BESPONSA POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 1MGVIAL

País: Singapur

Idioma: anglès

Font: HSA (Health Sciences Authority)

ingredients actius:

Inotuzumab Ozogamicin

Disponible des:

PFIZER PRIVATE LIMITED

Codi ATC:

L01XC26

formulario farmacéutico:

POWDER, FOR SOLUTION

Composición:

Inotuzumab Ozogamicin 1mg/vial

Vía de administración:

INTRAVENOUS

tipo de receta:

Prescription Only

Fabricat per:

Wyeth Pharmaceutical Division of Wyeth Holding LLC

Estat d'Autorització:

ACTIVE

Data d'autorització:

2019-07-17

Fitxa tècnica

1.
NAME OF THE MEDICINAL PRODUCT
BESPONSA
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 1 mg inotuzumab ozogamicin.
After reconstitution (see Section 6.6), 1 mL of solution contains 0.25
mg inotuzumab
ozogamicin.
For the full list of excipients, see Section 6.1.
Chemical structure:
Inotuzumab ozogamicin is a CD22-directed antibody-drug conjugate (ADC)
consisting of
3 components: 1) the recombinant humanized immunoglobulin class G
subtype 4 (IgG4)
kappa antibody inotuzumab, specific for human CD22, 2)
N-acetyl-gamma-calicheamicin
that causes double-stranded DNA breaks, and 3) an acid-cleavable
linker composed of the
condensation product of 4-(4’-acetylphenoxy)-butanoic acid (AcBut)
and
3-methyl-3-mercaptobutane hydrazide (known as dimethylhydrazide) that
covalently attaches
N-acetyl-gamma-calicheamicin to inotuzumab.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
White to off-white, lyophilized cake or powder.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Inotuzumab ozogamicin is indicated for the treatment of adults with
relapsed or refractory
B-cell precursor acute lymphoblastic leukemia (ALL).
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
For patients with circulating lymphoblasts, cytoreduction with a
combination of hydroxyurea,
steroids, and/or vincristine to a peripheral blast count ≤10,000/mm
3
is recommended prior to
the first dose.
Premedication with a corticosteroid, antipyretic, and antihistamine is
recommended prior to
dosing (see Section 4.4).
Patients should be observed during and for at least 1 hour after the
end of the infusion for
symptoms of infusion related reactions (see Section 4.4).
Posology
Administer inotuzumab ozogamicin in 3- to 4-week cycles.
For patients proceeding to a hematopoietic stem cell transplant
(HSCT), the recommended
duration of treatment with inotuzumab ozogamicin is 2 cycles. A third
cycle should be
considered for those patients who do not achieve a complete remission
(CR) or a complete
remission with incomplete hematologic