Pelex 45

Indications

Ponatinib is a targeted cancer medicine used in adults with chronic myeloid leukaemia (CML) in any phase, and Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL), when other similar medicines have not worked or cannot be used, or when the leukaemia carries a specific change called the T315I mutation.

How It Works

In these leukaemias, an abnormal gene (BCR ABL) produces an overactive enzyme, a tyrosine kinase, that drives the uncontrolled growth of leukaemia cells. Ponatinib blocks this enzyme, including forms with mutations that make other medicines stop working. This slows or stops the growth of leukaemia cells.

Dosage and Administration

Ponatinib must be taken exactly as prescribed by a specialist in blood cancers. It is taken by mouth once a day, with or without food, swallowed whole. The doctor often lowers the dose once a good response is reached, to reduce the risk of side effects, and may pause or change the dose based on blood tests and side effects. Do not change or stop the dose yourself.

Interactions

• Strong CYP3A4 blockers such as Ketoconazole, Itraconazole, Clarithromycin and grapefruit juice raise Ponatinib levels; the dose may need lowering.
• Strong CYP3A4 inducers such as Rifampicin, Carbamazepine, Phenytoin and St John's Wort lower its effect and should be avoided.
• Blood thinners and antiplatelet medicines increase bleeding risk.
• It may raise levels of some other medicines; tell your doctor about all medicines you take.

Contraindications

• Allergy to Ponatinib.
• Use is carefully weighed in people with a history of heart attack, stroke or blood clots, uncontrolled high blood pressure or severe heart disease.

Side Effects

Common side effects include high blood pressure, skin rash and dry skin, stomach pain, constipation, headache, joint and muscle pain, tiredness, low blood counts and raised pancreatic or liver enzymes. Serious risks include narrowing or blockage of arteries (which can cause heart attack, stroke or poor blood flow to the legs), blood clots in veins, heart failure, liver damage, pancreatitis, bleeding and fluid retention.

Get urgent medical help if you have chest pain or pressure, sudden weakness or numbness on one side, trouble speaking, sudden vision loss, pain or coldness in a leg, sudden breathlessness or swelling, severe stomach pain, yellowing of the skin or eyes, unusual bleeding, or fever.

Pregnancy and Lactation

Ponatinib may harm an unborn baby. Women who could become pregnant should use effective contraception during treatment and for at least 3 weeks after the last dose. Do not breastfeed during treatment and for at least 6 days after the last dose.

Precautions and Warnings

• Blood pressure, heart function, blood counts, liver and pancreatic tests will be monitored regularly.
• Tell your doctor about any heart disease, stroke, blood clots, diabetes or high cholesterol.
• It may slow wound healing; it is usually stopped before major surgery.
• Report vision changes promptly.

Overdose

Overdose may cause severe side effects including heart rhythm problems and low blood counts. Seek emergency medical help straight away. Treatment is supportive with monitoring.

Therapeutic Class

Anticancer medicine; BCR ABL tyrosine kinase inhibitor.

Storage

Store below 30°C in a dry place, away from light and out of the reach of children.