Sutent 12.5 mg hard capsules
Country: Thailand
Language: English
Source: myHealthbox
Summary of Product characteristics
(SPC)
21-11-2016
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Active ingredient:
sunitinib
Available from:
Pfizer
ATC code:
L01XE04
INN (International Name):
sunitinib
Dosage:
12.5 mg
Pharmaceutical form:
hard gelatin capsules
Administration route:
oral use
Therapeutic group:
Antineoplastic agents
Therapeutic indications:
Sunitinib is indicated for the treatment of gastrointestinal stromal tumor (GIST) after failure of imatinib mesylate treatment due to resistance or intolerance. Sunitinib is indicated for the treatment of advanced and/or metastatic renal cell carcinoma (MRCC). Sunitinib is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET) with disease progression.
Summary of Product characteristics
SUTENT
12.5MG HARD CAPSULES
SUNITINIB * For professionals * Adverse reactions * Company
INDEX * 1. NAME OF THE MEDICINAL PRODUCT * 2. QUALITATIVE AND QUANTITATIVE COMPOSITION * 3. PHARMACEUTICAL FORM * 4. CLINICAL PARTICULARS * 5. PHARMACOLOGICAL PROPERTIES * 6. PHARMACEUTICAL PARTICULARS *
1. NAME OF THE MEDICINAL PRODUCT
SUTENT *
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 12.5 mg of sunitinib (as malate). *
3. PHARMACEUTICAL FORM
12.5 mg capsules: hard gelatin capsules with orange cap and orange
body, printed with white ink “Pfizer” on the cap, “STN 12.5
mg” on the body, containing yellow to orange granules. *
4. CLINICAL PARTICULARS *
4.1 THERAPEUTIC INDICATIONS
Sunitinib is indicated for the treatment of gastrointestinal stromal
tumor (GIST) after failure of imatinib mesylate treatment due to
resistance or intolerance (see Section 5.1).
Sunitinib is indicated for the treatment of advanced and/or metastatic
renal cell carcinoma (MRCC) (see Section 5.1).
Sunitinib is indicated for the treatment of unresectable or
metastatic, well-differentiated pancreatic neuroendocrine tumors
(pNET) with disease progression (see Section 5.1). *
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For GIST and MRCC, the recommended dose of sunitinib is 50 mg taken
orally once daily for 4 consecutive weeks, followed by a 2-week off
period (Schedule 4/2) to comprise a complete cycle of 6 weeks.
For pNET, the recommended dose of sunitinib is 37.5 mg taken orally
once daily without a scheduled rest period.
Sunitinib may be taken with or without food.
If a dose is missed, the patient should not be given an additional
dose. The patient should take the usual prescribed dose on the
following day.
DOSE MODIFICATIONS
_SAFETY AND TOLERABILITY_
For GIST and MRCC, dose modifications in 12.5 mg increments or
decrements may be applied based on individual safety and tolerability
up to 75 mg or down to 25 mg.
For pNET, dose modification in 12.5 mg increments or decrements may be
applied based on individual safety and tole
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