TAFINLAR dabrafenib capsule

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

DABRAFENIB MESYLATE (UNII: B6DC89I63E) (DABRAFENIB - UNII:QGP4HA4G1B)

Հասանելի է:

GlaxoSmithKline LLC

INN (Միջազգային անվանումը):

DABRAFENIB MESYLATE

Կազմը:

DABRAFENIB 50 mg

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Լիազորման կարգավիճակը:

New Drug Application

Ապրանքի հատկությունները

TAFINLAR- DABRAFENIB CAPSULE
GLAXOSMITHKLINE LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TAFINLAR SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR TAFINLAR.
TAFINLAR (DABRAFENIB) CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2013
RECENT MAJOR CHANGES
Indications and Usage (1.2)
11/2015
Dosage and Administration (2)
11/2015
Warnings and Precautions (5)
11/2015
INDICATIONS AND USAGE
•
•
LIMITATION OF USE: TAFINLAR is not indicated for treatment of patients
with wild-type BRAF melanoma. (1.3, 5.2)
DOSAGE AND ADMINISTRATION
•
•
•
DOSAGE FORMS AND STRENGTHS
Capsules: 50 mg, 75 mg. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
•
•
•
•
TAFINLAR is a kinase inhibitor indicated as a single agent for the
treatment of patients with unresectable or
metastatic melanoma with BRAF V600E mutation as detected by an
FDA-approved test. (1.1, 2.1)
TAFINLAR is indicated, in combination with trametinib, for the
treatment of patients with unresectable or metastatic
melanoma with BRAF V600E or V600K mutations as detected by an
FDA-approved test. (1.2, 2.1, 14.2)
Confirm the presence of BRAF V600E mutation in tumor specimens prior
to initiation of treatment with TAFINLAR
as a single agent.
Confirm the presence of BRAF V600E or V600K mutation in tumor
specimens prior to initiation of treatment with
TAFINLAR in combination with trametinib. (2.1)
The recommended dose of TAFINLAR is 150 mg orally twice daily. Take
TAFINLAR at least 1 hour before or at least
2 hours after a meal. (2.2)
New primary malignancies, cutaneous and non-cutaneous: Can occur when
TAFINLAR is administered as a single
agent or with trametinib. Monitor patients for new malignancies prior
to, or while on therapy, and following
discontinuation of treatment. (5.1, 2.3)
Tumor promotion in BRAF wild-type melanoma: Increased cell
proliferation can occur with BRAF inhibitors. (5.2)
Hemorrhage: Major hemorrhagic events can occur in patients