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Other brands with the same active ingredient
These brands contain the same active ingredient (Venetoclax). Same strength and form. Confirm the switch with your doctor or pharmacist.
Indications & Uses
Ventoxen 10 is indicated for:
Pharmacology
Venetoclax is a selective small-molecule inhibitor of BCL-2, an antiapoptotic protein, and it is taken by mouth with good bioavailability. In CLL cells, BCL-2 has been shown to be overexpressed. This helps the tumor cells survive and has been linked with resistance to chemotherapeutics.
Venetoclax binds directly to the BCL-2 protein and displaces pro-apoptotic proteins such as BIM. This triggers mitochondrial outer membrane permeabilization and activates caspases, and so the process of apoptosis is restored. In nonclinical studies, venetoclax showed cytotoxic activity in tumor cells that overexpress BCL-2.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Treatment with Venetoclax starts at 20 mg once daily for 7 days. After that, the dose is raised step by step over 5 weeks until it reaches a daily dose of 400 mg. This 5-week titration schedule is meant to reduce the tumour burden (debulking) gradually and to lower the risk of tumour lysis syndrome.
Post-titration dose for Venetoclax in combination with Rituximab: the recommended dose is 400 mg once daily. Rituximab should be given only after the patient has finished the titration schedule and has taken the full 400 mg daily dose of Venetoclax for 7 days. Venetoclax should then be taken for 24 months, counted from Cycle 1 Day 1 of Rituximab.
Post-titration dose for Venetoclax monotherapy: the recommended dose is 400 mg once daily. Treatment continues until the disease progresses or the patient can no longer tolerate it.
Side Effects
In the combination study with Rituximab, the side effects seen most often (in more than 20% of patients, of any grade) with Venetoclax were neutropenia, diarrhoea and upper respiratory tract infection. In the monotherapy studies, the commonest ones were neutropenia or a decreased neutrophil count, diarrhoea, nausea, anaemia, fatigue and upper respiratory tract infection. For serious side effects, the picture was a little different. Patients taking Venetoclax with Rituximab most often reported pneumonia, febrile neutropenia and TLS (in more than 2%). In the monotherapy studies, the serious side effects reported most often (also in more than 2%) were pneumonia and febrile neutropenia.
Cautions & Contraindications
Warnings & Precautions
Tumour lysis syndrome Tumour lysis syndrome (TLS), including fatal events, has occurred in patients with previously treated CLL who have a high tumour burden and were treated with Venetoclax. Venetoclax can reduce the tumour very quickly, so there is a risk of TLS in the initial 5-week dose-titration phase. Electrolyte changes that point to TLS and need prompt management can appear as early as 6 to 8 hours after the first dose, and again at each dose increase. The risk of TLS sits on a continuum and depends on several factors, including comorbidities. Patients with a high tumour burden (for example, any lymph node with a diameter >5 cm or a high ALC >25 x 109/1) are at greater risk when starting Venetoclax. Reduced renal function (CrCl <80 ml/min) raises the risk further. Each patient should be assessed for risk and should receive appropriate prophylaxis for TLS, including hydration and anti-hyperuricaemics. Blood chemistries should be monitored and any abnormalities managed promptly. Dosing should be interrupted if needed. As the overall risk increases, more intensive measures (intravenous hydration, frequent monitoring, hospitalization) should be used. The instructions for "Prevention of tumour lysis syndrome" should be followed. Using this medicine together with strong or moderate CYP3A inhibitors increases Venetoclax exposure and may raise the risk of TLS at initiation and during the dose-titration phase. Inhibitors of P-gp or BCRP may also increase Venetoclax exposure. Neutropenia Grade 3 or 4 neutropenia has been reported in patients treated with Venetoclax, both in the combination study with Rituximab (G028667/MURANO) and in the monotherapy studies. Complete blood counts should be monitored throughout the treatment period. For patients with severe neutropenia, dose interruptions or reductions are recommended. Serious infections, including sepsis with a fatal outcome, have been reported. Supportive measures, including antimicrobials for any sign of infection, should be considered. Immunization The safety and efficacy of immunization with live attenuated vaccines during or after Venetoclax therapy have not been studied. Live vaccines should not be given during treatment, and not afterwards until B-cell recovery. CYP3A inducers Giving CYP3A4 inducers at the same time may lower Venetoclax exposure, and so there is a risk that the medicine will not work as it should. Venetoclax should not be used with strong or moderate CYP3A4 inducers. Women of childbearing potential Women of childbearing potential must use a highly effective method of contraception while taking Venetoclax.
