Ibrucent Ibrutinib Capsules 140mg

I. Drug Name

Generic Name: Ibrutinib Capsules

English Name: Ibrutinib Capsules

Brand Names: IMBRUVICA, Yike, Ibrucent

Dosage Form: Oral Capsules

Specification: 140 mg per capsule; 90 capsules per box

Manufacturer: Incepta Pharmaceutical Ltd

II. Indications and Usage

This product is a Bruton's tyrosine kinase (BTK) inhibitor indicated for the treatment of:

1.  Hematologic Malignancies:

Mantle Cell Lymphoma (MCL) [in patients who have received at least one prior therapy].

Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL).

Waldenström’s Macroglobulinemia (WM).

Marginal Zone Lymphoma (MZL) [in patients who have received at least one prior anti-CD20-based therapy].

Chronic Graft-versus-Host Disease (cGVHD) [in adult patients who have received one or more lines of systemic therapy].

2.  Limitations of Use: Concomitant use with strong CYP3A inhibitors is not recommended.

III. Dosage and Administration

Recommended Dosage (varies by disease):

MCL, MZL: 560 mg orally once daily (4 capsules of 140 mg or corresponding tablets). 

CLL/SLL, WM: 420 mg orally once daily (3 capsules of 140 mg or corresponding tablets). 

cGVHD: 420 mg orally once daily.

Administration Method: Swallow capsules/tablets whole with water; do not open, crush, or chew the capsules. Take at approximately the same time each day; may be taken with food.

Dosage Adjustments: Detailed dosage adjustment guidelines (including temporary interruption or dose reduction to 140 mg once daily) are provided for adverse reactions such as bleeding, infections, arrhythmias, and cytopenias. Discontinuation of treatment due to adverse reactions for more than one week may increase the risk of disease progression.

IV. Contraindications

Patients with severe hypersensitivity to ibrutinib or to any of the excipients.

V. Warnings and Precautions (Detailed)

1.  Hemorrhage: Major hemorrhage (Grade ≥3) may occur at any time during treatment. Use with caution in patients with a risk of bleeding. Discontinue use at least 3 to 7 days prior to elective surgery. 2.  Infections: Serious infections (e.g., pneumonia, sepsis) may occur. Monitor for signs of infection and treat promptly.

3.  Atrial Fibrillation and Atrial Flutter: Incidence is approximately 5–10%, particularly in patients aged 65 years and older. Monitor heart rhythm regularly during treatment. If arrhythmias occur, perform a risk-benefit assessment and adjust anticoagulation and treatment regimens.

4.  Cytopenias: Monitor complete blood counts monthly during treatment.

5.  Hypertension: Monitor blood pressure and initiate or adjust antihypertensive therapy.

6.  Second Primary Malignancies: The most common is non-melanoma skin cancer. Perform regular skin examinations and take sun protection measures.

7.  Tumor Lysis Syndrome (TLS): For patients with high tumor burden, assess the risk of TLS and take prophylactic measures.

VI. Adverse Reactions

Based on clinical trial data, common adverse reactions (incidence ≥20%) include:

Blood and Lymphatic System: Thrombocytopenia, neutropenia, anemia.

General Disorders: Fatigue, musculoskeletal pain, edema, pyrexia.

Gastrointestinal System: Diarrhea, nausea, abdominal pain, vomiting, constipation.

Skin and Subcutaneous Tissue: Rash, bruising.

Respiratory System: Upper respiratory tract infection, cough, dyspnea.

Nervous System: Headache, dizziness.

Cardiovascular System: Atrial fibrillation, hypertension.

Infections: Pneumonia, urinary tract infection.

VII. Drug Interactions

Strong CYP3A Inhibitors (e.g., ketoconazole, itraconazole, clarithromycin): Significantly increase ibrutinib exposure, thereby increasing the risk of toxicity. Concomitant use should be avoided. If concomitant use is unavoidable, reduce the ibrutinib dosage to 140 mg once daily.

