiving NORDITROPIN, especially in patients with existing diabetes mellitus or at risk for development. 4 ) • Intracranial Hypertension (IH) : Has been reported usually within 8 weeks of initiation.
Perform fundoscopic examinations prior to initiation and periodically thereafter. If papilledema occurs, stop treatment. 5 ) • Severe Hypersensitivity : Serious hypersensitivity reactions may occur. In the event of an allergic reaction, seek prompt medical attention.
6 ) • Fluid Retention : May occur in adults and may be dose dependent. 7 ) • Hypoadrenalism : Monitor patients for reduced serum cortisol levels and/or need for glucocorticoid dose increases in those with known hypoadrenalism. 8 ) • Hypothyroidism : Monitor thyroid function periodically as hypothyroidism may occur or worsen after initiation of somatropin.
9 ) • Slipped Capital Femoral Epiphysis in Pediatric Patients : May occur; evaluate patients with onset of a limp or hip/knee pain. 10 ) • Progression of Preexisting Scoliosis in Pediatric Patients : Monitor patients with scoliosis for progression.
11 ) • Pancreatitis : Has been reported; consider pancreatitis in patients with abdominal pain, especially pediatric patients. 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 after treatment with pharmacologic amounts of somatropin [see Contraindications (4) ].
Two placebo-controlled clinical trials in non-growth hormone deficient adult patients (n=522) with these conditions in intensive care units revealed a significant increase in mortality (42% vs. 3-8 mg/day) compared to those receiving placebo.
The safety of continuing NORDITROPIN treatment in patients receiving replacement doses for approved indications who concurrently develop these illnesses has not been established. NORDITROPIN is not indicated for the treatment of non-GH deficient adults.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
USOfficial regulatory label· Contraindications· revised July 7, 2025[3]
1) ]. 2) ]. 3) ]. • Hypersensitivity to NORDITROPIN or any of its excipients. 6) ]. • Active proliferative or severe non-proliferative diabetic retinopathy. • Pediatric patients with closed epiphyses. • Acute Critical Illness ( 4 ) • Pediatric patients with Prader-Willi syndrome who are severely obese, have history of severe upper airway obstruction, or have severe respiratory impairment due to risk of sudden death ( 4 ) • Active Malignancy ( 4 ) • Hypersensitivity to somatropin or excipients ( 4 ) • Active Proliferative or Severe Non-Proliferative Diabetic Retinopathy ( 4 ) • Pediatric patients with closed epiphyses ( 4 )
This is not medical advice. Consult a qualified healthcare professional.
These patients should undergo an appropriate dynamic test in order to diagnose or exclude a growth hormone deficiency. - Childhood onset: Patients who were growth hormone deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes.
Patients with childhood onset GHD should be re-evaluated for growth hormone secretory capacity after completion of longitudinal growth. e. a congenital cause or GHD secondary to a hypothalamic-pituitary disease or insult, an insulin-like growth factor-I (IGF-I) SDS < -2 off growth hormone treatment for at least 4 weeks should be considered sufficient evidence of profound GHD.
All other patients will require IGF-I assay and one growth hormone stimulation test.
How to take
EUOfficial regulatory label· revised August 5, 2025[4]
Diagnosis and therapy with somatropin should be initiated and monitored by physicians who are appropriately qualified and experienced in the diagnosis and management of patients with growth disorders. Posology Paediatric population The posology and administration schedule should be individualised.
0 mg/m2 body surface area per day is recommended. Even higher doses have been used. g. body composition, bone mass). e. standardized to average adult peak bone mass measured by dual energy X-ray absorptiometry taking into account sex and ethnicity) is one of the therapeutic objectives during the transition period.
For guidance on dosing see adult section below. 0 mg/m2 body surface area per day is recommended. 7 mg should not be exceeded. Treatment should not be used in paediatric patients with a growth velocity less than 1 cm per year and near closure of epiphyses.
