STEGLATRO FILM-COATED TABLETS 15MG

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Ertugliflozin L-PGA eqv to Ertugliflozin

Available from:

MSD PHARMA (SINGAPORE) PTE. LTD.

ATC code:

A10BK04

Pharmaceutical form:

TABLET, FILM COATED

Composition:

Ertugliflozin L-PGA eqv to Ertugliflozin 15mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Pfizer Manufacturing Deutschland GmbH

Authorization status:

ACTIVE

Authorization date:

2020-03-11

Summary of Product characteristics

CCDS-MK8835-T-032018
STEGLATRO® Film-coated Tablets 5 mg
STEGLATRO® Film-coated Tablets 15 mg
1.
INDICATIONS AND USAGE
STEGLATRO (ertugliflozin) is indicated as an adjunct to diet and
exercise to improve glycemic control
in adults with type 2 diabetes mellitus
[see 10. CLINICAL STUDIES]
.
2.
DOSAGE AND ADMINISTRATION
2.1
General
The recommended starting dose of STEGLATRO is 5 mg once daily, taken
in the morning, with or
without food. In patients tolerating STEGLATRO 5 mg once daily, the
dose may be increased to
15 mg once daily if additional glycemic control is needed.
In patients with volume depletion, correcting this condition prior to
initiation of STEGLATRO is
recommended
[see 5. WARNINGS AND PRECAUTIONS (5.1)]
.
2.2
Renal Impairment
Assessment of renal function is recommended prior to initiation of
STEGLATRO and periodically
thereafter
[see 5. WARNINGS AND PRECAUTIONS (5.3)]
.
STEGLATRO should not be initiated in patients with an estimated
glomerular filtration rate (eGFR)
less
than
60 mL/min/1.73 m
2
[see
5.
WARNINGS
AND
PRECAUTIONS
(5.3)
and
7.
USE
IN
SPECIFIC POPULATIONS (7.5)]
.
Use of STEGLATRO should be discontinued in patients with an eGFR
persistently between 45 to
<60 mL/min/1.73 m
2
or if eGFR falls below 45 mL/min/1.73 m
2
.
3.
INSTRUCTIONS FOR USE
Not applicable.
4.
CONTRAINDICATIONS
History of a serious hypersensitivity reaction to STEGLATRO.
5.
WARNINGS AND PRECAUTIONS
General
STEGLATRO is not recommended in patients with type 1 diabetes mellitus
or for the treatment of
diabetic ketoacidosis.
5.1
Hypotension
STEGLATRO causes an osmotic diuresis, which may lead to intravascular
volume contraction.
Therefore, symptomatic hypotension may occur after initiating
STEGLATRO
[see 8. ADVERSE
REACTIONS
(8.1)]
,
particularly
in
patients
with
impaired
renal
function
(eGFR
less
than
60 mL/min/1.73 m
2
),
elderly
patients
(≥ 65 years),
or
patients
on
diuretics.
Before
initiating
STEGLATRO, volume status should be assessed and corrected if
indicated. Monitor for signs and
symptoms after initiating therapy