Giltela

Indications

Gilteritinib is a targeted cancer medicine used to treat adults with acute myeloid leukaemia (AML), a fast-growing blood cancer, when the cancer has come back or has not responded to earlier treatment and the cancer cells carry a change (mutation) in a gene called FLT3. A test is needed to confirm the FLT3 mutation before treatment.

How It Works

Gilteritinib is a kinase inhibitor. It blocks the FLT3 protein and a related protein called AXL, which send signals that make leukaemia cells grow and divide. Blocking these signals slows or stops the growth of the cancer cells and helps them die.

Dosage and Administration

Take exactly as prescribed by a cancer specialist (haematologist or oncologist). Tablets are taken by mouth once daily at about the same time each day, with or without food, swallowed whole with water. Do not break or chew them. Treatment usually continues for several months, and the doctor may pause or change the dose based on side effects and blood tests.

Interactions

Strong CYP3A inhibitors (such as Ketoconazole, Itraconazole, Clarithromycin, Ritonavir) can raise Gilteritinib levels, and strong inducers (such as Rifampicin, Carbamazepine, Phenytoin, St John's Wort) can lower them and should be avoided. Medicines that act on certain serotonin or P-gp pathways may also be affected. Medicines that prolong the QT interval (a heart rhythm measure) add to the risk. Tell your doctor about every medicine and supplement you use.

Contraindications

Do not use if you are allergic to Gilteritinib or any ingredient of the tablets.

Side Effects

Common side effects include tiredness, muscle and joint pain, diarrhoea or constipation, nausea, cough, swelling of the hands or feet, rash, raised liver enzymes, low blood counts and infections. Serious effects include differentiation syndrome (a reaction in which leukaemia cells release chemicals that cause fever, breathing difficulty, swelling and kidney problems), changes in heart rhythm, pancreatitis and a rare brain condition called PRES.

Get urgent medical help if you develop fever, difficulty breathing, rapid weight gain or swelling, chest pain, fainting or a fast or irregular heartbeat, severe stomach pain, seizures, sudden headache, confusion or vision changes.

Pregnancy and Lactation

Gilteritinib can harm an unborn baby. Women should have a pregnancy test before starting and use effective contraception during treatment and for at least 6 months after the last dose; men with partners who could become pregnant should use condoms during treatment and for at least 4 months after. Do not breastfeed during treatment and for 2 months after the last dose.

Precautions and Warnings

Regular blood tests, heart tracings (ECG) and checks of potassium and magnesium are needed. Tell your doctor about heart problems, liver or kidney disease, or a history of pancreatitis. Report any sign of infection quickly because blood counts may be low.

Overdose

There is no specific antidote. If too much has been taken, contact the treating doctor or hospital immediately for monitoring, including heart checks.

Therapeutic Class

Antineoplastic agent (FLT3 tyrosine kinase inhibitor).

Storage

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