4 mg/m2 body surface area per day is recommended. 4 mg/m2 body surface area per day) is recommended. Higher doses may be needed if growth velocity is too low. 4). 1). Treatment should be discontinued after the first year of treatment if the height velocity SDS is below + 1.
Treatment should be discontinued if height velocity is < 2 cm/year and, if confirmation is required, bone age is > 14 years (girls) or > 16 years (boys), corresponding to closure of the epiphyseal growth plates. 5 mg per day. The dose should be gradually increased or decreased according to individual patient requirements as determined by the IGF-I concentration.
3 mg per day. The dose should be gradually increased according to individual patient requirements as determined by the IGF-I concentration. In both cases treatment goal should be insulin-like growth factor (IGF-I) concentrations within 2 SDS from the age corrected mean.
Patients with normal IGF-I concentrations at the start of the treatment should be administered growth hormone up to an IGF-I level into the upper range of normal, not exceeding the 2 SDS. Clinical response and side effects may also be used as guidance for dose titration.
It is recognized that there are patients with GHD who do not normalize IGF-I levels despite a good clinical response, and thus do not require dose escalation. 0 mg per day. Women may require higher doses than men, with men showing an increasing IGF-I sensitivity over time.
This means that there is a risk that women, especially those on oral oestrogen replacement are under-treated while men are over-treated. The accuracy of the growth hormone dose should therefore be controlled every 6 months. As normal physiological growth hormone production decreases with age, dose requirements may be reduced.
2 mg per day and should be slowly increased according to individual patient requirements. The minimum effective dose should be used. 5 mg per day. Method of administration The injection should be given subcutaneously and the site varied to prevent lipoatrophy.
6.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
EUOfficial regulatory label· Adverse reactions· revised August 5, 2025[4]
a. Summary of the safety profile Patients with growth hormone deficiency are characterised by extracellular volume deficit. When treatment with somatropin is started this deficit is rapidly corrected. Adverse reactions related to fluid retention, such as peripheral oedema and arthralgia are very common; musculoskeletal stiffness, myalgia and paraesthesia are common.
In general these adverse reactions are mild to moderate, arise within the first months of treatment and subside spontaneously or with dose-reduction. The incidence of these adverse reactions is related to the administered dose, the age of patients, and possibly inversely related to the age of patients at the onset of growth hormone deficiency.
Omnitrope has given rise to the formation of antibodies in approximately 1% of the patients. 4. b. Tabulated list of adverse reactions Table 1 shows the adverse reactions ranked under headings of System Organ Class and 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) for each of the indicated conditions.
Table 1 System organ Class Very commo n (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10, 0 00 to <1/100 0) Very rare (<1/10,00 0) Not known (cannot be estimated from available data) Neoplasms benign, malignant, and unspecified (including cysts and polyps) (Children) Leukaemia† 10 System organ Class Very commo n (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10, 0 00 to <1/100 0) Very rare (<1/10,00 0) Not known (cannot be estimated from available data) Endocrine disorders Hypothyroidism ** Metabolism and nutrition disorders (Adults and Children) Type 2 diabetes mellitus Nervous system disorders (Adults) Paraesthesia* (Adults) Carpal tunnel syndrome (Children) Benign intracranial hypertension (Children) Paraesthesia * (Adults) Benign intracranial hypertension (Adults and Children) Headache Skin and subcutaneous tissue disorders (Children) Rash**, Pruritus**, Urticaria** (Adults) Rash**, Pruritus**, Urticaria** Musculoskele tal and connective tissue disorders (Adults) Arthralg ia * (Adults) Myalgia* (Adults) Musculoskele tal stiffness* (Children) Arthralgia* (Children) Myalgia* (Children) Musculoskeletal stiffness* Reproductive system and breast disorders (Adults and Children) Gynaecomas tia General disorders and administratio n site conditions (Adults) Oedema peripher al * (Children) Injection-site reaction$ (Children) Oedema peripheral* (Adults and Children) Face oedema* (Adults) Injection-site reaction$ Investigations (Adults and Children) Blood cortisol decreased‡ *In general, these adverse effects are mild to moderate, arise within the first months of treatment, and subside spontaneously or with dose-reduction.
