QTERN fixed-dose combination will provide an
additional oral medicine option for patients taking FARXIGA®
(dapagliflozin) to improve blood sugar level
AstraZeneca (NYSE:AZN) today announced that the US Food and Drug
Administration (FDA) has approved once-daily QTERN® (10mg
dapagliflozin and 5mg saxagliptin) for the treatment of type-2
diabetes. The new medicine is indicated as an adjunct to diet and
exercise to improve glycemic (blood sugar level) control in adults
with type-2 diabetes who have inadequate control with dapagliflozin
(10mg) or who are already treated with dapagliflozin and
saxagliptin.
Elisabeth Bj�rk, Vice President, Head of Cardiovascular and
Metabolic Diseases, Global Medicines Development at AstraZeneca,
said: "Type-2 diabetes is a complex disease that is at epidemic
proportions, affecting more than 29 million people in the US alone.
The approval of QTERN is good news for patients who may benefit
from improved glycemic control by adding a DPP-4 inhibitor to a
SGLT-2 inhibitor in a convenient once-daily tablet.”
SGLT-2 inhibitors help patients achieve improved glycemic
control by reducing the reabsorption of glucose from the blood and
enabling its removal via the urine. SGLT-2 inhibitors, including
FARXIGA® (dapagliflozin), have demonstrated reductions in HbA1c and
have also been shown to reduce weight and blood pressure. DPP-4
inhibitors reduce blood glucose as measured by HbA1c. FARXIGA is
not indicated for weight loss or the treatment of hypertension.
QTERN is not indicated for the treatment of type 1 diabetes
mellitus or diabetic ketoacidosis. QTERN is contraindicated in
patients with prior serious hypersensitivity reaction to QTERN or
its components, patients with moderate to severe renal impairment,
end stage renal disease, or on dialysis. The most common adverse
reactions experienced were upper respiratory tract infection,
urinary tract infection, and dyslipidemia.
INDICATION AND LIMITATIONS OF USE for QTERN®
(dapagliflozin and saxagliptin)
QTERN is indicated as an adjunct to diet and exercise to improve
glycemic control in adults with type 2 diabetes mellitus (T2DM) who
have inadequate control with dapagliflozin or who are already
treated with dapagliflozin and saxagliptin.
QTERN is not indicated for the treatment of type 1 diabetes
mellitus or diabetic ketoacidosis. QTERN should only be used in
patients who tolerate 10 mg dapagliflozin.
IMPORTANT SAFETY INFORMATION for QTERN®
(dapagliflozin and saxagliptin)
Contraindications
- Prior serious hypersensitivity reaction
to QTERN or its components
- Moderate to severe renal impairment
(eGFR <45 mL/min/1.73 m2), end-stage renal disease, or patients
on dialysis
Warning and Precautions
- Pancreatitis: There have been
postmarketing reports of acute pancreatitis in patients taking
saxagliptin, and in the SAVOR cardiovascular outcomes trial.
Observe for pancreatitis. If pancreatitis is suspected, discontinue
QTERN
- Heart Failure: In the SAVOR
cardiovascular outcomes trial, more patients treated with
saxagliptin were hospitalized for heart failure compared to
placebo. Patients with a prior history of heart failure or renal
impairment had a higher risk for hospitalization for heart failure.
Consider the risks and benefits of QTERN in patients who have known
risk factors for heart failure. Monitor for signs and symptoms. If
heart failure develops, consider discontinuation of QTERN
- Hypotension: Dapagliflozin
causes intravascular volume contraction, and symptomatic
hypotension can occur. Assess and correct volume status before
initiating QTERN in patients with impaired renal function, elderly
patients, or patients on loop diuretics. Do not initiate QTERN in
patients with an eGFR <60 mL/min/1.73 m2. Monitor for
hypotension
- Ketoacidosis has been reported
in patients with type 1 and type 2 diabetes receiving
dapagliflozin. Some cases were fatal. Assess patients who present
with signs and symptoms of metabolic acidosis for ketoacidosis,
regardless of blood glucose level. If suspected, discontinue QTERN,
evaluate and treat promptly. Before initiating QTERN, consider risk
factors for ketoacidosis. Patients on QTERN may require monitoring
and temporary discontinuation in situations known to predispose to
ketoacidosis
- Acute Kidney Injury and Impairment
in Renal Function: Dapagliflozin causes intravascular volume
contraction and renal impairment, with reports of acute kidney
injury requiring hospitalization and dialysis. Consider temporarily
discontinuing in settings of reduced oral intake or fluid losses.
If acute kidney injury occurs, discontinue and promptly
treatDapagliflozin increases serum creatinine and decreases eGFR.
