Toujeo 300 units/ml SoloStar solution for injection in a pre-filled pen *
Pharmacy Only: Prescription

  • Company:

    SANOFI
  • Status:

    Updated
  • Legal Category:

    Product subject to medical prescription which may be renewed (B)
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

EDM Updated on 03 February 2023

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EDM Updated on 03 February 2023

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EDM Updated on 13 December 2022

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EDM Updated on 13 December 2022

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Updated on 18 January 2022

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Toujeo Solostar - PIL Text_1642501078.pdf

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  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 11 August 2020

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Ireland Toujeo Solostar PIL (1)_1597154133.pdf

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  • Previous version of PIL reinstated

Updated on 20 July 2020

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Ireland Toujeo and Toujeo Doublestar SmPC_1595256219.pdf

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  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 20 July 2020

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Solostar_1595248601.pdf

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  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 06 July 2020

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1.3.2.1 Ireland Toujeo Solostar PIL (1)_1582803795.pdf

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  • XPIL Removed

Updated on 27 February 2020

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1.3.2.1 Ireland Toujeo Solostar PIL (1)_1582803795.pdf

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  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 05 February 2020

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1.3.2.1 Ireland Toujeo Solostar PIL_1580913300.pdf

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  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 05 February 2020

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1.3.1.1 SmPC Toujeo and Toujeo Doublestar (2)_1580913205.pdf

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  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Label update requested by the PRAC during the insulin glargine PSUSA

Updated on 18 December 2019

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Toujeo Solostar PIL_1576677462.pdf

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  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains

Updated on 11 December 2019

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Toujeo and Toujeo Doublestar SmPC_1576082807.pdf

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  • 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 5.2 - Pharmacokinetic properties

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 09 December 2019

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Toujeo SmPC_1575891617.pdf

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  • 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 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 11 September 2019

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1.3.2 Mock-up PIL -544563- Toujeo SoloStar [034][035] - Ireland CP split - SA1135_1568186602.pdf

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  • Joint PIL superseded by individual PILs

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Replace UK/Ireland PIL with Ireland only PIL

EDM Updated on 04 September 2019

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2019-08-07 HPRA Approved Toujeo SoloStar Patient guide IE_1567594775.pdf

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Updated on 03 September 2019

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Ireland Toujeo PIL SA518 Update to PIL for DoubleStar and CCDS v02_1567497025.pdf

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Updated on 02 September 2019

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Updated on 02 September 2019

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Legal category:Product subject to medical prescription which may be renewed (B)

EDM Updated on 02 September 2019

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2019-08-07 HPRA Approved Toujeo SoloStar DoubleStar HCP guide IE_1567433025.pdf

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EDM Updated on 02 September 2019

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2019-08-07 HPRA Approved Toujeo DoubleStar Patient guide IE_1567432942.pdf

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EDM Updated on 22 August 2019

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2019-07-22 Final SoloStar DoubleStar HCP guide IE (002)_1565790072.pdf

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EDM Updated on 22 August 2019

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Updated on 21 March 2019

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Toujeo SoloStar PIL 544539 cropped-reduced-size_1553173762.pdf

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  • Improved presentation of PIL

Updated on 07 February 2019

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SPC Ireland TOUJEO new DoubleStar pen_1549532705.pdf

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 8 - Marketing authorisation number(s)

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

1.       NAME OF THE MEDICINAL PRODUCT

Toujeo 300 units/ml SoloStar, solution for injection in a pre-filled pen

Toujeo 300 units/ml DoubleStar, solution for injection in a pre-filled pen

2.       QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml contains 300 units insulin glargine* (equivalent to 10.91 mg).

SoloStar pen

Each pen contains 1.5 ml of solution for injection, equivalent to 450 units.

DoubleStar pen

Each pen contains 3 ml of solution for injection, equivalent to 900 units.

* Insulin glargine is produced by recombinant DNA technology in Escherichia coli.

For the full list of excipients, see section 6.1.

 

Toujeo must not be administered intravenously. The prolonged duration of action of Toujeo is dependent on its injection into subcutaneous tissue. Intravenous administration of the usual subcutaneous dose could result in severe hypoglycaemia.

Toujeo must not be used in insulin infusion pumps.

