Lanreotide


Generic Medicine Info
Indications and Dosage
Intramuscular
Thyrotrophic adenoma
Adult: In patients where surgery and/or radiotherapy were unable to lower the thyroid-stimulating hormone level: Initially, 30 mg once every 14 days, increased to 30 mg once every 10 days according to patient’s response.

Intramuscular
Acromegaly, Carcinoid syndrome
Adult: In patients with acromegaly where surgery and/or radiotherapy were unable to normalise the GH and/or IGF-1 levels: Initially, 30 mg once every 14 days, increased to 30 mg once every 7-10 days according to patient’s response.

Subcutaneous
Acromegaly
Adult: In patients with inadequate response to surgery and/or radiotherapy: Initially, 90 mg via deep SC injection once every 4 weeks (28 days) for 3 months. Dosage is individualised according to patient’s response, GH and/or IGF-1 (refer to country- or product-specific detailed product guideline). Dosing recommendations may vary among countries or individual products, refer to country- or product-specific detailed product guideline).

Subcutaneous
Gastroenteropancreatic neuroendocrine tumours
Adult: In patients with unresectable, well- or moderately differentiated, locally advanced or metastatic cases: 120 mg via deep SC injection once every 4 weeks (28 days) continued until disease progression or unmanageable toxicity.

Subcutaneous
Carcinoid syndrome
Adult: 60-120 mg via deep SC injection once every 4 weeks (28 days). Dose is adjusted according to patient’s response. May not give additional dose if the patient is already receiving treatment for gastroenteropancreatic neuroendocrine tumours (GEP-NETs).
Special Patient Group
Patients taking insulin, oral hypoglycaemic drugs, and β-blockers: Dose adjustment may be necessary.
Renal Impairment
SC
Acromegaly
CrCl <60 mL/minute: Initially, 60 mg via deep SC injection once every 4 weeks for 3 months, adjust dose according to patient’s response, GH and/or IGF-1 levels. Dosing recommendations may vary among countries or individual products or preparations. Refer to country- or product-specific recommendations.
Hepatic Impairment
SC
Acromegaly
Moderate to severe (Child-Pugh Class B and C): Initially, 60 mg via deep SC injection once every 4 weeks (28 days) for 3 months, adjust dose according to patient’s response, GH and/or IGF-1 levels. Dosing recommendations may vary among countries or individual products or preparations. Refer to country- or product-specific recommendations.
Special Precautions
Patient with pre-existing cardiac disease, biliary disorder (e.g. cholelithiasis), diabetes, thyroid disorder. Moderate to severe renal and hepatic impairment (if used in acromegaly treatment). Pregnancy.
Adverse Reactions
Significant: Cholelithiasis including complications (e.g. cholecystitis, cholangitis, pancreatitis), diarrhoea, abdominal pain, hyperglycaemia or hypoglycaemia, hypersensitivity (e.g. angioedema, anaphylaxis), hypothyroidism, bradycardia, hypertension.
Blood and lymphatic system disorders: Anaemia.
Cardiac disorders: Dyspnoea.
Gastrointestinal disorders: Constipation, flatulence, loose stools, nausea, steatorrhoea, vomiting.
General disorders and admin site conditions: Injection site reaction (e.g. induration, pain, mass, nodule, pruritus, abscess), lethargy.
Hepatobiliary disorders: Biliary dilatation, gallbladder sludge.
Immune system disorders: Antibody development.
Investigations: Weight loss.
Metabolism and nutrition disorders: Diabetes mellitus.
Musculoskeletal and connective tissue disorders: Arthralgia, musculoskeletal pain, muscle spasm, myalgia.
Nervous system disorders: Dizziness, headache.
Psychiatric disorders: Depression, insomnia.
Skin and subcutaneous tissue disorders: Alopecia.
Vascular disorders: Hot flushes.
Parenteral/SC: C
Patient Counseling Information
This drug may cause dizziness, if affected, do not drive or operate machinery.
Monitoring Parameters
Monitor serum GH and IGF-1 level, gallstone formation, thyroid function, renal and hepatic function, heart rate, blood pressure, blood glucose.
Drug Interactions
May increase serum concentration of bromocriptine. May decrease intestinal absorption and bioavailability of ciclosporin. May decrease metabolic clearance of drugs metabolised by CYP3A4 (e.g. terfenadine, quinidine).
Action
Description:
Mechanism of Action: Lanreotide, a synthetic octapeptide analogue of natural somatostatin has high affinity to human somatostatin receptors SSTR 2 and 5 found in pituitary gland and growth hormones secreting neoplasm of pituitary gland which results in the inhibition of growth hormone (GH) and insulin-like growth factor 1 (IGF-1) secretion.
Pharmacokinetics:
Absorption: Absolute bioavailability: Approx 55-80%. Time to peak plasma concentration: 7-12 hours.
Distribution: Volume of distribution: 15.14 L.
Excretion: Via urine (<5% as unchanged drug); faeces (<0.5% as unchanged drug). Terminal elimination half-life: Approx 2.5 hours (IV); approx 5-30 days (SC/IM).
Chemical Structure

Chemical Structure Image
Lanreotide

Source: https://pubchem.ncbi.nlm.nih.gov/

Storage
Store between 2-8°C. Do not freeze. Protect from light.
MIMS Class
Trophic Hormones & Related Synthetic Drugs
ATC Classification
H01CB03 - lanreotide ; Belongs to the class of antigrowth hormone. Used in hypothalamic hormone preparations.
References
Anon. Lanreotide acetate. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 03/11/2020.

Anon. Lanreotide. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 03/11/2020.

Buckingham R (ed). Lanreotide. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/11/2020.

Healthcare Logistics. Somatuline Autogel 60, 90 and 120 mg Solution for Injection in a Pre-filled Syringe data sheet 23 June 2020. Medsafe. http://www.medsafe.govt.nz. Accessed 13/11/2020.

Joint Formulary Committee. Lanreotide. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/11/2020.

Somatuline Autogel Prolonged-Release Solution for Injection in a Pre-filled Syringe (Ipsen Pharma Biotech). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 13/11/2020.

Somatuline Depot - Lanreotide Acetate Injection (Ipsen Biopharmaceuticals, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 13/11/2020.

Disclaimer: This information is independently developed by MIMS based on Lanreotide 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 © 2024 MIMS. All rights reserved. Powered by MIMS.com
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