A Breakthrough in Cardiovascular Outcomes

Reata
310 Houston Street
Fort Worth, TX 76102

Tuesday, May 23, 2017 at 6:30pm CT - 9:00pm CT
This event has ended.

310 Houston Street, Fort Worth, TX 76102

Info

Speaker(s)

Kenneth Mair, MD


Additional Information

Copyright © 2016 Boehringer Ingelheim Pharmaceuticals, Inc. All rights reserved. (12/16) PC-01078

Please see additional Important Safety Information on the next page and accompanying full Prescribing Information, including Patient Information.

BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.

AND LILLY USA, LLC CORDIALLY INVITE YOU

PRESENTATION

A BREAKTHROUGH IN

CARDIOVASCULAR OUTCOMES

This program is open to healthcare practitioners (HCPs) for whom the information presented is relevant to

their practice. Spouses or guests cannot be accommodated.

By registering for this event I agree to allow Boehringer lngelheim Pharmaceuticals, Inc. (BIPI), Lilly USA,

LLC, and third parties associated with the execution of this program to contact me, by phone, fax, e-mail,

or in person.

BIPI and Lilly USA, LLC have adopted the PhRMA (Pharmaceutical Research and Manufacturers of America)

Code on Interactions with Healthcare Professionals that went into effect on July 1, 2002. Pursuant to

the Code, inclusion of health care professionals' spouses or guests is not permitted. We appreciate your

understanding and support of our commitment to following the highest ethical standards as related to

interactions with healthcare professionals. To comply with federal regulations, attendance at the entire

session is required and early departures are not permitted.

INDICATIONS AND LIMITATIONS OF USE

JARDIANCE is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

JARDIANCE is indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease.

JARDIANCE is not recommended for patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

JARDIANCE should not be used in patients with a history of serious hypersensitivity to JARDIANCE or in

patients with severe renal impairment, end-stage renal disease, or dialysis.

Date -Tuesday, May 23, 2017

6:30 PM CT

Kenneth Mair, MD

Clinician

Reata Restaurant

310 Houston St

Fort Worth, TX 76102

RSVP

Thursday, May 18, 2017

Timothy Debysingh

(817) 905-5754

timothy.debysingh@boehringer-ingelheim.com

Copyright © 2016 Boehringer Ingelheim Pharmaceuticals, Inc. All rights reserved. (12/16) PC-01078

Please see accompanying full Prescribing Information, including Patient Information.

INDICATIONS AND LIMITATIONS OF USE

JARDIANCE is indicated as an adjunct to diet and exercise to improve glycemic

control in adults with type 2 diabetes mellitus.

JARDIANCE is indicated to reduce the risk of cardiovascular death in adults with

type 2 diabetes mellitus and established cardiovascular disease.

JARDIANCE is not recommended for patients with type 1 diabetes or for the

treatment of diabetic ketoacidosis.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

JARDIANCE should not be used in patients with a history of serious hypersensitivity

to JARDIANCE or in patients with severe renal impairment, end-stage renal

disease, or dialysis.

WARNINGS AND PRECAUTIONS

Hypotension

JARDIANCE causes intravascular volume contraction and symptomatic hypotension

may occur. Before initiating JARDIANCE, assess and correct volume status in

the elderly, in patients with renal impairment, low systolic blood pressure, or on

diuretics. Monitor for hypotension.

Ketoacidosis

Reports of ketoacidosis, a serious life-threatening condition requiring urgent

hospitalization have been identified in patients with type 1 and type 2 diabetes

mellitus receiving sodium glucose co transporter 2 (SGLT2) inhibitors, including

JARDIANCE. Fatal cases of ketoacidosis have been reported in patients taking

JARDIANCE. Patients who present with signs and symptoms of metabolic acidosis

should be assessed for ketoacidosis, even if blood glucose levels are less than

250 mg/dL. If suspected, discontinue JARDIANCE, evaluate and treat promptly.

Before initiating JARDIANCE, consider risk factors for ketoacidosis. Patients on

JARDIANCE may require monitoring and temporary discontinuation in situations

known to predispose to ketoacidosis.

Acute Kidney Injury and Impairment in Renal Function

JARDIANCE causes intravascular volume contraction and can cause renal

impairment. Acute kidney injury requiring hospitalization and dialysis have been

identified in patients taking SGLT2 inhibitors, including JARDIANCE; some reports

involved patients younger than 65 years of age. Before initiating JARDIANCE,

consider factors that may predispose patients to acute kidney injury including

hypovolemia, chronic renal insufficiency, congestive heart failure and concomitant

medications (diuretics, ACE inhibitors, ARBs, NSAIDs). Consider temporary

discontinuation in settings of reduced oral intake or fluid losses. Monitor patients

for signs and symptoms of acute kidney injury. If acute kidney injury occurs,

discontinue JARDIANCE promptly and institute treatment.

JARDIANCE increases serum creatinine and decreases eGFR. Patients with

hypovolemia may be more susceptible to these changes. Renal function should

be evaluated prior to initiating JARDIANCE and periodically thereafter. More

frequent monitoring is recommended in patients with eGFR <60 mL/min/1.73 m2.

JARDIANCE should be discontinued in patients with a persistent eGFR

<45 mL/min/1.73 m2.

Urosepsis and Pyelonephritis

Serious urinary tract infections including urosepsis and pyelonephritis requiring

hospitalization have been identified in patients receiving SGLT2 inhibitors, including

JARDIANCE. Treatment with SGLT2 inhibitors increases the risk for urinary

tract infections. Evaluate for signs and symptoms of urinary tract infections and

treat promptly.

Hypoglycemia with Concomitant Use with Insulin and Insulin

Secretagogues

Insulin and insulin secretagogues are known to cause hypoglycemia. The use

of JARDIANCE with these agents can increase the risk of hypoglycemia. A lower

dose of insulin or the insulin secretagogue may be required when used in combination

with JARDIANCE.

Genital Mycotic Infections

JARDIANCE increases the risk for genital mycotic infections. Patients with a

history of chronic or recurrent genital mycotic infections were more likely to

develop these infections. Monitor and treat as appropriate.

Genital Mycotic Infections

JARDIANCE increases the risk for genital mycotic infections, especially in patients

with prior infections. Monitor and treat as appropriate.

Increased Low-Density Lipoprotein Cholesterol (LDL-C)

Monitor and treat as appropriate.

ADVERSE REACTIONS

The most common adverse reactions (>5%) associated with placebo and

JARDIANCE 10 mg and 25 mg were urinary tract infections and female genital

mycotic infections.

DRUG INTERACTIONS

Diuretics may enhance the potential for volume depletion when administered

with JARDIANCE.

USE IN SPECIAL POPULATIONS

Pregnancy

JARDIANCE is not recommended during the second and third trimesters of pregnancy

based on animal data showing adverse renal effects.

Lactation

JARDIANCE is not recommended while breastfeeding because of the potential for

serious adverse reactions in breastfed infants.

Geriatric Use

JARDIANCE is expected to have diminished efficacy in elderly patients with renal

impairment. Urinary tract infections and volume depletion-related adverse

reactions increased in patients ≥75 years treated with JARDIANCE.

JAR PROF ISI 12.3.16