STEGLATRO- ertugliflozin tablet, film coated

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

ERTUGLIFLOZIN PIDOLATE (UNII: MLU731K321) (ERTUGLIFLOZIN - UNII:6C282481IP)

Fáanlegur frá:

Merck Sharp & Dohme LLC

INN (Alþjóðlegt nafn):

ERTUGLIFLOZIN PIDOLATE

Samsetning:

ERTUGLIFLOZIN 5 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

STEGLATRO® 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)] . - Hypersensitivity to ertugliflozin or any excipient in STEGLATRO, reactions such as angioedema have occurred [see Adverse Reactions (6.2)]. Risk Summary Based on animal data showing adverse renal effects, STEGLATRO is not recommended during the second and third trimesters of pregnancy. The limited available data with STEGLATRO in pregnant women are not sufficient to determine a drug-associated risk of adverse developmental outcomes. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see Clinical Considerations) . In animal studies, adverse renal changes were observed in rats when ertugliflozin was administered during a period of renal development corresponding to the late second and t

Vörulýsing:

STEGLATRO (ertugliflozin) tablets are available as follows: 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.

Leyfisstaða:

New Drug Application

Upplýsingar fylgiseðill

Merck Sharp & Dohme LLC
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MEDICATION GUIDE
STEGLATRO® [STEH-GLA-TROH]
(ERTUGLIFLOZIN)
TABLETS, FOR ORAL USE
This Medication Guide has been approved by the U.S. Food and Drug
Administration.
Revised: 09/2023
Read this Medication Guide carefully before you start taking STEGLATRO
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 STEGLATRO?
STEGLATRO may cause
serious side effects, including:
•
Diabetic ketoacidosis (increased ketones in your blood or urine) in
people with type 1 diabetes
and other ketoacidosis. STEGLATRO 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 STEGLATRO 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
•
Amputations. STEGLATRO may increase your risk of lower limb
amputations.
You may be at a higher risk of lower limb amputation

Vara einkenni

STEGLATRO- ERTUGLIFLOZIN TABLET, FILM COATED
MERCK SHARP & DOHME LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
STEGLATRO SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR STEGLATRO.
STEGLATRO (ERTUGLIFLOZIN) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2017
RECENT MAJOR CHANGES
Indications and Usage (1)
09/2023
Dosage and Administration (2.1, 2.2, 2.3)
09/2023
Contraindications (4)
09/2023
Warnings and Precautions (5.1)
09/2023
INDICATIONS AND USAGE
STEGLATRO is a sodium glucose co-transporter 2 (SGLT2) 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
Assess renal function before initiating and as clinically indicated.
(2.1)
Correct volume depletion before initiating STEGLATRO. (2.1)
Recommended starting dose is 5 mg once daily, taken in the morning,
with or without food. (2.2)
Increase dose to 15 mg once daily in those tolerating STEGLATRO 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 STEGLATRO for at least 4 days, if possible, prior to major
surgery or procedures associated
with prolonged fasting. (2.3)
DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg and 15 mg (3)
CONTRAINDICATIONS
Hypersensitivity to ertugliflozin or any of the excipients in
STEGLATRO. (4)
WARNINGS AND PRECAUTIONS
_Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and
Other Ketoacidosis:_ Consider
ketone monitoring in patients at risk for ketoacidosis, as indicated.
Assess for ketoacidosis regardless
of presenting blood glucose levels and discontinue STEGLATRO if
ketoacidosis is suspected. Monitor
patients for resolution of ketoacidosis before restarting. (5.1)
_Lower Limb Amputation:_ Consider factors that may increase the risk
of amputation