INTRODUCTION CLINICAL EXPERIENCE CLINICAL EFFICACY PEDIATRIC EXPERIENCE DOSING SUMMARY

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3 DOTAREM Administered Doses 3

4 Molecular Structure of DOTAREM DOTAREM offers high thermodynamic and kinetic stability provided by its macrocyclic and ionic structure* 3 *The clinical significance of these data is unknown. 4

5 Molecular Structure of DOTAREM DOTAREM is the only agent with macrocyclic and ionic properties Characteristics of GBCAs* 3,4-9 *The clinical significance of these data is unknown. Magnevist is a registered trademark and Gadavist is a trademark of the Bayer group of companies. MultiHance and ProHance are registered trademarks of Bracco Diagnostics Inc. Omniscan is a trademark of GE Healthcare. OptiMARK is a trademark of Mallinckrodt Inc. 5

6 Proven Safety Profile in Clinical Studies For adult and pediatric (2-17 years) patients *Not all studies have been reviewed by FDA. 6

7 Proven Safety Profile in Clinical Studies Ensuring use in a broad population of patients at recommended dose 7

8 Proven Safety Profile in Clinical Studies In patients with chronically reduced renal function, acute kidney injury requiring dialysis has occurred with the use of GBCAs. The risk of acute kidney injury may increase with increasing dose of the contrast agent; administer the lowest dose necessary for adequate imaging. Screen all patients for renal impairment by obtaining a history and/or laboratory tests. Consider follow-up renal function assessments for patients with a history of renal dysfunction. 8

9 Proven Safety Profile in Clinical Studies The most common AEs occurred in <1% of patients 1 *Most events are characterized as mild or moderate and reversible. Of the 2813 patients evaluated, 141 were children. 9

10 Information Regarding NSF 10

11 The Visualization Quality That You Require The efficacy profile of DOTAREM in pediatric and adult patients The possibility of serious or life-threatening anaphylactoid/anaphylactic reactions with cardiovascular, respiratory or cutaneous manifestations, ranging from mild to severe, including death, should be considered. Monitor patients closely for need of emergency cardiorespiratory support. In patients with chronically reduced renal function, acute kidney injury requiring dialysis has occurred with the use of GBCAs. Please consult Full Prescribing Information for DOTAREM. 11

12 The Visualization Quality That You Require DOTAREM efficacy was demonstrated in a phase III trial The possibility of serious or life-threatening anaphylactoid/anaphylactic reactions with cardiovascular, respiratory or cutaneous manifestations, ranging from mild to severe, including death, should be considered. Monitor patients closely for need of emergency cardiorespiratory support. In patients with chronically reduced renal function, acute kidney injury requiring dialysis has occurred with the use of GBCAs. Please consult Full Prescribing Information for DOTAREM. 12

13 The Visualization Quality That You Require DOTAREM efficacy was demonstrated in a phase III trial The possibility of serious or life-threatening anaphylactoid/anaphylactic reactions with cardiovascular, respiratory or cutaneous manifestations, ranging from mild to severe, including death, should be considered. Monitor patients closely for need of emergency cardiorespiratory support. In patients with chronically reduced renal function, acute kidney injury requiring dialysis has occurred with the use of GBCAs. Please consult Full Prescribing Information for DOTAREM. 13

14 The Visualization Quality That You Require DOTAREM provides signal enhancement 1 The possibility of serious or life-threatening anaphylactoid/anaphylactic reactions with cardiovascular, respiratory or cutaneous manifestations, ranging from mild to severe, including death, should be considered. Monitor patients closely for need of emergency cardiorespiratory support. In patients with chronically reduced renal function, acute kidney injury requiring dialysis has occurred with the use of GBCAs. Please consult Full Prescribing Information for DOTAREM. 14

15 The Visualization Quality That You Require DOTAREM provides signal enhancement 1 The possibility of serious or life-threatening anaphylactoid/anaphylactic reactions with cardiovascular, respiratory or cutaneous manifestations, ranging from mild to severe, including death, should be considered. Monitor patients closely for need of emergency cardiorespiratory support. In patients with chronically reduced renal function, acute kidney injury requiring dialysis has occurred with the use of GBCAs. Please consult Full Prescribing Information for DOTAREM. 15

16 The Visualization Quality That You Require DOTAREM provides signal enhancement 1 The possibility of serious or life-threatening anaphylactoid/anaphylactic reactions with cardiovascular, respiratory or cutaneous manifestations, ranging from mild to severe, including death, should be considered. Monitor patients closely for need of emergency cardiorespiratory support. In patients with chronically reduced renal function, acute kidney injury requiring dialysis has occurred with the use of GBCAs. Please consult Full Prescribing Information for DOTAREM. 16

17 Clinical Profile Established for Children DOTAREM is approved for use in children (2 years of age and older) 1 *The recommended dose of DOTAREM is administered at a flow rate of approximately 2 ml/second for adults and 1-2 ml/second for pediatric patients. 1 17

18 Patient Dosing Standard weight-based dosing used for administration of DOTAREM, and no dose reduction required in patients with renal impairment 1 Each ml injection contains mg gadoterate meglumine (equivalent to 0.5 mmol/ml) and is available in both vial and pre-filled syringe 1 DOTAREM is supplied as a solution containing 0.5 mmol/ml in vials and pre-filled syringes For adults and children (age 2 and older), the recommended dose of DOTAREM is 1 : 0.2 ml/kg (0.1 mmol/kg) body weight Administered as an intravenous bolus injection, manually or by power injector At a flow rate of approximately 2 ml/second for adults and 1-2 ml/second for children DOTAREM Injection is supplied in vials 1,10 10 ml in glass vial (NDC ) 15 ml in glass vial (NDC ) 20 ml in glass vial (NDC ) 100 ml in glass vial (NDC ) - Pharmacy Bulk Package DOTAREM Injection is supplied in pre-filled syringes 1 10 ml in glass pre-filled syringe (NDC ) 15 ml in glass pre-filled syringe (NDC ) 20 ml in glass pre-filled syringe (NDC ) Nephrogenic Systemic Fibrosis has occurred in patients with impaired elimination of GBCAs. Higher than recommended dosing or repeat dosing appear to increase the risk. Acute Kidney Injury: In patients with chronically reduced renal function, acute kidney injury requiring dialysis has occurred with the use of GBCAs. The risk of acute kidney injury may increase with increasing dose of the contrast agent; administer the lowest dose necessary for adequate imaging. Screen all patients for renal impairment by obtaining a history and/or laboratory tests. Consider follow-up renal function assessments for patients with a history of renal dysfunction. 1 Extravasation and Injection Site Reactions Ensure catheter and venous patency before the injection of DOTAREM. Extravasation into tissues during DOTAREM administration may result in tissue irritation. 18

19 Patient Dosing Physiochemical properties and weight adjusted volumes of DOTAREM Extravasation and Injection Site Reactions: Ensure catheter and venous patency before the injection of DOTAREM. Extravasation into tissues during DOTAREM administration may result in tissue irritation. Extravasation and Injection Site Reactions Ensure catheter and venous patency before the injection of DOTAREM. Extravasation into tissues during DOTAREM administration may result in tissue irritation. 19

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21 Dotarem is a registered trademark of Guerbet and is available by prescription only. GU

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