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Increlex 10mg/ml solution for injection

Last Updated on eMC 09-Jun-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 09-Jun-2015 and displayed until Current

Reasons for adding or updating:

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

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

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

$0In section 4.4 Special warnings and precautions for use - The information in bold has been added to the following paragraph:$0$0Slipped capital femoral epiphysis (with the potential to lead to avascular necrosis) and progression of scoliosis can occur in patients who experience rapid growth. These conditions and other symptoms and signs known to be associated with GH treatment in general should be monitored during INCRELEX treatment. Any patient with the onset of a limp or complaint of hip or knee pain should be evaluated.$0

Updated on 08-May-2015 and displayed until 09-Jun-2015

Reasons for adding or updating:

  • 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: 23-Apr-2015

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

Section 4.8 Undesirable effects:
This section has been updated in line with the updated Company Core Safety Information. Previously, the clinical trial data in this section originated from 76 subjects. This has been updated to 413 subjects. The adverse events and frequencies have been updated based on the updated clinical trial data and post-marketing data. Melanocytic naevus has been added as an adverse event. Please refer to the SPC for full details of all the changes.$0$0$0$0Section 5.1 Pharmacodynamic properties: $0$0This section has been updated to include 92 subjects from 76 subjects and the results have been updated accordingly. The following information has been added:$0$0 "Eighty-three (83) out of 92 patients were naïve to INCRELEX at baseline and 81 completed at least one year of INCRELEX treatment."$0$0$0$0$0$0" The height velocities for years 2 through 8 remained statistically greater than baseline. For the 21 treatment naïve subjects with near-adult height, the mean (± SD) of the difference between observed increase in height versus that expected from Laron was approximately 13 cm (± 8 cm) after an average of 11 years of treatment."$0$0$0$0$0" For subjects with bone age available for at least 6 years after treatment initiation, the mean increase in bone age was comparable to the mean increase in chronological age; for these subjects, there does not appear to be any clinically significant advance of bone age relative to chronological age."$0$0$0$0$0$0$0 "The dose of 120 μg/kg given SC and BID was associated with the greatest growth responses."$0$0$0$0$0$0 "Among all subjects included for safety evaluation (n=92), 83% of the subjects reported at least one adverse event during the course of the studies. There was no death during the studies. No subject discontinued the studies due to adverse events.$0Hypoglycaemia was the most frequently reported adverse event and a proper attention has to be given to meals in relation to dosing."$0$0Please refer to the SPC for full details of all the changes.$0$0$0$0$0$0$0$0$0

Updated on 19-Sep-2014 and displayed until 08-May-2015

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
  • Addition of black triangle

Date of revision of text on the SPC: 15-Jul-2014

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

Addition of black triangle - at the beginning of the SPC, a black triangle and the following wording has been added:

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

In section 4.8 Undesirable effects - the following wording has been added at the end of the section:

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation 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 national reporting system:
    -     In Ireland directly to the IMB Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, Website: www.imb.ie, e-mail: imbpharmacovigilance@imb.ie 
    -     In the United Kingdom via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard

