TREMFYA

国家: 印度尼西亚

语言: 印度尼西亚文

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

有效成分:

GUSELKUMAB

可用日期:

SOHO INDUSTRI PHARMASI - Indonesia

INN（国际名称）:

GUSELKUMAB

剂量:

100 MG

药物剂型:

INJEKSI

每包单位数:

DUS, 1 PREFILLED SYRINGE @ 1ML

厂商:

CILAG AG SWITZERLAND - Switzerland

授权日期:

2019-10-17

产品特点

PI TREMFYA (guselkumab) (CCDS 20Dec18 v.07 + TD BPOM 31Dec18, 6May19)
1
TREMFYA®
Guselkumab.
DOSAGE FORMS AND STRENGTHS
TREMFYA is available as a solution for injection in the following
presentation:
PRE-FILLED SYRINGE
Each 100 mg Prefilled syringe contains 100 mg of guselkumab per 1 mL
For excipients, see _List of Excipients_ (Pharmaceutical Information).
DESCRIPTION
Guselkumab is a fully human immunoglobulin G1 lambda (IgG1λ)
monoclonal antibody (mAb) that binds
selectively to the extracellular human interleukin 23 (IL-23) protein
with high specificity and affinity. Guselkumab
is produced in a mammalian cell line using recombinant DNA technology.
CLINICAL INFORMATION
INDICATIONS
PLAQUE PSORIASIS
_ADULTS _
TREMFYA by subcutaneous (SC) administration is indicated for the
treatment of adults patients with moderate
to severe plaque psoriasis who are candidates for phototherapy or
systemic therapy.
DOSAGE AND ADMINISTRATION
DOSAGE – ADULTS (18 YEARS AND OLDER)
TREMFYA is administered by subcutaneous injection.
_PLAQUE PSORIASIS_
The recommended dose of TREMFYA is 100 mg to be given as subcutaneous
injection at week 0, week 4 and
every 8 weeks thereafter.
GENERAL CONSIDERATIONS FOR ADMINISTRATION
TREMFYA is intended for use under the guidance and supervision of a
physician. TREMFYA may be administered
by a health care professional, or a patient may self-inject after
proper training in subcutaneous injection
technique.
Comprehensive instructions for the administration of TREMFYA are given
in “Instructions for use, handling, and
disposal” and in the package leaflet, “Instructions for
preparation and giving an injection of TREMFYA.” Full
amount of TREMFYA should be injected according to the directions
provided in the patient information leaflet.
SWITCHING FROM OTHER BIOLOGICS TO TREMFYA
TREMFYA has been shown to be safe and effective in patients with an
inadequate response to ustekinumab or
adalimumab therapy (see _Clinical studies_). When switching to
treatment with TREMFYA, administer TREMFYA at
week 0, we