SUNITINIB MALATE capsule

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Dr.Reddys Laboratories Inc

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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 SummaryBased 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 to

Ringkasan produk:

Sunitinib malate 12.5 mg capsules are yellow to orange colored granules filled in hard gelatin capsules with warm grey colored cap and warm grey colored body, imprinted with ‘SC’ on the cap and ‘12.5’ on body in white ink. Bottles of 28 NDC 43598-045-63 Unit-dose blister packages of 28 NDC 43598-045-28  Sunitinib malate 25 mg capsules are yellow to orange colored granules filled in hard gelatin capsules with black colored cap and black colored body, imprinted with ‘SC’ on the cap and ‘25’ on body in white ink. Bottles of 28 NDC 43598-046-63 Unit-dose blister packages of 28 NDC 43598-046-28  Sunitinib malate 37.5 mg capsules are yellow to orange colored granules filled in hard gelatin capsules with black colored cap and grey colored body, imprinted with ‘SC’ on the cap and ‘37.5’ on body in white ink. Bottles of 28 NDC 43598-047-63 Unit-dose blister packages of 28 NDC 43598-047-28  Sunitinib malate 50 mg capsules are yellow to orange colored granules filled in hard gelatin capsules with grey colored cap and grey colored body, imprinted with ‘SC’ on the cap and ‘50’ on body in white ink. Bottles of 28 NDC 43598-048-63 Unit-dose blister packages of 28 NDC 43598-048-28  Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Status otorisasi:

Abbreviated New Drug Application

Selebaran informasi

Dr.Reddys Laboratories Inc
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SPL MEDGUIDE SECTION
MEDICATION GUIDE
Sunitinib Malate (soo ni′ ti nib mal eyt ) 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 leadto death. Tell your healthcare
provider right awayif 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, orpermanently 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 is Sunitinib Malate Capsules?
Sunitinib malate capsules is 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 kidneycancer that has not spread(localized), and who
are at high riskof RCC coming back again
after having kidney surgery.
• a type of pancreatic cancercalled 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

Karakteristik produk

SUNITINIB MALATE - SUNITINIB MALATE CAPSULE
DR.REDDYS LABORATORIES INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SUNITINIB MALATE SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SUNITINIB
MALATE.
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
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 is 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 once daily for the first 4
weeks of a 6-