IMBRUVICA

国: インドネシア

言語: インドネシア語

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

から入手可能:

SOHO INDUSTRI PHARMASI - Indonesia

投薬量:

140 MG

医薬品形態:

KAPSUL

パッケージ内のユニット:

DUS, 1 BOTOL PLASTIK @ 90 KAPSUL

製:

CATALENT PHARM SOLUTION - USA

承認日:

2019-01-21

製品の特徴

PI IMBRUVICA
1
IMBRUVICA

Ibrutinib capsules
Ibrutinib tablets
DOSAGE FORMS AND STRENGTHS
CAPSULES
140mg capsules
IMBRUVICA capsules contain 140 mg of ibrutinib.
White opaque, size 0, hard gelatin capsule marked with “ibr 140
mg” in black ink.
FILM-COATED TABLETS
_140MG TABLETS _
IMBRUVICA tablets contain 140 mg of ibrutinib.
Yellow-green to green round film-coated tablet debossed with “ibr”
on one side and “140” on the other.
For excipients, see _List of Excipients_.
CLINICAL INFORMATION
INDICATIONS
MANTLE CELL LYMPHOMA (MCL)
Indicated for the treatment of adult patients with relapsed or
refractory MCL.
CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)
IMBRUVICA as a single agent or in combination with rituximab or
obinutuzumab is indicated for the treatment of adult
patients with previously untreated chronic lymphocytic leukemia (CLL)
(see _Pharmacodynamic properties_).
IMBRUVICA as a single agent is indicated for the treatment of adult
patients with CLL who have received at least one prior
therapy.
CHRONIC LYMPHOCYTIC LEUKEMIA WITH DELETION 17P
Indicated for the treatment of patients with CLL with deletion 17p.
WALDENSTRÖM’S MACROGLOBULINEMIA (WM)
IMBRUVICA as a single agent is indicated for the treatment of adult
patients with Waldenström’s macroglobulinaemia
(WM) who have received at least one prior therapy. IMBRUVICA in
combination with rituximab is indicated for the
treatment of adult patients with WM.
DOSAGE AND ADMINISTRATION
DOSAGE
IMBRUVICA
should be administered orally once daily with a glass of water at
approximately the same time each day. The
capsules or tablets should be swallowed whole with water. Do not open,
break, or chew the capsules. Do not break or
chew the tablets. IMBRUVICA must not be taken with grapefruit juice.
IMBRUVICA should continue until disease
progression or no longer tolerated by the patient.
_MANTLE CELL LYMPHOMA _
The recommended dose of IMBRUVICA for MCL is 560 mg once daily until
disease progression or no longer tolerated by
the patient.
_CHRONIC LYMPHOCYTIC LEUKEMIA