The incidence of these adverse effects is related to the administered dose, the age of the patients, and possibly inversely related to the age of the patients at the onset of growth hormone deficiency. **Adverse drug reaction (ADR) identified post-marketing.
$ Transient injection site reactions in children have been reported. 11 ‡ Clinical significance is unknown † Reported in growth hormone deficient children treated with somatropin, but the incidence appears to be similar to that in children without growth hormone deficiency.
c. Description of selected adverse reactions Reduced serum cortisol levels Somatropin has been reported to reduce serum cortisol levels, possibly by affecting carrier proteins or by increased hepatic clearance. The clinical relevance of these findings may be limited.
Nevertheless, corticosteroid replacement therapy should be optimised before initiation of therapy. Prader-Willi syndrome In the post-marketing experience rare cases of sudden death have been reported in patients affected by Prader-Willi syndrome treated with somatropin, although no causal relationship has been demonstrated.
Leukaemia Cases of leukaemia (rare or very rare) have been reported in growth hormone deficient children treated with somatropin and included in the post-marketing experience. However, there is no evidence of an increased risk of leukaemia without predisposition factors, such as radiation to the brain or head.
Slipped capital femoral epiphysis and Legg-Calvé-Perthes disease Slipped capital femoral epiphysis and Legg-Calvé-Perthes disease have been reported in children treated with GH. Slipped capital femoral epiphysis occurs more frequently in case of endocrine disorders and Legg-Calvé-Perthes is more frequent in case of short stature.
But it is unknown if these 2 pathologies are more frequent or not while treated with somatropin. Their diagnosis should be considered in a child with a discomfort or pain in the hip or knee. Other adverse drug reactions Other adverse drug reactions may be considered somatropin class effects, such as possible hyperglycaemia caused by decreased insulin sensitivity, decreased free thyroxin level and benign intra-cranial hypertension.
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.
EUOfficial regulatory label· Warnings and precautions· revised August 5, 2025[4]
2). 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. Hypoadrenalism Introduction of somatropin treatment may result in inhibition of 11βHSD-1 and reduced serum cortisol concentrations.
In patients treated with somatropin, previously undiagnosed central (secondary) hypoadrenalism may be unmasked and glucocorticoid replacement may be required. 5). Use with oral oestrogen therapy If a woman taking somatropin begins oral oestrogen therapy, the dose of somatropin may need to be increased to maintain the serum IGF-1 levels within the normal age-appropriate range.
5). Insulin sensitivity Somatropin may reduce insulin sensitivity. For patients with diabetes mellitus, the insulin dose may require adjustment after somatropin therapy is instituted. Patients with diabetes, glucose intolerance, or additional risk factors for diabetes should be monitored closely during somatropin therapy.
Thyroid function Growth hormone increases the extrathyroidal conversion of T4 to T3 which may result in a reduction in serum T4 and an increase in serum T3 concentrations. Whereas the peripheral thyroid hormone levels have remained within the reference ranges for healthy subjects, hypothyroidism theoretically may develop in subjects with subclinical hypothyroidism.
Consequently monitoring of thyroid function should therefore be conducted in all patients. In patients with hypopituitarism on standard replacement therapy, the potential effect of growth hormone treatment on thyroid function must be closely monitored Neoplasms In growth hormone deficiency, secondary to treatment of malignant disease, it is recommended to pay attention to signs of relapse of the malignancy.
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.
Slipped capital femoral epiphysis In patients with endocrine disorders, including growth hormone deficiency, slipped epiphyses of the hip may occur more frequently than in the general population. Patients limping during treatment with somatropin should be examined clinically.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
EUOfficial regulatory label· Contraindications· revised August 5, 2025[4]
1. Somatropin must not be used when there is any evidence of activity of a tumour. Intracranial tumours must be inactive and anti-tumour therapy must be completed prior to starting GH therapy. Treatment should be discontinued if there is evidence of tumour growth.
