Dear Pharmacist Lilly is refining its range of prefilled insulin pen
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1. 1 X 10ml vials 28 31 5 X 3ml cartridges 29 46 5 X 3ml Humalog Pens 29 46 5 X 3ml Humalog KwikPens Marketing Authorisation Numbers 00006 0216 and 0242 00006 0228 and 0257 00006 0233 and 0260 00006 0338 00006 0338 Humalog vial EU 1 96 007 002 Humalog cartridge EU 1 96 007 004 Humalog Pen EU 1 96 007 015 Humalog KwikPen EU 1 96 007 031 HUMALOG insulin lispro is a trademark of Eli Lilly and Company HUMALOG MIX25 VIAL CARTRIDGE PEN AND KWIKPEN HUMALOG MIX50 CARTRIDGE PEN AND KWIKPEN HUMALOG IS INSULIN LISPRO HUMAN INSULIN ANALOGUE Presentation Humalog Mix25 is a white sterile suspension of 100U ml 25 insulin lispro solution and 75 insulin lispro protamine suspension available as either 10ml vial 3ml cartridge 3ml Pen or 3ml KwikPen Humalog Mix50 is a white Sterile suspension of 100U ml 50 insulin lispro solution and 50 insulin lispro protamine suspension available as either 3ml cartridge 3ml Pen or 3ml KwikPen Uses Treatment of patients with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis Dosage and Administration Humalog Mix25 or Humalog Mix50 may be given shortly before meals and when necessary can be given soon after meals Humalog Mix25 or Humalog Mix50 should only be given by subcutaneous injection The rapid onset and early peak of activity of Humalog itself is observed following the subcutaneous administration of Humalog Mix25 or Humalog Mix2. Mix 25 and Humalog Mix 50 will continue to be available in a prefilled device The KwikPen This will help reduce NHS medicines costs as the Humulin KwikPens will be provided at a lower price than the older prefilled Humulin Pens please see Q amp A 3in document attached The transition from the older prefilled insulin Pens to the KwikPen has already taken place in France Spain and Italy with minimal patient impact It is hoped that a majority of transitions will coincide as part of a patients regular review with their diabetes healthcare professional and if implemented that their new KwikPen will be seen as an improvement compared to their older prefilled device Attached to this page is a question and answers section Also included is a Safety Range Chart Conversion leaflet and KwikPen user guide If you have any further questions please don t hesitate to e contact your local representative e telephone 01256 315 000 or e visit www lillydiabetes co uk Regards Lan D MAA lan Dane Senior Diabetes Director Lilly Diabetes UK and ROI HUMULIN VIAL CARTRIDGE PEN AND KWIKPEN HUMULIN IS HUMAN INSULIN PRB Presentation Humulin S is a sterile solution of 100IU ml human insulin available as either 10ml vial or 3ml cartridge Humulin is a sterile suspension of 100IU ml isophane human insulin available as either 10ml vial 3ml cartridge 3ml Pen or 3m KwikPen Humulin M3 is a sterile suspension of 100I
3. be done under strict medical supervision Changes in strength brand type species and or method of manufacture may result in the need for a change in dosage For fast acting insulins any patient also on basal insulin must optimise dosage of both insulins to obtain glucose control across the whole day particularly nocturnal fasting glucose control Some patients taking human insulin may require a change in dosage from that used with animal source insulins If an adjustment is needed it may occur with the first dose or during the first several weeks or months Changes in early warning symptoms of hypoglycaemia may occur on transfer between different types of insulin products The patient s ability to concentrate and react may be impaired as a result of hypoglycaemia This may constitute a risk in situations where these abilities are of special importance eg driving a car or operating machinery Treatment with human insulin may cause formation of antibodies but titres of antibodies are lower than those to purified animal insulin Undesirable Effects Hypoglycaemia is the most frequent undesirable effect of insulin therapy Local allergy is common and usually resolves Systemic allergy is rare but potentially more serious since severe cases may be life threatening Lipodystrophy is uncommon For full details of these and other side effects please see the Summary of Product Characteristics which is available at http emc medicines org uk Legal Ca
