Regolieva 40mg Tablet is used in the treatment of the following:

• Colorectal cancer has started to spread to other parts of the body
• Gastrointestinal stromal tumours (GIST) (a type of stomach and bowel cancer)
• Liver cancer in adult patients who have already undergone treatment with Sorafenib (anticancer medicine)

Regolieva 40mg Tablet binds to tyrosine kinase receptors and inhibits the VEGF (vascular endothelial growth factor) and EGFR (epidermal growth factor receptor) receptors on the cell surface. By binding to these receptors, this medication blocks an important pathway that promotes cell division. This helps to prevent the growth and multiplication of cancer cells.

It is important to inform your healthcare professional about all the medications you are taking, including prescription drugs, over-the-counter medications, nutritional supplements, and herbal products. Some medications may interact with Regolieva 40mg Tablet, potentially affecting their effectiveness or causing side effects.

• Keep this medicine out of sight and reach of children.
• Store at room temperature between 20°C to 25°C.

Always take Regolieva 40mg Tablet exactly as your doctor has told you. Swallow the tablets whole with water. Do not crush or chew the tablets. Avoid drinking grapefruit juice while taking this medicine.

Side Effects are unwanted symptoms caused by medicines. Although all medicines cause side effects, not everyone gets them.

Severe:

• Liver problems (yellowish discolouration of skin and whites of the eyes, dark urine, confusion)
• Bleeding
• Infection (high fever, cough with or without sputum, pain when urinating, unusual vaginal discharge, shortness of breath)
• Stomach and bowel problems (severe stomach pain, blood in vomit, red or black stools)

Common:

• Low blood cell count
• Decreased appetite, weight loss
• Nausea, vomiting
• High blood pressure
• Voice changes
• Diarrhea
• Dry mouth, painful tongue, mouth sores
• Changes in liver function
• Weakness, lack of energy
• Pain, redness, blisters and swelling of palms of the hands or soles of the feet
• Dehydration
• Hair loss, dry skin
• Headache
• Heartburn
• Low levels of potassium, phosphate, calcium, sodium or magnesium in blood
• Shaking
• Numbness, tingling
• Taste disorders
• Muscle spasms
• Abnormal clotting condition
• Protein in the urine

Talk to the doctor if the patient has any liver disorders, infection, bleeding problems, stomach and bowel problems, chest pain, heart diseases, high blood pressure, persistent headache, seizures or recently had or is going to have a surgical procedure before taking Regolieva 40mg Tablet. It is not recommended for adolescents and children. Avoid drinking grapefruit juice while taking Regolieva 40mg Tablet, as it can use the effectiveness of the medications. Avoid taking this medicine if the patient is planning for pregnancy or during pregnancy and breastfeeding, as it causes harmful effects for the developing baby.

1. Bayer plc, Electronic medicines compendium (emc), [Revised on August 2021] [ Accessed on 5th August 2021], https://www.medicines.org.uk/emc/files/pil.1263.pdf

2. Bayer Healthcare Pharmaceuticals Inc, US Food and Drug Administration, [Revised on April 2018] [ Accessed on 5th August 2021], https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203085lbl.pdf

3. Thomas J Ettrich, Thomas Seufferlein; Regorafenib; Recent Results in Cancer Research; Published on 2014; Accessed on 01/12/2021; https://pubmed.ncbi.nlm.nih.gov/24756792/ 
4. Dirk Strumberg, Beate Schultheis; Regorafenib for cancer; Expert Opinion on Investigational Drugs; Published on June 2012; Accessed on 01/12/2021; (https://pubmed.ncbi.nlm.nih.gov/22577890/ )