Soranix200 mg

Soranix is an oral multi-targeted tyrosine kinase inhibitor with the following evidence-based indications:

Established / Approved uses

• Unresectable hepatocellular carcinoma (HCC): Soranix is indicated for the treatment of patients with liver cancer that cannot be surgically removed.
• Advanced renal cell carcinoma (RCC): Soranix is indicated for the treatment of advanced kidney cancer, typically after failure of prior cytokine-based therapy or as an alternative targeted agent.
• Differentiated thyroid carcinoma (DTC): Soranix is indicated for locally recurrent or metastatic, progressive differentiated thyroid cancer that is refractory to radioactive iodine (RAI) treatment.

Soranix is not indicated for medullary or anaplastic thyroid cancer, and is not established for use in children.

Each film-coated tablet contains Sorafenib Tosylate equivalent to 200 mg of sorafenib (as the free base).

Soranix is an orally administered anti-cancer medicine that belongs to the multi-kinase inhibitor class. It is marketed internationally under the brand name Nexavar and is used for the treatment of certain liver, kidney, and thyroid cancers.

Soranix works by simultaneously blocking several proteins involved in the growth of new blood vessels feeding a tumour (angiogenesis) and in direct tumour cell proliferation, thereby slowing disease progression.

Antineoplastic agent; multi-targeted tyrosine kinase inhibitor (Soranix)

Sorafenib Tosylate is a small-molecule inhibitor that targets multiple intracellular and cell-surface kinases involved in tumour growth and angiogenesis.

• It inhibits RAF kinases (CRAF, wild-type BRAF, and mutant BRAF), which are part of the RAS/RAF/MEK/ERK signalling pathway that drives tumour cell proliferation.
• It also inhibits receptor tyrosine kinases including VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-β, KIT, FLT-3, and RET, which are involved in tumour angiogenesis and progression.

Through this combined antiproliferative and antiangiogenic action, Sorafenib Tosylate reduces tumour cell growth and the blood supply that tumours depend on. Peak plasma concentrations are generally reached within 3 hours of oral dosing, and the drug is metabolized mainly by the liver (CYP3A4 oxidation and UGT1A9 glucuronidation), with an elimination half-life of approximately 25–48 hours.

Soranix tablets should be swallowed whole with water, on an empty stomach (at least 1 hour before or 2 hours after eating). Do not crush or split the tablets unless advised by a physician, and avoid high-fat meals around the time of dosing.

The following are well-established, clinically significant interactions with Soranix:

• Strong CYP3A4 inducers (e.g., rifampin, phenytoin, carbamazepine, phenobarbital, St. John's Wort): may substantially reduce Soranix plasma concentrations and reduce its efficacy; avoid combination where possible or consider dose adjustment.
• Warfarin: concurrent use with Soranix may increase INR and bleeding risk; monitor INR/prothrombin time closely and watch for signs of bleeding (see Precautions and Warnings).
• Docetaxel and irinotecan: Soranix can increase the systemic exposure of these chemotherapy agents, increasing the risk of their toxicities; use with caution and monitor for increased toxicity when co-administered.
• Neomycin (oral): may reduce absorption/bioavailability of Soranix due to alteration of gut flora involved in its metabolism.

Side effects of Soranix range from common dermatologic and gastrointestinal effects to rare but serious systemic toxicities.

Very common / common

• Hand-foot skin reaction (palmar-plantar erythrodysesthesia)
• Diarrhea
• Fatigue and asthenia
• Alopecia (hair thinning/loss)
• Rash and dry skin
• Hypertension
• Anorexia, nausea, weight loss
• Mucositis / stomatitis

Serious (require prompt medical attention)

• Bleeding events, including severe or fatal hemorrhage
• Cardiac ischemia and myocardial infarction
• Hepatotoxicity (drug-induced liver injury, sometimes severe)
• Gastrointestinal perforation (rare)
• Hypertensive crisis
• QT interval prolongation
• Impaired wound healing

Pregnancy: Soranix can cause fetal harm based on its mechanism of action and animal reproduction data showing embryo-fetal toxicity and malformations. Soranix should not be used during pregnancy; women of reproductive potential should use effective contraception during treatment and for a period after the last dose, as advised by their physician. If pregnancy occurs during treatment, the patient should be informed of the potential risk to the fetus and should consult her physician immediately.

