SUNITINIB MALATE capsule

Country: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

NorthStar RxLLC

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

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 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 pregna

পণ্য সারাংশ:

12.5 mg capsules Hard gelatin capsule with opaque reddish brown cap and opaque reddish brown body, self-lock capsule, imprinted with ‘RM53’ on cap and ‘RM53’ on body in white ink, containing yellow to orange colored powder; available in: 25 mg capsules Hard gelatin capsule with opaque caramel cap and opaque reddish brown body, self-lock capsule, imprinted with ‘RM54’ on cap and ‘RM54’ on body in white ink, containing yellow to orange colored powder; available in: 37.5 mg capsules Hard gelatin capsule with opaque yellow cap and opaque yellow body, self-lock capsule, imprinted with ‘RM55’ on cap and ‘RM55’ on body in black ink, containing yellow to orange colored powder; available in: 50 mg capsules Hard gelatin capsule with opaque caramel cap and opaque caramel body, self-lock capsule, imprinted with ‘RM56’ on cap and ‘RM56’ on body in white ink, containing Yellow to orange colored powder ; available in: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [See USP Controlled Room Temperature]. Keep out of reach of children.

অনুমোদন অবস্থা:

Abbreviated New Drug Application

তথ্য লিফলেট

SUNITINIB MALATE- sunitinib malate capsule
NorthStar RxLLC
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Medication Guide
MEDICATION GUIDE
Sunitinib Malate (soo ni’ ti nib mal’ ate) Capsules
Rx only
What is the most important information I should know about sunitinib
malate capsules?
Sunitinib malate capsules can cause serious side effects including:
1.
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:
2.
itching
3.
yellow eyes or skin
4.
dark urine
5.
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 prescription medicine used to treat:
1.
a rare cancer of the stomach, bowel, or esophagus called
gastrointestinal stromal tumor (GIST) and
when:
2.
you have taken the medicine imatinib mesylate and it did not stop the
cancer from growing, or
3.
you cannot take imatinib mesylate.
4.
advanced kidney cancer (advanced renal cell carcinoma or RCC).
5.
adults with kidney cancer that has not spread (localized), and who are
at high risk of RCC coming back
again after having kidney surgery.
6.
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:
1.
have any heart problems
2.
have high blood pressure
3.
have thyroid problems
4.
have a

পণ্য বৈশিষ্ট্য

SUNITINIB MALATE- SUNITINIB MALATE CAPSULE
NORTHSTAR RXLLC
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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.
INITIAL U.S. APPROVAL: 2006
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: (1)
DOSAGE AND ADMINISTRATION
GIST and Advanced RCC: (2)
Adjuvant Treatment of RCC: (2)
pNET: (2)
DOSAGE FORMS AND STRENGTHS
CONTRAINDICATIONS
None (4) (4)
WARNINGS AND PRECAUTIONS
• 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)
• The recommended dosage is 50 mg orally once daily for the first 4
weeks of each 6-week cycle
(Schedule 4/2). (2.1)
• The recommended dosage is 50 mg orally once daily for the first 4
weeks of a 6-week cycle
(Schedule 4/2) for a maximum of 9 cycles. (2.2)
• The recommended dosage is 37.5 mg orally once daily. (2.3)
• Capsules: 12.5 mg, 25 mg, 37.5 mg, 50 mg sunitinib (3)
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