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Somatuline LA

Last Updated on eMC 13-Jun-2016 View document  | Ipsen Ltd Contact details

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC.  For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 13-Jun-2016 and displayed until Current

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 08-Jun-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4,4: removal of reference to checking for presence of obstructive intestinal tumour before prescribing Somatuline LA
Section 4.8: inclusion of AEs for patients suffering from GEP-NETS. Restructing of table to include new AEs in line with CCSI.

Updated on 20-Nov-2014 and displayed until 13-Jun-2016

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 04-Nov-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In section 4.2 - Posology and method of administration: The heading 'Thyroid tumours' has changed to 'Thyrotropic adenomas'. Addition of the following:
"Renal and/or hepatic impairment:
In patients with impaired renal or hepatic impairment, no dosage adjustment is necessary due to the wide therapeutic window of lanreotide (see section 5.2).'

In section 4.6 - Fertility, pregnancy and lactation: The following information has been added:
'Fertility:
Reduced fertility was observed in female rats due to the inhibition of GH secretion at doses in excess of those achieved in humans at therapeutic doses.'

In section 4.8 - Undesirable effects: Modification of adverse events to tabular format and addition of the standard adverse event reporting statement.

In section 5.1 - Pharmacodynamic properties: The following information has been added:
'A randomised, placebo controlled study has investigated the effects of lanreotide LA 30 mg administration every 10 days in 80 patients with inoperable upper intestinal obstruction of malignant origin due to confirmed peritoneal carcinomatosis. The primary objective was to assess the proportion of responders 7 days after a single injection of lanreotide LA 30 mg versus placebo. Treatment response was defined as 1 or less vomiting episode per day for at least 3 consecutive days, or no vomiting recurrence for at least 3 consecutive days for subjects in whom a nasogastric tube had been removed.

 

In the Intent-to-Treat [ITT] population (43 in the lanreotide group and 37 in the placebo group), when based on subject diary record cards (DRC) assessed at day 7, the responders rate was more favourable for lanreotide than placebo, although not statistically significant (41.9% [18/43] versus 29.7% [11/37], odds ratio=1.75 [95% CI 0.68 - 4.49, p=0.24]). When based on investigators’ assessment, there was a statistically significant difference in the responders rate in favour of lanreotide versus placebo in this population (50.0% [19/38] and 28.6% [10/35], respectively [odds ratio=2.82, 95% CI 1.001 - 7.86, p=0.048]).'

 

 

Updated on 07-May-2014 and displayed until 20-Nov-2014

Reasons for adding or updating:

  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 27-Nov-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

The Marketing Authorisation number has changed to PL 34926/0004

Updated on 19-Oct-2010 and displayed until 07-May-2014

Reasons for adding or updating:

  • Change to section 1 -Name of the Medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6.1 - List of Excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC: 20-Jul-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Sections 1, 2, 3 - Minor changes according to updated regulatory requirements.

Section 4.2  "Somatuline LA should not be prescribed during pregnancy and lactation, nor in patients presenting with hypersensitivity to the peptide or related peptides" changed to "

Hypersensitivity to lanreotide or related peptides or any of the excipients"

Section 4.4 - deletion of the following warnings "Fat concentrations in stools may increase to levels high enough to result in steatorrhoea, requiring the use of appropriate corrective therapy" and "In patients with hepatic/renal dysfunction, kidney and liver function should be regularly monitored and the dose interval adjusted if necessary".  Addition of the following "Slight decrease in thyroid function have been seen during treatment with Somatuline LA in acromegalic patients, though clinical hypothyroidism is rare. Thyroid function tests are recommended where clinically indicated" and "In patients without underlying cardiac problems Somatuline LA may lead to a decrease of heart rate without necessarily reaching the threshold of bradycardia. In patients suffering from cardiac disorders prior to Somatuline LA treatment, sinus bradycardia may occur.  care should be taken when initiating treatment with Somatuline in patients with  bradycardia (see section 4.5)" and "In patients with carcinoid tumours, Somatuline LA must not be prescribed before excluding the presence of an obstructive intestinal tumour".

 

Section 4.5 - minor rewording of some data, and addition of "Limited published data indicate that concomitant administration of somatostatin analogues and bromocriptine may increase the availability of bromocriptine. Concomitant administration of bradycardia-inducing drugs (e.g. beta blockers) may have an additive effect on the slight reduction of heart rate associated with Somatuline LA.  Dose adjustments of such concomitant medications may be necessary. The limited published data available indicate that somatostatin analogues may decrease the metabolic clearance of compounds known to be metabolised by Cytochrome P450 enzymes, which may be due to the suppression of growth hormone. Since it cannot be excluded that Somatuline may have this effect, other drugs mainly metabolized by CYP3A4 and which have a low therapeutic index (e.g. quinidine, terfenadine) should therefore be used with caution".

