Soracent(Sorafenib)

Therapeutic Group: Oncology

Presentation

Soracent 200: Each tablet contains Sorafenib Tosylate INN equivalent to Sorafenib 200 mg

Description

Sorafenib is a kinase inhibitor that decreases tumor cell proliferation in vitro. Sorafenib was

shown to inhibit multiple intracellular (CRAF, BRAF and mutant BRAF) and cell surface

kinases (KIT, FLT-3, RET, VEGFR-1, VEGFR-2, VEGFR-3, and PDGFR-ß). Several of these

kinases are thought to be involved in tumor cell signaling, angiogenesis, and apoptosis.

Sorafenib inhibited tumor growth and angiogenesis of human hepatocellular carcinoma and

renal cell carcinoma, and several other human tumor xenografts in immunocompromised

mice.

Indications

Sorafenib is a kinase inhibitor indicated for the treatment of Unresectable hepatocellular

carcinoma, advanced renal cell carcinoma and locally recurrent or metastatic, progressive,

differentiated thyroid carcinoma (DTC) refractory to radioactive iodine treatmenth.

Dosage & Administration

400 mg (2 tablets) orally twice daily without food
• Treatment interruption and/or dose reduction may be needed to manage suspected
adverse drug reactions. Dose may be reduced to 400 mg once daily or to 400 mg every 2
day.

Side Effects

The most common adverse reactions (≥20%), which were considered to be related to
Sorafenib, are fatigue, weight loss, rash/desquamation, hand-foot skin reaction, alopecia,
diarrhea, anorexia, nausea and abdominal pain

Precautions

• Cardiac ischemia and/or infarction may occur. Temporary or permanent discontinuation
of Sorafenib should be considered
• Bleeding may occur. If bleeding necessitates medical intervention, discontinuation of
Sorafenib should be considered
• Hypertension usually occurred early in the course of treatment and was managed with
antihypertensive therapy. Blood pressure should be monitored weekly during the first 6
weeks and periodically thereafter and treated, as required
• Hand-foot skin reaction and rash are common. Management may include topical
therapies for symptomatic relief, temporary treatment interruption and/or dose modification,
or in severe or persistent cases, permanent discontinuation
• Gastrointestinal perforation is an uncommon adverse reaction. In the event of a
gastrointestinal perforation, Sorafenib therapy should be discontinued
• Temporary interruption of Sorafenib therapy is recommended in patients undergoing major
surgical procedures
• Caution is recommended when co-administering substances metabolized/eliminated
predominantly by the UGT1A1 pathway (for example, Irinotecan)
• Caution is recommended when co-administering Docetaxel
• Caution is recommended when co-administering Doxorubicin
• Sorafenib may cause fetal harm when administered to a pregnant woman. Women of
childbearing potential should be advised to avoid becoming pregnant while on Sorafenib
Impairment of TSH suppression in DTC: TSH should be monitored monthly and thyroid
replacement therapy should be adjusted in patients with thyroid cancer.

Use in Pregnancy & Lactation

Pregnancy Category D
Based on its mechanism of action and animal data, Sorafenib can cause fetal harm when
administered to a pregnant woman. There are no available data on Sorafenib use in
pregnant women. Pregnant women should be advised of the potential risk to a fetus.
It is not known whether Sorafenib is excreted in human milk. Because many drugs are
excreted in human milk and because of the potential for serious adverse reactions in
nursing infants from Sorafenib, a decision should be made whether to discontinue nursing
or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use
The safety and effectiveness of Sorafenib in pediatric patients have not been established.
Geriatric Use
No differences in safety or efficacy were observed between older and younger patients, and
other reported clinical experience has not identified differences in responses between the
elderly and younger patients, but greater sensitivity of some older individuals cannot be
ruled out

Drug Interaction

• Carboplatin and Paclitaxel: Caution, Sorafenib and Paclitaxel AUC increases when
co-administered
• UGT1A1 (for example, Irinotecan) and UGT1A9 substrates: Caution, drug AUC increases
when co-administered with Sorafenib
• Docetaxel: Caution, Docetaxel AUC increases when co-administered with Sorafenib
• Doxorubicin: Caution, Doxorubicin AUC increases when coadministered with Sorafenib
• Fluorouracil: Caution, fluorouracil AUC changes when coadministered with Sorafenib
• CYP2B6 and CYP2C8 substrates: Caution, systemic exposure is expected to increase
when co-administered with Sorafenib
• CYP3A4 inducers: Expected to increase metabolism of Sorafenib and decrease Sorafenib
concentrations
• Neomycin: Caution, Sorafenib AUC decreases when coadministered with oral neomycin

Commercial Pack

Soracent 200: Each box contains 3 blister strips of 10 tablets