Imbruvica Ibrutinib Application Scope

Imbruvica is a targeted oral therapy indicated for the treatment of adult and pediatric patients aged 1 year and older with specific B-cell malignancies and immune disorders, including:

Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL)
CLL/SLL with 17p deletion
Mantle Cell Lymphoma (MCL)
Waldenström’s Macroglobulinemia (WM)
Marginal Zone Lymphoma (MZL)
Chronic Graft-Versus-Host Disease (cGVHD) after failure of one or more lines of systemic therapy
imbruvica ibrutinib

Imbruvica Ibrutinib Characteristics

Ingredients: Ibrutinib
Properties: A white or off-white solid, easily soluble in dimethyl sulfoxide (DMSO), soluble in methanol, but insoluble in water
Packaging Specification: 140 mg/capsule, 90 capsules/bottle
Storage: Store at room temperature (20°C to 25°C/68°F to 77°F)
Expiry Date: 24 months from the date of manufacture
Executive Standard: Follows the standards approved by relevant regulatory authorities
Approval Number: FDA: 205552; EMA: EU/1/14/963/001–003
Date of Revision: The prescribing information may be updated periodically.
Manufacturer: Pharmacyclics LLC, Janssen Biotech, Inc

Guidelines for the Use of Imbruvica Ibrutinib

Dosage and Administration:
- Recommended Dose:
  - For MCL: 560 mg (four 140 mg capsules) once daily.
  - For CLL/SLL, WM, MZL, cGVHD: 420mg (three 140mg capsules) once daily
- Administration:
  - Take orally, at approximately the same time each day.
  - Swallow the capsules whole with a glass of water. Do not open, break, chew, or crush the capsules.
  - It can be taken with or without food
- Missed Dose:
  - If a dose is missed within the same day, it can be taken as soon as possible.
  - If the missed dose is not remembered until the next day, skip the missed dose and take the next dose at the regular time. Do not take a double dose to make up for a missed one.
Adverse Reactions:
- Common Adverse Reactions:
  - Diarrhea
  - Fatigue
  - Nausea
  - Bruising
  - Anemia
  - Thrombocytopenia
- Serious Adverse Reactions:
  - Hemorrhage
  - Infections
  - Cytopenias
  - Arrhythmias
  - Hypertension
  - Tumor Lysis Syndrome (TLS)
Contraindications:
- There are no absolute contraindications listed in the sources reviewed, but the drug should be used with extreme caution in patients with known hypersensitivity to ibrutinib or any excipients.
- Concomitant use with strong CYP3A inhibitors (e.g., ketoconazole, itraconazole) or inducers (e.g., rifampicin, carbamazepine) is not recommended due to significant drug interactions.
Precautions:
- Hematologic Toxicity: Monitor blood counts regularly.
- Infections: Assess for signs of infection; consider prophylactic antimicrobials.
- Bleeding: Exercise caution in patients with bleeding disorders or those on anticoagulants.
- Cardiovascular: Monitor for arrhythmias and manage as necessary.
- Liver Function: Adjust dosage in patients with hepatic impairment.

Imbruvica Interactions

CYP3A Inhibitors: Concomitant use with strong or moderate CYP3A inhibitors may increase ibrutinib plasma concentrations; consider dose adjustments.
CYP3A Inducers: Concomitant use with strong CYP3A inducers may decrease ibrutinib plasma concentrations; avoid if possible.
Anticoagulants/Antiplatelet Agents: Increased risk of bleeding; monitor closely.
Vaccines: Avoid live vaccines during treatment.

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.