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Somatropin Biopartners is a brand name for Somatropin (also known as Somatotropin). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Somatropin Biopartners is indicated for the replacement therapy of endogenous growth hormone in adults with childhood- or adult-onset growth hormone deficiency (GHD). Adult-onset: Patients with GHD in adulthood are defined as patients with known hypothalamic-pituitary pathology and at least one additional known…
Verbatim from this product's EMA label. Tap a section to expand.
Diagnosis and therapy with this medicinal product should be initiated and monitored by physicians adequately experienced in the diagnosis and management of patients with GHD. Medicinal product no longer authorised 3 Starting dose Generally, 2 mg once a week for all patients apart from female patients receiving oral oestrogen therapy who should receive 3 mg once a week.
In older or overweight patients, lower doses may be necessary. 5. Samples should be drawn 4 days after the previous dose (Day 4). Repeated adjustments in dose may be required, dependent on patients’ IGF-I response. IGF-I levels should be acted upon, as indicated below.
5 mg (all patients) IGF-I = insulin-like growth factor-I, SDS = standard deviation score. 6). For other doses vials with 4 or 7 mg somatropin are available. The minimum effective dose should be used. 5 SDS of the age corrected mean. In order to reach the defined treatment goal, men may need lower growth hormone doses than women.
Oral oestrogen administration increases the dose requirements in women. An increasing sensitivity to growth hormone (expressed as change in IGF-I per growth hormone dose) over time may be observed, particularly in men. The accuracy of the growth hormone dose should therefore be controlled every 6 months.
5 mg at a time. If the symptoms leading to the dose reduction disappear, at the judgment of the physician, the dose may be maintained at the decreased level or increased according to the dose adjustment scheme described above. If the symptom reappears after the dose increase, then the dose should be maintained at the previous lower dose.
Special populations Older people Experience with somatropin treatment in patients above 60 years of age is limited. Dose requirements may decline with increasing age. Renal/hepatic impairment No information in patients with renal or hepatic impairment is available and particular dose recommendations cannot be given.
Paediatric population There is no relevant use of Somatropin Biopartners 2 mg in the paediatric population in the indication of long-term treatment of growth failure due to insufficient secretion of endogenous growth hormone. For the treatment of children and adolescents aged 2 to 18 years the 10 mg and 20 mg vials of this medicinal product should be used.
Method of administration The patient or carer should receive training to ensure understanding of the administration procedure before being allowed to (self-) inject. Somatropin Biopartners is administered subcutaneously once a week.
Summary of the safety profile Clinical trials included approximately 530 patients treated with Somatropin Biopartners. When adverse reactions occurred, they tended to be transient and severity was generally mild to moderate. The safety profile of Somatropin Biopartners is generally consistent with the well known safety profile of daily growth hormone treatments.
The adverse reactions most commonly reported were injection site related reactions, peripheral oedema, headache, myalgia, arthralgia, paraesthesia, hypothyroidism and decreased free thyroxine. Tabulated list of adverse reactions The following adverse reactions have been observed under treatment with Somatropin Biopartners in a 6-month controlled clinical study with 151 adult patients with GHD of adult- or childhood-onset and in a 6-month extension study.
