Frequently Asked Questions

Savings
Access

FOR ELIGIBLE COMMERCIAL AND PART D PATIENTS

GLYXAMBI supports ease of initiation

Over 8 million additional patients now have access to GLYXAMBI at the lowest branded co-pay.^*

^*Source: Fingertip Formulary, health plan or state listed below, and/or data on file, Boehringer Ingelheim Pharmaceuticals, Inc. as of 1/19/2019.

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Placement on formulary does not establish clinical comparability of products, including safety and efficacy, and is not a guarantee of full or partial coverage and/or payment. Contact health plan, state, or www.medicare.gov for most current information, as it may change without notice. This is not intended to be an exhaustive list of all plans in your area. Boehringer lngelheim Pharmaceuticals, Inc. and Lilly USA, LLC does not sponsor or endorse any particular plan, and the company/plan names listed do not imply their endorsement of Boehringer lngelheim Pharmaceuticals, Inc., Lilly USA, LLC, or the product(s) referenced. Boehringer lngelheim Pharmaceuticals, Inc. either owns or uses the trademark JARDIANCE® under license. Other referenced trademarks are owned by third parties.

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Savings

PART OF THE

^#1 PRESCRIBED SGLT2i
FAMILY^†

Eligible Patients^*

Pay as Little as

Help your patients save with the GLYXAMBI savings card

Eligible Patients can pay as little as $0 per prescription for an entire year—and then re-enroll for another 12 months of savings after that, as long as they still qualify.

Learn about the GLYXAMBI Savings Card^*

^*Terms & Conditions:
Eligible patients 18 years or older may pay as little as $0/month with a maximum savings up to $400/monthly prescription. Card valid for 12 consecutive months from activation date. Benefits not to exceed program expiration on December 31, 2019. If you live in Massachusetts, card expires on the earlier of June 30, 2019, or date AB-rated generic equivalent is available. One card per patient, not transferable, and cannot be combined with any other offer. Program not health insurance. Only valid for commercially insured patients in the 50 United States, DC, and Puerto Rico. Not eligible if prescriptions are paid for in part/full by state or federally funded program(s), like Medicare Part D, Medicaid, Vet. Aff., Dept. of Def., or TRICARE and where prohibited by law. Offer may change at any time, without notice.

^†As measured by TRx through 1/18/2019.

SGLT2i=sodium glucose co-transporter-2 inhibitor.

Help eligible patients obtain medication through an assistance program

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FAQs

What differentiates GLYXAMBI from other SGLT2 inhibitor-based FDCs?

GLYXAMBI is the only fixed-dose combination (FDC) that contains Jardiance® (empagliflozin), the #1 prescribed sodium glucose co-transporter-2 inhibitor (SGLT2i)*, in combination with Tradjenta® (linagliptin), a DPP-4 inhibitor.

GLYXAMBI Data

^*As measured by NBRx from 7/27/18 to 1/18/19.
DPP-4=dipeptidyl peptidase-4.

How can treatment with GLYXAMBI benefit my patients?

In the GLYXAMBI trial in patients with type 2 diabetes who were inadequately controlled on at least 1500 mg of metformin, patients treated with GLYXAMBI experienced a significant reduction in A1C from baseline at 24 weeks vs the individual components. In the EMPA-REG OUTCOME Trial, Jardiance® (empagliflozin), which is a component of GLYXAMBI, significantly reduced the risk of CV death in adults with type 2 diabetes and established CV disease on top of standard of care CV and type 2 diabetes medications. The effectiveness of GLYXAMBI on reducing the risk of CV death in adults with type 2 diabetes and CV disease has not been established.

GLYXAMBI Data

Jardiance CV Outcomes

Can my patients take GLYXAMBI with other type 2 diabetes medications?

In the GLYXAMBI trial in patients with type 2 diabetes who were inadequately controlled on at least 1500 mg of metformin, patients continued to receive metformin throughout the trial.

GLYXAMBI Dosing

What is the indication for GLYXAMBI?