4. inform their doctors if they are pregnant or contemplating pregnancy Insulin requirements may be reduced in the presence of renal impairment or hepatic impairment However in patients with chronic hepatic impairment an increase in insulin resistance may lead to increased insulin requirements Insulin requirements may be increased during illness or emotional disturbances Transferring a patient to another type or brand of insulin should be done under strict medical supervision Changes in strength brand type species and or method of manufacture may result in the need for a change in dosage For fast acting insulins any patient also on basal insulin must optimise dosage of both insulins to obtain glucose control across the whole day particularly nocturnal fasting glucose control Some patients taking human insulin may require a change in dosage from that used with animal source insulins If an adjustment is needed it may occur with the first dose or during the first several weeks or months Changes in early warning symptoms of hypoglycaemia may occur on transfer between different types of insulin products The patient s ability to concentrate and react may be impaired as a result of hypoglycaemia This may constitute a risk in situations where these abilities are of special importance eg driving a car or operating machinery Treatment with human insulin may cause formation of antibodies but titres of antibodies are lower than those to purified
5. 5 and HUMALOG MIX50 insulin lispro are trademarks of Eli Lilly and Company LILLY INSULINS GENERAL INFORMATION See Summaries of Product Characteristics for additional information including time action profiles of all formulations Dosage and Administration general The dosage or type of insulin should be determined according to the requirements of the patient The time course of action of any insulin may vary considerably in different individuals or at different times in the same individual Vials are packed with instructions regarding dose preparation and administration and these should be carefully followed Lilly insulin cartridges are to be used with a CE marked pen according to the instructions provided by the device manufacturer Patients should be advised to always keep a spare syringe and vial or a spare pen and cartridge Prefilled Pens are packed with instructions on how to use them These directions should be followed carefully Do not use if after resuspension the insulin remains at the bottom if there are clumps in the insulin or if solid white particles stick to the bottom or wall giving the container a frosted appearance Contra indications Hypersensitivity to the active ingredient or to any of the excipients Hypoglycaemia Warnings and Special Precautions general Usage in pregnancy Insulin requirements usually fall during the first trimester and increase during the second and third trimesters Patients should be advised to
6. 50 The duration of action of the insulin lispro protamine suspension component is similar to that of a basal insulin Warnings and Special Precautions Usage in pregnancy Data on a large number of exposed pregnancies do not indicate any adverse effect of insulin lispro on pregnancy or on the health of the foetus newborn Administration of insulin lispro in children should be considered only in case of an expected benefit when compared to soluble insulin Prices Mix25 Mix50 16 61 1 X 10ml Mix25 vial 29 46 5 X 3ml Mix25 cartridges 30 98 5 X 3ml Mix25 Pens 30 98 5 X 3ml Mix25 KwikPens 29 46 5 X 3ml Mix50 cartridges 30 98 5 X 3ml Mix50 Pens 30 98 5 X 3ml Mix50 KwikPens Marketing Authorisation Numbers Humalog Mix25 vial EU 1 96 007 005 Humalog Mix25 cartridge EU 1 96 007 008 Humalog Mix50 cartridge EU 1 96 007 006 Humalog Mix25 Pen EU 1 96 007 016 Humalog Mix50 Pen EU 1 96 007 017 Humalog Mix25 KwikPen EU 1 96 007 033 Humalog Mix50 KwikPen EU 1 96 007 035 HUMALOG MIX25 and HUMALOG MIX50 insulin lispro are trademarks of Eli Lilly and Company LILLY INSULINS GENERAL INFORMATION See Summaries of Product Characteristics for additional information including time action profiles of all formulations Dosage and Administration general The dosage or type of insulin should be determined according to the requirements of the patient The time course of action of any insulin may vary considerably in dif
7. 6 0341 Humulin M3 KwikPen 00006 0341 HUMULIN human insulin prb is a trademark of Eli Lilly and Company HUMALOG VIAL CARTRIDGE PEN AND KWIKPEN HUMALOG IS INSULIN LISPRO HUMAN INSULIN ANALOGUE Presentation Humalog is a sterile solution of 100U ml insulin lispro available as either 10ml vial 3ml cartridge 3ml Pen or 3m KwikPen Uses Treatment of adults and children with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis Humalog is also indicated for the initial stabilisation of diabetes mellitus Dosage and Administration Humalog may be given shortly before meals and when necessary soon after meals Humalog should be given by subcutaneous injection or by continuous subcutaneous infusion pump If necessary Humalog may also be administered intravenously for example for the control of blood glucose levels during ketoacidosis acute illness or perioperatively Humalog takes effect rapidly approximately 15 minutes and has a shorter duration of activity 2 to 5 hours as compared with soluble insulin Warnings and Special Precautions Usage in pregnancy Data on a large number of exposed pregnancies do not indicate any adverse effect of insulin lisoro on pregnancy or on the health of the foetus newborn Insulin lisoro should be used in children only when an advantage is expected compared to soluble insulin for example in the timing of the injection in relation to meals Prices Humalog 16 61