Additional reports based on published information for daily growth hormone treatments are listed with asterisks. The frequency of adverse reactions listed below is 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), not known (cannot be estimated from the available data): Infections and infestations Common: Herpes simplex Neoplasms benign, malignant and unspecified (including cysts and polyps) Common: Neoplasm progression (1 case of neoplasm progression in a female patient with a history of neurofibromatosis and radiation treatment), acrochordon, craniopharyngioma Blood and the lymphatic system disorders Common: Decreased or increased white blood cell count, increased glycosylated haemoglobin, decreased haemoglobin Immune system disorders Common: Formation of antibodies against growth hormone Endocrine disorders Common: Adrenal insufficiency, decreased free thyroxine, decreased free tri-iodothyronine, increased blood TSH, hypothyroidism* Metabolism and nutrition disorders Very common: Mild hyperglycaemia* Common: Impaired fasting glucose, hyperlipidaemia, increased blood insulin, increased blood cholesterol, decreased blood sodium, increased blood triglycerides, increased blood glucose, increased or decreased HDL, increased LDL Not known: Insulin resistance* Psychiatric disorders Common: Insomnia Nervous system disorders Very common: Headache Common: Paraesthesia, hypoaesthesia, carpal tunnel syndrome, dizziness, somnolence Rare: Benign intracranial hypertension*Medicinal product no longer authorised 8 Eye disorders Common: Conjunctivitis, visual acuity reduced Ear and labyrinth disorders Common: Vertigo Cardiac disorders Common: Tachycardia, heart rate abnormal/irregular Vascular disorders Common: Hypertension,increased blood pressure Respiratory, thoracic and mediastinal disorders Common: Epistaxis Gastrointestinal disorders Common: Nausea Hepatobiliary disorders Common: Hyperbilirubinaemia, cholecystitis, liver test abnormal Skin and subcutaneous tissue disorders Common: Swelling face, acne, allergic dermatitis, hyperhidrosis, urticaria, rash Musculoskeletal and connective tissue disorders Common: Back pain, pain in extremities, arthralgia, shoulder pain, musculoskeletal stiffness, bone pain, muscular weakness, sensation of heaviness, tendonitis, joint swelling, arthritis, musculosceletal pain, myalgia* Renal and urinary disorders Common: Haematuria, increased blood uric acid, increased blood creatinine Reproductive system and breast disorders Common: Nipple pain Uncommon: Gynaecomastia* General disorders and administration site conditions Very common: Oedema peripheral, oedema (local and generalised)* Common: Fatigue, pain, asthenia, face oedema, local swelling, oedema, thirst, malaise, chest pain, increased weight, injection site pain Investigations Common: Increased blood phosphorus, increased or decreased IGF Description of selected adverse reactions Immunogenicity Some patients may develop antibodies to rhGH.
Malignancies Patients with prior malignancies should be examined routinely for progression or recurrence. Benign intracranial hypertension 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 beMedicinal product no longer authorised 5 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. Insulin sensitivity Because human growth hormone (hGH) may induce a state of insulin resistance and hyperglycaemia, patients treated with this medicinal product should be monitored for evidence of glucose intolerance.
In patients with an already manifest diabetes mellitus, the anti-diabetic therapy might require adjustment when somatropin treatment is initiated. 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. Hypothyroidism may develop in patients with central subclinical hypothyroidism after initiating therapy with growth hormone.
Inadequate treatment of hypothyroidism may prevent optimal response to somatropin. In patients with hypopituitarism receiving thyroxin replacement therapy, hyperpituitarism may develop. Thyroid function should therefore be closely monitored in all patients.
Adrenal function Treatment with growth hormone may facilitate the development of adrenal insufficiency and potentially fatal adrenal crises in patients with organic GHD or idiopathic panhypopituitarism. It is therefore crucial to assess baseline and stress doses of glucocorticoids which may need to be adjusted when growth hormone therapy is initiated.
1. Somatropin must not be used when there is any evidence of tumour activity. Intracranial tumours must be inactive and antitumour therapy must be completed prior to the initiation of growth hormone therapy. Treatment should be discontinued if there is evidence of tumour (re)growth.
Somatropin treatment must not be started in patients with acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma, or to patients having acute respiratory failure or similar conditions.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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After reconstitution the injection should be administered immediately. The subcutaneous injection should always be administered at the same time of the day to increase compliance and the site of injection must be varied to prevent lipoatrophy.
6.
Somatropin Biopartners has given rise to the formation of antibodies in approximately 4% of adult patients. The binding activity of these antibodies has been low and no clinical consequences have been associated with their formation.
With regard to antibodies against host cell proteins, low anti-S. cerevisiae protein antibody titres similar to levels in the normal untreated population were found in some patients treated with this medicinal product. Medicinal product no longer authorised 9 Malignancies/tumours Cases of malignant and benign tumour recurrences, de-novo and secondary tumours have been reported in temporal relationship with somatropin therapy.
Paediatric population With the exception of injection site related reactions and the formation of antibodies to rhGH which were reported more frequently in children than in adults the safety profile of Somatropin Biopartners is similar for children and adults.
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.
1) before replacement therapy is commenced at the doses recommended for adults. Other precautions This medicinal product is not indicated for the treatment of patients with growth failure due to Prader-Willi syndrome unless they also have a diagnosis of GHD.
There have been reports of sleep apnoea and sudden death after initiating growth hormone therapy 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.
After accidental intramuscular injection, hypoglycaemia may occur. Antibodies Some patients may develop antibodies to this medicinal product. Somatropin Biopartners has given rise to the formation of antibodies in approximately 4% of adult patients.
The binding activity of these antibodies has been low and no clinical consequences have been associated with their formation. e. Medicinal product no longer authorised 6