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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 Tablet is indicated for:
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
The starting dose is 20 mg of Venetoclax once daily for 7 days. The dose must be gradually increased over a period of 5 weeks up to the daily dose of 400 mg. The 5-week dose-titration schedule is designed to gradually reduce tumour burden (debulk) and decrease the risk of tumor lysis syndrome.Post-titration dose for Venetoclax in combination with Rituximab: The recommended dose of Venetoclax in combination with Rituximab is 400 mg once daily. Rituximab should be administered after the patient has completed the dose-titration schedule and has received the recommended daily dose of 400 mg Venetoclax for 7 days. Venetoclax should be taken for 24 months from Cycle 1 Day 1 of Rituximab.Post-titration dose for Venetoclax monotherapy: The recommended dose of Venetoclax is 400 mg once daily. Treatment should be continued until disease progression or no longer tolerated by the patient.
Side Effects
The most commonly occurring side effects (>20%) of any grade in patients receiving Venetech in the combination study with Rituximab were neutropenia, diarrhoea, and upper respiratory tract infection. In the monotherapy studies, the most common side effects were neutropenia/neutrophil count decreased, diarrhoea, nausea, anaemia, fatigue, and upper respiratory tract infection. The most frequently reported serious side effects (>2%) in patients receiving Venetech in combination with Rituximab were pneumonia, febrile neutropenia, and TLS. In the monotherapy studies, the most frequently reported serious side effects (>2%) were pneumonia and febrile neutropenia.
Cautions & Contraindications
Warnings & Precautions
Tumour lysis syndrome: Tumour lysis syndrome, including fatal events, has occurred in patients with previously treated CLL with high tumour burden when treated with Venetech. Venetech can cause rapid reduction in tumour, and thus poses a risk for TLS in the initial 5-weeks dose-titration phase. Changes in electrolytes consistent with TLS that require prompt management can occur as early as 6 to 8 hours following the first dose of Venetech and at each dose increase. The risk of TLS is a continuum based on multiple factors, including comorbidities. Patients with high tumour burden (e.g., any lymph node with a diameter >5 cm or high ALC >25 x 109/1) are at greater risk of TLS when initiating enetoclax. Reduced renal function (CrCI <80 ml/min) further increases the risk. Patients should be assessed for risk and should receive appropriate prophylaxis for TLS, including hydration and anti-hyperuricaemics. Blood chemistries should be monitored and abnormalities managed promptly. Dosing should be interrupted if needed. More intensive measures (intravenous hydration, frequent monitoring, hospitalization) should be employed as overall risk increases. The instructions for "Prevention of tumour lysis syndrome" should be followed. Concomitant use of this medicinal product with strong or moderate CYP3A inhibitors increases Venetech exposure and may increase the risk for TLS at initiation and during the dose-titration phase. Also, inhibitors of P-gp or BCRP may increase Venetech exposure.Neutropenia: Grade 3 or 4 neutropenia has been reported in patients treated with Venetech in the combination study with Rituximab (G028667/MURANO) and in the monotherapy studies. Complete blood counts should be monitored throughout the treatment period. Dose interruptions or reductions are recommended for patients with severe neutropenia. Serious infections including events of sepsis with fatal outcome have been reported. Supportive measures including antimicrobials for any signs of infection should be considered.Immunization: The safety and efficacy of immunization with live attenuated vaccines during or following Venetech therapy have not been studied. Live vaccines should not be administered during treatment and thereafter until B-cell recovery.CYP3A inducers: Co-administration of CYP3A4 inducers may lead to decreased Venetech exposure and consequently a risk for lack of efficacy. Concomitant use of Venetech with strong or moderate CYP3A4 inducers should be avoided.Women of childbearing potential: Women of childbearing potential must use a highly effective method of contraception while taking Venetech.
Contraindications
Hypersensitivity to the active substance or to any of the excipients. Concomitant use of strong CYP3A inhibitors at initiation and during the dose-titration phase. Concomitant use of preparations containing St. John's wort