Sorafenib Tosylate 200 mg (Hepanib)

What is Sorafenib Tosylate?

Sorafenib Tosylate 200 mg (Hepanib) Tablet is the tosylate salt form of the drug sorafenib. It is a targeted cancer therapy, a small molecule kinase inhibitor, that works by blocking certain proteins which are involved in certain tumor cell growth and in the formation of new blood vessels that feed tumor cells.

Why is Sorafenib tosylate used for?

Specifically, the U.S. FDA label states that sorafenib tablets are indicated for the treatment of

• Patients with Unresectable hepatocellular carcinoma (HCC) (a liver cancer).
• Patients with advanced renal cell carcinoma (advanced kidney cancer).
• Patients with locally recurrent or metastatic, progressive differentiated thyroid carcinoma (DTC) that is refractory to radioactive iodine treatment.
• The label uses the film-coated tablet (Hepanib) containing 200 mg sorafenib (equivalent to 274 mg sorafenib tosylate) for oral use.

How does Sorafenib 200 mg work?

• As noted above, it is a multi-kinase inhibitor that blocks signaling pathways inside tumor cells and the tumor micro-environment.
• By inhibiting these kinases, the drug may slow tumor progression, shrink tumors, or delay their growth by limiting their ability to divide and to develop new blood supply.
• Because it works on specific molecular targets rather than broadly on all dividing cells (as chemotherapy often does), it is considered a targeted therapy.

What is the dosage and administration of Sorafenib Tosylate?

• The recommended dose (for most indications) is 400 mg orally twice daily (two 200 mg tablets in the morning and two 200 mg tablets in the evening) without food (take at least 1 hour before or 2 hours after a meal) when indicated.
• It is continued until the patient no longer clinically benefits or until unacceptable toxicity occurs.
• Guidance for dose modifications (interruptions, reductions) for adverse reactions. For example, in certain adverse events, you may reduce to 400 mg once daily, or 400 mg every other day, or 200 mg twice daily.
• For differentiated thyroid carcinoma, the label details a first-dose reduction (400 mg in the morning and 200 mg in the evening, OR 200 mg in the morning and 400 mg in the evening), etc.

Make sure to follow your healthcare provider’s instructions exactly, including instructions about food, timing, any dose reductions, and when to stop.

What are the side effects and adverse reactions of Sorafenib Tosylate?

Common side-effects

According to the prescribing information, the most common adverse reactions (those occurring in ≥ 20 % of patients) include:

• Diarrhea
• Fatigue
• Infection
• Alopecia (hair thinning or hair loss)
• Hand-foot skin reaction (also sometimes called palmar-plantar erythrodysesthesia)
• Rash
• Weight loss
• Decreased appetite
• Nausea
• Gastrointestinal and abdominal pain
• Hypertension (high blood pressure)
• Hemorrhage (bleeding)

What are the drug interactions of Sorafenib Tosylate 200 mg?

Hepanib 200 mg interacts with many other drugs either as a victim or perpetrator of metabolism/transport changes. Some key interaction points:

• Strong CYP3A4 inducers (certain anticonvulsants, rifampin) may decrease Hepanib concentrations and reduce effectiveness. 
• Hepanib may increase the exposure of co-administered substrates of UGT1A9, UGT1A1 (irinotecan) because of drug-drug interactions; caution is advised.
• It may increase the exposure of docetaxel, doxorubicin when used together.
• It may also interact with drugs that prolong the QT interval (because the drug itself may prolong QT), and electrolytes should be corrected.
• Because of bleeding risk, concomitant use of warfarin requires special precautions.
• Gastric pH-altering drugs (proton-pump inhibitors) did not show a clinically meaningful change in Hepanib exposure (omeprazole 40 mg once daily for 5 days).

Bottom line: Make sure your health-care professional knows all the other medications you take (prescription, over-the-counter, herbal supplements) to assess for interactions.

What precautions should be taken when taking sorafenib?

Here are key precautions/warnings you should be aware of as a patient:

• Bleeding/Hemorrhage: Because of increased risk of bleeding, including serious events. If you notice bleeding (vomit blood, black/tarry stools, bleeding from tumor sites), contact your doctor.
• Hypertension: High blood pressure may occur, often early in treatment. Your doctor will monitor your blood pressure weekly for the first 6 weeks and periodically thereafter. If uncontrolled, dose interruption or discontinuation may be required.
• Cardiovascular events: Including heart attack, heart failure. Prior heart disease may increase risk.
• Hand-Foot Skin Reaction / Dermatologic Toxicities: Painful redness, swelling, or blisters on palms/soles may happen. Also rash, Stevens-Johnson syndrome. Inform your doctor if you develop severe skin problems.
• Gastrointestinal perforation: Rare but serious. If you experience severe abdominal pain, fever, you should seek medical attention.
• Impaired wound healing: Because Hepanib 200 mg may interfere with healing, you may need to stop the drug before surgery and until wound healing is adequate.
• Liver injury: Monitor liver function. If you have unexplained elevations of liver enzymes (transaminases) or signs of liver injury (yellowing skin/eyes, dark urine) inform your doctor.
• Thyroid suppression impairment: For thyroid cancer patients on thyroid hormone/TSH-suppression therapy: Hepanib may cause elevated TSH – your doctor will monitor and adjust as needed.
• QT prolongation: If you have a known congenital long QT syndrome, bradycardia, electrolyte abnormalities, or are taking other QT-prolonging drugs, extra caution is needed.
• Pregnancy & fertility: Hepanib tablet may cause fetal harm. It is important to avoid becoming pregnant during treatment and for a specified period after (men and women).
• Lactation: Women should not breastfeed while on Hepanib.
• Renal and hepatic impairment: For certain levels of impairment, the drug may be used with caution; your doctor will evaluate your specific situation.

Sorafenib 200 mg price in Bangladesh

The price of Sorafenib 200 mg (Hepanib) in Bangladesh depends on its brand and manufacturer. The exact price depends on which brand you are suggested by your health care provider. This advanced kidney cancer generic medicine is only available for export. You can not get it in any local medicine shop.

Frequently Asked Questions (FAQs)

Disclaimer: This information is not for use as a medical alternative; always consult your doctor before administering any prescription medication.