Moderate CYP3A Inhibitors (e.g., fluconazole, diltiazem, verapamil): Increase ibrutinib exposure; consider reducing the ibrutinib dosage to 280 mg or 140 mg once daily. Potent CYP3A Inducers (e.g., rifampin, carbamazepine, St. John's wort): Significantly reduce ibrutinib exposure, thereby affecting efficacy. Concomitant use should be avoided. If concomitant use is unavoidable, an increase in the ibrutinib dosage should be considered.

Anticoagulants and Antiplatelet Agents (e.g., warfarin, clopidogrel, aspirin): Increase the risk of bleeding; use with caution.

VIII. Use in Specific Populations

Hepatic Impairment:

No dosage adjustment is required for patients with mild hepatic impairment.

For patients with moderate hepatic impairment, the dosage should be reduced (reduced to 140 mg for CLL/SLL/WM/cGVHD; reduced to 280 mg for MCL/MZL).

Use is not recommended for patients with severe hepatic impairment.

Renal Impairment: No dosage adjustment is required for patients with mild to moderate renal impairment. Data are limited for patients with severe renal impairment or end-stage renal disease; use with caution.

Pediatric Use: Safety and efficacy have not been established.

Geriatric Use: No specific dosage adjustment is required; however, elderly patients are at a higher risk of experiencing certain adverse reactions (e.g., atrial fibrillation, infections).

IX. Pharmacological Actions

Pharmacologic Class: Small molecule BTK inhibitor.

Mechanism of Action: Ibrutinib covalently binds to the active site of BTK, thereby irreversibly inhibiting its activity. BTK is a key kinase in the B-cell receptor signaling pathway; inhibition of BTK blocks the growth, migration, and survival signals of B-cell malignancies.

X. Storage

Store at room temperature (20°C–25°C); excursions between 15°C and 30°C are permitted during short-term transport.

Keep the medication in its original packaging to protect it from moisture.

Keep out of reach of children.

Important Note:

This package insert is not a substitute for professional medical advice. Before using ibrutinib, patients must undergo a comprehensive evaluation by a specialist physician and strictly adhere to the detailed medication instructions provided by their doctor and pharmacist. Regular monitoring and close follow-up are mandatory throughout the course of treatment. Product Specifications

Product Name: Ibrutinib Capsules 140mg * 90 Capsules/Box (Ibrucent)

Common Name: Ibrutinib Capsules

Active Ingredient: Ibrutinib

Dosage Form: Oral Capsules

Specification: 140mg per capsule; 90 capsules per box

Manufacturer: Incepta Pharmaceutical Ltd

Indications: This product is a Bruton's tyrosine kinase (BTK) inhibitor indicated for the treatment of:

1. Hematologic Malignancies:

Mantle Cell Lymphoma (MCL) in patients who have received at least one prior therapy.

Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL).

Waldenström’s Macroglobulinemia (WM).

Marginal Zone Lymphoma (MZL) in patients who have received at least one prior anti-CD20-based therapy.

Chronic Graft-versus-Host Disease (cGVHD) in adult patients who have received one or more lines of systemic therapy.

2. Limitations of Use: Concomitant use with strong CYP3A inhibitors is not recommended.

Dosage and Administration: Recommended Dosage (varies by disease):

MCL, MZL: 560 mg orally once daily (4 capsules of 140 mg or corresponding tablets).

CLL/SLL, WM: 420 mg orally once daily (3 capsules of 140 mg or corresponding tablets).

cGVHD: 420 mg orally once daily.

Administration Method: Swallow the capsules/tablets whole with water; do not open, crush, or chew the capsules. Take at approximately the same time each day; may be taken with food.

Dosage Adjustment: Detailed dosage adjustment guidelines are provided for adverse reactions such as bleeding, infections, arrhythmias, and cytopenias (involving temporary discontinuation or dose reduction to 140 mg once daily). Discontinuation of treatment for more than one week due to adverse reactions may increase the risk of disease progression.