GLYXAMBI contains Jardiance® (empagliflozin), a sodium glucose co-transporter-2 inhibitor (SGLT2i), and Tradjenta® (linagliptin), a DPP-4 inhibitor. GLYXAMBI is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and linagliptin is appropriate.

JARDIANCE, a component of GLYXAMBI, is indicated to reduce the risk of cardiovascular (CV) death in adults with type 2 diabetes mellitus and established CV disease. The effectiveness of GLYXAMBI on reducing the risk of CV death in adults with type 2 diabetes and CV disease has not been established.

GLYXAMBI Data

JARDIANCE CV Outcomes

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

DPP-4=dipeptidyl peptidase-4.

What are the components of GLYXAMBI?

GLYXAMBI is a combination of Jardiance® (empagliflozin), a sodium glucose co-transporter-2 inhibitor (SGLT2i), and Tradjenta® (linagliptin), a DPP-4 inhibitor. Only GLYXAMBI contains JARDIANCE, the #1 prescribed SGLT2i* together with lingaliptin.

^*As measured by NBRx from 7/27/18 to 1/18/19.
DPP-4=dipeptidyl peptidase-4.

What are the common side effects of GLYXAMBI?

The most common adverse reactions associated with GLYXAMBI (a 5% or greater incidence) were urinary tract infections, nasopharyngitis, and upper respiratory tract infections.

GLYXAMBI Safety

Please see Important Safety Information and full Prescribing Information for a more detailed description of safety.

When should I prescribe GLYXAMBI?

You can prescribe GLYXAMBI as an adjunct to diet and exercise for adults with type 2 diabetes who need glycemic control and may benefit from treatment with Jardiance® (empagliflozin) and Tradjenta® (linagliptin) in a single pill taken once a day.

GLYXAMBI Data

What is the recommended dosage for GLYXAMBI?

The recommended dose of GLYXAMBI is 10 mg empagliflozin/5 mg linagliptin once daily in the morning, taken with or without food. In patients tolerating GLYXAMBI, the dose may be increased to 25 mg empagliflozin/5 mg linagliptin once daily.

Assessment of renal function is recommended prior to initiation of GLYXAMBI and periodically thereafter. GLYXAMBI should not be initiated in patients with an eGFR less than 45 mL/min/1.73 m². No dose adjustment is needed in patients with an eGFR greater than or equal to 45 mL/min/1.73 m².

GLYXAMBI Dosing

Is there a Savings Card program for GLYXAMBI?

Yes. The Jardiance® (empagliflozin) Family Savings Card* can provide savings for all JARDIANCE Family medications, including GLYXAMBI. The Family Savings Card can help your eligible patients who are 18 years or older get their medication for as little as $0 per month for 12 consecutive months, with a maximum savings of up to $400 per monthly prescription. Your patients who currently have the GLYXAMBI Card can continue to use it for savings and will be enrolled in the JARDIANCE Family Savings Card program. One year after their original enrollment in the savings program, they will receive a notification to re-enroll in the JARDIANCE Family Savings Card program.

GLYXAMBI Savings

^*Terms & Conditions: Eligible patients 18 years or older may pay as little as $0/month with a maximum savings up to $400/monthly prescription. Card valid for 12 consecutive months from activation date. Benefits not to exceed program expiration on December 31, 2019. If you live in Massachusetts, card expires on the earlier of June 30, 2019, or date AB-rated generic equivalent is available. One card per patient, not transferable, and cannot be combined with any other offer. Program not health insurance. Only valid for commercially insured patients in the 50 United States, DC, and Puerto Rico. Not eligible if prescriptions are paid for in part/full by state or federally funded program(s), like Medicare Part D, Medicaid, Vet. Aff., Dept. of Def., or TRICARE and where prohibited by law. Offer may change at any time, without notice.

What type of coverage does GLYXAMBI have?

GLYXAMBI is covered for nearly 80% of commercial patients.*

GLYXAMBI Access

^*Source: Fingertip Formulary, health plan or state listed above, and/or data on file, Boehringer Ingelheim Pharmaceuticals, Inc. as of 1/19/2019. Placement on formulary does not establish clinical comparability of products, including safety and efficacy, and is not a guarantee of full or partial coverage and/or payment. Contact health plan, state, or www.medicare.gov for most current information, as it may change without notice.

