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.
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