8. Eli Lilly and Company Limited Priestley Road Basingstoke Hampshire RG24 9NL Tel 44 0 1256 315 000 Medical Information 44 0 1256 315000 Humulin Humulin M3 Hun la 25 KwikPen KwikPen a A KwikPen T aier isophane human insulin orb human insulin prb 25 insulin lispro rDNA origin injection 50 insulin lispro rDNA origin injection 30 soluble insulin 70 isophane insulin insulin lispro rDNA origin injection 75 insulin isoro bes bia RO iain fk 4 corer rig a la tara Dear Pharmacist Lilly is refining its range of prefilled insulin pen devices From September 21 2010 Humulin Humulin M3 Humalog and Humalog mixtures will all be available in the KwikPen our latest prefilled insulin device e The older Humalog and Humulin prefilled Pens that were in the market prior to KwikPen will be discontinued over a 6 month period KwikPen will be Lilly s only prefilled insulin device in the UK market from the 31st March 2011 e The launch of Humulin and Humulin M3 KwikPen has been planned for the last 2 years The subsequent removal of the older prefilled insulin pen was required as part of this launch e Inthe interest of continuity and insulin safety Lilly believe that removing all older prefilled insulin pens from the UK market and having just one prefilled insulin device the KwikPen will improve patient safety in the long term e Humulin Humulin M3 Humalog Humalog
9. U ml human insulin in the proportion of 30 soluble insulin and 70 isophane insulin available as either 10ml vial 3ml cartridge 3ml Pen or 3ml KwikPen Uses For the treatment of patients with diabetes mellitus who require insulin for the maintenance of glucose homeostasis Dosage and Administration All Humulin preparations should be given by subcutaneous injection Only Humulin S may be given intravenously Resuspension Humulin S does not require resuspension Humulin and Humulin M3 require resuspension immediately before use Please see Summaries of Product Characteristics or Patient Information Leaflets for details on how to do this Mixing of insulins vials only Humulin S may be administered in combination with Humulin The shorter acting insulin Humulin S should be drawn into the syringe first to prevent contamination of the vial by the longer acting preparation Humulin It is advisable to inject immediately after mixing Prices Humulin 15 68 1 X 10ml vials Humulin S 19 08 5 X 3ml cartridges Humulin S 15 68 1 X 10ml vials Humulin 19 08 5 X 3ml cartridges Humulin 28 44 5 X 3ml Humulin Pens 21 70 5 X 3ml Humulin KwikPens 15 68 1 X 10ml vials Humulin M3 19 08 5 X 3ml cartridges Humulin M3 28 44 5 X 3ml Humulin M3 Pens 21 70 5 X 3ml Humulin M3 KwikPens Product Licence Numbers Humulin S Humulin Humulin M3 Humulin Pen Humulin KwikPen Humulin M3 Pen 0000
10. animal insulin Undesirable Effects Hypoglycaemia is the most frequent undesirable effect of insulin therapy Local allergy is common and usually resolves Systemic allergy is rare but potentially more serious since severe cases may be life threatening Lipodystrophy is uncommon For full details of these and other side effects please see the Summary of Product Characteristics which is available at http emc medicines org uk Legal Category POM Date of Preparation or Last Review June 2010 Full Prescribing Information is Available From Eli Lilly and Company Limited Lilly House Priestley Road Basingstoke Hampshire RG24 9NL Telephone Basingstoke 01256 315 000 E mail ukmedinfo lilly com Website www lillypro co uk References 1 Data on File 2 Ignaut et al J Diabetes Sci Techno 2008 2 3 553 537 UKDBT00596 September 2010 Adverse events should be reported Reporting forms and information can be found at www yellowcard gov uk Adverse events should also be reported to Eli Lilly and Company Limited Tel No 0870 240 1125
