TRUSELTIQ- infigratinib capsule

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

INFIGRATINIB (UNII: A4055ME1VK) (INFIGRATINIB - UNII:A4055ME1VK)

Հասանելի է:

QED Therapeutics, Inc.

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

TRUSELTIQ is indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test [see Dosage and Administration ( 2.1)] . This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies ( 14.1)] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). None. Risk Summary Based on findings in animal studies and its mechanism of action TRUSELTIQ can cause fetal harm or loss of pregnancy when administered to a pregnant woman [ see Clinical Pharmacology (13.1) ]. There are no available data on the use of TRUSELTIQ during pregnancy. Oral administration of infigratinib to pregnant animals during the period of organogenesis at maternal exposures below the human exposure at

Ապրանքի ամփոփագիր:

TRUSELTIQ (infigratinib) capsules are available in the strengths and packages listed below: TRUSELTIQ capsules are supplied in 21-day blister pack dose presentations as follows: Store TRUSELTIQ at 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C and 30°C (59°F and 86°F).

Լիազորման կարգավիճակը:

New Drug Application

Ապրանքի հատկությունները

TRUSELTIQ- INFIGRATINIB CAPSULE
QED THERAPEUTICS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRUSELTIQ SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TRUSELTIQ.
TRUSELTIQ (INFIGRATINIB) CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2021
INDICATIONS AND USAGE
TRUSELTIQ is a kinase inhibitor indicated for the treatment of adults
with previously treated, unresectable
locally advanced or metastatic cholangiocarcinoma with a fibroblast
growth factor receptor 2 (FGFR2)
fusion or other rearrangement as detected by an FDA-approved test. (
1, 2.1)
This indication is approved under accelerated approval based on
overall response rate and duration of
response. Continued approval for this indication may be contingent
upon verification and description of
clinical benefit in confirmatory trial(s). ( 1)
DOSAGE AND ADMINISTRATION
Confirm the presence of an FGFR2 fusion or rearrangement prior to
initiation of treatment with
TRUSELTIQ. ( 2.1)
Recommended dosage: 125 mg orally once daily for 21 consecutive days
followed by 7 days off
therapy, in 28-day cycles. ( 2.2)
Take on an empty stomach at least 1 hour before or 2 hours after food,
at approximately the same
time each day. ( 2.2)
Swallow capsules whole with a glass of water. Do not crush, chew or
dissolve. ( 2.2)
Mild and Moderate Renal Impairment: The recommended dosage is 100 mg
orally once daily for 21
consecutive days followed by 7 days off therapy, in 28-day cycles. (
2.5)
Mild Hepatic Impairment: The recommended dosage is 100 mg orally once
daily for 21 consecutive
days followed by 7 days off therapy, in 28-day cycles. ( 2.6)
Moderate Hepatic Impairment: The recommended dosage is 75 mg orally
once daily for 21 consecutive
days followed by 7 days off therapy, in 28-day cycles. ( 2.6)
DOSAGE FORMS AND STRENGTHS
Capsules: 25 mg and 100 mg. ( 3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Ocular Toxicity TRUSELTIQ can cause retinal pigment epithelial
detachment (RPED). Perform
c