Lactation: It is not known whether Soranix passes into human breast milk, but because of the potential for serious adverse reactions in a nursing infant, breastfeeding should be avoided during treatment with Soranix and for a period after the last dose, on the advice of a physician.

Soranix carries several serious risks that require careful monitoring; these represent boxed-warning-level safety concerns and should be discussed with the prescribing physician.

• Bleeding risk: Soranix increases the risk of bleeding events, which can be severe or fatal. Use with caution in patients at risk of bleeding or those on anticoagulants (see Interactions).
• Cardiac ischemia/infarction: Soranix has been associated with an increased incidence of cardiac ischemia and myocardial infarction; use with caution in patients with coronary artery disease, and interrupt therapy if ischemia develops.
• Hepatotoxicity: Drug-induced liver injury, sometimes severe, has occurred with Soranix. Liver function tests should be monitored regularly during treatment, which is particularly important since many patients being treated for hepatocellular carcinoma already have compromised liver function.
• Gastrointestinal perforation: A rare but serious complication; discontinue Soranix permanently if perforation occurs.
• Hypertension: Blood pressure should be monitored regularly, especially during the first weeks of treatment, and treated with standard antihypertensive therapy if it develops.
• Hand-foot skin reaction and other dermatologic toxicity: Can be dose-limiting; manage with supportive care, and interrupt or reduce the dose for severe reactions.
• Wound healing complications: Soranix may impair wound healing. Treatment should be interrupted for patients undergoing major surgical procedures and resumed only after adequate wound healing has been confirmed.
• QT prolongation: Use with caution in patients with a history of QT prolongation, electrolyte abnormalities, or those taking other QT-prolonging drugs.

There is no specific antidote for Soranix overdose. The most common effects reported with doses higher than recommended have included diarrhea and dermatologic (skin) reactions.

In case of suspected overdose, seek immediate medical attention or contact emergency services / a poison control center. Treatment should consist of general supportive measures; Soranix should be discontinued and the patient monitored closely.

Store at room temperature (below 30°C), protected from moisture and light. Keep out of reach of children.

Pediatric use: The safety and efficacy of Soranix in pediatric patients have not been established; Soranix is not recommended for use in children.

Elderly (≥65 years): No overall differences in safety or efficacy have been observed between elderly and younger adult patients; no specific dose adjustment is required, though age-related organ function decline should be considered.

Hepatic impairment: No dose adjustment required in Child-Pugh A or B; use with caution and close liver function monitoring in Child-Pugh C (see Dosage and Administration).

Renal impairment: No dose adjustment generally required in mild-to-moderate impairment; limited data in severe impairment or dialysis patients — use with caution.

Soranix treatment should be continued as long as clinical benefit is observed and the drug is tolerated, or until disease progression or unacceptable toxicity occurs, as determined by the treating oncologist.

Multi-kinase inhibitors; Antineoplastic agents; Tyrosine kinase inhibitors

Sorafenib Tosylate exerts a dual antiproliferative and antiangiogenic effect by inhibiting intracellular RAF kinases (CRAF, wild-type BRAF, mutant BRAF) in the RAS/RAF/MEK/ERK pathway, and by inhibiting cell-surface receptor tyrosine kinases including VEGFR-1/2/3, PDGFR-β, KIT, FLT-3, and RET, which are involved in tumour angiogenesis and growth.

Safety and efficacy of Soranix have not been established in pediatric patients; therefore, Soranix is not recommended for use in children and adolescents outside of a clinical trial setting.