Venclexta (Venetoclax) – CLL | DengYueMed

Venclexta Application Scope

Venclexta is an oral BCL‑2 inhibitor used to treat certain blood cancers such as CLL, SLL, and AML.

Characteristics

• Ingredients: Venetoclax

• Properties:

  • Light yellow to dark yellow solid

  • Very low aqueous solubility

  • Orally bioavailable, highly protein‑bound (>99%)

  • Half‑life ~26 hours, metabolized by CYP3A4/5, excreted in feces

• Packaging Specification:

  • Film‑coated tablets: 10 mg, 50 mg, 100 mg

  • Packaging options: starter/ramps-up blister packs, bottles (28- or 120‑count)

• Storage:

  • Store in the original container

  • Temperature: 2–30 °C (≤86 °F) to protect from moisture

• Expiry Date:

  • As per the package, the shelf life in the original container is typically 2–3 years.

  • The label does not specify one fixed date. Use the printed expiry on the package.

• Executive Standard:

  • Meets FDA and EMA full prescribing information; TGA in Australia, HPFB in Canada, etc.

  • Safety classification:

    • reproductive toxicity Cat 2, systemic target organ toxicity repeated exposure Cat 1 per EU

• Approval Number:

  • US FDA NDA 208573

  • EU EMA: Venclyxto authorisation 21 Dec 2016

• Date of Revision:

  • US label revision June 2022

  • Canadian update April 5, 2022

• Manufacturer:

  • AbbVie Inc. (North Chicago, IL)

  • Marketed also by Genentech (Roche) in the US

Guidelines for the Use of Venclexta

• Dosage and Administration:

  • CLL/SLL: ramp‑up from 20 mg to 400 mg daily over 5 weeks; AML: over 3–4 days.

  • Prophylaxis against tumor lysis syndrome (TLS): hydration, anti‑hyperuricemics, lab monitoring

  • Modify dosage if strong CYP3A or P‑gp inhibitors are present; contraindicated during CLL ramp‑up

 

• Adverse Reactions:

  • Common in CLL/SLL:

    • neutropenia, thrombocytopenia, anemia, diarrhea, nausea

    • URT infections, cough, musculoskeletal pain, fatigue, edema

  • Serious: TLS, severe neutropenia, infections, sepsis (~4.9% fatal in 30 days), hemorrhage

• Contraindications:

  • Concomitant use with strong CYP3A inhibitors during CLL ramp‑up

  • Known hypersensitivity to venetoclax or excipients

• Precautions:

  • TLS risk: assess tumor burden, renal function, splenomegaly; monitor labs, provide prophylaxis

  • Neutropenia and infections: monitor blood counts

  • Embryo‑fetal toxicity: avoid in pregnancy, use contraception; lactation contraindicated

Venclexta Interactions

• Drug Interactions:

  • Avoid strong/moderate CYP3A inducers (e.g., rifampin)

  • Avoid strong CYP3A/P‑gp inhibitors during CLL ramp‑up

  • Narrow‑index P‑gp substrates: separate by ≥6 hours

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
• It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.