Elderly patients and patients with impaired renal function may be
more susceptible to these changes. Before initiating QTERN,
evaluate renal function and monitor periodically. Discontinue QTERN
in patients if eGFR falls persistently below 60 mL/min/1.73
m2
- Urosepsis and Pyelonephritis:
SGLT2 inhibitors increase the risk for urinary tract infections
(UTIs) and serious UTIs have been reported with dapagliflozin.
Evaluate for signs and symptoms of UTIs and treat promptly
- Hypoglycemia: QTERN can increase
the risk of hypoglycemia when coadministered with insulin and
insulin secretagogues. Consider lowering the dose of these agents
when coadministered with QTERN
- Hypersensitivity Reactions:
Serious reactions have been reported in patients treated with
saxagliptin, including anaphylaxis, angioedema, and exfoliative
skin conditions. Onset of these reactions occurred within the first
3 months after initiation of treatment with saxagliptin, with some
reports occurring after the first dose. If a serious
hypersensitivity reaction is suspected, discontinue QTERN. Use
caution in patients with a history of angioedema to another DPP-4
inhibitor
- Genital Mycotic Infections:
Dapagliflozin increases the risk of genital mycotic infections,
particularly in patients with prior genital mycotic infections.
Monitor and treat appropriately
- Increases in Low-Density Lipoprotein
Cholesterol (LDL-C) occur with dapagliflozin. Monitor LDL-C and
treat per standard of care
- Bladder cancer: An imbalance in
bladder cancers was observed in clinical trials. There were too few
cases to determine whether the emergence of these events is related
to dapagliflozin, and insufficient data to determine whether
dapagliflozin has an effect on pre-existing bladder tumors. QTERN
should not be used in patients with active bladder cancer. Use with
caution in patients with a history of bladder cancer
- Severe and Disabling Arthralgia
has been reported in patients taking DPP-4 inhibitors. The time to
onset of symptoms following initiation of drug therapy varied from
one day to years. Patients experienced relief of symptoms upon
discontinuation. A subset of patients experienced a recurrence of
symptoms when restarting the same drug or a different DPP-4
inhibitor. Consider discontinuing drug if appropriate
- Bullous Pemphigoid: There have
been postmarketing reports of bullous pemphigoid requiring
hospitalization in patients taking DPP-4 inhibitors. Tell patients
to report development of blisters or erosions. If suspected,
discontinue QTERN
- Macrovascular Outcomes: There
have been no clinical studies establishing conclusive evidence of
macrovascular risk reduction with QTERN
Adverse Reactions
Most common adverse reactions reported in ≥5% of patients
treated with 10 mg dapagliflozin and 5 mg saxagliptin were upper
respiratory tract infection (13.6%), urinary tract infection
(5.7%), and dyslipidemia (5.1%).
Drug Interactions
Strong CYP3A4/5 inhibitors (eg, ketoconazole): Coadministration
with QTERN significantly increases saxagliptin concentrations. Do
not coadminister QTERN.
Use in Specific Populations
- Pregnancy: Advise females of the
potential risk to a fetus especially during the second and third
trimesters
- Lactation: Advise females of the
potential risk to a fetus especially during the second and third
trimesters
Please click here for US Full Prescribing
Information and Medication Guide for QTERN.
INDICATION AND LIMITATIONS OF USE for FARXIGA®
(dapagliflozin)
FARXIGA is indicated as an adjunct to diet and exercise to
improve glycemic control in adults with type 2 diabetes
mellitus.
FARXIGA is not recommended for patients with type 1 diabetes
mellitus or for the treatment of diabetic ketoacidosis.
IMPORTANT SAFETY INFORMATION for FARXIGA®
(dapagliflozin)
Contraindications
- History of a serious hypersensitivity
reaction to FARXIGA
- Severe renal impairment (eGFR <30
mL/min/1.73 m2), end stage renal disease, or patients on
dialysis
Warnings and Precautions
- Hypotension: FARXIGA causes
intravascular volume contraction, and symptomatic hypotension can
occur. Assess and correct volume status before initiating FARXIGA
in patients with impaired renal function, elderly patients, or
patients on loop diuretics. Monitor for hypotension
- Ketoacidosis has been reported
in patients with type 1 and type 2 diabetes receiving FARXIGA. Some
cases were fatal. Assess patients who present with signs and
symptoms of metabolic acidosis for ketoacidosis, regardless of
blood glucose level. If suspected, discontinue FARXIGA, evaluate
and treat promptly. Before initiating FARXIGA, consider risk
factors for ketoacidosis. Patients on FARXIGA may require
monitoring and temporary discontinuation in situations known to
predispose to ketoacidosis
- Acute Kidney Injury and Impairment
in Renal Function: FARXIGA causes intravascular volume
contraction and renal impairment, with reports of acute kidney
injury requiring hospitalization and dialysis. Consider temporarily
discontinuing in settings of reduced oral intake or fluid losses.
