Ventoxen venetoclax 100mg

Product Name: Venetoclax

Specification: 100 mg × 60 tablets/box

Manufacturer: Everest Pharmaceuticals

VENCLEXTA (Venetoclax)

Venetoclax is provided in the form of tablets for oral administration, containing 100 mg of venetoclax as the active ingredient.

[Indications]

VENCLEXTA (Venetoclax) is indicated for the treatment of patients with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy.

[Recommended Dosage]

Instruct patients to take VENCLEXTA (Venetoclax) tablets daily at approximately the same time, with food and water. VENCLEXTA (Venetoclax) tablets should be swallowed whole; they should not be chewed, crushed, or broken prior to swallowing.

All VENCLEXTA (Venetoclax) treatment regimens begin with a 5-week dose escalation schedule.

Venclexta 5-Week Dose Escalation Schedule

Assess the patient's risk level for Tumor Lysis Syndrome (TLS) based on patient-specific factors, and provide prophylactic hydration and anti-hyperuricemic agents to the patient prior to the first dose of VENCLEXTA (Venetoclax) to reduce the risk of TLS.

The recommended daily dosage of VENCLEXTA (Venetoclax) is 400 mg.

The 5-week dose escalation schedule is designed to gradually reduce tumor burden (debulk) and minimize the risk of TLS. Week 1: Daily dose of VENCLEXTA 20 mg

Week 2: Daily dose of VENCLEXTA 50 mg

Week 3: Daily dose of VENCLEXTA 100 mg

Week 4: Daily dose of VENCLEXTA 200 mg

Week 5: Daily dose of VENCLEXTA 400 mg

For CLL/SLL, VENCLEXTA should be administered according to the 4-week ramp-up schedule using the starter pack (containing 10 mg and 50 mg tablets). Upon completion of the ramp-up phase, 100 mg tablets should be used to achieve the full daily dose of 400 mg.

Venclexta in Combination with Rituximab

Rituximab administration should begin after the patient has completed the 5-week VENCLEXTA ramp-up schedule and has received the 400 mg daily dose of VENCLEXTA for 7 days.

Rituximab is administered on Day 1 of each 28-day cycle for a total of 6 cycles: 375 mg/m² intravenously for Cycle 1, and 500 mg/m² intravenously for Cycles 2 through 6.

Patients should continue to take VENCLEXTA 400 mg orally once daily, starting from Day 1 of Cycle 1 of rituximab treatment, for a total duration of 24 months.

Venclexta as Monotherapy

After the patient has completed the 5-week ramp-up schedule, the recommended dose of VENCLEXTA is 400 mg taken orally once daily. VENCLEXTA (venetoclax) should be taken orally once daily until disease progression or unacceptable toxicity is observed.

**Risk Assessment and Prevention of Tumor Lysis Syndrome**

VENCLEXTA (venetoclax) can cause rapid reduction in tumor burden, thereby posing a risk of Tumor Lysis Syndrome (TLS) during the initial 5-week ramp-up phase. Changes in blood chemistry consistent with TLS require prompt management and should be monitored 6 to 8 hours after the first dose of VENCLEXTA (venetoclax) and at each dose increase.

The risk of TLS exists on a continuum based on multiple factors, including tumor burden and comorbidities. Reduced renal function (creatinine clearance [CrCl] <80 mL/min) further increases this risk. Assess tumor burden, including by radiologic evaluation (e.g., CT scan); assess blood chemistry (potassium, uric acid, phosphorus, calcium, and creatinine) in all patients; and correct pre-existing abnormalities prior to initiating treatment with VENCLEXTA (venetoclax). As tumor burden decreases, the risk may decrease.

**Dose Adjustments Based on Toxicity**

Dose interruption or reduction for toxicity: Refer to Tables 3 and 4 for recommended dose modifications for VENCLEXTA (venetoclax)-related toxicities. For patients who interrupt dosing for more than 1 week during the initial 5-week ramp-up phase, or for more than 2 weeks after completing the ramp-up phase, re-assess the risk of TLS to determine if re-initiation at a reduced dose is required (e.g., at a lower level of the ramp-up schedule).

**VENCLEXTA (venetoclax) Dose Adjustments**

**Dose Adjustments for CYP3A and P-gp Inhibitors**

Concomitant use of VENCLEXTA (venetoclax) with strong CYP3A inhibitors is contraindicated during the initiation and ramp-up phases. Concomitant use of VENCLEXTA (venetoclax) with strong CYP3A inhibitors increases VENCLEXTA (venetoclax) exposure (i.e., Cmax and AUC) and may increase the risk of TLS during the initiation and ramp-up phases. For patients who have completed the ramp-up phase and are on a stable daily dose of VENCLEXTA (venetoclax), reduce the VENCLEXTA dose by at least 75% when strong CYP3A inhibitors must be co-administered.

Avoid the concomitant use of VENCLEXTA with moderate CYP3A inhibitors or P-gp inhibitors. Consider alternative therapies. If a moderate CYP3A inhibitor or P-gp inhibitor must be used, reduce the VENCLEXTA dose by at least 50%. Monitor these patients more closely for signs of toxicity.

Resume the VENCLEXTA dose used prior to initiating the CYP3A inhibitor or P-gp inhibitor 2 to 3 days after discontinuing the inhibitor.

[Missed Dose]

If a patient misses a dose of VENCLEXTA within 8 hours of the usual scheduled time, the patient should take the missed dose as soon as possible and resume the normal daily dosing schedule. If a patient misses a dose by more than 8 hours, the patient should not take the missed dose and should resume the usual dosing schedule the following day.

If a patient vomits after dosing, an additional dose should not be taken on that day. The next prescribed dose should be taken at the regularly scheduled time.

[Storage Conditions]

Store at a temperature of 86°F (30°C) or below. [Side Effects]

The following serious adverse events are discussed in greater detail in other sections of the labeling:

Tumor Lysis Syndrome

[Product Specifications]

Product Name: Ventoxen (Venetoclax) Tablets | Everest Pharmaceuticals | Venetoclax 100 mg * 60 Tablets/Box

Generic Name: Venetoclax

Composition: Venetoclax

Dosage Form: Tablets

Specification: 100 mg * 60 tablets/box

Manufacturer: Everest Pharmaceuticals

Indications: Indicated for the treatment of patients with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy.

Dosage and Administration: Instruct patients to take VENCLEXTA (venetoclax) tablets daily at approximately the same time, with food and water. VENCLEXTA tablets should be swallowed whole; they should not be chewed, crushed, or broken prior to swallowing.

All VENCLEXTA treatment regimens begin with a 5-week ramp-up phase.

Venclexta 5-Week Dose Ramp-Up Schedule

Assess the patient-specific risk level for Tumor Lysis Syndrome (TLS) and provide prophylactic hydration and anti-hyperuricemic agents to the patient prior to the first dose of VENCLEXTA to reduce the risk of TLS.

The recommended daily dosage of VENCLEXTA is 400 mg.

The 5-week ramp-up schedule is designed to gradually reduce tumor burden (debulk) and minimize the risk of TLS. Week 1: Daily dose of VENCLEXTA (venetoclax) 20 mg

Week 2: Daily dose of VENCLEXTA (venetoclax) 50 mg

Week 3: Daily dose of VENCLEXTA (venetoclax) 100 mg

Week 4: Daily dose of VENCLEXTA (venetoclax) 200 mg

Week 5: Daily dose of VENCLEXTA (venetoclax) 400 mg