Updated on 27-Sep-2012 and displayed until 19-Sep-2014

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 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC: 30-Aug-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In section 4.1 Therapeutic indicationsThefollowing information in bold has been added : $0For the long-term treatment of growthfailure in children and adolescents from2 to 18 years with severe primary insulin-like growth factor‑1deficiency (Primary IGFD).$0The licensed age has not changed, but is nowmore explicit.$0$0$0$0$0In section 4.2 Posology and method of administration: The following section now reads:$0$0Paediatric population$0$0The safety and efficacy ofINCRELEX in children below age of 2 have not been established. No data areavailable.$0$0Therefore INCRELEX is notrecommended in children below age of 2. $0$0The following information has been added:$0$0Method of administration$0$0INCRELEX should not beadministered intravenously.$0$0 $0$0Precaution to be taken beforemanipulating or administering the product.$0$0The solution should be clear immediately after removal from therefrigerator. If the solution is cloudy, or contains particulate matter, itmust not be injected (see section 6.6).$0$0In section 4.3 Contraindications: Intravenous administration has been removed.$0$0$0$0$0In section 4.4 Special warnings and precautions for use: The following has been added:$0$0Excipients$0$0This medicinal product contains less than 1 mmol sodium(23 mg) per vial, i.e. essentially ‘sodium-free’.$0$0In section 4.6 Fertility, pregnancy and lactation: Thefollowing now reads:$0$0Women ofchildbearing potential / Contraception in males and females$0$0A negative pregnancy test is recommended for all women of child bearingpotential prior to treatment with INCRELEX. It is also recommended that allwomen of childbearing potential use adequate contraception during treatment$0$0Pregnancy$0$0There are no or limited amount of data for the use of mecasermin in pregnant women.$0$0Animal studies areinsufficient with respect to reproductive toxicity(see section 5.3). The potential risk for humans is unknown.$0$0The following has been added:$0$0Fertility$0$0INCRELEX has been tested in a ratteratology study with no effects on fœtus up to 16 mg/kg (20 fold the MRHDbased on Body surface Area) and in a rabbit teratology with no effects onfoetus at dose of 0.5 mg/kg (2 fold the MRHD based on Body surface Area).INCRELEX has no effects on fertility in rats  using intravenous doses0.25, 1, and 4 mg/day (up to 4 times the clinical exposure with the MRHDbased on AUC).$0$0The effects of INCRELEX on unborn child have not been studied. Therefore thereis insufficient medical information to determine whether there are significantrisks to a foetus. Studies have not been conducted with INCRELEX in nursingmothers. INCRELEX should not be given to pregnant or nursing women. A negativepregnancy test and adequate contraception is required in all pre-menopausalwomen receiving INCRELEX.$0$0In section 4.8 Undesirable effects: The columns within the Adverse Drug Reactionstable are now split as follows:$0$0 $0$0·Reactions observed in the pivotal clinical trial$0$0·Reactions observed from the post-marketingenvironment$0$0 $0$0The following has been added as an Adverse DrugReaction:$0$0$0$0$0Reactionsobserved from the post-marketing environment$0$0Notknown: Alopecia$0$0$0In section 4.9 Overdose: The following has been removed:$0$0No case ofoverdose has been reported.$0$0$0$0$0In section 6.5 Nature and contents of container: "latexfree stopper" has been removed to read:$0$0$04 ml of solution in a5 ml vial (type I glass) closed with a stopper (bromobutyl/isoprenepolymer) and a seal (lacquered plastic).$0$0

Updated on 25-Mar-2011 and displayed until 27-Sep-2012

Reasons for adding or updating:

  • Removal of Black Triangle

Date of revision of text on the SPC: 28-Jul-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Black triangle has been removed

Updated on 25-Oct-2010 and displayed until 25-Mar-2011

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: 28-Jul-2010

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

Section 4.4 has been updated from "As with any exogenous protein administration, local or systemic allergic reactions may occur. Parents and patients should be informed that such reactions are possible and that if an allergic reaction occurs, treatment should be interrupted and prompt medical attention should be sought" to "In post-marketing experience in patients treated with Increlex, cases of hypersensitivity, urticaria, pruritis and erythema have been reported. These have been observed both as local to the injection site and/or systemic.  A small number of cases indicative of anaphylaxis requiring hospitaisation have been reported. Parents and patients should be informed that such reactions are possible and that if a systemic allergic reaction occurs, treatment should be interrupted and prompt medical attention should be sought"

Section 4.8 has been updated from "As with all protein pharmaceuticals, some patients may develop antibodies to INCRELEX. Anti-IGFNON-BREAKING HYPHEN (8209)1 antibodies were observed in 11 of 23 children with severe primary IGFD tested during the first year of therapy. However, no clinical consequences of these antibodies were observed (e.g., allergic reactions or attenuation of growth)" to "During clinical trials in other indications totalling approximately 300 patients, reports of local and/or systemic hypersensitivity were received for 8% of patients.  All cases were mild or moderate in severity and none was serious.  As with all protein pharmaceuticals, some patients may develop antibodies to Increlex. Anti-IGF‑1 antibodies were observed in 11 of 23 children with severe Primary IGFD tested during the first year of therapy. No attenuation of growth was observed as a consequence of the development of antibodies". 

The following information has also been added:

The following adverse reactions have been identified during post approval use of Increlex. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency.

-Systemic hypersensitivity: anaphylaxis, generalised urticaria, angioedema, dyspnoea

The symptoms in the cases indicative of anaphylaxis included hives, angioedema and dyspnoea. Some patients required hospitalisation. Upon re-administration, symptoms did not re-occur in all patients.

-Local allergic reactions at the injection site: pruritis, urticaria.

Updated on 08-Apr-2010 and displayed until 25-Oct-2010

Reasons for adding or updating:

  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC: 14-Jul-2009

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

Change to MAH from Tercica to Ipsen Pharma
Update of ATC code

Updated on 17-Sep-2009 and displayed until 08-Apr-2010

Reasons for adding or updating:

  • Change to section 6. 3 - Shelf Life
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC: 17-Mar-2009

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

Section 6.3 - shelf life increased from 2 years to 3 years.

Updated on 04-Sep-2007 and displayed until 17-Sep-2009

Reasons for adding or updating:

  • New SPC for new product

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

mecasermin

Legal categories

POM - Prescription Only Medicine

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