Ivosenib

Indications

Ivosidenib is a targeted cancer medicine used for certain cancers that carry a change (mutation) in a gene called IDH1, confirmed by a laboratory test. Uses include acute myeloid leukaemia (AML), a fast-growing blood cancer, either newly diagnosed in people who cannot have intensive chemotherapy or when the disease has come back or not responded, as well as some other IDH1-mutated cancers such as cholangiocarcinoma (bile duct cancer) and myelodysplastic syndromes.

How It Works

The faulty IDH1 enzyme produces a substance called 2-hydroxyglutarate, which stops immature cancer cells from maturing into normal cells. Ivosidenib blocks this faulty enzyme. Levels of the substance fall, and the abnormal cells can mature or stop growing.

Dosage and Administration

Take exactly as prescribed by your cancer specialist (oncologist or haematologist). Tablets are taken by mouth once a day at about the same time, with or without food, but not with a high-fat meal, which raises the amount absorbed. Swallow whole; do not split, crush or chew. Treatment usually continues for months as long as it helps and side effects are manageable.

Interactions

Strong CYP3A4 inhibitors such as Ketoconazole, Itraconazole, Clarithromycin and Ritonavir raise ivosidenib levels; strong inducers such as Rifampicin, Carbamazepine, Phenytoin and St John's wort lower them. Avoid other medicines that prolong the QT interval (a heart rhythm measure), such as some antibiotics, antifungals and antinausea drugs, unless the doctor agrees. Ivosidenib may reduce the effect of some hormonal contraceptives. Avoid grapefruit and grapefruit juice.

Contraindications

Do not take if you are allergic to ivosidenib or any ingredient, or together with strong CYP3A4 inducers. It is avoided in people with uncorrected long QT syndrome.

Side Effects

Common effects include tiredness, joint pain, diarrhoea, nausea, swelling of the legs, cough, rash, reduced appetite and changes in blood tests.

Get urgent medical help for signs of differentiation syndrome, a serious reaction that can occur in AML, such as fever, breathlessness, cough, chest pain, rapid weight gain or swelling, dizziness or reduced urine. Also seek help at once for fainting or a fast or irregular heartbeat, and for numbness, tingling or weakness spreading in the arms or legs or difficulty breathing (possible Guillain-Barré syndrome).

Pregnancy and Lactation

Ivosidenib may harm an unborn baby. Women who could become pregnant should use effective non-hormonal or additional contraception during treatment and for at least 1 month after the last dose, as advised by the doctor. Do not breastfeed during treatment and for 1 month after the last dose.

Precautions and Warnings

ECG (heart tracing), blood counts, blood salts (potassium, magnesium) and liver tests are checked before and during treatment. Report any new medicines to your specialist. Care is needed in heart disease and severe liver or kidney disease. Do not stop or change the dose yourself.

Overdose

Overdose may increase side effects, especially heart rhythm problems. Get medical help at once; the heart is monitored and treatment is supportive.

Therapeutic Class

Antineoplastic, targeted therapy (IDH1 inhibitor).

Storage

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