Somatropin


Generic Medicine Info
Indications and Dosage
Subcutaneous
Growth retardation in children who were born small for gestational age
Child: In children with no catch-up growth by 2-4 years of age: 0.035-0.070 mg/kg once daily. May initiate doses at the higher end of the dosing range in patients with significant growth retardation. Alternatively, up to 0.48 mg/kg weekly, divided in 6 or 7 doses a week. Dose is individualised and adjusted according to the patient's clinical response. Dosage recommendations may vary among countries or individual products (refer to specific product guidelines).

Subcutaneous
Growth retardation due to chronic renal insufficiency
Child: 0.045-0.05 mg/kg daily. Alternatively, 0.35 mg/kg weekly, divided into daily inj. Continue treatment until the time of renal transplantation. Dose is individualised and adjusted according to the patient's clinical response. Dosage recommendations may vary among countries or individual products (refer to specific product guidelines).

Subcutaneous
Prader-Willi syndrome
Child: Approx 0.035 mg/kg or 1 mg/m2 daily (Max: 2.7 mg daily). Alternatively, 0.24 mg/kg weekly, divided daily into 6 or 7 doses a week. Dose is individualised and adjusted according to the patient's clinical response. Dosage recommendations may vary among countries or individual products (refer to specific product guidelines).

Subcutaneous
Turner syndrome
Child: 0.045-0.067 mg/kg (0.14 units/kg) daily or 1.3-2 mg/m2 daily. Alternatively, 0.35-0.375 mg/kg weekly, divided into equal doses 7 days a week. Dose is individualised and adjusted according to the patient's clinical response. Dosage recommendations may vary among countries or individual products (refer to specific product guidelines).

Subcutaneous
Growth hormone deficiency
Adult: Non-weight-based dosing: 0.2-0.4 mg daily; higher doses (e.g. 50% of the dose used in childhood) may be required if transitioning from paediatric treatment. Weight-based dosing: Initially, ≤0.006 mg/kg (0.018 units/kg) daily; may increase gradually according to patient's response. Max: 0.0125 mg/kg daily. Dose is individualised and adjusted according to the patient's clinical and biochemical response. Dosage recommendations may vary among countries or individual products (refer to specific product guidelines).
Child: 0.025-0.035 mg/kg (0.07-0.1 units/kg) daily or 0.7-1 mg/m2 daily. Alternatively, 0.16-0.24 mg/kg weekly, divided into equal doses 6 or 7 days a week. Dose is individualised and adjusted according to the patient's clinical response. Dosage recommendations may vary among countries or individual products (refer to specific product guidelines).
Elderly: Initiate at a lower dose with smaller dose increments.

Subcutaneous
HIV-associated wasting or cachexia
Adult: Initially, 0.1 mg/kg once daily at bedtime. May be given on alternate days for patients at increased risk of adverse effects. Max: 6 mg daily. Dose is individualised and adjusted according to the patient's clinical response and safety. Refer to specific product guidelines for further information.

Subcutaneous
Short stature homeobox-containing gene (SHOX) deficiency
Child: 0.35 mg/kg weekly, divided into equal doses 6 or 7 days a week. Dose is individualised and adjusted according to the patient's clinical response. Dosage recommendations may vary among countries or individual products (refer to specific product guidelines).

Subcutaneous
Short bowel syndrome
Adult: 0.1 mg/kg once daily for 4 weeks. Max: 8 mg daily. Dose is individualised and adjusted or discontinued according to patient safety.

Subcutaneous
Short stature associated with Noonan syndrome
Child: Up to 0.066 mg/kg daily. Dose is individualised according to the patient's clinical response. Dosage recommendations may vary among countries or individual products (refer to specific product guidelines).

