Ibrucent 140 Mg (Ibrutinib) – 90 Capsules

Ibrucent 140 mg (Ibrutinib)

Brand: Incepta Pharmaceuticals

Indication Of Ibrucent 140 Mg

1. Mantle Cell Lymphoma: Ibrucent 140 mg is indicated for the treatment of patients with Mantle Cell Lymphoma (MCL) who have received at least one prior therapy.

2. Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma: Ibrutinib is also indicated for the treatment of patients with chronic lymphocytic leukemia. Chronic Lymphocytic Leukaemia/Small Lymphocytic Lymphoma with 17p deletion Ibrutinib is indicated for the treatment of patients with chronic lymphocytic leukaemia.

3. Waldenstrom Macroglobulinemia (WM): Treatment of patients with Waldenstrom Macroglobulinemia (WM).

4. Marginal Zone Lymphoma: Ibrucent 140 mg is indicated for patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least 1 prior anti-CD20-based therapy.

*Take as directed by your doctor

Therapeutic Class Of Ibrucent 140 Mg

Targeted Cancer Therapy

Pharmacology

Ibrucent 140 mg is a small-molecule inhibitor of BTK. Ibrutinib forms a covalent bond with a cysteine residue in the BTK active site, inhibiting BTK enzymatic activity. BTK is a signaling molecule of the B-cell antigen receptor (BCR) and cytokine receptor pathways. BTK’s role in signaling through the B-cell surface receptors activates pathways necessary for B-cell trafficking, chemotaxis, and adhesion. Nonclinical studies show that ibrutinib inhibits malignant B-cell proliferation and survival in vivo, as well as cell migration and substrate adhesion in vitro.

Dosage

Mantle Cell Lymphoma and Marginal Zone Lymphoma: The recommended dose of ibrutinib for MCL and MZL is 560 mg (four 140 mg capsules) orally once daily until disease progression or unacceptable toxicity.

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma and Waldenstrom Macroglobulinemia (WM): The recommended dose of Ibrutinib for CLL/SLL and WM is 420 mg (three 140 mg capsules) orally once daily until disease progression or unacceptable toxicity. The recommended dose of Ibrutinib for CLL/SLL, when used in combination with bendamustine and rituximab (administered every 28 days for up to 6 cycles), is 420 mg ( three 140 mg capsules ) orally once daily until disease progression or unacceptable toxicity.
*Take according to the doctor’s advice.

Administration

Administer Ibrutinib orally once daily at approximately the same time each day.
Swallow the capsules whole with water. Do not open, break, or chew the capsules.
*Take according to the doctor’s advice.

Interaction

CYP3A Inhibitors: Co-administration with strong and moderate CYP3A inhibitors should be avoided. If a moderate CYP3A inhibitor must be used, the dose of Ibrutinib should be reduced.

CYP3A Inducers: Co-administration with strong CYP3A inducers should be avoided
contraindications
Hypersensitivity to the active substance or any of the excipients.

Side Effects

Other sections of the labeling discuss the following adverse reactions in more detail: Hemorrhage, Infections, Cystenias, Atrial Fibrillation, Hypertension, Second Primary Malignancies, and Tumor Lysis Syndrome. Additional Important Adverse Reactions are diarrhea and visual Disturbance.

Pregnancy & Lactation

Pregnancy: Ibrutinib, a kinase inhibitor, can cause fetal harm based on findings from animal studies. In animal reproduction studies, administration of Ibrutinib to pregnant rats and rabbits during the period of organogenesis at exposures up to 2-20 times the clinical doses of 420-560 mg daily produced embryofetal toxicity, including malformations. If Ibrutinib is used during pregnancy or if the patient becomes pregnant while taking Ibrutinib, the patient should be apprised of the potential hazard to the fetus. The estimated background risk of major congenital disabilities and miscarriage for the indicated population is unknown.

Lactation: There is no information regarding the presence of Ibrutinib or its metabolites in human milk, its effects on breastfed infants, or its effects on milk production.

Overdose Effects

There is no specific experience in the management of Ibrucent 140 MG Ibrutinib overdose in patients. One healthy subject experienced reversible Grade 4 hepatic enzyme increases (AST and ALT) after a dose of 1680 mg. Closely monitor patients who ingest more than the recommended dosage and provide appropriate supportive treatment.
Use in Special Population

-Pediatric Use: The safety and effectiveness of Ibrucent 140 MG Ibrutinib in pediatric patients has not been established.

-Geriatric Use: Of the 905 patients in clinical studies of Ibrutinib, 62% were ≥ 65, while 21% were ≥75. No overall differences in effectiveness were observed between younger and older patients. Anemia (all grades) and Grade 3 or higher pneumonia occurred more frequently among older patients treated with Ibrutinib.

-Hepatic Impairment: Ibrutinib is metabolized in the liver. Data from a hepatic impairment study showed an increase in Ibrutinib exposure. The safety of Ibrutinib has not been evaluated in cancer patients with mild to severe hepatic impairment by the Child-Pugh criteria. Monitor patients for signs of Ibrutinib toxicity and follow dose modification guidance as needed. It is not recommended to administer Ibrutinib to patients with moderate or severe hepatic impairment.

Storage Conditions

Ibrucent 140 mg store in a dry place below 30°C, and protect from light. Keep out of the reach of children.

Disclaimer

The information provided is intended for educational and informational purposes only and should not be regarded as medical advice or a replacement for consulting with a licensed healthcare professional. Always consult your doctor or pharmacist before starting, stopping, or changing the dosage of Ibrucent 140 Mg (Ibrutinib). If you are taking this medication, you should follow strict medical instructions.