Orgalutran

  • Name:

    Orgalutran

  • Company:
    info
  • Active Ingredients:

    Ganirelix

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 12/06/19

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Summary of Product Characteristics last updated on medicines.ie: 11/6/2019

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MSD Ireland (Human Health) Limited

MSD Ireland (Human Health) Limited

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When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 12 June 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

Updated on 11 June 2019 SmPC

Reasons for 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
  • Correction of spelling/typing errors

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update to sections 4.4 and 4.8 of the SmPC regarding hypersensitivity reactions to include anaphylaxis (including anaphylactic shock), angioedema, and urticaria

 

Updated on 15 March 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Updated on 15 March 2019 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update of sections 4.4 and 6.5 of the SmPC to clarify that this product is in contact with dry natural rubber/latex, which may cause allergic reactions.

Updated on 27 July 2018 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 26 July 2018 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update to Marketing Authorisation Holder name and address in section 7 of the SPC

Updated on 26 June 2018 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.2 of the SPC, subsection Special populations / Hepatic impairment,  has been updated as follows (new text highlighted in red):

                  Hepatic impairment

There is no experience on the use of Orgalutran in subjects with hepatic impairment, as they were excluded from clinical studies. Therefore, the use of Orgalutran is contraindicated in patients with moderate or severe hepatic impairment (see section 4.3).”

Updated on 16 January 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 16 January 2017 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 9 May 2016 PIL

Reasons for updating

  • Change to date of revision
  • Change to improve clarity and readability
  • Addition of information on reporting a side effect.

Updated on 6 May 2016 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Which SPC sections have changed: 1 Name of the medicinal product, 2 Qualitative and Quantitative composition, 4.1 Indications, 4.2 Posology, 4.4 Special warnings and precautions for use, 4.6 Fertility, pregnancy and lactation, 4.8 Undesirable effects, 5.1 Pharmacodynamic properties, 5.2 Pharmacokinetic properties, 6.5 Nature and contents of container, 9 Renewal of the authorisation and 10 Date of revision of the text. 
Detailed SPC change information: Updates to SPC following Implementation of QRD to version 9.1

Updated on 6 May 2016 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 16 December 2014 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 16 October 2013 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Changes to sections: 7 and 10 - updated Marketing Authorisation Holder

Updated on 16 October 2013 PIL

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder
  • Correction of spelling/typing errors

Updated on 10 September 2013 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 23 November 2012 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to improve clarity and readability

Updated on 26 September 2012 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Updates to Sections: 4.3, 4.4, 4.8, 6.5 and 10.
Updates to section 4.4 with the addition of a precaution "the packaging of this medicinal product contains natural rubber latex which may cause allergic reactions" and minor amends to sections 4.3, 4.8 and 6.5

Updated on 25 September 2012 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Updates to : Sections 4.3, 4.4, 4.8, 6.5 and 10.
Updates to section 4.4 with the addition of a precaution "the packaging of this medicinal product contains natural rubber latex which may cause allergic reactions" and minor amends to sections 4.3, 4.8 and 6.5

Updated on 27 January 2012 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 20 July 2011 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Change to section 4.1 - Therapeutic indications Change to section 4.2 - Posology and method of administration Change to section 5.1 - Pharmacodynamic Properties As a consequence of the marketing approval of the sustained follicle stimulant corifollitropin alfa (trade name Elonva) in the EU for Controlled Ovarian Stimulation, the MAH has added this product to the product information for Orgalutran where relevant. Change to section 4.8 - Undesirable Effects - Update of section 4.8 of the SmPC following the approval of EMEA/H/C/0274/FUM25 showing a similar safety profile for Orgalutran, whether started on day 5 or day 6 of an ovarian stimulation protocol for assisted reproduction techniques. Change to section 6. 3 - Shelf Life Shelf life has been updated from 2 years to 3 years Change to section 10 date of revision of the text 27-Jan-2011

Updated on 18 July 2011 PIL

Reasons for updating

  • Change to, or new use for medicine

Updated on 2 June 2010 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Editorial changes replacing the words "trials" and "patients" with "studies" and "women", and the inclusion of the word "medicinal" in front of "product"

The following updates to section 4.2 (Posology and method of administration), including two new sub headings, "Timing of last injection" and "Paediatric population". A statement confirming the use of Orgalutran is contraindicated in patients with moderate and severe renal or hepatic impairment

Editorial change of text from "lactation" to "breast-feeding" in section 4.3 (Contraindications)

The addition of a statement confirming that Orgalutran is "essentially sodium-free", in section 4.4 (Special warnings and precautions for use.

