SPI of Somatropin for Injection I.P. GENOTROPIN^®

Composition:
Recombinant Somatotropin I.P. (Sterile, Lyophilized Powder) for solution for subcutaneous Injection; 5.3 mg (16IU) and 12 mg (36IU) with sterile diluents (Metacresol-Mannitol-Water) for injection.    

Recombinant Somatotropin I.P. (Sterile, Lyophilized Powder); 12 mg (36IU) with sterile diluents (Metacresol-Mannitol-Water) for injection. (GoQuick).       

Recombinant Somatotropin I.P. (Sterile, Lyophilized Powder) for solution for subcutaneous Injection; 5.3 mg (16 IU) with sterile diluents (Metacresol-Mannitol-Water) for injection (GoQuick)

Indications: for treatment of children with growth disturbance due to, Short stature due to inadequate or failed secretion of pitutory growth hormone; Turner syndrome; Chronic renal insufficiency; Born small for gestational age; For improvement of body composition in children with Prader-Willi syndrome; For replacement therapy in adults with growth hormone deficiency;For the treatment of idiopathic short stature.

Contraindications: Any evidence of neoplastic activity, anti-tumor therapy, acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma, or acute respiratory failure and hypersensitivity to active substance or any of the excipients  listed in section 2 Qualitative and Quantitative  Composition.

Warnings and Precautions: In the case of myalgia or disproportionate pain at injection site, myositis should be considered and if confirmed, a Somatropin presentation without Metacresol should be used. Treatment should be interrupted in patients with Prader-Willi syndrome taking Somatropin who show signs of upper airway obstruction Somatropin reduces insulin sensitivity and therefore patients should be observed for evidence of glucose intolerance.In rare cases, therapy with Somatropin may produce sufficient glucose intolerance to meet the diagnosis criteria for Type 2 diabetes mellitus. The risk of developing diabetes during treatment with somatropin is greatest in those patients with other risk factors for Type 2 diabetes mellitus, such as obesity, family history of diabetes, treatment with steroids, or prior impaired glucose tolerance. Dose adjustment of anti-diabetic therapy may be required in patients with preexisting diabetes mellitus who are on Somatropin. It is advisable test thyroid function shortly after the start of treatment with somatropin, and after dose adjustments. Hypoadrenalism: Introduction of somatropin treatment may result in inhibition of 1113HSD-1 and reduced serum cortisol concentrations. In patients treated with somatropin, previously undiagnosed central (secondary) hypoadrenalism may be unmasked and gluoocorticoid replacement may be required. In addition, patients treated with glucocorticoid replacement therapy for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses, following initiation of somatropin treatment In patients with hypopituitarism on standard replacement therapy, the potential effect of growth hormone treatment on thyroid function must be closely monitored.Benign intracranial hypertension, Leukaemia, Antibodies, Elderly patients, Acute critical illness 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. 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. Conversely, if a woman on somatropin discontinues oral oestrogen therapy, the dose of somatropin may need to be reduced to avoid excess of growth hormone and/or side effects. In case of severe or recurrent headache, visual problems, nausea and/or vomiting, a fundoscopy for papilloedema is recommended. Progression of scoliosis can occur in patients who experienoe rapid growth. Somatropin should discontinue at renal transplantation. Somatropin is ineffective for growth promotion in children with closed epiphyses. Side Effects: Injection site reaction. Arthralgia, Myalgia, Peripheral oedema, Type 2 diabetes mellitus, Paraesthesia, Benign intracranial hypertension, Leukemia. In children, such as adverse effects are uncommon.

Posology: The dosage and administration schedule should be individualized, drug should be given subcutaneously. In growth hormone deficiency(GHD) in children, daily dose of 0.025 - 0.035 mg/kg body weight (0.07 - 0.1 O IU/kg) or 0.7 - 1.0 mg/m2 body surface area ( 2.1 - 3.0 IU/m2) is recommended. In Turner syndrome and chronic renal insufficiency, the daily dose of 0.045 - 0.050 mg/kg body weight (0.14 IU/kg) or 1.4 mg/m2 body surface area (4.3 IU/m2) is recommended. In Prader-Willi syndrome (PWS) in children, the daily dose of 0.035 mg/kg body weight (0.10 IU/kg) or 1.0 mg/m2 body surface area (3.0 IU/m2) is recommended. In small for gestational age, the daily dose of 0.035 mg/kg body weight (0.10 - 0.20 IU/kg) or 1.0 mg/m2 body surface area (3.0 - 6.0 IU/m2} is recommended. In idiopathic short stature, the recommended dose of Somatropin is up to 0.067 mg/kg body weight (0.20 IU/kg) or upto 2.0 mg/m2 body surface area (6.0 IU/m2). Dosage Recommendations for Adult Patients with Growth Hormone Deficiency: The recommended starting dose is 0.15 to 0.30 mg (0.45 to 0.90 IU) per day. The final dose should be individually titrated as needed with respect to age and gender. The daily maintenance dose seldom exceeds 1.3 mg (4 IU) per day. Clinical response, side effects, and determination of IGF-1 in serum may be used as guidance for dose titration. Somatropin is not to be injected intravenously. Somatropin may be given in the thigh, buttocks or abdomen. The site of injection should be rotated daily to help prevent lipoatrophy.

Adapted from       

Local Product document Genotropin 5.3mg and 12 mg formulation LPDGEN072022.     
Local Product Document: Recombinant Somatropin for Injection I.P. Somatropin^® GoQuickâ   12 mg LPDGEN072022.    
Local Product Document: Recombinant Somatropin for Injection I.P.Somatropin^® GoQuickâ   5.3 mg LLPDGEN072022.      

^® Trademark Proprietor: Pfizer Health AB. Licensed User: Pfizer Products India Private Limited, India