Subcutaneous
Idiopathic short stature
Child: In patients with height standard deviation score of ≤ -2.25 and growth rate unlikely to attain adult height in normal range: Initially, 0.24 mg/kg weekly, divided into equal doses 6-7 days a week; up to 0.47 mg/kg weekly in divided doses may be required in some patients. Dose is individualised according to the patient's clinical response. Dosage recommendations may vary among countries or individual products (refer to specific product guidelines).
Special Patient Group
Patients taking oral estrogen: Dose adjustments may be required when estrogen is initiated or discontinued.
Reconstitution
Instructions for preparation of inj may vary among individual products. Refer to specific product guidelines.
Contraindications
Hypersensitivity. Acute critical illness due to complications following open-heart surgery, abdominal surgery, multiple accidental traumas, acute respiratory failure, active malignancy; active proliferative or severe non-proliferative diabetic retinopathy. Children with closed epiphyses. Refer to specific product guidelines for other indication- or product-specific contraindications (e.g. severe obesity or severe respiratory impairment in patients treated for Prader-Willi syndrome).
Special Precautions
Patient with or at risk of diabetes mellitus (e.g. familial history, obesity); with pre-existing tumours or growth hormone deficiency secondary to an intracranial lesion, existing or at risk for pituitary hormone deficiency, undiagnosed or untreated hypothyroidism, scoliosis. Patients taking oral estrogen. Children and elderly. Pregnancy and lactation. Treatment recommendations may vary among countries and individual products. Refer to specific product guidelines for more precise information.
Adverse Reactions
Significant: Fluid retention, carpal tunnel syndrome (particularly in adults); hypothyroidism; impaired glucose tolerance, new onset type 2 diabetes mellitus or exacerbation of pre-existing diabetes mellitus; benign intracranial hypertension, otitis media (particularly in patients with Turner syndrome), lipoatrophy at inj site (prolonged administration at the same site), serious systemic hypersensitivity reactions (e.g. anaphylactic reactions, angioedema). Rarely, pancreatitis.
General disorders and administration site conditions: Flu syndrome, inj site pain.
Musculoskeletal and connective tissue disorders: Arthralgia, myalgia; musculoskeletal stiffness (adults).
Nervous system disorders: Headache, paraesthesia.
Reproductive system and breast disorders: Gynaecomastia.
Respiratory, thoracic and mediastinal disorders: Upper respiratory infection, pharyngitis.
Parenteral/SC: C
Monitoring Parameters
Perform funduscopic examination before initiating treatment to exclude pre-existing papilloedema and periodically during therapy; thyroid function test periodically. Monitor glucose levels periodically; clinical response, serum insulin-like growth factor-1 (IGF-1); skin lesions for malignant transformation. Assess for progression of scoliosis in children with history of the condition. Evaluate children with new onset of limp or with hip or knee pain. For children with CKD: Monitor for progression of renal osteodystrophy. For Prader-Willi syndrome: Monitor for signs of upper airway obstruction (including onset of or increased snoring), sleep apnoea, and respiratory infections. Initiate effective weight control. For Turner syndrome: Monitor for signs and symptoms of ear disorders (e.g. otitis media); CV disorders (e.g. aortic aneurysm or dissection, stroke, hypertension).
Drug Interactions
May increase the clearance of compounds known to be metabolised by CYP3A4 isoenzyme (e.g. corticosteroids, sex steroids, anticonvulsants, ciclosporin). Glucocorticoids may inhibit the growth promoting effect of somatropin. May diminish therapeutic effect with oral estrogen.
Action
Description: Somatropin is a synthetic human growth hormone of recombinant deoxyribonucleic acid (DNA) origin. It promotes bone, skeletal muscle, and organ growth by stimulating chondrocyte proliferation and differentiation, lipolysis, protein synthesis, and hepatic glucose output. It also exerts both insulin-like and diabetogenic effects, enhances the transmucosal transport of water, electrolytes, and nutrients across the gut, and stimulates erythropoietin which increases RBC mass.
Synonym: human growth hormone.
Pharmacokinetics:
Absorption: Well absorbed after SC inj. Bioavailability: Approx 60-80%.
Metabolism: Metabolised in the liver and kidneys.
Excretion: Via urine. Elimination half-life: 3-5 hours.
Storage
Storage recommendations may vary among individual products. Refer to specific product guidelines.
MIMS Class
Trophic Hormones & Related Synthetic Drugs
ATC Classification
H01AC01 - somatropin ; Belongs to the class of somatropin and somatropin agonists. Used in anterior pituitary lobe hormone and analogue preparations.
References
Anon. Somatropin. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 04/08/2021.

Buckingham R (ed). Growth Hormone. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 04/08/2021.

Genotropin Injection (Pharmacia and Upjohn Company LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 22/09/2021.

Genotropin Powder and Solvent for Solution for Injection (Pfizer [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 22/09/2021.

Humatrope (Eli Lilly and Company). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 04/08/2021.

Joint Formulary Committee. Somatropin. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 04/08/2021.

Norditropin NordiFlex 5 mg/1.5 mL Solution for Injection in Pre-Filled Pen (Novo Nordisk Pharma [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 22/09/2021.

Norditropin NordiFlex 5 mg/1.5 mL, Solution for Injection in Pre-filled Pen (Novo Nordisk Limited). MHRA. https://products.mhra.gov.uk. Accessed 04/08/2021.

Norditropin SimpleXx 15 mg/1.5 mL Solution for Injection in Cartridge (Novo Nordisk Limited). MHRA. https://products.mhra.gov.uk. Accessed 04/08/2021.

Nutropin AQ Nuspin 5, 10 and 20 Injection, Solution (Genentech, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 04/08/2021.

Pfizer New Zealand Limited. Genotropin 5 mg, 5.3 mg and 12 mg Powder for Injection with Solvent; Genotropin GoQuick 5 mg, 5.3 mg and 12 mg Powder for Injection with Solvent data sheet 11 November 2019. Medsafe. http://www.medsafe.govt.nz. Accessed 04/08/2021.

Saizen Liquid Solution for Injection (Merck Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 22/09/2021.

Serostim (EMD Serono, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 09/08/2021.

Zorbtive (EMD Serono, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 09/08/2021.

Disclaimer: This information is independently developed by MIMS based on Somatropin from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 MIMS. All rights reserved. Powered by MIMS.com
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