Changes

Added (underline) deleted (strikethrough)

INSTRUCTIONS FOR USE

Change to format of the product name:

Instructions for use

KwikPen^®

ABASAGLAR^® 100 units/mL KwikPen^® solution for injection in a pre-filled pen

iInsulin glargine

This leaflet was last revised in April July 2020

Changes

 Added (underline) deleted (strikethrough)

ABASAGLAR^® 100 units/mL KwikPen^® solution for injection in a pre-filled pen

insulin glargine

2.             What you need to know before you use ABASAGLAR

Warnings and precautions

……..

Insulin mix-ups

You must always check the pack and insulin label before each injection to avoid mix-ups between ABASAGLAR and other insulins.

………

Important information about some of the ingredients of ABASAGLAR contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per dose, which means it is essentially ‘sodium-free’.

3.             How to use ABASAGLAR

How to handle ABASAGLAR KwikPen

……….

Insulin Mix-ups

You must always check the insulin label before each injection to avoid mix-ups between ABASAGLAR and other insulins.

If you use more ABASAGLAR than you should

-           If you have injected too much ABASAGLAR or are unsure how much you have injected, your blood sugar level may become too low (hypoglycaemia). Check your blood sugar frequently. In general, to prevent hypoglycaemia you must eat more food and monitor your blood sugar. For information on the treatment of hypoglycaemia, see box at the end of this leaflet.

If you forget to use ABASAGLAR

-           If you have missed a dose of ABASAGLAR or if you have not injected enough insulin or are unsure how much you have injected, your blood sugar level may become too high (hyperglycaemia). Check your blood sugar frequently. For information on the treatment of hyperglycaemia, see box at the end of this leaflet.

-              Do not take a double dose to make up for a forgotten dose.

After injecting

If you are unsure how much you have injected then check your blood sugar levels before deciding if you need another injection.

6.             Contents of the pack and other information

What ABASAGLAR contains

……….

The other ingredients are: zinc oxide, metacresol, glycerol, sodium hydroxide (see section 2 “Important information about some of the ingredients of ABASAGLAR contains sodium”), hydrochloric acid and water for injections.

The format of the SmPC has changed from a combined Abasaglar cartridge & pre-filled pen SmPC to that of a separate SmPC for Abasaglar pre-filled pens (i.e- KwikPen). The SmPC for Abasaglar pre-filled pens also includes new text relating to the non-marketed Tempo pen.

In addition, other minor formatting changes (sub-headings) have been made in sections 4.2, 4.8, 5.1 and 5.2

Added (underline) deleted (strikethrough)

1.       NAME OF THE MEDICINAL PRODUCT

ABASAGLAR 100 units/mL KwikPen solution for injection in a pre-filled pen

ABASAGLAR 100 units/mL Tempo Pen solution for injection in a pre-filled pen

2.       QUALITATIVE AND QUANTITATIVE COMPOSITION

………

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

………

3.       PHARMACEUTICAL FORM

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

………

4.       CLINICAL PARTICULARS

4.2   Posology and method of administration

………

KwikPen

The KwikPen is registered in two presentations. One delivers 1 –60 units in steps of 1 unit in a single injection and the other delivers 1 – 80 units in steps of 1 unit in a single injection. The needed dose is dialled in units. The number of units is shown in the dose window of the pen.

Tempo Pen

The Tempo Pen delivers 1 – 80 units in steps of 1 unit in a single injection. The needed dose is dialled in units. The number of units is shown in the dose window of the pen.

The Tempo Pen can be used with the optional transfer module Tempo Smart Button (see section 6.6).

As with any insulin injection, when using the Tempo Pen, Smart Button and the mobile application, the patient should be instructed to check their blood sugar levels when considering or making decisions about another injection if they are unsure how much they have injected.

4.4   Special warnings and precautions for use

Traceability

In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.

Diabetic ketoacidosis

ABASAGLAR is not the insulin of choice for the treatment of diabetic ketoacidosis. Instead, regular insulin administered intravenously is recommended in such cases.

Insulin requirements and dose adjustments

In case of insufficient glucose control or a tendency to hyperglycaemic or hypoglycaemic episodes, the patient's adherence to the prescribed treatment regimen, injection sites and proper injection technique and all other relevant factors must be reviewed before dose adjustment is considered.

……….

Medication errors

Medication errors have been reported in which other insulins, particularly short‑acting insulins, have been accidentally administered instead of insulin glargine. Insulin label must always be checked before each injection to avoid medication errors between ABASAGLAR pre-filled pen as well asand other insulins.

