Nitib 140mg Capsule (Ibrutinib)

Nitib 140mg Capsule contains ibrutinib, an oral covalent Bruton’s tyrosine kinase (BTK) inhibitor. The medicine is used in the treatment of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), Waldenström macroglobulinemia (WM), and chronic graft-versus-host disease (cGVHD). BTK is central to B-cell receptor signalling, so its inhibition disrupts survival and trafficking of malignant B cells. However, the 140 mg capsule is a strength, not the usual total daily dose for most adult indications.

Nitib 140mg Capsule is an oral medication targeting various blood malignancies and immunological disorders. The key indications include the following:

• ​Chronic lymphocytic leukemia (CLL) / Small lymphocytic lymphoma (SLL)
  
• Waldenström macroglobulinemia (WM)
  
• Chronic graft-versus-host disease (cGVHD)

In the context of CLL/SLL, the medicine is prescribed both to patients without any prior treatment and after receiving some form of prior therapy. Ibrutinib capsules may be used alone or together with other drugs depending on the regimen. The decision to use the therapy also depends on heart complications, risks of bleeding, therapy resistance, and the availability of novel BTK inhibitors.

The ibrutinib 140mg capsule is a permanent inhibitor of the BTK protein. Inhibiting the activity of this protein leads to the inhibition of signals responsible for the development, survival, and migration of abnormal B cells. Thus, the medicine acts against blood cancer cells.

RESONATE: The Ibrutinib 140mg capsule improved progression-free and overall-survival outcomes versus ofatumumab in previously treated CLL.

RESONATE-2: Nitib 140mg improved outcomes versus chlorambucil in older treatment-naïve CLL patients.

INNOVATE: Nitib capsule plus rituximab improved outcomes in Waldenström macroglobulinaemia.

Side effects due to the Ibrutinib 140mg capsule may arise, which may be different for everyone. Some may be relatively minor, whereas some may require medical attention.

Common side effects

• Diarrhea
  
• Fatigue
  
• Musculoskeletal pain
  
• Bruising
  
• Rash
  
• Nausea
  
• Upper respiratory infections
  

Serious side effects

• Major hemorrhage
  
• Atrial fibrillation/other arrhythmias
  
• Hypertension
  
• Serious infection
  
• Cytopenias
  
• Second primary malignancies
  
• Tumor lysis syndrome
  

Important: Dose and regimen must be prescribed by the treating specialist. Tablet/vial strength is not necessarily the patient dose. Do not start, stop, split, combine or substitute treatment based on website information.

If a dose is missed on the same day, take it when remembered. If not remembered until the next day, skip it; do not double. Follow the specific product leaflet.

• Routine blood work may be performed on a regular basis in order to monitor blood cell counts.
  
• The patient’s blood pressure needs to be measured.
  
• The heart rhythm and such symptoms as tachycardia (abnormally fast heart rate) should be assessed.
  
• Symptoms indicating an infection like fever or chills need to be reported.
  
• Bleeding problems and easy bruising should be reported to the doctor.
  
• The liver function tests and drug interactions may be considered as well.
  

• Current ibrutinib prescribing information (Imbruvica/reference) https://www.rxabbvie.com/pdf/imbruvica_pi.pdf​
  
• Byrd JC, et al. RESONATE. New England Journal of Medicine https://www.nejm.org/doi/full/10.1056/NEJMoa1400376?referrer=https%3A%2F%2Fwww.google.com%2F​
  
• Burger JA, et al. RESONATE-2. New England Journal of Medicine https://pubmed.ncbi.nlm.nih.gov/26639149/​
  
• Current NCCN CLL/SLL and Waldenström guidelines https://www.nccn.org/guidelines/guidelines-detail?category=1&id=1475​