Reknib 100

Indications

Entrectinib is a targeted cancer medicine used to treat adults with advanced non-small cell lung cancer that is ROS1-positive, and adults and children with advanced solid tumours that carry an NTRK gene fusion (a specific genetic change), when other suitable treatments are not available. These genetic changes are confirmed by a laboratory test before treatment.

How It Works

Entrectinib is a tyrosine kinase inhibitor. Some cancers grow because of abnormal, always-switched-on proteins (TRK, ROS1 or ALK) caused by gene fusions. Entrectinib blocks these proteins, stopping the growth signals and slowing or shrinking the cancer. It can also reach the brain, so it may act on cancer that has spread there.

Dosage and Administration

Entrectinib capsules are taken by mouth once daily, with or without food, at about the same time each day, exactly as prescribed by the cancer specialist. The dose for children depends on body size. Swallow the capsules whole. If you vomit after a dose, do not take an extra dose; take the next dose at the usual time. Your doctor may lower the dose or pause treatment if side effects occur.

Interactions

• Strong or moderate CYP3A inhibitors such as Ketoconazole, Clarithromycin or Itraconazole: raise Entrectinib levels; avoid or reduce dose.
• CYP3A inducers such as Rifampicin, Carbamazepine, Phenytoin or St John's wort: lower levels and reduce effect; avoid.
• Grapefruit and grapefruit juice: avoid.
• Medicines that prolong the QT interval: added heart rhythm risk.

Contraindications

• Allergy to Entrectinib or any ingredient.

Side Effects

Common side effects include tiredness, change in taste, dizziness, constipation, diarrhoea, nausea, weight gain, swelling of the legs or hands, muscle and joint pain, tingling in hands and feet, blurred vision and shortness of breath. Entrectinib can also cause memory or mood changes, sleep problems, raised uric acid, liver problems, heart failure, heart rhythm changes and bone fractures.

Get urgent medical help if you have chest pain, fainting, a fast or irregular heartbeat, sudden breathlessness or swelling, confusion or hallucinations, yellowing of the skin or eyes, a fall with bone pain, or severe dizziness.

Pregnancy and Lactation

Entrectinib may harm an unborn baby. Women who could become pregnant should use effective contraception during treatment and for 5 weeks after the last dose, and men with partners who could become pregnant for 3 months after. It may reduce the effect of hormonal contraceptives, so a barrier method is also advised. Do not breastfeed during treatment and for 7 days after the last dose.

Precautions and Warnings

• Regular checks of liver tests, uric acid, heart function and ECG are needed.
• It may cause dizziness, blurred vision or confusion; do not drive or use machines if affected.
• Report any new bone pain or problems with walking.

Overdose

An overdose may increase side effects. Seek medical help at once and bring the pack with you.

Therapeutic Class

Antineoplastic, tyrosine kinase inhibitor (TRK, ROS1 and ALK inhibitor).

Storage

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