Contraindications
Venetoclax must not be given to anyone who is hypersensitive to the active substance or to any of the excipients. It must also not be used together with strong CYP3A inhibitors when treatment is starting and during the dose-titration phase. Preparations containing St. John's wort are not to be taken with venetoclax either.
Pregnancy & Breastfeeding
Women should avoid becoming pregnant while taking Venetoclax and for at least 30 days after treatment ends. So women who could become pregnant must use highly effective contraception during treatment and for 30 days after stopping. It isn't known yet whether Venetoclax lowers the effectiveness of hormonal contraceptives, so women using them should add a barrier method.
Animal studies of embryo-foetal toxicity suggest the medicine may harm the fetus when given to pregnant women. There is no adequate, well-controlled data from its use in pregnant women, and animal studies have shown reproductive toxicity. Venetoclax is not recommended during pregnancy, or for women who could become pregnant and are not using highly effective contraception.
It is unknown whether Venetoclax or its metabolites pass into human milk. A risk to the breast-feeding child can't be excluded, so breast-feeding should be stopped during treatment.
No human data are available on the effect on fertility. Testicular toxicity was seen in dogs at clinically relevant exposures, so male fertility may be compromised by treatment. Before starting, counselling on sperm storage may be considered for some male patients.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Use in Special Populations
Elderly: Venetoclax needs no specific dose adjustment in elderly patients (aged >65 years).
Renal impairment: Patients with mild or moderate renal impairment (CrCI >30 ml/min and <90 ml/min) don't need a dose adjustment. Those with reduced renal function (CrCI <80 ml/min) may need more intensive prophylaxis and monitoring, to reduce the risk of TLS at the start of treatment and during the dose-titration phase. Safety in patients with severe renal impairment (CrCI <30 ml/min) or on dialysis has not been established, and no recommended dose has been determined for them. Venetoclax should be given to patients with severe renal impairment only if the benefit outweighs the risk. They should be monitored closely for signs of toxicity, because the risk of TLS is increased.
Hepatic impairment: No dose adjustment is recommended for patients with mild or moderate hepatic impairment. Those with moderate hepatic impairment should be watched more closely for signs of toxicity at the start of treatment and during the dose-titration phase. For patients with severe hepatic impairment, a dose reduction of at least 50% throughout treatment is recommended, and they should also be monitored more closely for signs of toxicity.
Pediatric population: The safety and efficacy of Venetoclax in children aged less than 18 years have not been established. No data is available.
Overdose
There is no specific antidote for Venetoclax. If a patient takes an overdose, they should be watched closely and given suitable supportive treatment. During the dose-titration phase, treatment should be interrupted, and the patient should be monitored carefully for signs and symptoms of TLS along with other toxicities. These include fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness, muscle or joint pain, and abdominal pain and distension.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Keep Venetoclax below 30°C and away from moisture and light. Store it out of the sight and reach of children.
Drug Interactions
Common questions about Ventoxen 10 10 mg
What is Ventoxen 10 10 mg Tablet?
Ventoxen 10 10 mg Tablet is a medicine that contains Venetoclax. It is made by Everest Pharmaceuticals Ltd. It belongs to the Cytotoxic Chemotherapy group of medicines.
What is Ventoxen 10 used for?
Ventoxen 10 is used for: Cancer.
What are the side effects of Ventoxen 10?
In the combination study with Rituximab, the side effects seen most often (in more than 20% of patients, of any grade) with Venetoclax were neutropenia, diarrhoea and upper respiratory tract infection. In the monotherapy studies, the commonest ones were neutropenia or a decreased neutrophil count, diarrhoea, nausea, anaemia, fatigue and upper respiratory tract infection.
Can I take Ventoxen 10 during pregnancy or while breastfeeding?
Women should avoid becoming pregnant while taking Venetoclax and for at least 30 days after treatment ends. So women who could become pregnant must use highly effective contraception during treatment and for 30 days after stopping. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Ventoxen 10?
There is no specific antidote for Venetoclax. If a patient takes an overdose, they should be watched closely and given suitable supportive treatment. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Ventoxen 10?
Keep Venetoclax below 30°C and away from moisture and light. Store it out of the sight and reach of children.
Can I take other medicines with Ventoxen 10?
Some medicines can interact with Venetoclax, for example: Erythromycin, Carbamazepine, Fluconazole, Ciprofloxacin, Clarithromycin, Itraconazole. Tell your doctor or pharmacist about every medicine you take.
Do I need a prescription for Ventoxen 10?
Ventoxen 10 is a prescription (Rx) medicine. Take it as your doctor advises.