Ponatinib Incyte 15mg film-coated tablets

Ponatinib Incyte 15 mg film-coated tablets

Ponatinib Incyte 30 mg film-coated tablets

Ponatinib Incyte 45 mg film-coated tablets

ponatinib

Ponatinib Incyte is used to treat adults with the following leukaemia types who are no longer benefiting from treatment with other medicines, or have a certain genetic difference known as a T315I mutation:

• chronic myeloid leukaemia (CML): a blood cancer involving too many abnormal white blood cells in the blood and the bone marrow (where blood cells are formed).
• Philadelphia-chromosome positive acute lymphoblastic leukaemia (Ph+ ALL): a type of leukaemia involving too many immature white blood cells in the blood and blood forming bone marrow. In this kind of leukaemia, some of the DNA (genetic material) has become rearranged to form an abnormal chromosome, the Philadelphia chromosome.

Ponatinib Incyte belongs to a group of medicines called tyrosine kinase inhibitors. In patients with CML and Ph+ ALL, changes in the DNA trigger a signal that tells the body to produce abnormal white blood cells. Ponatinib Incyte blocks this signal, thereby stopping the production of these cells.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Ponatinib Incyte therapy should be prescribed by a doctor experienced in leukaemia treatment.

Ponatinib Incyte is available as:

• a 45 mg film-coated tablet for the recommended dose.
• a 15 mg film-coated tablet and a 30 mg film-coated tablet to allow for dose adjustments.

The recommended starting dose is one 45 mg film-coated tablet once daily.

Your doctor may reduce your dose or tell you to temporarily stop taking Ponatinib Incyte if:

• an appropriate response to the treatment is reached
• the number of white blood cells called neutrophils is reduced.
• the number of blood platelets is reduced.
• a severe side effect occurs, not affecting the blood
  • pancreas inflammation.
  • increased levels of the serum proteins lipase or amylase.
• you develop heart or blood vessel problems.
• you have a liver disorder.

Ponatinib Incyte use may be resumed at the same, or a reduced dose, after the event is resolved or controlled. Your doctor may evaluate your response to the treatment at regular intervals.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Patients aged 65 and over are more likely to be affected by side effects.

Seek medical attention immediately if you experience any of the following serious side effects.

If abnormal results from blood tests are received, a doctor should be contacted immediately.

Serious side effects (common: may affect up to 1 in 10 people):

• lung infection (may cause breathing difficulty)
• pancreas inflammation. Inform your doctor immediately if pancreas inflammation occurs. Symptoms are severe pain in the stomach and back.
• fever, often with other signs of infection due to decreased number of white blood cells
• heart attack (symptoms include: sudden feeling of increased heart rate, chest pain, breathlessness)
• changes in blood levels:
  • decreased number of red blood cells (symptoms include: weakness, dizziness, fatigue)
  • decreased number of blood platelets (symptoms include: increased tendency to bleed or bruise)
  • decreased number of white blood cells called neutrophilis (symptoms include: increase tendency of infection)
  • increased level of the serum protein known as lipase
• a heart rhythm disorder, abnormal pulse
• heart failure (symptoms include: weakness, fatigue, swollen legs)
• uncomfortable pressure, fullness, squeezing or pain in the centre of the chest (Angina pectoris) and chest pain not in connection with the heart
• high blood pressure
• narrowing of the arteries in the brain
• problems of the blood vessels in the heart muscle
• blood infection
• swollen, or red area of skin that feels hot and tender (cellulitis)
• dehydration
• breathing difficulties
• fluid in the thorax (may cause breathing difficulty)
• diarrhoea
• blood clot in a deep vein, sudden vein obstruction, blood clot in a blood vessel of the lung (symptoms include: hot flush, flushing, redness of the face, breathing difficulty)
• stroke (symptoms include: difficulty to speak or move, sleepiness, migraine, abnormal sensations)
• blood circulation problems (symptoms include: pain in the legs or arms, coldness of the extremities of the limbs)
• blood clot in the main arteries carrying blood to the head or neck (carotid artery)
• constipation
• sodium decrease in the blood
• increased tendency to bleed or bruise

