Veneta 50 mg (Venetoclax) Tablets

Veneta 50 mg (Venetoclax) Tablets—Targeted Therapy for Chronic Lymphocytic Leukemia (CLL)

Veneta 50 mg (Venetoclax) Tablets is an innovative targeted therapy designed to treat adult patients with chronic lymphocytic leukemia (CLL). As a potent and selective BCL-2 inhibitor, Venetoclax plays a crucial role in restoring apoptosis (programmed cell death), thereby effectively reducing cancer cell survival. This targeted approach has revolutionized leukemia treatment by specifically addressing the underlying mechanism of tumor growth, improving patient outcomes, and reducing disease progression.

Supplier: Saif Pharma
Manufacturer: Drug International Ltd

Indications

Veneta 50 mg is indicated for the treatment of CLL in the following cases:

• Combination Therapy: Used with Rituximab in adult patients who have received at least one prior therapy.
• Monotherapy for High-Risk Patients: Recommended for CLL patients with 17p deletion or TP53 mutation who are unsuitable for or have failed a B-cell receptor pathway inhibitor.
• Monotherapy for Other CLL Patients: For patients without 17p deletion or TP53 mutation, Veneta is used if they have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor.

Pharmacology – How Venetoclax Works

Venetoclax works by inhibiting the BCL-2 protein, a key anti-apoptotic factor that promotes cancer cell survival. Overexpression of BCL-2 is commonly found in CLL and prevents normal cell death, allowing malignant cells to thrive uncontrollably. Venetoclax directly binds to BCL-2, triggering mitochondrial outer membrane permeabilization (MOMP), which subsequently activates caspases and restores apoptosis.

Clinical studies have demonstrated that Venetoclax effectively targets and eliminates tumor cells overexpressing BCL-2, leading to tumor reduction and long-term remission in many patients.

Dosage & Administration

Veneta 50 mg should always be used under medical supervision, following a physician’s prescription. The dosing regimen includes:

• Starting Dose: 20 mg once daily for 7 days.
• Dose Titration: Gradual dose increase over 5 weeks to minimize the risk of tumor lysis syndrome (TLS). The final maintenance dose is 400 mg per day.
• Combination with Rituximab: Once titration is complete, 400 mg daily is administered in combination with Rituximab, for a total treatment duration of 24 months.
• Monotherapy: 400 mg daily until disease progression or intolerance.

Important Note:

• Always follow hydration guidelines and take Veneta with food to optimize absorption.
• Dose modifications may be required in case of severe side effects or specific drug interactions.

Drug Interactions

Venetoclax metabolism is affected by interactions with CYP3A inhibitors, inducers, and P-gp inhibitors:

• CYP3A Inhibitors: Strong inhibitors like ketoconazole and ritonavir increase Venetoclax exposure, leading to toxicity. Their use is contraindicated during dose titration.
• CYP3A Inducers: Strong (e.g., rifampin) and moderate (e.g., modafinil) inducers reduce Venetoclax efficacy and should be avoided.
• P-gp and BCRP Inhibitors: These increase Venetoclax levels, requiring close monitoring.
• Food Interactions: Avoid grapefruit, Seville oranges, and starfruit, as they contain CYP3A inhibitors that can interfere with Venetoclax metabolism.

Contraindications

Veneta 50 mg should not be used in patients with:

• Hypersensitivity to Venetoclax or its excipients.
• Strong CYP3A inhibitor use during dose titration.
• Concomitant use of St. John’s Wort, as it reduces Venetoclax effectiveness.

Side Effects

Venetoclax is generally well-tolerated, but some patients may experience side effects. These include:

• Common Side Effects (≥20% Incidence):
  • Neutropenia (low white blood cell count)
  • Diarrhea, nausea, and vomiting
  • Anemia
  • Fatigue
  • Upper respiratory tract infections
• Serious Side Effects:
  • Pneumonia
  • Febrile neutropenia
  • Tumor Lysis Syndrome (TLS) – Requires monitoring and preventive measures.

Warnings & Precautions

• Tumor Lysis Syndrome (TLS): Patients must be closely monitored during dose escalation. Prophylactic hydration and uric acid-lowering medications may be required.
• Neutropenia: Blood counts should be regularly monitored due to increased infection risks.
• Hepatic & Renal Impairment: Patients with severe impairment should be closely monitored with potential dose adjustments.
• Immunization: Live vaccines should be avoided during and after treatment until immune function recovers.

Use in Specific Populations

• Pregnancy & Lactation: Venetoclax is contraindicated due to potential fetal harm. Effective contraception is required during and for 30 days post-treatment.
• Pediatric Use: Safety and efficacy in children under 18 years have not been established.
• Elderly Patients: No dose adjustment is needed for patients over 65 years.
• Renal & Hepatic Impairment: Requires careful monitoring with potential dose modifications.

Overdose Management

There is no specific antidote for Venetoclax overdose. Supportive treatment, symptom monitoring, and hospitalization may be required for severe cases.

Conclusion

Veneta 50 mg (Venetoclax) Tablets represents a breakthrough in CLL treatment, offering a targeted approach that selectively eliminates cancer cells. By inhibiting BCL-2, Venetoclax restores natural apoptosis, improving survival rates and reducing disease progression. Its effectiveness in monotherapy and combination therapy makes it a vital treatment option for patients who have failed previous therapies.

However, due to potential drug interactions, side effects, and risks like TLS, patients should only take Venetoclax under the guidance of an oncologist or hematologist. If you or a loved one is considering Venetoclax treatment, consult a healthcare professional for personalized medical advice.