Humalog 100 units/ml KwikPen solution for injection in a pre-filled pen

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4. Possible side effects

Reporting of Side effects

United Kingdom (Northern Ireland): Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

6. Contents of the pack and other information

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For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Ireland and United Kingdom (Northern Ireland)

Eli Lilly and Company (Ireland) Limited

Tel: + 353-(0) 1 661 4377

United Kingdom

Eli Lilly and Company Limited

Tel: + 44-(0) 1256 315000

This leaflet was revised in September 2020 September 2021

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2.         What you need to know before you use Humalog  

Warnings and precautions

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Skin changes at the injection site

The injection site should be rotated to prevent skin changes such as lumps under the skin. The insulin may not work very well if you inject into a lumpy area (See How to use Humalog KwikPen). Contact your doctor if you are currently injecting into a lumpy area before you start injecting a different area. Your doctor may tell you to check your blood sugar more closely, and to adjust your insulin or your other antidiabetic medications dose.

 4.         Possible side effects

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Lipodystrophy (thickening or pitting of the skin) is uncommon (³ 1/1,000 to <1/100). If you notice your skin thickening or pitting at the injection site, tell your doctor. If you inject insulin too often at the same place, the fatty tissue may either shrink (lipoatrophy) or thicken (lipohypertrophy). Lumps under the skin may also be caused by build-up of a protein called amyloid (cutaneous amyloidosis). The insulin may not work very well if you inject into a lumpy area. Change the injection site with each injection to help prevent these skin changes.

6.             Contents of the pack and other information

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 This leaflet was last revised in September 2020.

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4.       CLINICAL PARTICULARS

4.2   Posology and method of administration

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Method of administration

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Use of injection sites should be rotated so that the same site is not used more than approximately once a month, in order to reduce the risk of lipodystrophy and cutaneous amyloidosis (see section 4.4 and 4.8).

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4.4   Special warnings and precautions for use

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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.

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4.8   Undesirable effects

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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); not known (cannot be estimated form the available data).

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

Description of selected adverse reactions

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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).

Lipodystrophy

Lipodystrophy at the injection site is uncommon.

10.          DATE OF REVISION OF THE TEXT

23 July 2020 03 September 2020

                                                                                                     HGL81M, HGL82M, HGL83M, HLG84

Revised images for steps 10 & 11.

Amendment to storage temperature (In-use pen).

Date of revison updated.

Minor amendments to wording & formatting have been made throughout sections of the PIL.

Changes

The SmPC for Humalog 100 units/mL vial, cartridge, KwikPen, Junior KwikPen, Tempo Pen now includes new text relating to the non-marketed Tempo pen.

In addition, other minor formatting changes have been made throughout SmPC sections.

 Added (underline) deleted (strikethrough)

1.       NAME OF THE MEDICINAL PRODUCT

 Humalog 100 units/ml solution for injection in vial

Humalog 100 units/ml solution for injection in cartridge

Humalog 100 units/ml KwikPen solution for injection in a pre-filled pen

Humalog 100 units/ml Junior KwikPen solution for injection in a pre-filled pen

Humalog 100 units/ml Tempo Pen solution for injection in a pre-filled pen

2.       QUALITATIVE AND QUANTITATIVE COMPOSITION

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 KwikPen and Tempo Pen

Each pre-filled pen contains 300 units of insulin lispro in 3 ml solution.

Each pre-filled pen KwikPen delivers 1-60 units in steps of 1 unit.

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4.       CLINICAL PARTICULARS

 4.2   Posology and method of administration

Posology

The dosage dose should be determined by the physician, according to the requirement of the patient.

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Humalog KwikPens

Humalog KwikPen is available in two strengths. The Humalog 100 units/ml KwikPen (and Humalog 200 units/ml KwikPen, see separate SmPC) delivers 1 – 60 units in steps of 1 unit in a single injection. The Humalog 100 units/ml Junior KwikPen delivers 0.5 – 30 units in steps of 0.5 units in a single injection. The number of insulin units is shown in the dose window of the pen regardless of strength and no dose conversion should be done when transferring a patient to a new strength or to a pen with a different dose step.

Humalog Tempo Pen

The Humalog 100 units/ml Tempo Pen delivers 1 – 60 units in steps of 1 unit in a single injection. The number of insulin units is shown in the dose window of the pen regardless of strength and no dose conversion should be done when transferring a patient to a new strength or to a pen with a different dose step. 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.

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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 medicinal product should be clearly recorded.

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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.

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6.             PHARMACEUTICAL PARTICULARS

6.2       Incompatibilities

Vial

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

Cartridge, KwikPen, and Junior KwikPen and Tempo Pen

These medicinal products should not be mixed with any other insulin or any other medicinal product.

Vial

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

6.4       Special precautions for storage

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KwikPen, and Junior KwikPen and Tempo Pen

Store below 30°C. Do not refrigerate. The pre-filled pen should not be stored with the needle attached.

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6.5   Nature and contents of container

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Junior KwikPen

Type I glass cartridges, sealed with halobutyl disc seals secured with aluminium seals and bromobutyl plunger heads. Dimeticone or silicone emulsion may be used to treat the cartridge plunger. The 3 ml cartridges are sealed in a disposable pen injector, called the “Junior KwikPen”. Needles are not included.

3 ml Junior KwikPen: Packs of 1 pre-filled pen, 5 pre-filled pens or a multipack of 10 (2 packs of 5) pre-filled pens. Not all packs may be marketed.

Tempo Pen

Type I glass cartridges, sealed with halobutyl disc seals secured with aluminium seals and bromobutyl plunger heads. Dimeticone or silicone emulsion may be used to treat the cartridge plunger. The 3 ml cartridges are sealed in a disposable pen injector, called the “Tempo Pen”. The Tempo Pen contains a magnet (see section 4.4). Needles are not included.

3 ml Tempo Pen: Packs of 5 prefilled pens or a multipack of 10 (2 packs of 5) prefilled pens. Not all packs may be marketed.

6.6   Special precautions for disposal and other handling

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Humalog 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 Humalog 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)

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EU/1/96/007/046

EU/1/96/007/047

10.          DATE OF REVISION OF THE TEXT

13 January 2019 23 July 2020

HLG77M

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.

4.8            Undesirable effects

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

10.      DATE OF REVISION OF THE TEXT

17 May  201816 January 2020

HLG69MHLG73M

No change of content.  SmPC Date of revision of the text:  17 May 2018.

A major change in this variation is the consolidation of the 10 individual SmPCs (1 per presentation) into 4 combined SmPCs, divided as follows:

• 100 u/ml cartridge, vial, KwikPen, Junior KwikPen
• Mix25 100 u/ml cartridge, vial, KwikPen
• Mix50 100 u/ml cartridge, KwikPen
• 200 u/ml KwikPen

New information in SmPCs

• All cartridges to be used in a Lilly reusable pen only
• Clarification that vials only to be used for intravenous administration
• 100 u/ml cartridges can be used in compatible pump systems for continuous subcutaneous insulin infusion (CSII)
• New vial text in section 6.6: ‘Patients using vials must never share needles or syringes. The patient should discard the needle after every injection.’
• Insulin requirements in Renal/Hepatic impairment text – moved from section 4.4 (Special warnings and precautions for use) to 4.2 (Posology and method of administration)