Product InformationRegistration Status: Active
SOMATULINE AUTOGEL PROLONGED RELEASE SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE 60mg is approved to be sold in Singapore with effective from 2013-01-16. It is marketed by ZUELLIG PHARMA PTE LTD, with the registration number of SIN14291P.
This product contains Lanreotide 60mg in the form of INJECTION, SOLUTION. It is approved for SUBCUTANEOUS use.
This product is manufactured by Ipsen Pharma Biotech IPSEN PHARMA BIOTECH in FRANCE.
It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.
Lanreotide (INN) is a medication used in the management of acromegaly and symptoms caused by neuroendocrine tumors, most notably carcinoid syndrome. It is a long-acting analogue of somatostatin, like octreotide. Its sequence is H-D-2Nal-Cys(1)-Tyr-D-Trp-Lys-Val-Cys(1)-Thr-NH2. Lanreotide (as lanreotide acetate) is manufactured by Ipsen, and marketed under the trade name Somatuline. It is available in several countries, including the United Kingdom, Australia and Canada, and was approved for sale in the United States by the Food and Drug Administration (FDA) on August 30, 2007.
Lanreotide is a somatostatin analog approved for treatment of neuroendocrine tumours and acromegaly. (2)
Mechanism of Action
Lanreotide is a somatostatin analogue (SSA) and has mainly inhibitory effects which are mediated via somatostatin receptors (SSTRs) 2 and 5 and include inhibition of growth hormone release in the brain. Tumor SSTR activation induces downstream cell cycle arrest and/or apoptosis, and also results in blunted production of substances that support tumor growth as well as tumor angiogenesis. This leads to the anti-proliferative effects of Lanreotide. (3)
- Lanreotide forms a drug depot at the site of injection (4); therefore, there are 2 phases that describe the absorption of Lanreotide: 1. Initial rapid subcutaneous release during the first few days of treatment where drug that has not precipitated is rapidly absorbed. 2. Slow release of drug from the depot via passive diffusion. (1) Absorption is independent of body weight, gender, and dosage. (5)
- Estimated Volume of Distribution = 15.1 L (1)
Estimated Clearance = 23.1 L/h (1)
The most common adverse events are GI related, occurring in 67-84% of patients, and are typically mild to moderate. GI related effects are often transient, improve with subsequent injections, and most frequently include diarrhea and abdominal pain. Other GI symptoms such as nausea, vomiting, and abdominal distension are less common. It is not clear whether or not GI effects are dose related. Adverse effects relating to site of injection occur in 43% of patients and are more common in patients who self-inject as opposed to those who had health-care professionals administer the injection. A small number of patients report newly impaired glucose tolerance, fasting glucose or diabetes mellitus. Patients being treated for diabetes mellitus may experience hypoglycemia. After 1 year, up to 30% of patients may experience gallstone formation and the presence of sludge within the gallbladder due to inhibition of gallbladder and GI motility. This may be influenced by previous exposure to somatostatin analogues. Other adverse effects include reduction in left ventricular end-diastolic and end-systolic volumes, bradycardia, nasopharyngitis, and alopecia. (5) Lanreotide is classified as Pregnancy Category C. (4)
Lanreotide | Lanreotide |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.