An update to section 4.6 (Fertility, pregnancy and lactation), that includes formatting changes and the addition of three new sub headings, "Fertility", "Pregnancy" and "Breast-feeding". The following new paragraph under the sub heading, "Fertility" has been added, "Ganirelix is used in the treatment of women undergoing controlled ovarian hyperstimulation in assisted reproduction programmes. Ganirelix is used to prevent premature LH surges that might otherwise occur in these women during ovarian stimulation"

Section 4.8 (Undesirable effects) has been reformatted according to the MedDRA system organ class and frequency. There is no change in the adverse effects.

The following statement has been added to section 4.9 (Overdose), "In case of overdose, Orgalutran treatment should be (temporarily) discontinued"

The pharmacotherapeutic group definition now includes "Pituitary and hypothalamic hormones and analogues" in section 5.1 (Pharmacodynamic properties).

Updated on 28 May 2010 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to instructions about overdose
  • Change to side-effects
  • Change to further information section
  • Change to date of revision

Updated on 20 May 2010 PIL

Reasons for updating

  • Change to dosage and administration

Updated on 1 March 2010 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Text in bold has been added
Strikethrough text has been removed

 

2.          QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Each pre-filled syringe contains 0.25 mg of ganirelix in 0.5 ml aqueous solution. Orgalutran contains the The active substance ganirelix (INN) is a synthetic decapeptide ganirelix (INN) with high antagonistic activity to the naturally occurring gonadotrophin releasing hormone (GnRH). The amino acids at positions 1, 2, 3, 6, 8 and 10 of the natural GnRH decapeptide have been substituted resulting in N-Ac-D-Nal(2)1, D-
-pClPhe2, D-Pal(3)3, D-hArg(Et2)6, L-hArg(Et2)8, D-Ala10]-GnRH with a molecular weight of 1570.4.


Each pre filled syringe of Orgalutran contains the active substance ganirelix, 0.25 mg in a 0.5 ml aqueous solution.

 

For a full list of excipients, see section 6.1.

 

3.          PHARMACEUTICAL form

 

Solution for injection.

 

The aqueous solution contained within the syringe is clear and colourless Clear and colourless aqueous solution.

 

4.2        Posology and method of administration

 

Orgalutran should only be prescribed by a specialist experienced in the treatment of infertility.

 

Posology

Orgalutran is used to prevent premature LH surges in patients undergoing COH. Controlled ovarian hyperstimulation with FSH may start at day 2 or 3 of menses. Orgalutran (0.25 mg) should be injected subcutaneously once daily, starting on day 5 or day 6 of FSH administration, depending on the ovarian response, i.e. the number and size of growing follicles and/or the amount of circulating oestradiol.

 The start of Orgalutran may be delayed in absence of follicular growth, although clinical experience is based on starting Orgalutran on day 5 or day 6 of FSH. Orgalutran and FSH should be administered approximately at the same time. However, the preparations should not be mixed and different injection sites are to be used.
FSH dose adjustments should be based on the number and size of growing follicles, rather than on the amount of circulating oestradiol (see Ssection 5.1 Pharmacocynamic Properties). Daily treatment with Orgalutran should be continued up to the day that sufficient follicles of adequate size are present. Final maturation of follicles can be induced by administering human chorionic gonadotrophin (hCG). Because of the half-life of ganirelix, the time between two Orgalutran injections as well as the time between the last Orgalutran injection and the hCG injection should not exceed 30 hrs, as otherwise a premature LH surge may occur. Therefore, when injecting Orgalutran in the morning, treatment with Orgalutran should be continued throughout the gonadotrophin treatment period including the day of triggering ovulation. When injecting Orgalutran in the afternoon the last Orgalutran injection should be given in the afternoon prior to the day of triggering ovulation.

