Venetomed 50mg Tablet is used for:

• Chronic lymphocytic leukaemia (CLL): A type of blood cancer affecting lymphocytes, a type of white blood cell. Venetoclax may be used alone or in combination with other anticancer medicines.

• Acute myeloid leukaemia (AML): A rapidly progressing blood and bone marrow cancer. Venetoclax is used in combination with medicines such as Azacitidine, Decitabine or low-dose Cytarabine in eligible adults who are unsuitable for intensive chemotherapy.

The doctor decides whether this medicine is appropriate, along with the treatment combination, dose and duration. Approved indications may vary by country.

Venetomed 50mg Tablet contains Venetoclax, which blocks a protein called B-cell lymphoma 2 (BCL-2). This protein helps certain cancer cells survive by preventing their natural death.

By blocking BCL-2, Venetoclax allows cancer cells to undergo a natural process of cell death called apoptosis. This helps reduce the number of cancer cells and control the progression of the disease.

Some medicines can change the amount of Venetoclax in the body, increasing the risk of side effects or reducing its effectiveness. Tell your doctor about all prescription medicines, over-the-counter medicines, vitamins and herbal supplements you take.

• Strong CYP3A inhibitors: Medicines such as Itraconazole, Ketoconazole, Clarithromycin and Posaconazole can increase Venetoclax levels and the risk of toxicity. Some combinations are contraindicated during the initial dose-escalation phase.

• Moderate CYP3A inhibitors: Medicines such as Fluconazole, Diltiazem and Verapamil can increase Venetoclax exposure and may require dose adjustments.

• CYP3A inducers: Medicines such as Rifampicin and Carbamazepine can lower Venetoclax levels and reduce its effectiveness. Their use together should generally be avoided.

• P-glycoprotein (P-gp) inhibitors: These medicines can increase Venetoclax levels and the risk of side effects. Your doctor may need to adjust the dose and monitor you more closely.

• Warfarin: Venetoclax may increase Warfarin exposure and the risk of bleeding. More frequent monitoring of blood clotting (INR) may be required.

• St John's wort: This herbal supplement can reduce Venetoclax levels and should not be used during treatment.

Avoid grapefruit, Seville oranges and starfruit during treatment, as they can increase Venetoclax levels.

Do not start, stop or change any medicine without consulting your doctor.

• Store Venetomed 50mg Tablet according to the instructions provided on the product packaging.

• Keep the tablets in their original packaging until required.

• Keep the medicine out of the sight and reach of children.

• Do not use the medicine after its expiry date.

Product-specific Indian packaging instructions should be confirmed before publication. The EMA information for Venclyxto 50mg tablets does not specify special storage conditions.

• Take Venetomed 50mg Tablet exactly as prescribed by your doctor.

• Swallow the tablet whole with water. Do not crush, chew or break it.

• Take the tablet with a meal, at approximately the same time each day.

• The dose is usually increased gradually according to a prescribed schedule to reduce the risk of tumour lysis syndrome (TLS).

• The treatment schedule and total daily dose depend on the type of blood cancer and other medicines used alongside Venetoclax.

• Drink adequate fluids as advised by your doctor, particularly during the initial dose-escalation period.

• Attend all scheduled blood tests and monitoring appointments.

• Do not stop treatment, change the dose or take an additional tablet without medical advice.

Important: The 50 mg strength is used as part of certain dose-escalation schedules. It does not mean that every patient should take one 50 mg tablet daily. Follow your individual treatment plan.

Venetomed 50mg Tablet may cause side effects in some people, although not everyone experiences them. The side effects may vary depending on the treatment combination.

Common side effects

• Low white blood cell count (neutropenia)

• Low platelet count (thrombocytopenia)

• Anaemia

• Nausea

• Diarrhoea

• Constipation

• Vomiting

• Fatigue

• Upper respiratory tract infections

• Cough

• Fever

• Swelling (oedema)

Some side effects can affect blood cell counts and increase the risk of infections. Regular blood tests help your doctor monitor these changes.

Serious side effects

Seek immediate medical attention if you experience symptoms of the following serious conditions:

• Tumour lysis syndrome (TLS): Rapid breakdown of cancer cells can cause changes in blood electrolytes and affect kidney function. Symptoms may include nausea, vomiting, muscle cramps, weakness, irregular heartbeat or seizures.

• Severe infections: Fever, chills, persistent cough or other signs of infection may indicate a serious infection, particularly when white blood cell counts are low.

• Severe bleeding: Unusual bruising, prolonged bleeding, blood in the urine or stools, or other signs of bleeding may occur with low platelet counts.

• Severe anaemia: Unusual tiredness, weakness, breathlessness or dizziness may indicate a significant reduction in red blood cells.

Contact your doctor promptly if you develop any unusual or worsening symptoms.

• Follow the prescribed dose-escalation schedule carefully. Do not increase the dose on your own.

• Attend scheduled blood tests, particularly during the initial weeks of treatment, to monitor blood cell counts, kidney function and electrolyte levels.

• Maintain adequate hydration as advised by your doctor to help reduce the risk of tumour lysis syndrome.

• Report fever, chills or signs of infection promptly, as Venetoclax can lower white blood cell counts.

• Inform your doctor about all medicines and herbal supplements you take before starting treatment.

• Avoid grapefruit, Seville oranges and starfruit during treatment.

• Do not receive live vaccines during treatment without discussing vaccination safety with your doctor.

• Use effective contraception during treatment and follow your doctor's advice about pregnancy planning.

• Do not take an extra dose if you vomit after taking the medicine. Contact your doctor or pharmacist for guidance.