Fotivda 890 microgram Capsules

The active substance in Fotivda is tivozanib, which is a protein kinase inhibitor. Tivozanib reduces the supply of blood to the cancer, which slows down the growth and spread of cancer cells. It works by blocking the action of a protein called vascular endothelial growth factor (VEGF). Blocking the action of VEGF prevents the formation of new blood vessels.

Fotivda is used to treat adults with advanced kidney cancer. It is used where other treatments such as interferon-alpha or interleukin-2 have either not yet been used or have not helped to stop your disease.

Do not take Fotivda:

• If you are allergic (hypersensitive) to tivozanib or any of the other ingredients of Fotivda.
• If you are taking St. John’s Wort (also known as Hypericum perforatum, a herbal remedy used for treatment of depression and anxiety).
• If you are pregnant and breastfeeding your baby.
• If you have severe liver disease.
• If you have uncontrolled / not well controlled severe high blood pressure.
• If you have an “under active” thyroid gland (hypothyroidism) not well controlled with treatment.
• If you have uncontrolled / not well controlled heart failure.
• If you have recently suffered from the effects of venous or arterial blood clots.
• If you have or have had a condition of the brain called “posterior reversible encephalopathy syndrome” (PRES).
• If you have an unresolved or not well controlled bleeding tendency.

Warnings and precautions

Take special care with Fotivda:

• If you have high blood pressure. Fotivda can increase your blood pressure. Your doctor will monitor your blood pressure regularly and, if it is too high, may either give you a medicine to lower it, or reduce your dose of Fotivda. However, if your blood pressure remains too high, your doctor may decide to interrupt or to stop treatment with Fotivda. If you are already taking a medicine to treat high blood pressure, and your doctor reduces the dose of Fotivda or interrupts or stops treatment, you will be regularly checked for low blood pressure.
• If you have or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall.
• If you have had problems with blood clots. Treatment with Fotivda may raise the risk of developing a blood clot (thrombus) in your blood vessels that could break loose and be carried by the blood stream to block another blood vessel.

Do not share medicines prescribed for you with any other person. Always use Fotivda exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will prescribe the correct dose for you. The usual dose is one Fotivda 1340 microgram capsule, taken once daily for 21 days (3 weeks), followed by a 7-day (1-week) period when no capsules are taken. This schedule is repeated in cycles of 4 weeks.

Your doctor will check you regularly, and you will normally continue to take Fotivda as long as it is working, and you do not suffer unacceptable side effects.

Reduced dose

In case you experience severe side effects, your doctor may decide to interrupt Fotivda therapy and/or lower the dose to: One Fotivda 890 microgram capsule, taken once daily for 21 days (3 weeks), followed by a 7-day (1-week) period when no capsules are taken. This schedule is repeated in cycles of 4 weeks.

Liver problems

If you have liver problems, your doctor may reduce how often you take your dose to every other day (i.e. one 1340 microgram capsule every other day). Your doctor will tell you how long your treatment with Fotivda will last.

If you have the impression that the effect of Fotivda is too strong or too weak, tell your doctor or pharmacist.

If you take more Fotivda than you should:

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. Tell your doctor straightaway if you have taken more than your prescribed dose of 1 capsule per day. Taking too much Fotivda makes side effects more likely or to become more severe, especially high blood pressure. Get medical help straightaway if you experience confusion, changes in your mental state or headaches. These are all symptoms of high blood pressure.

If you forget to take/missed a dose of Fotivda:

If you have missed taking a capsule do not take a replacement capsule. Continue to take your next dose at the usual time. Do not take a double dose to make up for forgotten individual doses. If you vomit after taking Fotivda, do not take a replacement capsule. Continue to take your next dose at the usual time.

If you stop taking/using Fotivda

Do not stop taking Fotivda unless your doctor tells you to. If you stop taking the capsules your condition may get worse. If you have any further questions on the use of Fotivda, ask your doctor, pharmacist or nurse.

Fotivda can have side effects. Not all side effects reported for Fotivda are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking Fotivda, please consult your healthcare professional for advice.

