XALKORI- crizotinib capsule XALKORI- crizotinib capsule, coated pellets

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

CRIZOTINIB (UNII: 53AH36668S) (CRIZOTINIB - UNII:53AH36668S)

Tilgjengelig fra:

Pfizer Laboratories Div Pfizer Inc

INN (International Name):

CRIZOTINIB

Sammensetning:

CRIZOTINIB 250 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

XALKORI is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK) or ROS1-positive as detected by an FDA-approved test [see Dosage and Administration (2.1)] . XALKORI is indicated for the treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive. Limitations of Use : The safety and efficacy of XALKORI have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL. XALKORI is indicated for the treatment of adult and pediatric patients 1 year of age and older with unresectable, recurrent, or refractory inflammatory myofibroblastic tumor (IMT) that is ALK-positive. None. Risk Summary Based on findings from animal studies and its mechanism of action, XALKORI can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)] . There are no available dat

Produkt oppsummering:

Capsules: Store at room temperature 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].          Oral Pellets: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Autorisasjon status:

New Drug Application

Informasjon til brukeren

XALKORI- CRIZOTINIB CAPSULE, COATED PELLETS
Pfizer Laboratories Div Pfizer Inc
----------
This Medication Guide has been approved by the U.S. Food and Drug
Administration. Revised: Sep
2023
MEDICATION GUIDE
XALKORI® (zal-KOR-ee)
(crizotinib)
capsules
XALKORI® (zal-KOR-ee)
(crizotinib)
oral pellets
What is the most important information I should know about XALKORI?
XALKORI may cause serious side effects, including:
•
Liver problems. XALKORI may cause life-threatening liver injury that
may lead to death. Your
healthcare provider should do blood tests to check your liver every 2
weeks during the first 2
months of treatment with XALKORI, then 1 time a month and as
recommended by your healthcare
provider during treatment. Tell your healthcare provider right away if
you develop any of the
following new or worsening symptoms:
o
yellowing of your skin or the white part
of your eyes
o
severe tiredness
o
dark or brown (tea color) urine
o
nausea or vomiting
o
decreased appetite
o
pain on the right side of your stomach
o
bleed or bruise more easily than normal
o
itching
•
Lung problems (pneumonitis). XALKORI may cause life-threatening lung
problems that may lead
to death. Symptoms may be similar to those symptoms from lung cancer.
Tell your healthcare
provider right away if you have any new or worsening symptoms,
including:
o
trouble breathing or shortness of breath
o
cough with or without mucous
o
fever
•
Heart problems. XALKORI may cause very slow, very fast, or abnormal
heartbeats. Your
healthcare provider may check your pulse rate and blood pressure
regularly during treatment with
XALKORI. Tell your healthcare provider right away if you feel dizzy or
faint or have abnormal
heartbeats. Tell your healthcare provider if you take any heart or
blood pressure medicines.
•
Severe vision problems. Vision problems are common with XALKORI. These
problems usually
happen within 1 week of starting treatment with XALKORI. Vision
problems with XALKORI can
be severe and may cause partial or complete loss of vision in one or
bo

Preparatomtale

XALKORI- CRIZOTINIB CAPSULE
XALKORI- CRIZOTINIB CAPSULE, COATED PELLETS
PFIZER LABORATORIES DIV PFIZER INC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
XALKORI SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR XALKORI.
XALKORI (CRIZOTINIB) CAPSULES, FOR ORAL USE
XALKORI (CRIZOTINIB) ORAL PELLETS
INITIAL U.S. APPROVAL: 2011
RECENT MAJOR CHANGES
Dosage and Administration (2)
9/2023
INDICATIONS AND USAGE
XALKORI is a kinase inhibitor indicated for the treatment of
•
•
•
DOSAGE AND ADMINISTRATION
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Capsules: 200 mg, 250 mg (3)
Oral pellets: 20 mg, 50 mg, 150 mg (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
®
®
®
adult patients with metastatic non-small cell lung cancer (NSCLC)
whose tumors are anaplastic
lymphoma kinase (ALK) or ROS1-positive as detected by an FDA-approved
test. (1.1, 2.1)
pediatric patients 1 year of age and older and young adults with
relapsed or refractory, systemic
anaplastic large cell lymphoma (ALCL) that is ALK-positive. (1.2, 2.3)
o
Limitations of Use: The safety and efficacy of XALKORI have not been
established in older adults
with relapsed or refractory, systemic ALK-positive ALCL.
adult and pediatric patients 1 year of age and older with
unresectable, recurrent, or refractory
inflammatory myofibroblastic tumor (IMT) that is ALK-positive. (1.3,
2.3)
Metastatic NSCLC: The recommended dosage is 250 mg orally twice daily.
(2.3)
Systemic ALCL: The recommended dosage is 280 mg/m orally twice daily
based on body surface
area. (2.3)
2
Unresectable IMT:
o
o
Adult: The recommended dosage is 250 mg orally twice daily. (2.3)
Pediatric: The recommended dosage is 280 mg/m orally twice daily based
on body surface area.
(2.3)
2
See full prescribing information for dosage adjustments by indication
for patients with moderate or
severe hepatic impairment or severe renal impairment. (2.7, 2.8)
Hepatotoxicity: Fatal hepatotoxicity has occurred. Monitor wi