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.

3.       PHARMACEUTICAL FORM

Solution for injection (injection).

Solution for injection (injection) in pre‑filled pen (KwikPen).

Solution for injection. KwikPen. (Injection).

4.2   Posology and method of administration

…

The ABASAGLAR dose regimen (dose and timing) should be individually adjusted.

Paediatric population

Adolescents and children aged 2 years and older

The safety and efficacy of insulin glargine have been established in adolescents and children aged 2 years and older (see section 5.1). The dose regimen (dose and timing) should be individually adjusted.

Children below 2 years of age

The safety and efficacy of insulin glargine have not been established No data are available.

Safety and efficacy of insulin glargine have been established in adolescents and children aged 2 years and older. Currently available data are described in sections 4.8, 5.1 and 5.2.

Safety and efficacy of insulin glargine have not been established in children below the age of 2 years. No data are available.

…

Before using ABASAGLAR solution for injection in pre‑filled penKwikpen, the instructions for use included in the package leaflet must be read carefully (see section 6.6).

4.4   Special warnings and precautions for use

…

Insulin administration may cause insulin antibodies to form. In rare cases, the presence of such insulin antibodies may necessitate adjustment of the insulin dose in order to correct a tendency to hyper- or hypoglycaemia (see section 4.8).

…                        

Insulin antibodies

Insulin administration may cause insulin antibodies to form. In rare cases, the presence of such insulin antibodies may necessitate adjustment of the insulin dose in order to correct a tendency to hyper- or hypoglycaemia (see section 5.1).

…

Sodium contentExcipients

4.6   Fertility, pregnancy and lactation

…

The use of ABASAGLAR may be considered during pregnancy, if clinically needednecessary.

4.7   Effects on ability to drive and use machines

This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or operating using machines).

4.8   Undesirable effects

Summary of safety profile

Hypoglycaemia (very common), in general the most frequent adverse reaction of insulin therapy, may occur if the insulin dose is too high in relation to the insulin requirement (see section 4.4).

…

Insulin administration may cause insulin antibodies to form. In clinical studies, antibodies that cross-react with human insulin and insulin glargine were observed with the same frequency in both NPH-insulin and insulin glargine treatment groups. In rare cases, the presence of such insulin antibodies may necessitate adjustment of the insulin dose in order to correct a tendency to hyper- or hypoglycaemia.

…

Skin and subcutaneous tissue disorders

As with any insulin therapy, lLipodystrophy may occur at the injection site and delay local insulin absorption.

….

Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, website: www.hpra.ie, e-mail: medsafety@hpra.ie,

5.1   Pharmacodynamic properties

…

Clinical safety and efficacy

In clinical studies, antibodies that cross-react with human insulin and insulin glargine were observed with the same frequency in both NPH-insulin and insulin glargine treatment groups.

…

The ORIGIN (Outcome Reduction with Initial Glargine INtervention) study was a multicenter, randomizsed, 2x2 factorial design study conducted in 12,537 participants at high cardiovascular (CV) risk with impaired fasting glucose (IFG) or impaired glucose tolerance (IGT) (12% of participants) or type 2 diabetes mellitus treated with ≤1 antidiabetic oral agent (88% of participants). Participants were randomizsed (1:1) to receive insulin glargine (n=6,264), titrated to reach FPG ≤95 mg/dL (5.3 mM), or standard care (n=6,273).

6.1   List of excipients

…

Gglycerol

Hhydrochloric acid (for pH adjustment)

Ssodium hydroxide (for pH adjustment)

Wwater for injections

6.5   Nature and contents of container

Cartridges

Packs of 5 and 101, 2, 5, 10 and multipacks containing 10 (2 packs of 5) cartridges. Not all pack sizes may be marketed.

Pre-filled pens

Packs of 1, 2, 5 pens and multipacks containing 10 (2 packs of 5) pens. Not all pack sizes may be marketed.

6.6   Special precautions for disposal and other handling

ABASAGLAR Pre- filled pen (KwikPen)

…

Handling of the pen

…

The patient should be advised to read the instructions for use included in the package leaflet carefully before using ABASAGLAR solution for injection in pre‑filled pen. Kwikpen.

8.         MARKETING AUTHORISATION NUMBER(S)

Cartridges

EU/1/14/944/001                       Pack of 1 cartridge

EU/1/14/944/002                       Pack of 2 cartridges

EU/1/14/944/003                       Pack of 5 cartridges

EU/1/14/944/004                       Pack of 10 (2 x 5) cartridges

EU/1/14/944/009                       Pack of 10 cartridges

Pre‑filled pens (60 Units)  

EU/1/14/944/005                       Pack of 1 pre-filled pen

EU/1/14/944/006                       Pack of 2 pre-filled pens

EU/1/14/944/007                       Pack of 5 pre-filled pens

EU/1/14/944/008                       Pack of 10 (2 x 5) pre-filled pens

Pre‑filled pens (80 Units)  

EU/1/14/944/010                       Pack of 1 pre-filled pen

EU/1/14/944/011                       Pack of 2 pre-filled pens

EU/1/14/944/012                       Pack of 5 pre-filled pens

EU/1/14/944/013                       Pack of 10 (2 x 5) pre-filled pens

9.         DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 9 September 2014

Date of latest renewal: 25 July 2019

10.       DATE OF REVISION OF THE TEXT

27 February 201825 July 2019

                                                                                                                        AB5MAB6M

Changes

Added (underline) deleted (strikethrough)

7.         MARKETING AUTHORISATION HOLDER

Eli Lilly Regional Operations GmbH., Kölblgasse 8-10, 1030, Vienna, Austria.

Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands

10.       DATE OF REVISION OF THE TEXT

             1 February 201827 February 2018

1.       NAME OF THE MEDICINAL PRODUCT

ABASAGLAR^] 100 units/mL solution for injection in a cartridge

4.8   Undesirable effects

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 Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, website: www.hpra.ie, e-mail: medsafety@hpra.ie, United Kingdom: Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

6.5   Nature and contents of container

Cartridges

3 mL solution in a cartridge (type 1 colourless glass) with a plunger (chlorobutylhalobutyl rubber) and a disc seal (laminate of polyisoprene and bromobutylhalobutyl rubber) with aluminium seal.

Packs of 1, 2, 5, 10 and multipacks containing 10 (2 packs of 5) cartridges. Not all pack sizes may be marketed.

Pre‑filled pens   

3 mL solution in a cartridge (type 1 colourless glass) with a plunger (chlorobutylhalobutyl rubber) and a disc seal (laminate of polyisoprene and bromobutylhalobutyl rubber) with aluminium seal.

10.       DATE OF REVISION OF THE TEXT

             19 January 20171 February 2018

New text is underlined in bold, removed text is struckthough in bold.

Changes

4.         CLINICAL PARTICULARS

4.2      Posology and method of administration

……

Transition Switch from other insulins to ABASAGLAR

When changing switching from a treatment regimen with an intermediate or long-acting insulin to a regimen with ABASAGLAR, a change of the dose of the basal insulin may be required and the concomitant antidiabetic treatment may need to be adjusted (dose and timing of additional regular insulins or fast-acting insulin analogues or the dose of oral antidiabetic medicinal products).

Switch from twice daily NPH insulin to ABASAGLAR

To reduce the risk of nocturnal and early morning hypoglycaemia, patients who are changing their basal insulin regimen from a twice daily NPH insulin to a once daily regimen with ABASAGLAR should reduce their daily dose of basal insulin by 20-30 % during the first weeks of treatment.

Switch from insulin glargine 300 units/ml to ABASAGLAR

ABASAGLAR and Toujeo (insulin glargine 300 units/ml) are not bioequivalent and are not directly interchangeable. To reduce the risk of hypoglycemia, patients who are changing their basal insulin regimen from an insulin regimen with once daily insulin glargine 300 units/ml to a once daily regimen with ABASAGLAR should reduce their dose by approximately 20%.

During the first weeks the reduction should, at least partially, be compensated by an increase in mealtime insulin, after this period the regimen should be adjusted individually.

As with other insulin analogues, patients with high insulin doses because of antibodies to human insulin may experience an improved insulin response with ABASAGLAR.

Close metabolic monitoring is recommended during the transition switch and in the initial weeks thereafter.

With improved metabolic control and resulting increase in insulin sensitivity a further adjustment in dose regimen may become necessary. Dose adjustment may also be required, for example, if the patient's weight or life-style changes, change of timing of insulin dose or other circumstances arise that increase susceptibility to hypoglycaemia or hyperglycaemia (see section 4.4).

Patients with high insulin doses because of antibodies to human insulin may experience an improved insulin response with ABASAGLAR.

………..

4.4       Special warnings and precautions for use

……….

Pens to be used with ABASAGLAR cartridges

The cartridges should only be used in conjunction with a Lilly reusable insulin pen recommended for the use with Lilly insulin cartridges and should not be used with any other reusable pen as the dosing accuracy has not been established with other pens.

………..

6.         PHARMACEUTICAL PARTICULARS

6.6          Special precautions for disposal and other handling

ABASAGLAR must not be mixed with any other insulin or medicinal products or diluted. Mixing or diluting can change its time/action profile and mixing can cause precipitation.

Insulin pen

The ABASAGLAR cartridges are to be used only in conjunction with a Lilly reusable insulin pen recommended for the use with Lilly insulin cartridges (see section 4.4).

The pen should be used as recommended in the information provided bywith the device manufacturer.

The manufacturer's instructions for using the pen must be followed carefully for loading the cartridge, attaching the needle, and administering the insulin injection.

If the insulin pen is damaged or not working properly (due to mechanical defects) it has to be discarded, and a new insulin pen has to be used.

If the pen malfunctions (see instructions for using the pen), the solution may be drawn from the cartridge into a syringe (suitable for an insulin with 100 units/mL) and injected.

It is important to ensure that syringes do not contain traces of any other material.

 ………….

10.          DATE OF REVISION OF THE TEXT

19 January 2017