Skip to content
SPC Logo

Somatuline Autogel 60mg, Somatuline Autogel 90mg, Somatuline Autogel 120mg New device

Last Updated on eMC 06-May-2015 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 06-May-2015 and displayed until Current

Reasons for adding or updating:

  • 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: 21-Apr-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 5.1 Pharmacodynamic properties - The following information has been added:$0$0$0$0In an open-labelstudy, Somatuline Autogel 120mg was administered every 28 days for 48 weeks in90 previously untreated acromegalic patients diagnosed with pituitarymacroadenoma. Patients expected to require pituitary surgery or radiotherapyduring the study period were excluded.$0$0$0$0$0At week 48, 63%of the patients showed a reduction in tumour volume of  ≥20% (which was the primaryefficacy endpoint) although statistical significance was not reached (95% CI:52%-73%). A less than 20% reduction was obtained in 24 patients (27%) and anincrease in tumour volume was observed in 9 patients (10%).$0$0$0$0$0The mean percentagereduction of tumour volume was 26.8%, GH levels were below 2.5 μg/L in 77.8% ofthe patients and IGF-1 levels normalised in 50%. Normalised IGF-1 levelscombined with GH levels below 2.5 μg/L were observed in 43.5% of the patients.$0$0$0$0$0Patients reporteda relief of acromegaly symptoms such as fatigue (56.5%), excess perspiration(66.1%), arthralgia (59.7%) and soft tissue swelling (66.1%). Less patients hadrelief of headache (38.7) %.$0$0$0$0$0A reduction intumour volume and concentrations of GH and IGF-1 was shown from week 12 and wasmaintained for 48 weeks). $0

Updated on 13-Mar-2015 and displayed until 06-May-2015

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 27-Feb-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.1 (Therapeutic indications) - The following indication has been added:
"The treatment of grade 1 and a subset of grade 2 (Ki67 index up to 10%) gastroenteropancreatic neuroendocrine tumours (GEP-NETs) of midgut, pancreatic or unknown origin where hindgut sites of origin have been excluded, in adult patients with unresectable locally advanced or metastatic disease (see section 5.1)."

Section 4.2 (Posology and method of administration) - The following information has been added under the subheading 'Acromegaly':
"Treatment of grade 1 and a subset of grade 2 (Ki67 index up to 10%) gastroenteropancreatic neuroendocrine tumours of midgut, pancreatic or unknown origin where hindgut sites of origin have been excluded, in adult patients with unresectable locally advanced or metastatic disease
The recommended dose is one injection of Somatuline Autogel 120 mg administered every 28 days. The treatment with Somatuline Autogel should be continued for as long as needed for tumour control."

The information under the subheading 'Method of administration' has been replaced with the following:
Somauline Autogel is administered by deep subcutaneous injection in the superior external quadrant of the buttock.

For patients treated for acromegaly or treated for symptoms associated with NETs who receive a stable dose of Somatuline Autogel, and after appropriate training, the product may be administered either by the patient or by a trained person. In case of self-injection the injection should be given in the upper outer thigh.

The decision of administration by the patient or a trained person should be taken by a healthcare professional.

Regardless of the injection site, the skin should not be folded and the needle should be inserted rapidly and to its full length, perpendicularly to the skin.The injection site should alternate between the right and left side."

Section 4.4 (Special warnings and precautions for use) - The following information has been removed:
"In patients with carcinoid tumours, lanreotide must not be prescribed before excluding the presence of an obstructive intestinal tumour."

Section 4.7 (Effects on ability to drive and use machines) - The information has been replaced with the followimg:
"Somatuline Autogel has minor or moderate influence on the ability to drive and use machines. No studies on the effects on the ability to drive and use machines have been performed.

However, dizziness has been reported with Somatuline Autogel (see section 4.8). If a patient is affected, he/she should not drive or operate machinery."

Section 4.8 (Undesirable effects) - The words in bold have been added to the first sentence:
"Undesirable effects reported by patients suffering from acromegaly and GEP-NETs treated with lanreotide in clinical trials are listed under the corresponding body organ systems according to the following classification:"

An additional column has been added to the adverse event table - 'Post-marketing safety experience (frequency not known)' and adverse events added based on a pool of studies conducted in patients with GEP-NETs have been added to the table.

The following information has been removed and been included in the table instead:
"Post-marketing safety experience
Post-marketing safety experience has not identified any other relevant information other than occasional reports of pancreatitis."

The following information has been added:
"Reporting of suspected adverse reactions
Reporting of suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard."
 
Section 5.1 (Pharmacodynamic properties) - The following information has been added after the second sentence of the second paragraph:
"Additionally, it decreases the levels of plasma chromogranin A and urinary 5-HIAA (5 Hydroxyindolacetic acid) in patients with GEP-NETs and elevated levels of these tumour markers."

The following information has been added in addition to tables and firgures not included here:

"A phase III, 96-week, fixed duration, randomized, double-blind, multi-centre, placebo-controlled trial of Somatuline Autogel was conducted in patients with gastroenteropancreatic neuroendocrine tumours to assess the antiproliferative effect of lanreotide.