Somatropin must not be used for growth promotion in children with closed epiphyses. 4).
This is not medical advice. Consult a qualified healthcare professional.
Treatment with somatropin should be discontinued at the time of renal transplantation. The effects of growth hormone on recovery were studied in two placebo-controlled clinical trials involving 522 adult patients who were critically ill due to complications following open heart or abdominal surgery, multiple accidental trauma, or who were having acute respiratory failure.
9 % vs. 3-8 mg/day) compared to those receiving placebo. The safety of continuing growth hormone in patients receiving replacement doses for approved indications who concurrently develop these illnesses has not been established. Therefore, the potential benefit of treatment continuation in patients having acute critical illnesses should be weighed against the potential risks.
If a woman taking somatropin begins oral oestrogen therapy, the dose of somatropin may need to be increased to maintain the serum IGF-1 levels within the normal age-appropriate range. 5). If a change of the route of oestrogen administration (oral to transdermal or vice-versa) is made, growth hormone should be newly titrated.
An increasing sensitivity to growth hormone (expressed as change in serum IGF-I per growth hormone dose) over time may be observed, particularly in men. Introduction of somatropin treatment may result in inhibition of 11βHSD-1 and reduced serum cortisol concentrations.
In patients treated with somatropin, previously undiagnosed central (secondary) hypoadrenalism may be unmasked and glucocorticoid replacement may be required. 5). Unless patients with Prader-Willi syndrome also have a diagnosis of growth hormone deficiency, Humatrope is not indicated for the treatment of patients who have growth failure due to genetically confirmed Prader-Willi syndrome.
There have been reports of sleep apnoea and sudden death after initiating therapy with growth hormone in 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.
Because somatropin may reduce insulin sensitivity, patients should be monitored for evidence of glucose intolerance. For patients with diabetes mellitus, the insulin dose may require adjustment after somatropin therapy is instituted.
Patients with diabetes or glucose intolerance should be monitored closely during somatropin therapy. Elderly patients (age ≥65 years) are more sensitive to […]
Treatment with Omnitrope for short stature should be discontinued when the epiphyses are fused. 24 mg/kg body weight/week SC Divided into 6-7 doses diagnosis of GHD should be confirmed before Omnitrope is administered. 48 mg/kg body weight per week SC Divided into 6-7 doses 1 Omnitrope dosage must be adjusted for the individual patient.
33 mg. Women may require higher doses than men. This means that there is a risk that women, especially those on oral estrogen replacement may be under-treated. As normal physiological growth hormone production decreases with age, dose requirements may be reduced.
3 Treatment should stop when near adult height is achieved (height velocity < 2 cm/ yr and/or bone age >16 yr in boys and >14 yr in girls) or when height is in the normal adult range (above -2 SDS). 4 Omnitrope may be administered in the thigh, buttocks or abdomen; the site of SC injections (administered preferably in the evenings) should be rotated daily to help prevent lipoatrophy.
OMNITROPE (somatropin for injection) Page 7 of 69 Adults Growth Hormone Deficiency Clinical response, side effects and determination of IGF-1 in serum may be used as guidance for dose titration. The level of IGF-1 should not exceed the upper limit of normal IGF-1 levels matched to age and sex.
It is recommended that IGF-1 concentrations be monitored regularly and GH dose be reduced in children with a plasma IGF-1 above + 2SD. 24 mg/kg/week) should be considered if substantial catch-up growth is observed during the first few years of therapy.
24 mg/kg/week), and titrating the dose as needed over time. In all children, clinicians should carefully monitor the growth response, and adjust the somatropin dose as necessary. Dosing should continue until final height is reached. Treatment should be discontinued after the first year of treatment if the height velocity SDS is below + 1.
