Olverembatinib Application Scope

Olverembatinib is an oral, third-generation BCR-ABL1 tyrosine kinase inhibitor (TKI) developed by Ascentage Pharma. It is indicated for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) or accelerated-phase CML (CML-AP) who are resistant or intolerant to at least two prior TKIs, including those harboring the T315I mutation.

Olverembatinib Characteristics

Ingredients: Olverembatinib
Properties: A small-molecule protein tyrosine kinase inhibitor
Packaging Specification: Oral tablet; 40 mg/tablet
Storage: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F)
Expiry Date: Refer to the packaging for the expiration date
Executive Standard: Complies with the Chinese Pharmacopoeia (2020 Edition) and relevant national drug standards
Approval Number: Approved in China on November 25, 2021
Date of Revision: Please consult the latest official package insert for the most recent revision date
Manufacturer: Ascentage Pharma

Guidelines for the Use of

Olverembatinib

Dosage and Administration:
- Recommended Dose: The recommended dosage is 40 mg, taken once every other day (every 48 hours), orally, with meals. Treatment continues until disease progression or unacceptable toxicity.
- Administration: Tablets should be swallowed whole with water and must not be crushed, broken, or chewed. It is recommended to take it at approximately the same time each day.
- Missed Dose: If a dose is missed, take it as soon as remembered on the same day. If the next dose is due, skip the missed dose—do not double the dose.
Adverse Reactions:
- Common Adverse Reactions:
  - Thrombocytopenia
  - Anemia
  - Leukopenia
  - Elevated liver enzymes (ALT/AST)
  - Skin rash
  - Fatigue
- Serious Adverse Reactions:
  - Severe thrombocytopenia
  - Hepatotoxicity
  - Severe skin reactions
  - QT interval prolongation
Contraindications:
- Hypersensitivity to olverembatinib or any component of the formulation.
- Severe hepatic impairment.
Precautions:
- Vascular Occlusion: Monitor patients with risk factors for vascular events.
- Cytopenias: Monitor complete blood counts regularly. Manage cytopenias with dose interruptions or reductions and supportive care as needed.
- Hepatic Impairment: Assess liver function before initiation and monitor periodically during treatment. Manage elevations in liver enzymes with dose interruption and reduction.
- Hypertension: Monitor blood pressure regularly. Manage hypertension appropriately.
- Cardiac Arrhythmias: Monitor for signs and symptoms of arrhythmias.
- Fluid Retention: Monitor for signs and symptoms of fluid retention and manage with supportive care or dose modification.
- Potential Phototoxicity: Although not fully established, it is advised to avoid direct sunlight and use sun protection measures while taking this medication

Olverembatinib Interactions

CYP3A4 Inhibitors: Concomitant use may increase olverembatinib plasma concentrations; consider dose adjustment.
CYP3A4 Inducers: Concomitant use may decrease olverembatinib plasma concentrations; consider dose adjustment.
Anticoagulants: Monitor for increased bleeding risk.
Other Medications: Consult with a healthcare provider before starting or stopping any medications.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.