SUNITINIB MALATE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Pharmaceuticals Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

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

Summary of Product characteristics

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