Orgalutran has shown to be safe and effective in patients undergoing multiple treatment cycles.

The need for luteal phase support in cycles using Orgalutran has not been studied. In clinical trials, luteal phase support was given according to study centres’ practice.

 

Subjects with renal or hepatic impairment: There is no experience of the use of Orgalutran in subjects with renal or hepatic impairement. Therefore, specific dose recommendations cannot be given (see section 4.3 Contraindications).


Method of administration

Orgalutran should be administered subcutaneously, preferably in the upper leg. The injection site should be varied to prevent lipoatrophy. The patient or her partner may perform the injections of Orgalutran themselves, provided that they are adequately instructed and have access to expert advice.

 

4.4        Special warnings and precautions for use

 

Special care should be taken in women with signs and symptoms of active allergic conditions. In the absence of clinical experience, Orgalutran treatment is not advised in women with severe allergic conditions.

 

Ovarian hyperstimulation syndrome (OHSS) may occur during or following ovarian stimulation. OHSS must be considered an intrinsic risk of gonadotrophin stimulation. OHSS should be treated symptomatically, e.g. with rest, intravenous infusion of electrolyte solutions or colloids and heparin.

 

Since infertile women undergoing assisted reproduction, and particularly IVF, often have tubal abnormalities the incidence of ectopic pregnancies might be increased.  Early ultrasound confirmation that a pregnancy is intrauterine is therefore important.

 

 

The incidence of congenital malformations after Assisted Reproductive Technologies (ART) may be higher than after spontaneous conceptions. This is thought to be due to differences in parental characteristics (e.g. maternal age, sperm characteristics) and an increased incidence of multiple gestations. In clinical trials investigating more than 1000 newborns it has been demonstrated that the incidence of congenital malformations in children born after COH treatment using Orgalutran is comparable with that reported after COH treatment using a GnRH agonist.

 

The safety and efficacy of Orgalutran have not been established in women weighing less than 50 kg or more than 90 kg (see also section 5.1 Pharmacodynamic properties and section 5.2 Pharmacokinetic properties).

 

4.5        Interaction with other medicinal products and other forms of interaction

 

No interaction studies have been performed. Interactions of Orgalutran with other medicines have not been investigated.

 

The possibility of interactions with commonly used medicinal products, including histamine liberating products, cannot be excluded.

 

4.6        Pregnancy and lactation

 

There are no adequate data from the use of ganirelix in pregnant women.

No clinical data on exposed pregnancies are available.  See also section 4.4, Special earnings and special precautions for use.  In animals, exposure to ganirelix at the time of implantation resulted in litter resorption (see section 5.3 Preclinical safety data). The relevance of these data for humans is unknown.

 

It is not known whether ganirelix is excreted in breast milk.

 

The use of Orgalutran is contraindicated during pregnancy and lactation (see section 4.3).

 

4.8        Undesirable effects

 

From clinical studies involving 1589 patients who started Orgalutran treatment on day 6, the following undesirable effects and their incidences became apparent

 

General disorders and administration site conditions

Orgalutran may cause a local skin reaction at the site of injection (predominantly redness, with or without swelling). In clinical studies, one hour after injection, the incidence of at least once a moderate or severe local skin reaction per treatment cycle, as reported by patients, was 12% in Orgalutran treated patients and 25% in patients treated subcutaneously with a GnRH agonist. The local reactions generally disappear within 4 hours after administration. Adverse reactions for Orgalutran are all uncommon (<1%).  The incidences as reported in clinical trials are: nausea (0.5%), headache (0.4%) and malaise (0.3%).   Malaise was reported in 0.3% of patients.

 

Immune system disorders

Very rarely cases of hypersensitivity reactions including various symptoms such as rash, facial swelling and dyspnoea have been reported among patients administered Orgalutran with FSH. Worsening of a pre-existing eczema has been reported in one subject after the first Orgalutran dose.

 

Nervous system disorders

Headache (0.4%).

