This page contains a Flash digital edition of a book.
® CARDIOVASCULAR


SAFETY EVIDENCE


The only DPP-4 inhibitor with cardiovascular safety evidence in very high risk Type 2 diabetes patients (with recent ACS**)1


HbA1C HbA1c


DURABLE REDUCTION


The only DPP-4 inhibitor to demonstrate a durable reduction in


levels at 2 years that was statistically superior to a sulphonylurea (glipizide – mean dose 5.2 mg) when added to metformin2


The DPP-4 inhibitor with the lowest acquisition cost3,4


The NICE guideline on the management of type 2 diabetes in adults (NG28) suggests that prescribers should choose the individual DPP-4 inhibitor with the lowest acquisition cost available to them, if two drugs in the same class are appropriate5 * Based on NHS list price as of December 2015 ** ACS - Acute Coronary Syndrome


Lowering costs as well as HbA1c


PRESCRIBING INFORMATION Refer to summary of Product Characteristics (SmPC) before prescribing. Presentation: Alogliptin 6.25 mg, 12.5 mg and 25 mg film-coated tablets. Indication: Adults aged 18 years and older with Type 2 diabetes mellitus to improve glycaemic control in combination with other glucose lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control. Dosage & Administration: In adults the usual recommended dose of Vipidia is one tablet of 25 mg once daily (o.d.) with or without food.Elderly: No dose adjustment is necessary. Renal impairment: Mild renal impairment, no dose adjustment is necessary. Moderate renal impairment 12.5 mg o.d. Severe renal impairment or end-stage renal disease requiring dialysis 6.25 mg o.d. Experience in patients on dialysis is limited. Vipidia has not been studied in patients undergoing peritoneal dialysis. Hepatic impairment: No dose adjustment is necessary for patients with mild to moderate hepatic impairment. Has not been studied in patients with severe hepatic impairment, therefore not recommended for use in these patients. Paediatric population: No data are available. Contraindications: Hypersensitivity to the active substance or to its excipients or history of a serious hypersensitivity reaction to any dipeptidyl-peptidase-4 (DPP-4) inhibitor. Warnings & Precautions: General: Do not use in patients with Type 1 diabetes mellitus or for treatment of diabetic ketoacidosis. Use with other antihyperglycaemic medicinal products and hypoglycaemia: When used in combination with a sulphonylurea, insulin or combination therapy with thiazolidinedione plus metformin, a lower dose of these medications may be considered to reduce the risk of hypoglycaemia. Combinations not studied: Has not been studied in combination with sodium glucose cotransporter 2 (SGLT-2) inhibitors or glucagon like peptide 1 (GLP-1) analogues nor formally as triple therapy with metformin and sulphonylurea.Renal impairment: Renal function assessment is recommended prior to initiation of Vipidia therapy and periodically thereafter. Cardiac failure: Not recommended in patients with congestive heart failure of New York Heart Association (NYHA) functional class III – IV. Hypersensitivity reactions: Anaphylactic reactions, angioedema and exfoliative skin conditions including Stevens-Johnson syndrome and erythema multiforme have been observed for DPP-4 inhibitors and have been spontaneously reported for alogliptin in the post-marketing setting. Acute pancreatitis: Use of DPP-4 inhibitors has been associated with a risk of developing acute pancreatitis. Spontaneous reports of adverse reactions of acute pancreatitis in the post-marketing setting. Patients should be informed of the characteristic