Treatment should be discontinued if height velocity is < 2 cm/year and, if confirmation is required, bone age is > 14 years (girls) or > 16 years (boys) corresponding to closure of the epiphyseal growth plates. In short […]
2 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. Patients with Prader-Willi syndrome should be evaluated for signs of upper airway obstruction and sleep apnea before initiation of treatment with somatropin.
If, during treatment with NORDITROPIN, patients show signs of upper airway obstruction (including onset of or increased snoring) and/or new onset sleep apnea, treatment should be interrupted. All patients with Prader-Willi syndrome treated with NORDITROPIN should also have effective weight control and be monitored for signs of respiratory infection, which should be diagnosed as early as possible and treated aggressively [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 complete prior to instituting therapy with NORDITROPIN.
Discontinue NORDITROPIN if there is evidence of recurrent activity. Risk of Second Neoplasm in Pediatric Patients There is an increased risk of a second neoplasm in pediatric cancer survivors who were treated with radiation to the brain/head and who developed subsequent GH deficiency and were treated with somatropin.
Intracranial tumors, in particular meningiomas, were the most common of these second neoplasms. In adults, it is unknown whether there is any relationship between somatropin replacement therapy and CNS tumor recurrence. Monitor all patients receiving NORDITROPIN who have a history of GH deficiency secondary to an intracranial neoplasm for progression or recurrence of the tumor.
New Malignancy During Treatment Because pediatric patients with certain rare genetic causes of short stature have an increased risk of developing malignancies, thoroughly consider the risks and benefits of starting NORDITROPIN in these patients.
If NORDITROPIN is initiated, carefully monitor patients for development of neoplasms. Monitor all patients receiving NORDITROPIN carefully for increased growth, or potential malignant changes, of preexisting nevi. Advise patients/caregivers to report marked changes in behavior, onset of headaches, vision disturbances and/or changes in skin pigmentation or changes in the appearance of pre-existing nevi.
4 Glucose Intolerance and Diabetes Mellitus Treatment with somatropin may decrease insulin sensitivity, particularly at higher doses. New onset type 2 diabetes mellitus has been reported in patients taking somatropin. Previously undiagnosed impaired glucose tolerance and overt diabetes mellitus may be unmasked.
Monitor glucose levels periodically in all patients receiving NORDITROPIN, 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 impaired glucose tolerance should be monitored closely.
The doses of antidiabetic agents may require adjustment when NORDITROPIN is initiated. 5 Intracranial Hypertension Intracranial hypertension (IH) with papilledema, visual changes, headache, nausea, and/or vomiting has been reported in a small number of patients treated with somatropins.
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 the somatropin dose.
Funduscopic examination should be performed routinely before initiating treatment with NORDITROPIN to exclude preexisting papilledema, and periodically thereafter. If papilledema is observed by funduscopy during somatropin treatment, treatment should be stopped.
If somatropin-induced IH is diagnosed, treatment with NORDITROPIN can be restarted at a lower dose after IH-associated signs and symptoms have resolved. Patients with Turner syndrome may be at increased risk for the development of IH.
6 Severe Hypersensitivity Serious systemic hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with postmarketing use of somatropins. Patients and caregivers should be informed that such reactions are possible and that prompt medical attention should be sought if an allergic reaction occurs [see Contraindications (4) ].
7 Fluid Retention Fluid retention during somatropin replacement therapy in adults may frequently occur. g. edema, arthralgia, myalgia, nerve compression syndromes including carpal tunnel syndrome/paraesthesias) are usually transient and dose dependent.
8 Hypoadrenalism Patients receiving somatropin 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 NORDITROPIN treatment.
Monitor patients for reduced serum cortisol levels and/or need for glucocorticoid dose increases in those with known hypoadrenalism [see Drug Interactions (7) ]. 9 Hypothyroidism Undiagnosed/untreated hypothyroidism may prevent an optimal response to NORDITROPIN, in particular, the growth response in pediatric patients.
