NINLARO CAPSULE 4mg

Χώρα: Σιγκαπούρη

Γλώσσα: Αγγλικά

Πηγή: HSA (Health Sciences Authority)

Δραστική ουσία:

Ixazomib citrate 5.7mg eqv ixazomib

Διαθέσιμο από:

TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.

Φαρμακολογική κατηγορία (ATC):

L01XX50

Φαρμακοτεχνική μορφή:

CAPSULE

Σύνθεση:

Ixazomib citrate 5.7mg eqv ixazomib 4mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

Prescription Only

Κατασκευάζεται από:

HAUPT PHARMA AMAREG GMBH

Καθεστώς αδειοδότησης:

ACTIVE

Ημερομηνία της άδειας:

2017-01-20

Αρχείο Π.Χ.Π.

1.
NAME OF THE MEDICINAL PRODUCT
NINLARO
®
ixazomib (as ixazomib citrate)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each NINLARO
®
capsule contains 5.7 mg, 4.3 mg, or 3.3 mg of ixazomib citrate which
is equivalent to 4
mg, 3 mg, or 2.3 mg, respectively, of ixazomib.
DRUG SUBSTANCE
Proper name:
Ixazomib citrate
Chemical name:
1,3,2-dioxaborolane-4,4-diacetic
acid,
2-[(1
_R_
)-1-[[2-[(2,5-
dichlorobenzoyl)amino]acetyl]amino]-3-methylbutyl]-5-oxo-
Molecular formula and molecular mass:
C
20
H
23
BCl
2
N
2
O
9
517.12
Structural formula:
Physicochemical properties: Ixazomib citrate has one chiral center and
has been unambiguously
determined to be the R-stereoisomer. The solubility of ixazomib
citrate in 0.1N HCl (pH 1.2) at 37°C is 0.61 mg/mL (reported as
ixazomib). The solubility increases as the pH increases.
For excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
NINLARO
®
is supplied as capsules as follows:
4 mg: Light orange, marked “Takeda” on the cap and “4 mg” on
the body with black ink
3 mg: Light grey, marked “Takeda” on the cap and “3 mg” on the
body with black ink
2.3 mg: Light pink, marked “Takeda” on the cap and “2.3 mg” on
the body with black ink
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
NINLARO
®
[ixazomib (as ixazomib citrate)] in combination with lenalidomide and
dexamethasone is
indicated for the treatment of adult patients with multiple myeloma
who have received at least one prior
therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
RECOMMENDED DOSE
AND DOSAGE ADJUSTMENT
_NINLARO_
®
_ in combination with lenalidomide and dexamethasone _
The recommended starting dose of NINLARO
®
is 4 mg (one capsule) administered orally once a week on
Days 1, 8, and 15 of a 28-day treatment cycle.
_ _
The recommended starting dose of lenalidomide is 25 mg administered
daily on Days 1 through 21 of a 28-
day treatment cycle.
The recommended starting dose of dexamethasone is 40 mg administered
on Days 1, 8, 15, and 22 of a 28-
day treatment cycle.
_ _
TABLE 1 DOSING SCHEDULE: N