Regocent

Indications

Regorafenib is an oral anticancer medicine. It is used to treat advanced colorectal (bowel) cancer that has spread and has already been treated with other therapies, advanced gastrointestinal stromal tumours (GIST) that no longer respond to Imatinib and Sunitinib, and liver cancer (hepatocellular carcinoma) previously treated with Sorafenib. It is prescribed and supervised by a cancer specialist.

How It Works

Regorafenib is a multi-kinase inhibitor. Kinases are proteins that pass growth signals inside cells. Regorafenib blocks several kinases involved in cancer cell growth and in forming new blood vessels that tumours need for oxygen and nutrients (angiogenesis). This slows the growth and spread of the cancer.

Dosage and Administration

Take exactly as prescribed by your cancer specialist. It is usually taken once a day for a set number of weeks followed by a break, in repeated cycles, and the dose may be reduced or paused if side effects occur. Swallow the tablets whole with water after a low-fat meal, at the same time each day. Do not take two doses to make up for a missed one.

Interactions

Strong enzyme inhibitors such as Ketoconazole, Itraconazole, Clarithromycin and grapefruit juice can raise Regorafenib levels; strong inducers such as Rifampicin, Phenytoin, Carbamazepine and St John Wort can lower them. It can increase bleeding risk with Warfarin and other blood thinners and may increase levels of Irinotecan and some cholesterol medicines such as Rosuvastatin. Tell your doctor about all medicines and supplements.

Contraindications

• Allergy to Regorafenib or any ingredient of the tablet.
• Pregnancy.

Side Effects

Common effects include hand-foot skin reaction (redness, pain, blisters on palms and soles), tiredness, diarrhoea, loss of appetite and weight, high blood pressure, voice changes, mouth sores, infections, rash, raised liver tests and low blood counts.

Get urgent medical help for yellow skin or eyes, dark urine or pain in the upper right abdomen (possible severe liver injury, which can be fatal), heavy bleeding or black stools, chest pain, severe headache or confusion, severe stomach pain (possible bowel tear), fever with chills, or severe skin blistering.

Pregnancy and Lactation

Regorafenib can harm an unborn baby. Do not use during pregnancy. Women and men should use effective contraception during treatment and for at least 8 weeks after the last dose. Do not breastfeed during treatment.

Precautions and Warnings

• Liver blood tests are checked before and regularly during treatment.
• Blood pressure is monitored and treated if raised.
• Stop before planned surgery, as it can slow wound healing; ask your doctor.
• Use moisturising cream and avoid pressure on hands and feet to reduce skin reactions.
• Handle tablets as directed; do not share them.

Overdose

Overdose may cause severe skin reactions, voice changes, diarrhoea, mouth sores, tiredness and high blood pressure. Contact your doctor or go to hospital at once.

Therapeutic Class

Antineoplastic; multi-kinase inhibitor (targeted cancer therapy).

Storage

Store below 30°C in the original bottle, tightly closed, protected from moisture, and out of the reach of children. Keep any drying agent in the bottle.