11. dges Humulin S 15 68 1 X 10ml vials Humulin 19 08 5 X 3ml cartridges Humulin 28 44 5 X 3ml Humulin Pens 21 70 5 X 3ml Humulin KwikPens 15 68 1 X 10ml vials Humulin M3 19 08 5 X 3ml cartridges Humulin M3 28 44 5 X 3ml Humulin M3 Pens 21 70 5 X 3ml Humulin M3 KwikPens Product Licence Numbers Humulin S Humulin Humulin M3 Humulin Pen Humulin KwikPen Humulin M3 Pen 00006 0341 Humulin M3 KwikPen 00006 0341 HUMULIN human insulin prb is a trademark of Eli Lilly and Company HUMALOG VIAL CARTRIDGE PEN AND KWIKPEN HUMALOG IS INSULIN LISPRO HUMAN INSULIN ANALOGUE Presentation Humalog is a sterile solution of 100U ml insulin lispro available as either 10ml vial 3ml cartridge 3ml Pen or 3m KwikPen Uses Treatment of adults and children with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis Humalog is also indicated for the initial stabilisation of diabetes mellitus Dosage and Administration Humalog may be given shortly before meals and when necessary soon after meals Humalog should be given by subcutaneous injection or by continuous subcutaneous infusion pump If necessary Humalog may also be administered intravenously for example for the control of blood glucose levels during ketoacidosis acute illness or perioperatively Humalog takes effect rapidly approximately 15 minutes and has a shorter duration of activity 2 to 5 hou
12. ferent individuals or at different times in the same individual Vials are packed with instructions regarding dose preparation and administration and these should be carefully followed Lilly insulin cartridges are to be used with a CE marked pen according to the instructions provided by the device manufacturer Patients should be advised to always keep a spare syringe and vial or a spare pen and cartridge Prefilled Pens are packed with instructions on how to use them These directions should be followed carefully Do not use if after resuspension the insulin remains at the bottom if there are clumps in the insulin or if solid white particles stick to the bottom or wall giving the container a frosted appearance Contra indications Hypersensitivity to the active ingredient or to any of the excipients Hypoglycaemia Warnings and Special Precautions general Usage in pregnancy Insulin requirements usually fall during the first trimester and increase during the second and third trimesters Patients should be advised to inform their doctors if they are pregnant or contemplating pregnancy Insulin requirements may be reduced in the presence of renal impairment or hepatic impairment However in patients with chronic hepatic impairment an increase in insulin resistance may lead to increased insulin requirements Insulin requirements may be increased during illness or emotional disturbances Transferring a patient to another type or brand of insulin should
13. itional features 3 How much of a saving will the NHS benefit from the Humulin KwikPen The cost saving will vary depending on the formulation Please see the table below Cost Formulation Older prefilled insulin Pen KwikPen KwikPen PIP Code Humalog 29 46 29 46 339 1844 Humalog Mix25 30 98 30 98 339 1828 Humalog Mix50 30 98 30 98 339 1836 28 44 21 70 350 8991 Humulin M3 28 44 21 70 350 9015 4 What is Lilly doing to ensure patients are trained on the KwikPen e For Healthcare professionals HCP o Your local representative is available to demonstrate to HCPs how to use the KwikPen o Local Representative can deliver patient KwikPen user guides o The patient KwikPen guide is also available as a download for HCPs in English Polish Urdu Gujarati Bengali and Punjabi Visit www lillydiabetes co uk e For Patients o Each KwikPen comes with a comprehensive user manual in the box o Patients can telephone the free phone device helpline 24 hours a day on 0800 783 6764 o Ortelephone Lilly on 01256 315 OOO 5 Is Lilly planning on discontinuing any other insulin devices Lilly has no plans to discontinue any other insulin devices Lilly regularly reviews its product portfolio and makes decisions based on patient demand the needs of our prescribing customers as well as market conditions 6 How long will the older prefilled insulin Pen be available The older prefilled in
14. rs as compared with soluble insulin Warnings and Special Precautions Usage in pregnancy Data on a large number of exposed pregnancies do not indicate any adverse effect of insulin lisoro on pregnancy or on the health of the foetus newborn Insulin lisoro should be used in children only when an advantage is expected compared to soluble insulin for example in the timing of the injection in relation to meals Prices Humalog 16 61 1 X 10ml vials 28 31 5 X 3ml cartridges 29 46 5 X 3ml Humalog Pens 29 46 5 X 3ml Humalog KwikPens Marketing Authorisation Numbers 00006 0216 and 0242 00006 0228 and 0257 00006 0233 and 0260 00006 0338 00006 0338 Humalog vial EU 1 96 007 002 Humalog cartridge EU 1 96 007 004 Humalog Pen EU 1 96 007 015 Humalog KwikPen EU 1 96 007 031 HUMALOG insulin lispro is a trademark of Eli Lilly and Company HUMALOG MIX25 VIAL CARTRIDGE PEN AND KWIKPEN HUMALOG MIX50 CARTRIDGE PEN AND KWIKPEN HUMALOG IS INSULIN LISPRO HUMAN INSULIN ANALOGUE Presentation Humalog Mix25 is a white sterile suspension of 100U ml 25 insulin lispro solution and 75 insulin lispro protamine suspension available as either 10ml vial 3ml cartridge 3ml Pen or 3ml KwikPen Humalog Mix50 is a white Sterile suspension of 100U ml 50 insulin lispro solution and 50 insulin lispro protamine suspension available as either 3ml cartridge 3ml Pen or 3ml KwikPen Uses Treatment of patients with diabetes mellitus