Section 4.6 - updated from "Studies in animals showed transitory growth retardation of offspring prior to weaning. Although no teratogenic effects have been observed in animals, in the absence of clinical experience, lanreotide must not be administered to pregnant or lactating women" to "Pregnancy:  Non-clinical data: Studies in animals showed no evidence of teratogenic effects associated with Somatuline LA during organogenesis. Reduced fertility was observed in female rats due to the inhibition of GH secretion at doses in excess of those achieved in humans at therapeutic doses.  Clinical data: Data on a limited number of exposed pregnancies indicate no adverse effects of Somatuline on pregnancy or on the health of the foetus/new born child. To date, no other relevant epidemiological data are available. Because animal studies are not always predictive of human responses, Somatuline LA should be administered to pregnant women only if clearly needed. Breast-feeding: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Somatuline is administered during lactation".

Section 4.7 - updated from "Therapy with Somatuline LA is unlikely to impair a patient's ability to drive or use machinery" to "While no effect on the ability to drive and use machines has been established, dizziness has been reported with Somatuline LA.  If a patient is affected, he/she should not drive or operate machinery"

Section 4.8 - in line with regulatory requirements which have changed since the last SPC was approved in 2003, section 4.8 has been updated extensively to list undesirable effects according to frequency. Please refer to the updated SPC for full details.

 

Section 4.9 - the following is deleted "There is no human experience of overdosage. Animal data do not predict any effects other than those on insulin and glucagon secretion and the gastrointestinal system"

Section 5.1 - reworded, no major changes

Section 5.2 - update of section. Notably, addition of the following "Renal/Hepatic impairment - Subjects with severe renal impairment show an approximately 2-fold decrease in total serum clearance of Somatuline LA, with a consequent increase in half-life and AUC.  In subjects with moderate to severe hepatic impairment, a reduction in clearance was observed (30%). Volume of distribution and mean residence time increased in subjects with all degrees of hepatic insufficiency. It is not necessary to alter the starting dose in patients with renal or hepatic impairment, as Somatuline LA serum concentrations in these populations are expected to be well within the range of serum concentrations safely tolerated in healthy subjects.  Elderly patients - Elderly subjects show an increase in half-life and mean residence time compared with healthy young subjects. It is not necessary to alter the starting dose in elderly patients, as Somatuline LA serum concentrations in this population are expected to be well within the range of serum concentrations safely tolerated in healthy subjects".

 

Section 5.3 - updated from "In vitro and animal toxicology studies have not shown any specific toxic potential for lanreotide. The observed effects are related to the pharmacological properties of lanreotide on the endocrine system. The resorption of Somatuline LA is complete in 45-60 days" to "In carcinogenic bioassays studies conducted in rats and mice, no systemic neoplastic changes were observed at doses in excess of those achieved in humans at therapeutic doses. Increased incidence of subcutaneous tumours were observed at the injection sites likely due to the increased dose frequency in animals (daily) compared to monthly dosing in humans and therefore may not be clinically relevant.  In in vitro and in vivo standard battery tests, Somatuline LA did not show any genotoxic potential. Resorption of micropheres is completed in 45 – 60 days".

Section 6.1 - no change in excipients themselves, only how listed

Sections 6.2, 6.3, 6.4 - minor updates only

 

 

 

 

Section 10 - date of revision updated from 4 August 2003 to 20 July 2010 

 

Updated on 17-Sep-2003 and displayed until 19-Oct-2010

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic Indications

Updated on 30-Jan-2002 and displayed until 17-Sep-2003

Reasons for adding or updating:

  • Removal of Black Triangle

Updated on 16-Aug-2001 and displayed until 30-Jan-2002

Reasons for adding or updating:

  • Transferred from eMC version 1

Updated on 09-Apr-2001 and displayed until 16-Aug-2001

Reasons for adding or updating:

  • No reasons supplied

Updated on 04-Feb-2000 and displayed until 09-Apr-2001

Reasons for adding or updating:

  • No reasons supplied

Updated on 06-Sep-1999 and displayed until 04-Feb-2000

Reasons for adding or updating:

  • No reasons supplied

Company contact details

Ipsen Ltd

Company image
Address

190 Bath Road, Slough, Berkshire, SL1 3XE

Fax

+44 (0)1753 627 778

Medical Information e-mail
Telephone

+44 (0)1753 627 777

Medical Information Direct Line

+44 (0)1753 627 777

Customer Care direct line

+44 (0)1753 627 627

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Active ingredients

lanreotide acetate

Legal categories

POM - Prescription Only Medicine

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