Toujeo is available in two pre-filled pens. The dose window shows the number of units of Toujeo to be injected. The Toujeo SoloStar and Toujeo DoubleStar pre-filled pens have been specifically designed for Toujeo and no dose re-calculation is required for either pen.

Before using Toujeo SoloStar pre-filled pen or Toujeo DoubleStar pre-filled pen, the instructions for use included in the package leaflet must be read carefully (see section 6.6).

With Toujeo SoloStar pre-filled pen, a dose of 1-80 units per single injection, in steps of 1 unit, can be injected.

 The dose window shows the number of Toujeo units to be injected. The Toujeo SoloStar pre-filled pen has been specifically designed for Toujeo, therefore no dose re-calculation is required.

With Toujeo DoubleStar pre-filled pen a dose of 2-160 units per single injection, in steps of 2 units, can be injected.

When changing from Toujeo SoloStar to Toujeo DoubleStar, if the patient’s previous dose was an odd number (e.g. 23 units) then the dose must be increased or decreased by 1 unit (e.g. 24 or 22 units).

Toujeo DoubleStar prefilled pen is recommended for patients requiring at least 20 units per day. (see section 6.6)

Toujeo must not be drawn from the cartridge of the Toujeo SoloStar pre-filled pen or Toujeo DoubleStar pre-filled pen into a syringe or severe overdose can result (see section 4.4, 4.9 and 6.6).

 

 

Particular caution should be exercised, and intensified blood glucose monitoring is advisable in patients in whom hypoglycaemic episodes might be of particular clinical relevance, such as in patients with significant stenosis stenoses of the coronary arteries or of the blood vessels supplying the brain (risk of cardiac or cerebral complications of hypoglycaemia) as well as in patients with proliferative retinopathy, particularly if not treated with photocoagulation (risk of transient amaurosis following hypoglycaemia).

To avoid dosing errors and potential overdose, the patients must be instructed to never use a syringe to remove Toujeo (insulin glargine 300 units/ml) from the Toujeo SoloStar pre‑filled pen or Toujeo DoubleStar pre-filled pen (see section 4.9 and 6.6)

 

It is essential for patients with pre‑existing or gestational diabetes to maintain good metabolic control throughout pregnancy to prevent adverse outcomes associated with hyperglycaemiahyperglycemia. Insulin requirements may decrease during the first trimester and generally increase during the second and third trimesters. Immediately after delivery, insulin requirements decline rapidly (increased risk of hypoglycaemia). Careful monitoring of glucose control is essential.

 

 

 

As observed in euglycaemiceuglycemic clamp studies in patients with type 1 diabetes, the glucose lowering effect of Toujeo was more stable and prolonged in comparison with insulin glargine 100 units/ml  after subcutaneous injection. Figure 1 shows results from a cross-over study in 18 patients with type 1 diabetes conducted for a maximum of 36 hours after injection.The effect of Toujeo was beyond 24 hours (up to 36 hours) at clinically relevant doses.

The total therapeutic insulin concentration (insulin glargine and its metabolites) found in type 1 diabetic patients was markedly lower than what would be required for a half maximalhalfmaximal occupation of the IGF‑1 receptor and the subsequent activation of the mitogenic‑proliferative pathway initiated by the IGF‑1 receptor.

The superiority of Toujeo over insulin glargine 100 units/ml in lowering the risk of confirmed nocturnal hypoglycaemiahypoglycemia was shown in patients with type 2 diabetes treated with basal insulin in combination with either non‑insulin anti‑hyperglycaemic medicinal product (18% risk reduction) or mealtime insulin (21% risk reduction) during the period from week 9 to end of study period.

 

6.3     Shelf life

Toujeo SoloStar

30 months.

Toujeo DoubleStar

24 months.

Shelf life after first use of the pen

The medicinal product may be stored for a maximum of 6 weeks below 30°C and away from direct heat or direct light. Pens in use must not be stored in the refrigerator. The pen cap must be put back on the pen after each injection in order to protect from light.

6.5     Nature and contents of container

SoloStar penPre-filled pen

Cartridge (type 1 colourless glass) with a blackgrey plunger (bromobutyl rubber) and a flanged cap (aluminium) with a stopper (laminate of isoprene and bromobutyl rubber).The cartridge is sealed in a disposable pen injector. Each cartridge contains 1.5 ml solution.

