TREZILENT

Država: Indonezija

Jezik: indonezijski

Izvor: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Jedinice u paketu:

DUS (DOSIS HARIAN 200 MG), 1 AMPLOP @ 2 BLISTER @ 7 TABLET SALUT ...

Datum autorizacije:

2022-12-31

Svojstava lijeka

TREZILENT™ (alpelisib)
50 mg, 150 mg and 200 mg Film-coated tablets
LEAFLET
DISETUJUI OLEH BPOM: 19/12/2022
EREG10000512000255
EREG10000512000256
EREG10000512000257
SERIOUS WARNINGS AND PRECAUTIONS
Treatment of Trezilent should be initiated by the physician
experienced in the use of anti-
cancer agents.
The following serious adverse reactions were reported in patients
treated with Trezilent.
•
Hypersensitivity, including anaphylactic reactions (see section 6
Warnings and
precautions)
•
Severe cutaneous reactions including Stevens-Johnson Syndrome, Drug
Reaction
with Eosinophilia and Systemic Symptoms and Erythema Multiforme (see
section 6
Warnings and precautions)
•
Hyperglycemia, including hyperglycaemic hyperosmolar non-ketocic
syndrome and
some fatal cases of diabetic ketoacidosis (see section 6 Warnings and
precautions)
•
Pneumonitis (see section 6 Warnings and precautions)
1
TRADENAME
TREZILENT

50 mg film-coated tablets
TREZILENT

150 mg film-coated tablets
TREZILENT

200 mg film-coated tablets
1
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM
FILM-COATED TABLETS
•
50 mg: Light pink, unscored, round and curved with beveled edges,
imprinted with “L7” on
one side and “NVR” on the other side.
•
150 mg: Pale red, unscored, ovaloid and curved with beveled edges,
imprinted with “UL7”
on one side and “NVR” on the other side.
•
200 mg: Light red, unscored, ovaloid and curved with beveled edges,
imprinted with “YL7”
on one side and “NVR” on the other side.
ACTIVE SUBSTANCE
Film-coated tablets containing alpelisib
EXCIPIENTS
Film-coated
tablet
core:
Microcrystalline
cellulose,
mannitol,
sodium
starch
glycolate,
hypromellose and magnesium stearate.
DISETUJUI OLEH BPOM: 19/12/2022
EREG10000512000255
EREG10000512000256
EREG10000512000257
Coating material: Hypromellose, titanium dioxide, macrogol /
polyethylene glycol (PEG), talc,
iron oxide red, and iron oxide black.
Information might differ in some countries.
2
INDICATIONS
Trezilent
is
an
alpha-specific
class
I
phosphati