15. sulin Pens will cease to be available from the 31 March 2011 HUMULIN VIAL CARTRIDGE PEN AND KWIKPEN HUMULIN IS HUMAN INSULIN PRB Presentation Humulin S is a sterile solution of 100IU ml human insulin available as either 10ml vial or 3ml cartridge Humulin is a sterile suspension of 100IU ml isophane human insulin available as either 10ml vial 3ml cartridge 3ml Pen or 3m KwikPen Humulin M3 is a sterile suspension of 100IU ml human insulin in the proportion of 30 soluble insulin and 70 isophane insulin available as either 10ml vial 3ml cartridge 3ml Pen or 3ml KwikPen Uses For the treatment of patients with diabetes mellitus who require insulin for the maintenance of glucose homeostasis Dosage and Administration All Humulin preparations should be given by subcutaneous injection Only Humulin S may be given intravenously Resuspension Humulin S does not require resuspension Humulin and Humulin M3 require resuspension immediately before use Please see Summaries of Product Characteristics or Patient Information Leaflets for details on how to do this Mixing of insulins vials only Humulin S may be administered in combination with Humulin The shorter acting insulin Humulin S should be drawn into the syringe first to prevent contamination of the vial by the longer acting preparation Humulin It is advisable to inject immediately after mixing Prices Humulin 15 68 1 X 10ml vials Humulin S 19 08 5 X 3ml cartri
16. tegory POM Date of Preparation or Last Review June 2010 Full Prescribing Information is Available From Eli Lilly and Company Limited Lilly House Priestley Road Basingstoke Hampshire RG24 9NL Telephone Basingstoke 01256 315 000 E mail ukmedinfo lilly com Website www lillypro co uk References 1 Data on File 2 Ignaut et al J Diabetes Sci Techno 2008 2 3 553 537 UKDBT00596 September 2010 Adverse events should be reported Reporting forms and information can be found at www yellowcard gov uk Adverse events should also be reported to Eli Lilly and Company Limited Tel No 0870 240 1125 Question and Answer Document for Pharmacist 1 Why is Lilly discontinuing their older prefilled insulin pens The launch of Humulin and Humulin M3 KwikPen has been planned for the last 2 years The subsequent removal of the older prefilled insulin Pen was as part of this launch In the interest of continuity and insulin safety Lilly felt removing all older prefilled insulin Pens and having just one prefilled insulin device the KwikPen in UK market will improve patient safety in the long term 2 What is the difference between the KwikPen and the older prefilled insulin Pen The KwikPen is designed for improved patient outcomes It is simple to teach and easy to use has a low smooth injection pressure and enhanced colour coding for identification It also has only two steps to inject instead of 4 steps as well as many add
17. who require insulin for the maintenance of normal glucose homeostasis Dosage and Administration Humalog Mix25 or Humalog Mix50 may be given shortly before meals and when necessary can be given soon after meals Humalog Mix25 or Humalog Mix50 should only be given by subcutaneous injection The rapid onset and early peak of activity of Humalog itself is observed following the subcutaneous administration of Humalog Mix25 or Humalog Mix50 The duration of action of the insulin lispro protamine suspension component is similar to that of a basal insulin Warnings and Special Precautions Usage in pregnancy Data on a large number of exposed pregnancies do not indicate any adverse effect of insulin lispro on pregnancy or on the health of the foetus newborn Administration of insulin lispro in children should be considered only in case of an expected benefit when compared to soluble insulin Prices Mix25 Mix50 16 61 1 X 10ml Mix25 vial 29 46 5 X 3ml Mix25 cartridges 30 98 5 X 3ml Mix25 Pens 30 98 5 X 3ml Mix25 KwikPens 29 46 5 X 3ml Mix50 cartridges 30 98 5 X 3ml Mix50 Pens 30 98 5 X 3ml Mix50 KwikPens Marketing Authorisation Numbers Humalog Mix25 vial EU 1 96 007 005 Humalog Mix25 cartridge EU 1 96 007 008 Humalog Mix50 cartridge EU 1 96 007 006 Humalog Mix25 Pen EU 1 96 007 016 Humalog Mix50 Pen EU 1 96 007 017 Humalog Mix25 KwikPen EU 1 96 007 033 Humalog Mix50 KwikPen EU 1 96 007 035 HUMALOG MIX2
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