Patients with Turner syndrome have an inherently increased risk of developing autoimmune thyroid disease and primary hypothyroidism. In patients with GH deficiency, central (secondary) hypothyroidism may first become evident or worsen during somatropin treatment.
Therefore, patients should have periodic thyroid function tests and thyroid hormone replacement therapy should be initiated or appropriately adjusted when indicated. 10 Slipped Capital Femoral Epiphysis in Pediatric Patients Slipped capital femoral epiphysis may occur more frequently in patients with endocrine disorders (including GH deficiency and Turner syndrome) or 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, including NORDITROPIN.
Evaluate pediatric patients receiving NORDITROPIN with the onset of a limp or complaints of hip or knee pain for slipped capital femoral epiphysis and osteonecrosis and manage accordingly . 11 Progression of Preexisting Scoliosis in Pediatric Patients Somatropin increases the growth rate, and progression of existing scoliosis can occur in patients who experience rapid growth.
Somatropin has not been shown to increase the occurrence of scoliosis. Monitor patients with a history of scoliosis for progression of scoliosis. 12 Pancreatitis Cases of pancreatitis have been reported in pediatric patients and adults receiving somatropin products.
There may be a greater risk in pediatric patients compared with adults. Published literature indicates that females who have Turner syndrome may be at greater risk than other pediatric patients receiving somatropin products. Pancreatitis should be considered in patients who develop persistent severe abdominal pain.
13 Lipoatrophy When somatropin products are administered subcutaneously at the same site over a long period of time, tissue atrophy may result. 1) ]. 14 Laboratory Tests Serum levels of inorganic phosphorus, alkaline phosphatase, parathyroid hormone (PTH) and IGF-I may increase after NORDITROPIN treatment.
6 Benign intracranial hypertension In case of severe or recurrent headache, visual problems, nausea and/or vomiting, a fundoscopy for papilloedema is recommended. If papilloedema is confirmed, a diagnosis of benign intracranial hypertension should be considered and, if appropriate, the growth hormone treatment should be discontinued.
At present there is insufficient evidence to give specific advice on the continuation of growth hormone treatment in patients with resolved intracranial hypertension. If growth hormone treatment is restarted, careful monitoring for symptoms of intracranial hypertension is necessary.
Leukaemia Leukaemia has been reported in a small number of growth hormone deficiency patients, some of whom have been treated with somatropin. However, there is no evidence that leukaemia incidence is increased in growth hormone recipients without predisposition factors.
Antibodies A small percentage of patients may develop antibodies to Omnitrope. Omnitrope has given rise to the formation of antibodies in approximately 1% of patients. The binding capacity of these antibodies is low and there is no effect on growth rate.
Testing for antibodies to somatropin should be carried out in any patient with otherwise unexplained lack of response. Pancreatitis Although rare, pancreatitis should be considered in somatropin-treated patients who develop abdominal pain, especially in children.
Scoliosis Scoliosis is known to be more frequent in some of the patient groups treated with somatropin. In addition, rapid growth in any child can cause progression of scoliosis. Somatropin has not been shown to increase the incidence or severity of scoliosis.
Signs of scoliosis should be monitored during treatment. Acute critical illness The effects of somatropin on recovery were studied in two placebo controlled trials involving 522 critically ill adult patients suffering complications following open heart surgery, abdominal surgery, multiple accidental trauma or acute respiratory failure.
3 or 8 mg somatropin daily compared to patients receiving placebo, 42% vs. 19%. Based on this information, these types of patients should not be treated with somatropin. As there is no information available on the safety of growth hormone substitution therapy in acutely critically ill patients, the benefits of continued 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 somatropin must be weighed against the potential risk involved. Elderly patients Experience in patients above 80 years is limited.
Elderly patients may be more sensitive to the action of Omnitrope, and therefore may be more prone to develop adverse reactions. Prader-Willi syndrome In patients with PWS, treatment should always be in combination with a calorie-restricted diet.
7 There have been reports of fatalities associated with the use of growth hormone in paediatric patients with PWS who had one or more of the following risk factors: […]