WARNINGS AND PRECAUTIONS
Pancreatitis: GLYXAMBI, TRADJENTA
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
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
Hypotension: GLYXAMBI, JARDIANCE
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
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:
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,
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
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
Hypersensitivity Reactions: GLYXAMBI, JARDIANCE,
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
linagliptin as a possible cause for severe joint pain and
discontinue if appropriate.
Bullous Pemphigoid: GLYXAMBI, TRADJENTA
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
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