If acute kidney injury occurs, discontinue and promptly treat.
FARXIGA increases serum creatinine and decreases eGFR. Elderly
patients and patients with impaired renal function may be more
susceptible to these changes. Before initiating FARXIGA, evaluate
renal function and monitor periodically. FARXIGA is not recommended
in patients with an eGFR persistently between 30 and <60
mL/min/1.73 m2
- Urosepsis and Pyelonephritis:
SGLT2 inhibitors increase the risk for urinary tract infections
[UTIs] and serious UTIs have been reported with FARXIGA. Evaluate
for signs and symptoms of UTIs and treat promptly
- Hypoglycemia: FARXIGA can
increase the risk of hypoglycemia when coadministered with insulin
and insulin secretagogues. Consider lowering the dose of these
agents when coadministered with FARXIGA
- Genital Mycotic Infections:
FARXIGA increases the risk of genital mycotic infections,
particularly in patients with prior genital mycotic infections.
Monitor and treat appropriately
- Increases in Low-Density Lipoprotein
Cholesterol (LDL-C) occur with FARXIGA. Monitor LDL-C and treat
per standard of care
- Bladder cancer: An imbalance in
bladder cancers was observed in clinical trials. There were too few
cases to determine whether the emergence of these events is related
to FARXIGA, and insufficient data to determine whether FARXIGA has
an effect on pre- existing bladder tumors. FARXIGA should not be
used in patients with active bladder cancer. Use with caution in
patients with a history of bladder cancer
- Macrovascular Outcomes: There
have been no clinical studies establishing conclusive evidence of
macrovascular risk reduction with FARXIGA
Adverse Reactions
In a pool of 12 placebo-controlled studies, the most common
adverse reactions (≥5%) associated with FARXIGA 5 mg, 10 mg, and
placebo respectively were female genital mycotic infections (8.4%
vs 6.9% vs 1.5%), nasopharyngitis (6.6% vs 6.3% vs 6.2%), and
urinary tract infections (5.7% vs 4.3% vs 3.7%).
Use in Specific Populations
- Pregnant Women: There are no
adequate and well-controlled studies of FARXIGA in pregnant women.
Consider appropriate alternative therapies, especially during the
second and third trimesters. Use during pregnancy only if the
potential benefit justifies the potential risk to the fetus
- Nursing Mothers: Discontinue
FARXIGA or discontinue nursing
Please click here for US Full Prescribing
Information and Medication Guide for FARXIGA.
NOTES TO EDITORS
About QTERN
QTERN combines two anti-hyperglycemic agents with complementary
mechanisms of action in a once-daily tablet: Dapagliflozin, a
sodium-glucose cotransporter 2 (SGLT-2) inhibitor; and saxagliptin,
a dipeptidyl peptidase-4 (DPP-4) inhibitor. The FDA approved QTERN
based on data from a 24-week, Phase III, multi-center, randomized,
double-blind, placebo-controlled trial (n=315) designed to evaluate
the efficacy and safety of saxagliptin added to dapagliflozin in
adult patients with type-2 diabetes who experienced inadequate
glycemic control (HbA1c ≥7% to ≤10.5%) with metformin (≥1,500 mg
per day). The safety of combined use of dapagliflozin and
saxagliptin has been evaluated in a pooled safety analysis
(N=1,169; 492 treated with QTERN) of three Phase III
placebo-controlled clinical trials for up to 52 weeks.
About AstraZeneca in Diabetes
AstraZeneca is pushing the boundaries of science with the goal
of developing life-changing medicines that aim to reduce the global
burden and complications of diabetes. As a core therapy area for
the company, we are focusing our research and development efforts
on diverse populations and patients with significant
co-morbidities, such as cardiovascular disease, obesity,
non-alcoholic steatohepatitis (NASH), and chronic kidney
disease.
Our commitment to diabetes is exemplified by the depth and
breadth of our global clinical research program. This commitment is
advancing understanding of the treatment effects of our diabetes
medicines in broad patient populations, as well as exploring
combination product approaches to help more patients achieve
treatment success earlier in their disease progression. Our
ambition is to reduce the long-term impact of diabetes.
About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company
that focuses on the discovery, development and commercialization of
prescription medicines, primarily for the treatment of diseases in
three main therapy areas - Oncology, Cardiovascular & Metabolic
Diseases and Respiratory. The Company also is selectively active in
the areas of autoimmunity, neuroscience and infection. AstraZeneca
operates in over 100 countries and its innovative medicines are
used by millions of patients worldwide. For more information,
please visit www.astrazeneca-us.com and follow us on Twitter
@AstraZenecaUS.
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