POMALID 3

Country: Indonesia

Language: Indonesian

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

Units in package:

DUS, 3 BLISTER @ 7 KAPSUL

Authorization date:

2022-07-08

Summary of Product characteristics

POMALID
POMALIDOMIDE
Capsules 1 mg
Capsules 2 mg
Capsules 3 mg
Capsules 4 mg
1.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pomalid 1 mg capsules
: Each capsule contains 1 mg of pomalidomide.
Pomalid 2 mg capsules
: Each capsule contains 2 mg of pomalidomide.
Pomalid 3 mg capsules
: Each capsule contains 3 mg of pomalidomide.
Pomalid 4 mg capsules
: Each capsule contains 4 mg of pomalidomide.
2.
PHARMACEUTICAL FORM
Pomalid 1 mg capsules
Hard gelatin capsule, with a yellow body and red cap, with “PLM 1”
printed axial rectified in white in the
body. Capsule size 4.
Pomalid 2 mg capsules
Hard gelatin capsule, with an orange body and red cap, with “PLM
2” printed axial rectified in white in
the body. Capsule size 2.
Pomalid 3 mg capsules
Hard gelatin capsule, with a turquoise body and red cap, with “PLM
3” printed axial rectified in white in
the body. Capsule size 2.
Pomalid 4 mg capsules
Hard gelatin capsule, with a dark blue body and red cap, with “PLM
4” printed axial rectified in white in
the body. Capsule size 2.
3.
THERAPEUTIC INDICATIONS
Pomalid in combination with bortezomib and dexamethasone is indicated
in the treatment of adult
patients with multiple myeloma who have received at least one prior
treatment regimen including
lenalidomide.
Pomalid in combination with dexamethasone is indicated in the
treatment of adult patients with relapsed
and refractory multiple myeloma who have received at least two prior
treatment regimens, including both
lenalidomide and bortezomib, and have demonstrated disease progression
on the last therapy.
DISETUJUI OLEH BPOM: 21/06/2022
ID: EREG10019112100009; EREG10019112100067;
EREG10019112100068; EREG10019112100069
4. POSOLOGY AND METHOD OF ADMINISTRATION
Treatment must be initiated and monitored under the supervision of
physicians experienced in the
management of multiple myeloma.
Dosing is continued or modified based upon clinical and laboratory
findings (see section 6).
POSOLOGY
•
_POMALIDOMIDE IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE _
The recommended