Vipidia® (alogliptin) in Type 2 diabetes


symptoms of acute pancreatitis. If pancreatitis is suspected, Vipidia should be discontinued; if acute pancreatitis is confirmed, Vipidia should not be restarted. Caution should be exercised in patients with a history of pancreatitis. Hepatic effects: Postmarketing reports of hepatic dysfunction, including failure, have been received. Patients should be observed for possible liver abnormalities and liver function should be obtained promptly in patients with any symptoms. Discontinue Vipidia treatment if an abnormality is found and an alternative aetiology is not established. Interactions: Primarily excreted unchanged in the urine and metabolism by the cytochrome (CYP) P450 system is negligible. Studies show no clinically relevant pharmacokinetic interactions. Fertility, Pregnancy & Lactation: No data from use in pregnant women. Avoid use during pregnancy. Unknown whether Vipidia is excreted in human milk, a risk to the suckling child cannot be excluded. Consider the risk-benefit balance of use in breast-feeding mothers. The effect of Vipidia on fertility in humans has not been studied. Undesirable Effects: Common (≥1/100 to <1/10): Upper respiratory tract infections; nasopharyngitis; headache; abdominal pain; gastro-oesophageal reflux disease; pruritis; rash. Other serious undesirable effects (frequency unknown): Acute pancreatitis; hepatic dysfunction including hepatic failure; angioedema; hypersensitivity; exfoliative skin conditions. Refer to the SmPC for details on full side effect profile and interactions. Basic NHS Price: £26.60 for 28 tablets. Legal Classification: POM. Marketing Authorisation: EU/1/13/844/009 6.25 mg; EU/1/13/844/018 12.5 mg; EU/1/13/844/027 25 mg. Takeda UK Ltd. is responsible for the sale and supply of Vipidia in the UK. Further information is available from Takeda UK Ltd, Building 3, Glory Park, Glory Park Avenue, Wooburn Green, Bucks, HP10 0DF. Tel 01628 537900. Fax 01628 526617. PI Approval Code: UK/VIP/1411/0121(1). Date of revision: February 2015.


Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/. Adverse events should also be reported to Takeda UK Ltd. Tel 01628 537900.


VIPIDIA is a registered trademark of Takeda Pharmaceutical Company Limited.


References: 1. White WB, et al. N Engl J Med 2013; 369: 1327-1335. 2. Del Prato S, et al. Diabetes Obes Metab 2014; 16 (12): 1239-1246. 3. Midlands Therapeutic Review and Advisory Committee – Commissioning Support for DPP-4 inhibitors. 2014. Available from http://centreformedicinesoptimisationco.uk/files/MTRAC guidance on the gliptins final public version Dec 2014.pdf; last accessed December 2015. 4. MIMS. Available from www.mims.co.uk; last accessed December 2015. 5. National Institute for Health and Care Excellence, 2015. Type 2 diabetes in adults: management, NG28. Available from https://www.nice.org.uk/guidance/ ng28; last accessed December 2015.


Job Code: UK/VIP/1509/0131e Date of Prep: December 2015


The DPP-4 inhibitor with the lowest acquisition cost*


Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36  |  Page 37  |  Page 38  |  Page 39  |  Page 40  |  Page 41  |  Page 42  |  Page 43  |  Page 44  |  Page 45  |  Page 46  |  Page 47  |  Page 48  |  Page 49  |  Page 50  |  Page 51  |  Page 52  |  Page 53  |  Page 54  |  Page 55  |  Page 56  |  Page 57  |  Page 58  |  Page 59  |  Page 60  |  Page 61  |  Page 62  |  Page 63  |  Page 64  |  Page 65  |  Page 66  |  Page 67  |  Page 68  |  Page 69  |  Page 70  |  Page 71  |  Page 72  |  Page 73  |  Page 74  |  Page 75  |  Page 76  |  Page 77  |  Page 78  |  Page 79  |  Page 80  |  Page 81  |  Page 82  |  Page 83  |  Page 84  |  Page 85  |  Page 86  |  Page 87  |  Page 88  |  Page 89  |  Page 90  |  Page 91  |  Page 92  |  Page 93  |  Page 94  |  Page 95  |  Page 96  |  Page 97  |  Page 98  |  Page 99  |  Page 100  |  Page 101  |  Page 102  |  Page 103  |  Page 104  |  Page 105  |  Page 106  |  Page 107  |  Page 108