Ventoxen Tablet

Indications

Venetoclax is a targeted cancer medicine taken by mouth. It is used in adults for:

• Chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL), alone or with other cancer medicines
• Acute myeloid leukaemia (AML), together with Azacitidine, Decitabine or low-dose Cytarabine, in people who cannot have intensive chemotherapy

It is prescribed and monitored by a cancer specialist (haematologist or oncologist).

How It Works

Cancer cells in these blood cancers make too much of a protein called BCL-2, which stops them from dying naturally. Venetoclax blocks BCL-2, so the cancer cells die and the number of cancer cells falls.

Dosage and Administration

Take exactly as prescribed. Treatment starts with a low dose that is raised step by step over several weeks (called the ramp-up), to lower the risk of tumour lysis syndrome (see Side Effects). The final dose depends on the type of cancer and the other medicines used.

• Take once a day at about the same time, with a meal and water.
• Swallow the tablets whole; do not chew, crush or break them.
• Drink plenty of water (about 1.5 to 2 litres a day) starting 2 days before the first dose and on each day the dose is increased, or as the doctor advises.
• If you miss a dose or vomit after taking it, follow the leaflet or ask your doctor or pharmacist. Never take two doses to make up.
• Avoid grapefruit, Seville oranges and starfruit during treatment.

Interactions

• Strong CYP3A inhibitors such as Ketoconazole, Itraconazole, Posaconazole, Voriconazole, Clarithromycin and Ritonavir greatly raise Venetoclax levels. In CLL they must not be started with or during the ramp-up; at other times the dose must be reduced.
• Moderate inhibitors such as Fluconazole, Erythromycin, Diltiazem and Verapamil also need dose changes.
• Rifampicin, Carbamazepine, Phenytoin and St John's wort lower Venetoclax levels and should be avoided.
• It can raise levels of Digoxin and may affect Warfarin; monitoring is needed.
• Live vaccines should not be given during treatment.

Always tell the specialist about every medicine and herbal product you take.

Contraindications

• Allergy to Venetoclax or any ingredient
• Use of strong CYP3A inhibitors at the start of treatment and during the ramp-up (CLL)
• Products containing St John's wort

Side Effects

Common: low white blood cells (neutropenia), anaemia, low platelets, infections such as pneumonia, diarrhoea, nausea, vomiting, constipation and tiredness.

Get urgent medical help if you notice signs of tumour lysis syndrome (a sudden release of cancer cell contents into the blood, most likely in the first weeks):

• Fever or chills, nausea or vomiting, confusion, shortness of breath
• Fits, irregular heartbeat, muscle cramps or joint pain
• Dark or cloudy urine, or much less urine

Also get urgent help for fever, chills or other signs of infection, and for unusual bleeding or bruising.

Pregnancy and Lactation

Venetoclax may harm an unborn baby. Women who could become pregnant should have a pregnancy test before starting and use effective contraception during treatment and for at least 30 days after the last dose. Hormonal contraceptives may be less reliable, so a barrier method is also advised. Do not breastfeed during treatment. It may affect male fertility; men can ask about sperm storage before starting.

Precautions and Warnings

• Regular blood tests are needed, especially during the ramp-up, to check for tumour lysis syndrome and blood counts.
• Tell the doctor about kidney or liver problems, as the risk of side effects may be higher.
• Infections can be serious; report fever promptly.
• Do not have live vaccines during or soon after treatment.
• It can cause tiredness; take care when driving.

Overdose

If too much is taken, contact the doctor or go to hospital at once. There is no specific antidote; blood counts and signs of tumour lysis syndrome are closely monitored and treated.

Therapeutic Class

Antineoplastic (cancer medicine); BCL-2 inhibitor.

Storage

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