INDICATIONS AND LIMITATIONS OF USE FOR GLYXAMBI, JARDIANCE, AND TRADJENTA

GLYXAMBI is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and linagliptin is appropriate.

Empagliflozin is indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease. However, the effectiveness of GLYXAMBI on reducing the risk of cardiovascular death in adults with type 2 diabetes mellitus and cardiovascular disease has not been established.

JARDIANCE and TRADJENTA are each indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

GLYXAMBI, JARDIANCE, and TRADJENTA are not recommended for patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. GLYXAMBI and TRADJENTA have not been studied in patients with a history of pancreatitis, and it is unknown if using GLYXAMBI or TRADJENTA increases the risk of developing pancreatitis in these patients.

IMPORTANT SAFETY INFORMATION FOR GLYXAMBI, JARDIANCE, AND TRADJENTA IMPORTANT SAFETY INFORMATION, INDICATIONS AND LIMITATIONS OF USE FOR GLYXAMBI, JARDIANCE, AND TRADJENTA

CONTRAINDICATIONS
GLYXAMBI: Severe renal impairment, end-stage renal disease, or dialysis; history of hypersensitivity reaction to empagliflozin, linagliptin, or any of the excipients in GLYXAMBI such as anaphylaxis, angioedema, exfoliative skin conditions, urticaria, or bronchial hyperreactivity.

JARDIANCE: History of serious hypersensitivity to empagliflozin or any of the excipients in JARDIANCE; severe renal impairment, end-stage renal disease, or dialysis.

TRADJENTA: History of hypersensitivity to linagliptin, such as anaphylaxis, angioedema, exfoliative skin conditions, urticaria, or bronchial hyperactivity.

WARNINGS AND PRECAUTIONS
Pancreatitis: GLYXAMBI, TRADJENTA
Acute pancreatitis, including fatal pancreatitis, has been reported in patients taking linagliptin. Take careful notice of potential signs and symptoms of pancreatitis, and if suspected, promptly discontinue and initiate appropriate management. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using GLYXAMBI or TRADJENTA.

Heart Failure: GLYXAMBI, TRADJENTA
Heart failure has been observed with 2 other members of the dipeptidyl peptidase-4 (DPP-4) inhibitor class. Consider risks and benefits of GLYXAMBI or TRADJENTA in patients at risk for heart failure, such as those with a prior history of heart failure and a history of renal impairment. Monitor patients for signs and symptoms. Advise patients of the symptoms of heart failure and to immediately report such symptoms. If heart failure develops, consider discontinuation of GLYXAMBI or TRADJENTA.

Hypotension: GLYXAMBI, JARDIANCE
Empagliflozin causes intravascular volume contraction, and symptomatic hypotension may occur. Before initiating, assess and correct volume status in the elderly, in patients with renal impairment, low systolic blood pressure, or on diuretics. Monitor for hypotension.

Ketoacidosis: GLYXAMBI, JARDIANCE
Ketoacidosis, a serious life-threatening condition requiring urgent hospitalization, has been identified in patients with type 1 and type 2 diabetes mellitus receiving sodium glucose cotransporter 2 (SGLT2) inhibitors, including empagliflozin. Fatal cases of ketoacidosis have been reported in patients taking empagliflozin. Patients who present with signs and symptoms of metabolic acidosis should be assessed for ketoacidosis, even if blood glucose levels are <250 mg/dL. If suspected, discontinue, evaluate and treat promptly. Before initiating, consider risk factors for ketoacidosis. Patients may require monitoring and temporary discontinuation of therapy in situations known to predispose to ketoacidosis.

Acute Kidney Injury and Impairment in Renal Function: GLYXAMBI, JARDIANCE
Empagliflozin 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 empagliflozin; some reports involved patients younger than 65 years of age. Before initiating, consider factors that may predispose patients to acute kidney injury. Consider temporary discontinuation in settings of reduced oral intake or fluid losses. Monitor patients for signs and symptoms of acute kidney injury. If it occurs, discontinue and treat promptly. Empagliflozin increases serum creatinine and decreases eGFR. Patients with hypovolemia may be more susceptible to these changes. Before initiating, evaluate renal function and monitor thereafter. More frequent monitoring is recommended in patients with eGFR <60 mL/min/1.73 m². Discontinue in patients with a persistent eGFR <45 mL/min/1.73 m².

