QTERN- dapagliflozin and saxagliptin tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DAPAGLIFLOZIN (UNII: 1ULL0QJ8UC) (DAPAGLIFLOZIN - UNII:1ULL0QJ8UC), SAXAGLIPTIN HYDROCHLORIDE (UNII: Z8J84YIX6L) (SAXAGLIPTIN ANHYDROUS - UNII:8I7IO46IVQ)

Available from:

AstraZeneca Pharmaceuticals LP

INN (International Name):

DAPAGLIFLOZIN

Composition:

DAPAGLIFLOZIN 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

QTERN is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use QTERN is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see WARNINGS AND PRECAUTIONS (5.1) ] . QTERN is contraindicated in patients with: Risk Summary Based on animal data showing adverse renal effects from dapagliflozin, QTERN is not recommended during the second and third trimesters of pregnancy. The limited available data with QTERN or its components (dapagliflozin and saxagliptin) in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see Clinical Considerations) . In animal studies, adverse renal pelvic and tubular dilatations, that were not fully reversible, were observed in rats when dapagliflozin (a component of QTERN) was administered during a period of renal

Product summary:

How Supplied QTERN® (dapagliflozin and saxagliptin) tablets are available in packages as listed: Tablet Strength Film‑Coated Tablet Color / Shape Tablet Markings Pack Size NDC Code 5 mg dapagliflozin /5 mg saxagliptin Light purple to reddish purple, biconvex, round “1120” printed on both sides, in blue ink Bottles of 30 Bottles of 90 Bottles of 500 0310-6770-30 0310-6770-90 0310-6770-50 10 mg dapagliflozin /5 mg saxagliptin Light brown to brown, biconvex, round “1122” printed on both sides, in blue ink Bottles of 30 Bottles of 90 Bottles of 500 0310‑6780‑30 0310‑6780‑90 0310‑6780‑50 Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].

Authorization status:

New Drug Application

Patient Information leaflet

AstraZeneca Pharmaceuticals LP
----------
MEDICATION GUIDE
QTERN® [CUE-turn]
(dapagliflozin and saxagliptin)
tablets, for oral use
What is the most important information I should know about QTERN?
Serious side effects can happen to people taking QTERN, including:
•
• Diabetic Ketoacidosis (increased ketones in your blood or urine)
in people with type 1 diabetes
and other ketoacidosis. QTERN can cause ketoacidosis that can be
life-threatening and may lead to
death. Ketoacidosis is a serious condition which needs to be treated
in a hospital. People with type
1 diabetes have a high risk of getting ketoacidosis. People with type
2 diabetes or pancreas
problems also have an increased risk of getting ketoacidosis.
Ketoacidosis can also happen in
people who are sick, cannot eat or drink as usual, skip meals, are on
a diet high in fat and low in
carbohydrates (ketogenic diet), take less than the usual amount of
insulin or miss insulin doses,
drink too much alcohol, have a loss of too much fluid from the body
(volume depletion), or who
have surgery. Ketoacidosis can happen even if your blood sugar is less
than 250 mg/dL. Your
healthcare provider may ask you to periodically check ketones in your
urine or blood.
Stop taking QTERN and call your healthcare provider or get medical
help right away if you get any
of the following. If possible, check for ketones in your urine or
blood, even if your blood sugar is
less than 250 mg/dL.
∘
nausea
∘
vomiting
∘
stomach area (abdominal) pain
∘
tiredness
∘
trouble breathing
∘
ketones in your urine or blood
•
Inflammation of the pancreas (pancreatitis). Saxagliptin, one of the
medicines in QTERN, can
cause inflammation of the pancreas, which may be severe and lead to
death. Certain medical
problems make you more likely to get pancreatitis.
Before you start taking QTERN, tell your healthcare provider if you
have ever had:
∘
inflammation of your pancreas (pancreatitis)
∘
stones in your gallbladder (gallstones)
∘
a history of alcoholism
∘
high blood triglyceride le

Summary of Product characteristics

QTERN- DAPAGLIFLOZIN AND SAXAGLIPTIN TABLET, FILM COATED
ASTRAZENECA PHARMACEUTICALS LP
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
QTERN SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR QTERN.
QTERN® (DAPAGLIFLOZIN AND SAXAGLIPTIN) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2017
RECENT MAJOR CHANGES
Indications and Usage (1) 09/2023
Dosage and Administration (2.5) 09/2023
Warnings and Precautions (5.1) 09/2023
INDICATIONS AND USAGE
QTERN is a combination of dapagliflozin, a sodium-glucose
cotransporter 2 (SGLT2) inhibitor and saxagliptin, a dipeptidyl
peptidase-4
(DPP-4) inhibitor indicated as an adjunct to diet and exercise to
improve glycemic control in adults with type 2 diabetes mellitus. (1)
Limitations of Use:
Not recommended for use to improve glycemic control in patients with
type 1 diabetes mellitus. (1)
DOSAGE AND ADMINISTRATION
•
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Tablets:
•
•
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
•
•
•
•
•
ADVERSE REACTIONS
Assess renal function before initiation of therapy and periodically
thereafter. (2.1)
Take orally, once daily in the morning with or without food. (2.2)
For patients not already taking dapagliflozin, the recommended
starting dose of QTERN is a 5 mg dapagliflozin/5 mg saxagliptin
tablet once daily. (2.2)
In patients tolerating 5 mg dapagliflozin and 5 mg saxagliptin once
daily who require additional glycemic control, the QTERN dose
can be increased to 10 mg dapagliflozin/5 mg saxagliptin tablet once
daily. (2.2)
Swallow tablet whole. Do not crush, cut or chew. (2.2)
Withhold QTERN for at least 3 days, if possible, prior to major
surgery or procedures associated with prolonged fasting. (2.5)
5 mg dapagliflozin/5 mg saxagliptin (3)
10 mg dapagliflozin/5 mg saxagliptin (3)
History of a serious hypersensitivity reaction to dapagliflozin or to
saxagliptin. (4)
Moderate to severe renal impairment (eGFR <45 mL/min/1.73 m ),