DoubleStar pen

Cartridge (type 1 colourless glass) with a black plunger (bromobutyl rubber) and a flanged cap (aluminium) with a stopper (laminate of isoprene and bromobutyl rubber).The cartridge is sealed in a disposable pen injector. Each cartridge contains 3 ml solution.

Packs of 1, 3, 6 (2 packs of 3) and 9 (3 packs of 3) pens are available. Not all pack sizes may be marketed.

Needles are not included in the pack.

6.6     Special precautions for disposal and other handling

Before first use, the pen must be stored at room temperature at least 1 hour before use.

Before using Toujeo SoloStar or Toujeo DoubleStar pre-filled pen, the Instructions for Use included in the package leaflet must be read carefully. Toujeo SoloStar pre-filled pens havehas to be used as recommended in these Instructions for Use (see section 4.2). Instruct patients to perform a safety test as described in Step 3 of the Instructions for Use. If they don’t, the full dose might not be delivered. If this occurs, patients should increase the frequency of checking their blood glucose levels and might need to administer additional insulin.

Insulin label must always be checked before each injection to avoid medication errors between Toujeo and other insulins.The strengthstrengh“300” is highlighted in honey gold on the label (see section 4.4).

Patients should be informed that the dose counter of Toujeo SoloStar or Toujeo DoubleStar pre-filled pen shows the number of units of Toujeo to be injected. No dose re-calculation is required.

  • The Toujeo SoloStar pen contains 450 units of Toujeo. It delivers doses of 1-80 units per injection, in steps of 1 unit.
  • The Toujeo DoubleStar pen contains 900 units of Toujeo. It delivers doses of 2-160 units per injection, in steps of 2 units.
    • To reduce potential underdose, Toujeo DoubleStar is recommended for patients requiring at least 20 units per day.
  • If safety tests are not performed before the first use of a new pen, insulin underdose can occur.

A syringe must never be used to withdraw Toujeo from the cartridge of the SoloStar pre‑filled pen or severe overdose can result (see section 4.2, 4.4 and 4.9).

 

8.       MARKETING AUTHORISATION NUMBER(S)

EU/1/00/133/033

EU/1/00/133/034

EU/1/00/133/035

EU/1/00/133/036

EU/1/00/133/037

EU/1/00/133/038

EU/1/00/133/039

EU/1/00/133/040

 

Updated on 05 December 2017

File name

PIL_16412_94.pdf

Reasons for updating

  • New PIL for new product

Updated on 05 December 2017

Reasons for updating

  • Improved presentation of PIL

Updated on 21 November 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 21 November 2017

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.2

Wording repositioned in Section

·         Before using Toujeo SoloStar pre-filled pen, the instructions for use included in the package leaflet must be read carefully (see section 6.6).

Added:-

·         4.4

Section 4.4 added:-

·         Medication errors have been reported in which other insulins, particularly rapid acting insulins, have been accidentally administered instead of long acting insulins. Insulin label must always be checked before each injection to avoid medication errors between Toujeo and other insulins (see section 6.6).

·         To avoid dosing errors and potential overdose, the patients must be instructed to never use a syringe to remove Toujeo (insulin glargine 300 units/ml) from the SoloStar pre filled pen (see section 4.9 and 6.6)

·         A new sterile needle must be attached before each injection. Patients must also be instructed to not re use needles. Re use of needles increases the risk of blocked needles which may cause underdosing or overdosing. In the event of blocked needle, the patients must follow the instructions described in Step  3 of the Instructions for Use accompanying the package leaflet (see section  6.6).

Section 5.1

Amendments to graph

Section 6.6 added:-

·         4.4 and 4.9

·         A new sterile needle must be attached before each injection.

·         Needles must not be re used

·         and 4.4).

Removed:-

·         A new sterile needle must be attached before each injection.

Updated on 21 December 2016

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 01 November 2016

Reasons for updating

  • Change to legal category

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

product subject to medical prescription

Updated on 30 September 2016

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company



Type II Group variation –

Type II-B.II.d.1.e)-To widen the specification limit for sum of related impurities/degradation products from ≤ 2.0% to ≤ 2.5%.
Type IB-B.II.f.1.d)-To change the storage conditions of the finished product to extend the in-use period after first opening from 4 to 6 weeks when stored below 30°C.

Updated on 21 July 2015

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 17 July 2015

Reasons for updating

  • New PIL for new product