Urosepsis and Pyelonephritis: GLYXAMBI, JARDIANCE
Serious urinary tract infections including urosepsis and pyelonephritis requiring hospitalization have been identified in patients receiving SGLT2 inhibitors, including empagliflozin. Treatment with SGLT2 inhibitors increases the risk for urinary tract infections. Evaluate for signs and symptoms of urinary tract infections and treat promptly.

Hypoglycemia: GLYXAMBI, JARDIANCE, TRADJENTA
The use in combination with insulin or insulin secretagogues can increase the risk of hypoglycemia. A lower dose of insulin or insulin secretagogue may be required.

Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene): GLYXAMBI, JARDIANCE
Serious, life-threatening cases have occurred in both females and males. Assess patients presenting with pain or tenderness, erythema, or swelling in the genital or perineal area, along with fever or malaise. If suspected, institute prompt treatment and discontinue GLYXAMBI or JARDIANCE.

Genital Mycotic Infections: GLYXAMBI, JARDIANCE
Empagliflozin increases the risk for genital mycotic infections, especially in patients with prior infections. Monitor and treat as appropriate.

Hypersensitivity Reactions: GLYXAMBI, JARDIANCE, TRADJENTA
Discontinue GLYXAMBI, JARDIANCE or TRADJENTA, treat promptly, and monitor until signs and symptoms resolve. Use caution in a patient with a history of angioedema to another DPP‐4 inhibitor because it is unknown whether such patients will be predisposed to angioedema with linagliptin.

Increased Low‐Density Lipoprotein Cholesterol (LDL‐C): GLYXAMBI, JARDIANCE
Monitor and treat as appropriate.

Severe and Disabling Arthralgia: GLYXAMBI, TRADJENTA
Consider linagliptin as a possible cause for severe joint pain and discontinue if appropriate.

Bullous Pemphigoid: GLYXAMBI, TRADJENTA
There have been reports of bullous pemphigoid requiring hospitalization in patients taking DPP-4 inhibitors. Tell patients to report development of blisters or erosions. If bullous pemphigoid is suspected, discontinue.

Macrovascular Outcomes: GLYXAMBI, TRADJENTA
There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction.

MOST COMMON ADVERSE REACTIONS (≥ 5%)

GLYXAMBI: Urinary tract infections, nasopharyngitis, and upper respiratory tract infections.

JARDIANCE: Urinary tract infections and female genital mycotic infections.

TRADJENTA: Nasopharyngitis, hypoglycemia (when used in combination with sulfonylurea).

DRUG INTERACTIONS: GLYXAMBI, JARDIANCE, TRADJENTA

Empagliflozin: Coadministration with diuretics may enhance the potential for volume depletion.

Linagliptin: The efficacy may be reduced when administered in combination with a strong P-gp or CYP3A4 inducer. Alternative treatments should be used.

USE IN SPECIAL POPULATIONS

Pregnancy: GLYXAMBI and JARDIANCE are not recommended during the second and third trimesters of pregnancy. TRADJENTA should be used during pregnancy only if clearly needed.

Lactation: GLYXAMBI, JARDIANCE, and TRADJENTA are not recommended while breastfeeding.

Geriatric Use: Empagliflozin 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 GLYXAMBI or JARDIANCE.

INDICATIONS AND LIMITATIONS OF USE FOR GLYXAMBI, JARDIANCE, AND TRADJENTA

GLYXAMBI is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and linagliptin is appropriate.

JARDIANCE and TRADJENTA are each indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

CL-GLX-100022 10.30.18

Please see Prescribing Information and Medication Guide for GLYXAMBI.

Please see Prescribing Information and Medication Guide for JARDIANCE.

Please see Prescribing Information and Medication Guide for TRADJENTA.