Other possible side effects that may occur with the following frequencies are:

Very common side effects (may affect more than 1 in 10 people):

• upper airway infection (may cause breathing difficulty)
• decreased appetite
• insomnia
• headache, dizziness
• cough
• diarrhoea, vomiting, nausea
• increased blood levels of several liver enzymes called:
  • alanine aminotransferase
  • aspartate aminotransferase
• rash, dry skin, itching
• pain in bones, joints, pain in muscles, back, arms or legs, muscle spasms
• fatigue, accumulation of fluid in arms and/or legs, fever, pain

Common side effects (may affect up to 1 in 10 people):

• inflammation of hair follicles, swollen, red area of skin or underneath skin that feels hot and tender
• decreased activity of thyroid gland
• fluid retention
• low calcium, phosphate or potassium levels in the blood
• increased blood sugar or uric acid levels in the blood, high blood fat values of triglycerides
• weight loss
• mini stroke
• nerve disorder in the arms and/or legs (often causes numbness and pain in the hands and feet)
• lethargy, migraine
• increased or reduced sense of touch or sensation, abnormal sensation such as prickling, tingling and itchiness
• blurred vision, dry eye, infection in the eye, visual disturbance
• tissue swelling in eyelid or around the eyes, caused by excess fluid
• palpitation
• pain in one or both legs when walking or exercising, which disappears after some minutes of rest
• hot flush, flushing
• nosebleed, difficulty producing voice sounds, hypertension in the lungs
• increased blood levels of liver and pancreatic enzymes:
  • amylase
  • alkaline phosphatase
  • gamma-glutamyltransferase
• heartburn caused by reflux of stomach juices, inflammation in the mouth, abdominal swelling or discomfort or indigestion, dry mouth
• stomach bleeding (symptoms include: stomach pain, vomiting blood)
• increased blood level of bilirubin - the yellow breakdown substance of the blood pigment (symptoms include: dark amber urine)
• pain in skeletal system or neck
• skin rash, peeling of the skin, abnormal thickening of the skin, redness, bruising, skin pain, changes in skin colour, hair loss
• tissue swelling in face caused by excess fluid
• night sweats, increased sweating
• inability to develop or maintain an erection
• chills, flu-like illness

Uncommon side effects (may affect up to 1 in 100 people):

• metabolic disorders caused by the break-down products of dying cancer cells
• bleeding in the brain
• obstruction of the blood vessels in the eye
• heart problems, left sided chest pain, dysfunction of the left heart chamber
• narrowing of the blood vessels, poor blood circulation, sudden increase in blood pressure
• renal artery stenosis (narrowing of the blood vessels to one or both kidneys)
• circulatory problems in the spleen
• liver damage, jaundice (symptoms include: yellowing of the skin and eyes)
• headache, confusion, seizures, and loss of vision, which may be symptoms of a brain condition known as posterior reversible encephalopathy syndrome (PRES).

Rare side effects (may affect up to 1 in 1000 people):

• painful red lumps, skin pain, skin reddening (inflammation of fatty tissue under the skin)

Not known (frequency cannot be estimated from the available data):

• recurrence (reactivation) of Hepatitis B infection when you have had hepatitis B in the past (a liver infection).
• troubling skin rashes involving blisters or peeling and spread across the body, and involving tiredness. Inform your doctor immediately if you experience these symptoms.
• an enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall (aneurysms and artery dissections).

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the bottle label and carton after EXP. The expiry date refers to the last day of that month.

Store in the original container in order to protect from light.

The bottle contains one sealed plastic canister containing a molecular sieve desiccant. Keep the canister in the bottle. Do not swallow the desiccant canister.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.