BALVERSA FILM-COATED TABLETS 4MG

Country: Singapura

Bahasa: Inggeris

Sumber: HSA (Health Sciences Authority)

Bahan aktif:

Erdafitinib

Boleh didapati daripada:

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

Kod ATC:

Pending

Borang farmaseutikal:

TABLET, FILM COATED

Komposisi:

Erdafitinib 4.00 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

Prescription Only

Dikeluarkan oleh:

Janssen Cilag SpA

Status kebenaran:

ACTIVE

Tarikh kebenaran:

2020-08-07

Ciri produk

1
PRODUCT NAME
BALVERSA™ (erdafitinib) film-coated tablets.
DOSAGE FORMS AND STRENGTHS
BALVERSA™ is formulated as 3 mg, 4 mg, and 5 mg tablets for oral
use.
•
3 mg: Yellow, round biconvex shaped, film coated, debossed with
“3” on one side; and “EF”
on the other side.
•
4 mg: Orange, round biconvex shaped, film coated, debossed with
“4” on one side; and “EF”
on the other side.
•
5 mg: Brown, round biconvex shaped, film coated, debossed with “5”
on one side; and “EF”
on the other side.
For excipients, see
_List of Excipients_
.
CLINICAL INFORMATION
INDICATIONS
BALVERSA™
is
indicated
for
the
treatment
of
adult
patients
with
locally
advanced
or
metastatic urothelial carcinoma (UC), whose tumors have susceptible
fibroblast growth factor
receptor (FGFR) 3 genetic alterations, who have disease progression
during or following at least
one
line
of
prior
chemotherapy
including
within
12 months
of
neoadjuvant
or
adjuvant
chemotherapy (see
_Pharmacodynamic Effects - Clinical Studies_
).
DOSAGE AND ADMINISTRATION
DOSAGE – ADULTS (≥18 YEARS)
_RECOMMENDED DOSE_
_ _
_ _
The
recommended
starting
dose
of
BALVERSA™
is
8 mg
orally
once
daily;
with
pharmacodynamically
guided
up-titration,
based
on
serum
phosphate
concentrations
and
tolerability at 14 to 21 days, to 9 mg daily if criteria are met (see
_ Dosage and Administration - _
_Dose Modifications_
).
_ADMINISTRATION _
Before taking BALVERSA™, patients must have confirmation of
susceptible FGFR3 gene
alterations as confirmed by a validated test (see
_Pharmacodynamic Effects - Clinical studies_
).
The tablets should be swallowed whole with or without food. If
vomiting occurs any time after
taking BALVERSA™, the next dose should be taken the next day.
Treatment should continue until disease progression or unacceptable
toxicity occurs.
2
_MISSED DOSE _
If a dose of BALVERSA™ is missed, it can be taken as soon as
possible. Resume the regular
daily dose schedule for BALVERSA™ the next day. Extra tablets should
not be taken to make
up f