KOSELUGO HARD CAPSULES 25MG

Nchi: Singapoo

Lugha: Kiingereza

Chanzo: HSA (Health Sciences Authority)

Viambatanisho vya kazi:

Selumetinib hyd-sulfate eqv Selumetinib

Inapatikana kutoka:

ASTRAZENECA SINGAPORE PTE LTD

ATC kanuni:

L01EE04

Dawa fomu:

CAPSULE

Tungo:

Selumetinib hyd-sulfate eqv Selumetinib 25mg

Njia ya uendeshaji:

ORAL

Dawa ya aina:

Prescription Only

Viwandani na:

Patheon Pharmaceuticals Inc.

Idhini hali ya:

ACTIVE

Idhini ya tarehe:

2021-07-09

Tabia za bidhaa

1
KOSELUGO
®
(SELUMETINIB)
1.
NAME OF THE MEDICINAL PRODUCT
KOSELUGO (selumetinib) 10 mg, hard capsules
KOSELUGO (selumetinib) 25 mg, hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 mg hard capsule contains 10 mg of selumetinib (as hydrogen
sulfate).
Each 25 mg hard capsule contains 25 mg of selumetinib (as hydrogen
sulfate).
For the full list of excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard.
KOSELUGO 10 mg hard capsule
White to off-white, opaque, size 4 hard capsule, banded and marked
with “SEL 10” in black
ink.
KOSELUGO 25 mg hard capsule
Blue, opaque, size 4 hard capsule, banded and marked with “SEL 25”
in black ink.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
KOSELUGO is indicated for the treatment of paediatric patients aged 3
years and above with
neurofibromatosis type 1 (NF1) who have symptomatic, inoperable
plexiform neurofibromas
(PN).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be initiated by a physician experienced in the
diagnosis and the treatment of
patients with NF1-related tumours.
POSOLOGY
The recommended dose of KOSELUGO is 25 mg/m
2
of body surface area (BSA), taken orally
twice daily (approximately every 12 hours).
Dosing is individualised based on BSA (mg/m
2
) and rounded to the nearest achievable 5 mg
or 10 mg dose (up to a maximum single dose of 50 mg). Different
strengths of KOSELUGO
capsules can be combined to attain the desired dose (Table 1).
TABLE 1
KOSELUGO RECOMMENDED DOSAGE BASED ON BODY SURFACE AREA
2
BODY SURFACE AREA (BSA)
A
RECOMMENDED DOSAGE
0.55 – 0.69 m
2
20 mg in the morning and 10 mg in the evening
0.70 – 0.89 m
2
20 mg twice daily
0.90 – 1.09 m
2
25 mg twice daily
1.10 – 1.29 m
2
30 mg twice daily
1.30 – 1.49 m
2
35 mg twice daily
1.50 – 1.69 m
2
40 mg twice daily
1.70 – 1.89 m
2
45 mg twice daily
≥1.90 m
2
50 mg twice daily
a
The recommended dosage for patients with a BSA less than 0.55 m
2
has not been established.
Treatment with KOSELUGO should continue as long as clinical benefit is
o