 

Gastrointestinal disorders

Nausea (0.5%).

 

Other reported undesirable effects are related to the controlled ovarian hyperstimulation treatment for ART, notably pelvic pain, abdominal distension, OHSS (Ssee also section 4.4 Special warnings and precautions for use of this SPC), ectopic pregnancy and spontaneous abortion.

 

5.         PHARMACOLOGICAL PROPERTIES

 

5.1        Pharmacodynamic properties

 

Pharmacotherapeutic group: anti-gonadotrophin-releasing hormones, ATC code: H01CC01.

 

Orgalutran is a GnRH antagonist, which modulates the hypothalamic-pituitary-gonadal axis by competitive binding to the GnRH receptors in the pituitary gland. As a result a rapid, profound, reversible suppression of endogenous gonadotrophins occurs, without initial stimulation as induced by GnRH agonists. Following administration of multiple doses of 0.25 mg Orgalutran to female volunteers serum LH, FSH and E2 concentrations were maximally decreased by 74%, 32% and 25% at 4, 16 and 16 hours after injection, respectively. Serum hormone levels returned to pre-treatment values within two days after the last injection.

 

In patients undergoing controlled ovarian stimulation the median duration of Orgalutran treatment was 5 days. During Orgalutran treatment the average incidence of LH rises (>10 IU/l) with concomitant progesteron rise (>1 ng/ml) was 1.2% compared to 0.8% during GnRH agonist treatment. There was a tendency towards an increased incidence of LH and progesterone rises in women with a higher body weight (>80 kg), but no effect on clinical outcome was observed. However, based on the small number of patients treated so far, an effect can not be excluded. In case of a high ovarian response, either as a result of a high FSH exposure in the early follicular phase or as a result of high ovarian responsiveness, premature LH rises may occur earlier than day 6 of stimulation. Initiation of Orgalutran treatment on day 5 can prevent these premature LH rises without compromising the clinical outcome.

 

Early LH rises, prior to the start of Orgalutran at day 6 of stimulation, did occur especially in high responders, but did not affect the clinical outcome. In these patients LH production was rapidly suppressed after the first Orgalutran administration.

 

In controlled studies of Orgalutran, using a long protocol of GnRH agonist as a reference, treatment with the Orgalutran regimen resulted in a faster follicular growth during the first days of stimulation but the final cohort of growing follicles was slightly smaller and produced on average less oestradiol. This different pattern of follicular growth, requires that FSH dose adjustments are based on the number and size of growing follicles, rather than on the amount of circulating oestradiol.

 

 

6.1        List of excipients

 

Acetic acid,;

mMannitol and;

water Water for injections.

The pH may have been adjusted with sodium hydroxide and acetic acid.

 

6.2        Incompatibilities

 

In the absence of incompatibility studies, this medicinal product must not be mixed with other medicinal products.

 

6.5        Nature and contents of container

 

Orgalutran is presented as a sterile, ready to use, aqueous solution and supplied in dDisposable pre-filled syringes (siliconised Type I glass), containing 0.5 ml of sterile, ready for use, aqueous solution closed with a rubber piston. Each pre-filled syringe is affixed with a needle closed by a needle shield of natural rubber.

 

Supplied in cartons containing 1 or 5 pre-filled syringes.

 

Not all pack sizes may be marketed

 

10.        DATE OF REVISION OF THE TEXT

 

June 2007

 

22 January 2010

 

 

Updated on 22 February 2010 PIL

Reasons for updating

  • Change to storage instructions
  • Change to side-effects
  • Change to how the medicine works
  • Change to further information section
  • Change to date of revision
  • Change to dosage and administration
  • Change to warnings or special precautions for use

Updated on 25 October 2006 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 22 August 2006 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - MA number
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 3 - Inclusion of visual description
Section 4.4 - Addition of special warning
Section 4.8 - Revision of undesirable effects
Section 6.5 - Addition of statement "Not all pack sizes may be marketed."
Section 8 - Additional information for clarification of numbers
Section 9 - Update to Renewal Date
Section 10 - Update to Date of Revision of Text

Updated on 23 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may not be renewed (A)