Ponatinib - Oral

Ponatinib is used to treat certain types of chronic myeloid leukaemia (a type of cancer where the bone marrow produces too many white blood cells called granulocytes) and acute lymphoblastic leukaemia (a type of cancer where there are too many immature white blood cells in the blood and bone marrow).

This medicine is used for those who are no longer benefiting from or intolerant of previous treatment or those who have a gene mutation called T315I.

Take Ponatinib exactly as directed by your doctor or according to the instructions on the label. Do not take more or less than instructed by your doctor.

You may take this medicine with or without food. Try to take it at the same time each day.

Swallow the tablet whole with a glass of water. Do not crush or dissolve the tablet.

The dose of this medicine will be decided by your doctor. Your doctor will advise you on the treatment timeframe depending on your condition and response to the medication.

Ponatinib must be taken regularly for it to be effective. Continue taking this medicine even when you feel better. Do not stop taking it unless instructed by the doctor.

If you miss a dose, skip the missed dose and return to your normal dosing schedule.

DO NOT double a dose under any circumstances.

If you often forget to take your medicine, let your doctor and pharmacist know.

Inform your doctor if you have the following conditions:

• history of heart disease
• high blood pressure
• diabetes
• high cholesterol levels in the blood
• pancreatitis (inflammation of the pancreas)
• liver disease
• kidney disease
• hepatitis B (contagious liver infection caused by a virus that is spread through contact with infected blood or other body fluids)

Let your doctor know if you are pregnant or planning to become pregnant.

It is important that you do not get pregnant while being treated with Ponatinib. Both men and women must use proven birth control methods during Ponatinib therapy. You may wish to discuss birth control methods with your doctor or pharmacist.

If you are breastfeeding, inform your doctor. You should not breastfeed during treatment.

Why is it important to keep my appointments with the doctor?

Keep your appointments with your doctor. Your doctor needs to monitor your condition and check your response to the medication regularly.

• Pregnancy and hepatitis B screening tests must be done before treatment to know if this medicine is suited for you to take.
• Routine tests (e.g. liver and heart function, uric acid levels, electrolyte levels, complete blood count, eye examination) may be done while you are being treated with this medicine. Your doctor will advise you about how often you need to have these tests.
• Regular monitoring of signs of liver problems, bleeding, heart problems and stomach problems may also be needed.

Ponatinib may cause dizziness, tiredness, or blurred vision. If affected, do not drive or take part in any activity in which you need to be alert or need to see clearly.

Other side effects include any of the following: headache, diarrhoea, vomiting, constipation, nausea, stomach pain, muscle or joint pain, and hot flushes.

Some side effects may need immediate medical help. Alert your doctor quickly if you experience any of the following:

• pain, swelling and tenderness in your leg accompanied by redness and warmth
• weakness or numbness on one side of the body, trouble speaking, vision problems, changes in balance or coordination
• shortness of breath, chest pain, cough which may contain blood
• unusual bleeding or bruising
• pass out bloody or black as tar stools and vomiting blood or ground coffee-like material
• yellowing of the skin or eyes, abdominal pain, dark coloured urine, tiredness, swelling in the legs and ankles
• pain or difficulty in passing urine, change in how much urine is passed, blood in the urine

Ponatinib will cause the level of your red blood cells, white blood cells and platelets to drop.

Red blood cells carry oxygen around your body. A fall in the level of red blood cells may make you feel tired and worn out.

White blood cells help your body to fight infections. A fall in the level of your white blood cells may put you at higher risk for infections, such as coughs, colds and flu, which may lead to more serious infections. Avoid crowded places and people who are sick. Alert your doctor if you have a fever, cough or flu that does not go away.

Platelets help your blood to clot when there is a cut in the skin. A fall in the level of your platelets may put you at risk of bleeding more than usual. Do not take part in activities where you may fall or get injured, such as contact sports. Alert your doctor if you get any unusual bruising (large bruises or several bruises, especially if the bruises appeared on their own) or bleeding that takes a long time to stop (for example, too much bleeding when you floss or brush your teeth).

Inform your doctor if any of these side effects do not go away or are severe, or if you experience other side effects.

Inform your doctor and pharmacist if you are taking any of these medicines:

• certain antibiotics e.g. clarithromycin
• medicines to treat fungal infection e.g. ketoconazole, itraconazole
• medicines for HIV infection e.g. ritonavir, nelfinavir, saquinavir
• medicines for epilepsy (fits or seizures) e.g. carbamazepine, phenobarbital, phenytoin
• nefazodone (medicine to treat depression)
• rifampicin (medicine to treat TB [lung infection known as tuberculosis])
• cholesterol-lowering medicines e.g. pravastatin, rosuvastatin
• digoxin (medicine for heart disease)
• methotrexate (other medicine for cancer)
• St. John's wort (herbal medicine)

This list does not include all medicines that may interact with Ponatinib.

Always notify your doctor and pharmacist if you are taking any other medicines, including herbal tonics such as traditional Chinese medicines, supplements, and medicines that you buy without a prescription.

Avoid alcohol.

Avoid excessive consumption of grapefruit or grapefruit juice (more than 1 litre a day).

Store in a cool, dry place away from the reach of children.

Medicines must not be used past the expiry date.

As Ponatinib is a cancer medicine, always return any unused or expired tablets to the clinic, hospital, or pharmacy for disposal. Do not throw it away in the household waste.