Humalog Mix50 100 units/ml Kwikpen suspension for injection

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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 Mix50 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

Updated images for steps 10 & 11.

Amendment to storage temperature (In-use pen).

Date of revision updated.

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

Changes 

Minor formatting changes have been made throughout SmPC.  No new text/concepts with exception of below:

 Added (underline) deleted (strikethrough)

 10.          DATE OF REVISION OF THE TEXT

 13 January 2019 23 July 2020

HLG79M

Changes 

Minor formatting changes have been made throughout SmPC.  No new text/concepts with exception of below:

 Added (underline) deleted (strikethrough)

 10.          DATE OF REVISION OF THE TEXT

 13 January 2019 23 July 2020

HLG79M

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

HLG71MHLG75M

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

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)