• Advanced kidney cancer

It belongs to the category of tyrosine kinase inhibitors, which interfere with the growth of blood vessels inside the cancer cells. It also acts against a protein called receptor tyrosine kinases to interrupt cell signalling, ultimately stopping the growth and spread of cancer cells.

Inform your healthcare provider about all the medicines you take, including prescription medications, over-the-counter medications, nutritional or vitamin supplements, and herbal products. Certain medications may interact with Axilieva 1mg Tablet and reduce effectiveness by causing undesirable side effects.

• Store Axilieva 1mg Tablet in the original package at room temperature (20°C to 25°C).
• Keep it out of reach from children.

Your doctor will decide the dose and duration of Axilieva 1mg Tablet based on the disease condition. Always take this medicine as prescribed by your doctor. The recommended starting oral dose of Axilieva 1mg Tablet is 5 mg twice daily. Take the tablet at the same time every day, with or without food. Do not chew, crush, or break the tablet. Swallow the whole tablet with water. If you forgot to take the tablet, take your next dose at the scheduled time. Do not take a double dose to make up for a forgotten dose.

Side effects are unwanted symptoms caused by medicines. Even though all drugs cause side effects, not everyone gets them.

Serious:

• Extreme tiredness and swelling
• Pressure or pain in the chest, arms, back, neck or jaw
• Breathlessness
• Numbness and weakness on one side of the body
• Difficulty speaking or communicating verbally
• Headache
• Vision changes or dizziness
• Serious bleeding problems like black tarry stools, bloody cough or bloody sputum
• Severe stomach pain
• High blood pressure

Common:

• Kidney problems
• Dehydration
• Hyper-active thyroid gland
• Sore throat
• Loss of appetite
• Joint pain
• Lack of energy
• Weight loss
• Constipation
• Mouth sores
• Skin itching, redness of skin and hair loss

• Axilieva 1mg Tablet may cause dizziness or weakness; avoid driving or operating heavy machinery if you experience these symptoms.

• Grapefruit or grapefruit juice can increase the plasma concentration of Axilieva 1mg Tablet and should be avoided.

• Some formulations may contain lactose, which can cause bloating and abdominal pain in lactose-intolerant individuals—inform your doctor if you have lactose intolerance.

• If you experience severe diarrhea, avoid high-fibre foods and drink plenty of fluids.

• Report any persistent confusion, tiredness, or digestive issues to your healthcare provider.

1. Pfizer, [Revised on 13th Jan 2020] [Accessed on 23rd March 2023], https://www.pfizer.ca/sites/default/files/202001/INLYTA_PM_Approved_03Jan2020_E_DC.pdf
2. Pfizer Labs, Electronic Medicines Compendium(EMC), [Revised on Mar 2021] [Accessed on 23rd March 2023], https://www.medicines.org.uk/emc/files/pil.4325.pdf
3. Pfizer, Fact sheet, [Revised on Sep 2012] [Accessed on 23rd March 2023], https://cdn.pfizer.com/pfizercom/news/esmo/renal_cell_carcinoma_fact_sheet.pdf
4. Annex I summary of Product Characteristics - European Medicines Agency. Available at:https://www.ema.europa.eu/en/documents/product-information/inlyta-epar-product-information_en.pdf (Accessed on March 25, 2023).
5. Edward Chu, Cancer Chemotherapy, Lange’s Basic and Clinical Pharmacology, 14th Edition, 2018, 948-976.