If any of the following happens, stop taking Fotivda and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing;
• rash or itching;
• fainting;
• yellowing of the skin and eyes, also called jaundice.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to Fotivda. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following: High blood pressure is the most serious and a very common side effect (see also “Take special care with Fotivda”). Tell your doctor immediately if you think you have high blood pressure. Symptoms include severe headaches, blurred vision, shortness of breath, changes in your mental state, such as feeling anxious, confused or disorientated.

Your doctor will check your blood pressure regularly during treatment with Fotivda. If you develop high blood pressure, your doctor may prescribe a medicine to treat your high blood pressure, lower your dose of Fotivda, or stop your treatment with Fotivda. These are all serious side effects. You may need urgent medical attention.

The following side effects have been reported more frequently:

• Difficulty speaking
• Diarrhoea
• Loss of appetite; weight loss
• Headache
• Difficult breathing; shortness of breath during exercise; coughing.
• Tiredness; unusual weakness; pain (including in the mouth, bone, extremities, side of the body, groin, tumour).
• Inflammation of the mouth; slight mouth pain or discomfort; feeling sick; pain, discomfort and tightness in the stomach.
• Hand-foot-syndrome with skin reddening, swelling, numbness and skin peeling on palms and soles.
• Back pain
• Tiredness and lack of energy.
• Underactive thyroid gland which may cause symptoms such as tiredness, lethargy, muscle weakness, slow heart rate, weight gain.
• Unable to sleep
• Nerve damage including numbness, pins and needles, sensitive skin or numbness and weakness in the arms and legs.
• Sight problems including blurred vision.
• Rapid heart rate; tightness of the chest; heart attack/reduced blood flow to heart; blood clot in an artery (blood vessel).
• Blood clot in the lung. Symptoms include cough, chest pain, sudden shortness of breath or coughing up blood.
• Blood clot in a deep vein such as in the leg.
• Very high blood pressure leading to a stroke; flushed skin.
• Nose bleed; runny nose; blocked nose.
• Flatulence; heartburn; difficult and painful swallowing; sore throat; bloated stomach; swollen and painful tongue; inflamed painful and/or bleeding gums.
• Taste changes or loss of taste.
• Dizziness; ringing in the ears; dizziness and a spinning sensation (vertigo).
• Bleeding, e.g. in the brain, from the mouth, gums, lungs, stomach, gut ulcers, female genitals, anus, adrenal gland.
• Coughing up blood; vomiting up blood.
• Paleness and tiredness from excess bleeding.
• Being sick; indigestion; constipation; dry mouth.
• Itchy skin; rash; itching of the body; skin peeling; dry skin; hair loss; redness of the skin including the hands and body; acne.
• Fever; chest pain; swelling of feet and legs; chills and low body temperature.
• Joint pain; muscle pain.
• Increased amount of protein in the urine.
• Abnormal blood test results for liver, pancreas, kidney, and thyroid.

Inflammation of the pancreas causing severe stomach pain which may spread to your back. The following side effects have been reported less frequently:

• Rashes with pus; fungal infections.
• Bruising easily, bleeding into the skin.
• Overactive thyroid gland (which may cause symptoms like increased appetite, loss of weight, intolerance to heat, increased sweating, tremors, rapid heart rate); enlarged thyroid gland.
• Increase in number of red blood cells.
• Memory loss.
• Temporary reduced blood flow to the brain.
• Watery eyes.
• Blocked ears.
• Lack of blood flow through the heart blood vessels.
• Peptic ulcer in the small intestines.
• Red, swollen and sore skin; blistering skin; excessive sweating; hives.
• Muscle weakness.
• Swelling or irritation of the mucous membranes.
• Abnormal electrocardiogram (ECG), rapid and/or irregular heartbeat.
• Heart failure. Symptoms include shortness of breath or ankle swelling. Swelling in the lungs caused by fluid build-up.

The following side effects have been reported, but the frequency is not known:

• An enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall (aneurysms and artery dissections).

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of Fotivda.

• Store all medicines out of reach of children.
• Store at or below 25 °C.
• Store in the original container.
• Keep the container tightly closed to protect from moisture.
• Do not store in a bathroom.
• Do not use after the expiry date stated on the label or carton.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).