……….

Tempo Pen

The Tempo Pen contains a magnet (see section 6.5) that may interfere with the functions of an implantable electronic medical device, such as a pacemaker. The magnetic field extends to approximately 1.5 cm.

……….

6.5   Nature and contents of container

KwikPen

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

The cartridge is sealed in a disposable pen injector.

Packs of 5 pre-filled pens and multipacks containing 10 (2 packs of 5) pre-filled pens.

Tempo Pen

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

The cartridge is sealed in a disposable pen injector. The Tempo Pen contains a magnet (see section 4.4).

Packs of 5 pre-filled pens and multipacks containing 10 (2 packs of 5) pre-filled pens.

Not all pack sizes may be marketed.

Needles are not included in the pack.

  6.6   Special precautions for disposal and other handling

……….

Tempo Pen

The Tempo Pen is designed to work with the Tempo Smart Button. The Tempo Smart Button is an optional product that can be attached to the Tempo Pen dose knob and aids in transmitting Abasaglar dose information from the Tempo Pen to a compatible mobile application. The Tempo Pen injects insulin with or without the Tempo Smart Button attached. To transmit data to the mobile application, follow the instructions provided with the Tempo Smart Button and the instructions with the mobile application.

8.             MARKETING AUTHORISATION NUMBER(S)

……….

EU/1/14/944/014

EU/1/14/944/015

10.          DATE OF REVISION OF THE TEXT

13 January 2019 23 July 2020

AB108M

Changes

Added (underline) deleted (strikethrough)

4.       CLINICAL PARTICULARS

4.2   Posology and method of administration

……….

Method of administration

………

Injection sites should always be rotated within the same region in order to reduce the risk of lipodystrophy and cutaneous amyloidosis (see section 4.4 and 4.8).

Injection sites must be rotated within a given injection area from one injection to the next.

………

4.4   Special warnings and precautions for use

………

Injection technique

Patients must be instructed to perform continuous rotation of the injection site to reduce the risk of developing lipodystrophy and cutaneous amyloidosis. There is a potential risk of delayed insulin absorption and worsened glycaemic control following insulin injections at sites with these reactions. A sudden change in the injection site to an unaffected area has been reported to result in hypoglycaemia. Blood glucose monitoring is recommended after the change in the injection site, and dose adjustment of antidiabetic medications may be considered.

……….

4.8   Undesirable effects

………

Description of selected adverse reactions

………

Skin and subcutaneous tissue disorders

Lipodystrophy and cutaneous amyloidosis may occur at the injection site and delay local insulin absorption. Continuous rotation of the injection site within the given injection area may help to reduce or prevent these reactions (see section 4.4).

8.             MARKETING AUTHORISATION NUMBER(S)

Cartridges

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

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

Pre‑filled pens (60 Units)  

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

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

10.          DATE OF REVISION OF THE TEXT

13 January 2019 23 July 2020

4.  Possible side effects

Common side effects (may affect up to 1 in 10 people)

• Skin changes at the injection site

Skin changes at the injection site

If you inject your insulin too often at the same skin site, fatty tissue underplace the skin at this site may either shrink (lipoatrophy, may affect up to 1 in 100 people) or thicken (lipohypertrophy, may affect up to 1 in 10 people). Also lumps under the skin caused by a build-up of a protein called amyloid may occur (cutaneous amyloidosis, how often they occur is not known).). The insulin may not work very well. Change the injection site with each injection to help prevent these skin changes.

Common side effects (may affect up to 1 in 10 people)

6. Contents of the pack and other information

This leaflet was last revised in July 2019January 2020

4.       CLINICAL PARTICULARS

4.8   Undesirable effects

………

Tabulated list of adverse reactions

The following related adverse reactions from clinical trials are listed below as MedDRA preferred term by system organ class and in order of decreasing incidence (very common: ≥1/10; common: ≥1/100 to <1/10; uncommon: ≥1/1,000 to <1/100; rare: ≥1/10,000 to <1/1,000; very rare: <1/10,000 and not known (cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Description of selected adverse reactions

………

Skin and subcutaneous tissue disorders

Lipodystrophy and cutaneous amyloidosis may occur at the injection site and delay local insulin absorption. Continuous rotation of the injection site within the given injection area may help to reduce or prevent these reactions.

10.          DATE OF REVISION OF THE TEXT

25 July 2019 13 January 2019

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