Keytruda (100mg/4ml ) Vial Solution for Infusion 100 mg/4ml

Țară: Iordania

Limbă: engleză

Sursă: JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

Ingredient activ:

Pembrolizumab 100 mg/4ml

Disponibil de la:

مستودع أدوية أداتكو - Adatco Drug Store

Codul ATC:

L01XC18

INN (nume internaţional):

Pembrolizumab 100 mg/4ml

Dozare:

100 mg/4ml

Unități în pachet:

1 vial

Produs de:

MSD Ireland ( Carlow) (ايرلندا)

Prospect

HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
KEYTRUDA SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR KEYTRUDA.
KEYTRUDA
®
(PEMBROLIZUMAB) FOR INJECTION, FOR INTRAVENOUS USE
KEYTRUDA
®
(PEMBROLIZUMAB) INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2014
---------------------------RECENT MAJOR CHANGES
---------------------------
Indications and Usage (1)
06/2019
Dosage and Administration (2)
06/2019
Warnings and Precautions (5)
06/2019
----------------------------INDICATIONS AND
USAGE----------------------------
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking
antibody indicated:
Melanoma

for the treatment of patients with unresectable or metastatic
melanoma. (1.1)

for the adjuvant treatment of patients with melanoma with
involvement of lymph node(s) following complete resection. (1.1)
Non-Small Cell Lung Cancer (NSCLC)

in combination with pemetrexed and platinum chemotherapy, as
first-line treatment of patients with metastatic nonsquamous
NSCLC, with no EGFR or ALK genomic tumor aberrations. (1.2)

in combination with carboplatin and either paclitaxel or paclitaxel
protein-bound, as first-line treatment of patients with metastatic
squamous NSCLC. (1.2)

as a single agent for the first-line treatment of patients with
NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%]
as determined by an FDA-approved test, with no EGFR or ALK
genomic tumor aberrations, and is:
o
stage III where patients are not candidates for surgical
resection or definitive chemoradiation, or
o
metastatic. (1.2, 2.1)

as a single agent for the treatment of patients with metastatic
NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined
by an FDA-approved test, with disease progression on or after
platinum-containing chemotherapy. Patients with EGFR or ALK
genomic tumor aberrations should have disease progression on
FDA-approved therapy for these aberrations prior to receiving
KEYTRUDA. (1.2, 2.1)
Small Cell Lung Cancer (SCLC)
