국가: 미국
언어: 영어
출처: NLM (National Library of Medicine)
SUNITINIB MALATE (UNII: LVX8N1UT73) (SUNITINIB - UNII:V99T50803M)
Mylan Pharmaceuticals Inc.
ORAL
PRESCRIPTION DRUG
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. 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 pregnant rats and
Sunitinib Malate Capsules are available containing 12.5 mg, 25 mg, 37.5 mg or 50 mg of sunitinib equivalent to 16.7 mg, 33.4 mg, 50.1 mg or 66.8 mg of sunitinib malate, respectively. The 12.5 mg capsules are hard-shell gelatin capsules with a pink-brown opaque cap and pink-brown opaque body filled with yellow to orange powder. The capsules are axially printed with MYLAN over SM 12.5 in black ink on cap and body. They are available as follows: NDC 0378-6678-28 bottles of 28 capsules The 25 mg capsules are hard-shell gelatin capsules with a yellow opaque cap and pink-brown opaque body filled with yellow to orange powder. The capsules are axially printed with MYLAN over SM 25 in black ink on cap and body. They are available as follows: NDC 0378-6679-28 bottles of 28 capsules The 37.5 mg capsules are hard-shell gelatin capsules with an ivory opaque cap and ivory opaque body filled with yellow to orange powder. The capsules are axially printed with MYLAN over SM 37.5 in black ink on cap and body. They are available as follows: NDC 0378-6681-28 bottles of 28 capsules The 50 mg capsules are hard-shell gelatin capsules with a yellow opaque cap and yellow opaque body filled with yellow to orange powder. The capsules are axially printed with MYLAN over SM 50 in black ink on cap and body. They are available as follows: NDC 0378-6680-28 bottles of 28 capsules Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.
Abbreviated New Drug Application
Mylan Pharmaceuticals Inc. ---------- Medication Guide Sunitinib Malate Capsules (soo ni′ ti nib mal eyt) 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: o itching o yellow eyes or skin o dark urine o 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: o you have taken the medicine imatinib mesylate and it did not stop the cancer from growing, or o 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 • have kidney 전체 문서 읽기
SUNITINIB MALATE- SUNITINIB MALATE CAPSULE MYLAN PHARMACEUTICALS 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: • • • • DOSAGE AND ADMINISTRATION GIST and Advanced RCC: • Adjuvant Treatment of RCC: • pNET: • DOSAGE FORMS AND STRENGTHS • CONTRAINDICATIONS • 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 전체 문서 읽기