SEGLUROMET- ertugliflozin and metformin hydrochloride tablet, film coated

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

ERTUGLIFLOZIN PIDOLATE (UNII: MLU731K321) (ERTUGLIFLOZIN - UNII:6C282481IP), METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)

Disponible des:

Merck Sharp & Dohme LLC

Designació comuna internacional (DCI):

ERTUGLIFLOZIN PIDOLATE

Composición:

ERTUGLIFLOZIN 2.5 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

SEGLUROMET® 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 (5.2)]. - Hypersensitivity to ertugliflozin, metformin, or any excipient in SEGLUROMET, reactions such as angioedema or anaphylaxis have occurred [see Adverse Reactions (6.2)]. - Patients with severe renal impairment (eGFR less than 30 mL/min/1.73 m2 ), end stage-renal disease (ESRD), or on dialysis [see Use in Specific Populations (8.6)] . - Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Risk Summary Based on animal data showing adverse renal effects, from ertugliflozin, SEGLUROMET is not recommended during the second and third trimesters of pregnancy. Published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage r

Resumen del producto:

SEGLUROMET (ertugliflozin and metformin hydrochloride) 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.

Estat d'Autorització:

New Drug Application

Informació per a l'usuari

Merck Sharp & Dohme LLC
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MEDICATION GUIDE
SEGLUROMET® [SEG-LUR-OH-MET]
(ERTUGLIFLOZIN AND METFORMIN HYDROCHLORIDE)
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
SEGLUROMET 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 SEGLUROMET?
SEGLUROMET may cause serious side effects, including:
Lactic Acidosis. Metformin, one of the medicines in SEGLUROMET, can
cause a rare but serious
condition called lactic acidosis (a buildup of an acid in the blood)
that can cause death. Lactic acidosis is
a medical emergency and must be treated in the hospital.
Call your healthcare provider right away if you have any of the
following symptoms, which could be
signs of lactic acidosis:
•
you feel cold in your hands or feet
•
you feel very weak or tired
•
you have trouble breathing
•
you have stomach pains, nausea or vomiting
•
you have a slow or
irregular heartbeat
•
you have unusual (not
normal) muscle pain
•
you have unusual
sleepiness or sleep longer
than usual
•
you feel dizzy or
lightheaded
Most people who have had lactic acidosis had other conditions that, in
combination with metformin use,
led to the lactic acidosis. Tell your healthcare provider if you have
any of the following, because you
have a higher chance for getting lactic acidosis with SEGLUROMET if
you:
•
have severe kidney problems or your kidneys are affected by certain
x-ray tests that use injectable
dye.
•
have liver problems.
•
drink alcohol very often or drink a lot of alcohol in the short term
("binge") drinking.
•
get dehydrated (lose a large amount of body fluids). This can happen
if you are sick with a fever,
vomiting, or diarrhea. Dehydration can also happen when you sweat a
lot with activity

Fitxa tècnica

SEGLUROMET- ERTUGLIFLOZIN AND METFORMIN HYDROCHLORIDE TABLET, FILM
COATED
MERCK SHARP & DOHME LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SEGLUROMET SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SEGLUROMET.
SEGLUROMET (ERTUGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLETS, FOR
ORAL USE
INITIAL U.S. APPROVAL: 2017
WARNING: LACTIC ACIDOSIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
POSTMARKETING CASES OF METFORMIN-ASSOCIATED LACTIC ACIDOSIS HAVE
RESULTED IN DEATH,
HYPOTHERMIA, HYPOTENSION, AND RESISTANT BRADYARRHYTHMIAS. SYMPTOMS
INCLUDED
MALAISE, MYALGIAS, RESPIRATORY DISTRESS, SOMNOLENCE, AND ABDOMINAL
PAIN.
LABORATORY ABNORMALITIES INCLUDED ELEVATED BLOOD LACTATE LEVELS, ANION
GAP ACIDOSIS,
INCREASED LACTATE/PYRUVATE RATIO, AND METFORMIN PLASMA LEVELS
GENERALLY >5 MCG/ML.
(5.1)
RISK FACTORS INCLUDE RENAL IMPAIRMENT, CONCOMITANT USE OF CERTAIN
DRUGS, AGE ≥65
YEARS OLD, RADIOLOGICAL STUDIES WITH CONTRAST, SURGERY AND OTHER
PROCEDURES, HYPOXIC
STATES, EXCESSIVE ALCOHOL INTAKE, AND HEPATIC IMPAIRMENT. STEPS TO
REDUCE THE RISK
OF AND MANAGE METFORMIN-ASSOCIATED LACTIC ACIDOSIS IN THESE HIGH RISK
GROUPS ARE
PROVIDED IN THE FULL PRESCRIBING INFORMATION. (5.1)
IF LACTIC ACIDOSIS IS SUSPECTED, DISCONTINUE SEGLUROMET AND INSTITUTE
GENERAL
SUPPORTIVE MEASURES IN A HOSPITAL SETTING. PROMPT HEMODIALYSIS IS
RECOMMENDED.
(5.1)
RECENT MAJOR CHANGES
Indications and Usage (1)
Dosage and Administration (2.1, 2.4)
Warnings and Precautions (5.2)
09/2023
09/2023
09/2023
INDICATIONS AND USAGE
SEGLUROMET is a combination of ertugliflozin, a sodium glucose
co-transporter 2 (SGLT2) inhibitor, and
metformin, a biguanide, 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 prior to initiation and as clin