Patients were randomized 1:1 to receive either Somatuline Autogel 120 mg every 28 days (n=101) or placebo (n=103). Randomization was stratified by previous therapy at entry and the presence/absence of progression at baseline as assessed by RECIST 1.0 (Response Evaluation Criteria in Solid Tumours) during a 3 to 6 month screening phase.

Patients had metastatic and /or locally advanced inoperable disease with histologically confirmed well or moderately well differentiated tumours primarily localized in the pancreas (44.6% patients), midgut (35.8%), hindgut (6.9%) or of other/unknown primary location 12.7%).

69% of patients with GEP-NETs had tumour grade 1 (G1), defined by either a  proliferation index Ki67 ≤ 2% (50.5% of the overall patient population) or a mitotic index < 2 mitosis/10 HPF (18.5% of the overall patient population) and 30% of patients with GEP-NETs had tumours in the lower range of grade 2 (G2) (defined by a Ki67 index > 2% - ≤ 10%). Grade was not available in 1% of the patients. The study excluded patients with G2 GEP-NETs with a higher cellular proliferation index (Ki 67 >10% - ≤ 20%) and G3 GEP neuroendocrine carcinomas (Ki 67 index > 20%).

Overall, 52.5% of the patients had an hepatic tumour load ≤10%, 14.5% had an hepatic tumour load > 10 and ≤25% and 33% had an hepatic tumour load >25%. 

The primary endpoint was progression-free survival (PFS) measured as time to either disease progression by RECIST 1.0 or death within 96 weeks after first treatment administration. Analysis of PFS utilized independent centrally-reviewed radiological assessment of progression.

The beneficial effect of lanreotide in reducing the risk of progression or death was consistent regardless of the location of primary tumour, hepatic tumour load, previous chemotherapy, baseline Ki67, tumour grade or other pre-specified characteristics as shown in Figure 2.

A clinically-relevant benefit of treatment with Somatuline Autogel was seen in patients with tumours of pancreatic, midgut and other/unknown origin as in the overall study population. The limited number of patients with hindgut tumours (14/204) contributed to difficulty in interpreting the results in this subgroup. The available data suggested no benefit of lanreotide in these patients.

Crossover from placebo to open-label Somatuline Autogel, in the extension study, occurred in 45.6% (47/103) of the patients.

Paediatric population
The European Medicines Agency has waived the obligation to submit the results of studies with Somatuline Autogel in all subsets of the paediatric population in acromegaly and pituitary gigantism (see section 4.2 for information on paediatric use). The European Medicines Agency has listed gastroenteropancreatic neuroendocrine tumours (excluding neuroblastoma, neuroganglioblastoma, phaechromocytoma) on the list of class waivers."

The following information has been removed:

"Somatostatin analogues are reported to have an anti-proliferative effect.

This has been evidenced for lanreotide by stabilisation of tumour growth similar to that seen with octreotide in two small uncontrolled studies. This effect is relevant for those patients with well differentiated advanced neuroendocrine tumours of the midgut."

Section 5.2 (Pharmacokinetic properties) - The following information has been added:
"In a population PK analysis in 290 GEP-NET patients receiving Somatuline Autogel 120 mg, rapid initial release was seen with mean Cmax values of 7.49 ± 7.58 ng/mL reached within the first day after a single injection. Steady-state concentrations were reached after 5 injections of Somatuline Autogel 120 mg every 28 days and were sustained up to the last assessment (up to 96 weeks after the first injection). At steady-state the mean Cmax values were 13.9 ± 7.44 ng/mL and the mean trough serum levels were 6.56 ± 1.99 ng/mL. The mean apparent terminal half-life was 49.8 ± 28.0 days."

The following information has been added under the subheading 'Renal/Hepatic impairment':
"No effect on clearance of lanreotide was observed in a population PK analysis of GEP-NET patients including 165 with mild and moderate renal impairment (106 and 59 respectively) treated with Somatuline Autogel. GEP-NET patients with severely impaired renal function were not studied.

No GEP-NET patients with hepatic impairment (as per Child-Pugh score) were studied."

The following information has been added under the subheading 'Elderly patients':
"In a population PK analysis of GEP-NET patients including 122 aged 65 to 85 years, no effect of age on clearance and volume of distribution of lanreotide was observed."


Updated on 19-Dec-2013 and displayed until 13-Mar-2015

Reasons for adding or updating:

  • 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: 18-Oct-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In section 5.1 Pharmacodynamic properties - The following information has been added:

Somatostatin analogues are reported to have an anti-proliferative effect. This has been evidenced for lanreotide by stabilisation of tumour growth similar to that seen with octreotide in two small uncontrolled studies. This effect is relevant for those patients with well differentiated advanced neuroendocrine tumours of the midgut.

Updated on 25-Oct-2011 and displayed until 19-Dec-2013

Reasons for adding or updating:

  • New SPC for new product

Legal Category:POM

Black Triangle (CHM): NO

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

This site uses cookies. By continuing to browse the site you are agreeing to our policy on the use of cookies. Continue