SUNITINIB MALATE capsule

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

SUNITINIB MALATE (UNII: LVX8N1UT73) (SUNITINIB - UNII:V99T50803M)

Διαθέσιμο από:

Teva Pharmaceuticals USA, Inc.

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Sunitinib malate capsules are indicated for the treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. Sunitinib malate capsules are indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC). Sunitinib malate capsules are indicated for the adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. Sunitinib malate capsules are indicated for the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. None. Risk Summary Based on animal reproduction studies and its mechanism of action, sunitinib malate can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)] . There are no available data in pregnant women to inform a drug-associated risk. In animal developmental and reproductive toxicology studies, oral administration of sunitinib t

Περίληψη προϊόντος:

12.5 mg capsules Hard gelatin capsule with maroon opaque cap and body, imprinted with TEVA over 8199 on both cap and body in black ink. Available as follows: Bottles of 28 capsules: NDC 0093-8199-28 25 mg capsules Hard gelatin capsule with light brown opaque cap and maroon opaque body, imprinted with TEVA over 8224 on both cap and body in black ink. Available as follows: Bottles of 28 capsules: NDC 0093-8224-28 37.5 mg capsules Hard gelatin capsule with yellow opaque cap and body, imprinted with TEVA over 8229 on both cap and body in black ink. Available as follows: Bottles of 28 capsules: NDC 0093-8229-28 50 mg capsules Hard gelatin capsule with light brown opaque cap and body, imprinted with TEVA over 8231 on both cap and body in black ink. Available as follows: Bottles of 28 capsules: NDC 0093-8231-28 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Φύλλο οδηγιών χρήσης

Teva Pharmaceuticals USA, Inc.
----------
MEDICATION GUIDE
Sunitinib Malate (soo ni' ti nib mal' ate) Capsules
What is the most important information I should know about sunitinib
malate capsules?
Sunitinib malate capsules can cause serious side effects including:
•
Severe liver problems, that can lead to death. Tell your healthcare
provider right away if you develop any of the following signs and
symptoms of
liver problems during treatment with sunitinib malate capsules:
•
itching
•
yellow eyes or skin
•
dark urine
•
pain or discomfort in the right upper stomach area
Your healthcare provider should do blood tests to check your liver
function before you start taking and during treatment with sunitinib
malate capsules.
Your healthcare provider may temporarily stop, reduce your dose, or
permanently stop treatment with sunitinib malate capsules if you
develop liver
problems.
See “What are the possible side effects of sunitinib malate
capsules?” for more information about side effects.
What are sunitinib malate capsules?
Sunitinib malate capsules are a prescription medicine used to treat:
•
a rare cancer of the stomach, bowel, or esophagus called
gastrointestinal stromal tumor (GIST) and when:
•
you have taken the medicine imatinib mesylate and it did not stop the
cancer from growing, or
•
you cannot take imatinib mesylate.
•
advanced kidney cancer (advanced renal cell carcinoma or RCC).
•
adults with kidney cancer that has not spread (localized), and who are
at high risk of RCC coming back again after having kidney surgery.
•
a type of pancreatic cancer called pancreatic neuroendocrine tumors
(pNET), that has progressed and cannot be treated with surgery.
It is not known if sunitinib malate capsules are safe and effective in
children.
Before taking sunitinib malate capsules tell your healthcare provider
about all of your medical conditions, including if you:
•
have any heart problems
•
have high blood pressure
•
have thyroid problems
•
have a history of low blood sugar or diabetes
�

Αρχείο Π.Χ.Π.

SUNITINIB MALATE- SUNITINIB MALATE CAPSULE
TEVA PHARMACEUTICALS USA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SUNITINIB MALATE
CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
SUNITINIB MALATE
CAPSULES.
SUNITINIB MALATE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2006
WARNING: HEPATOTOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
HEPATOTOXICITY MAY BE SEVERE, AND IN SOME CASES FATAL. MONITOR HEPATIC
FUNCTION AND
INTERRUPT, DOSE REDUCE, OR DISCONTINUE SUNITINIB MALATE CAPSULES AS
RECOMMENDED _[SEE_
_WARNINGS AND PRECAUTIONS (5.1)]_.
RECENT MAJOR CHANGES
Dosage and Administration, Dosage Modifications for Adverse Reactions
(2.4)
8/2021
Dosage and Administration, Dosage Modification for Drug Interactions
(2.5)
8/2021
Warnings and Precautions, Hepatotoxicity (5.1)
8/2021
Warnings and Precautions, Hypertension (5.4)
8/2021
Warnings and Precautions, Hemorrhagic Events and Viscous Perforation
(5.5)
8/2021
Warnings and Precautions, Reversible Posterior Leukoencephalopathy
Syndrome (5.10)
8/2021
Warnings and Precautions, Hypoglycemia (5.12)
8/2021
Warnings and Precautions, Osteonecrosis of the Jaw (5.13)
8/2021
INDICATIONS AND USAGE
Sunitinib malate capsules are a kinase inhibitor indicated for:
treatment of adult patients with gastrointestinal stromal tumor (GIST)
after disease progression on or
intolerance to imatinib mesylate. (1.1)
treatment of adult patients with advanced renal cell carcinoma (RCC).
(1.2)
adjuvant treatment of adult patients at high risk of recurrent RCC
following nephrectomy. (1.3)
treatment of progressive, well-differentiated pancreatic
neuroendocrine tumors (pNET) in adult patients
with unresectable locally advanced or metastatic disease. (1.4)
DOSAGE AND ADMINISTRATION
GIST and Advanced RCC:
The recommended dosage is 50 mg orally once daily for the first 4
weeks of each 6-week cycle
(Schedule 4/2). (2.1)
Adjuvant Treatment of RCC:
The recommended dosage is 50 mg orally onc