STEGLUJAN- ertugliflozin and sitagliptin tablet, film coated

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

ERTUGLIFLOZIN PIDOLATE (UNII: MLU731K321) (ERTUGLIFLOZIN - UNII:6C282481IP), SITAGLIPTIN PHOSPHATE (UNII: TS63EW8X6F) (SITAGLIPTIN - UNII:QFP0P1DV7Z)

Sẵn có từ:

Merck Sharp & Dohme LLC

INN (Tên quốc tế):

ERTUGLIFLOZIN PIDOLATE

Thành phần:

ERTUGLIFLOZIN 5 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

STEGLUJAN® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use - Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions (5.1)]. - Has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using STEGLUJAN [see Warnings and Precautions (5.2)] . - Patients with severe renal impairment (<30 mL/min/1.73 m2 ), end-stage renal disease (ESRD), or on dialysis [see Warnings and Precautions (5.4) and Use in Specific Populations (8.6)] . - Hypersensitivity to sitagliptin, ertugliflozin, or any excipient, in STEGLUJAN, reactions such as anaphylaxis or angioedema have occurred [see Warnings and Precautions (5.11) and Adverse Reactions (6.2)]. Risk Summary Based on animal data showing adverse renal effects, from ertugliflozin, STEGLUJAN is

Tóm tắt sản phẩm:

STEGLUJAN (ertugliflozin and sitagliptin) tablets are available in the strengths listed below: Store at 20°C-25°C (68°F-77°F), excursions permitted between 15°C-30°C (between 59°F-86°F) [see USP Controlled Room Temperature]. Protect from moisture. Store in a dry place.

Tình trạng ủy quyền:

New Drug Application

Tờ rơi thông tin

Merck Sharp & Dohme LLC
----------
This Medication Guide has been approved by the U.S. Food and Drug
Administration.
Revised: 10/2023
Medication Guide
STEGLUJAN® [STEG-loo-jan]
(ertugliflozin and sitagliptin)
tablets, for oral use
Read this Medication Guide carefully before you start taking STEGLUJAN
and each time you get a
refill. There may be new information. This information does not take
the place of talking with your
healthcare provider about your medical condition or your treatment.
What is the most important information I should know about STEGLUJAN?
STEGLUJAN may cause serious side effects, including:
•
Diabetic ketoacidosis (increased ketones in your blood or urine) in
people with type 1 diabetes
and other ketoacidosis. STEGLUJAN 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 STEGLUJAN 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) which may be severe and
lead to death. Certain
medical problems make

Đặc tính sản phẩm

STEGLUJAN- ERTUGLIFLOZIN AND SITAGLIPTIN TABLET, FILM COATED
MERCK SHARP & DOHME LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
STEGLUJAN SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR STEGLUJAN.
STEGLUJAN (ERTUGLIFLOZIN AND SITAGLIPTIN) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2017
RECENT MAJOR CHANGES
Indications and Usage (1)
09/2023
Dosage and Administration (2.1, 2.3)
09/2023
Warnings and Precautions (5.1)
09/2023
INDICATIONS AND USAGE
STEGLUJAN is a combination of ertugliflozin, a sodium glucose
co-transporter 2 (SGLT2) inhibitor, and
sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, is indicated
as an adjunct to diet and exercise to
improve glycemic control in adults with type 2 diabetes mellitus.
Limitations of Use:
Not recommended for use to improve glycemic control in patients with
type 1 diabetes mellitus. (1)
Has not been studied in patients with a history of pancreatitis. (1,
5.2)
DOSAGE AND ADMINISTRATION
Assess renal function before initiating and as clinically indicated.
(2.1)
Correct volume depletion before initiating. (2.1)
Recommended starting dose is 5 mg ertugliflozin/100 mg sitagliptin
once daily, taken in the morning,
with or without food. (2.2)
Increase dose to 15 mg ertugliflozin/100 mg sitagliptin once daily in
those tolerating STEGLUJAN and
needing additional glycemic control. (2.2)
Use is not recommended in patients with an eGFR less than 45
mL/min/1.73 m . (2.2)
Withhold STEGLUJAN for at least 4 days, if possible, prior to major
surgery or procedures associated
with prolonged fasting. (2.3)
DOSAGE FORMS AND STRENGTHS
Tablets:
Ertugliflozin 5 mg and sitagliptin 100 mg (3)
Ertugliflozin 15 mg and sitagliptin 100 mg (3)
CONTRAINDICATIONS
Severe renal impairment (<30 mL/min/1.73 m ), end-stage renal disease,
or dialysis. (4)
Hypersensitivity to sitagliptin, ertugliflozin, or any excipient in
STEGLUJAN. (4, 5.11, 6.2)
WARNINGS AND PRECAUTIONS
_Diabetic Ketoacidosis in Patients with Type 1 Diabe