Imbruvica

IBRUTINIB

Manufacturer: Pharmacyclics LLC

Score: 141.0

Quick Summary

Imbruvica (Ibrutinib) is a kinase inhibitor used for the treatment of adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), Waldenström’s macroglobulinemia (WM), and chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy. It works by inhibiting Bruton’s tyrosine kinase (BTK), a signaling molecule involved in B-cell development and survival. The recommended dosage is 420 mg orally once daily, with dosage modifications required for certain adverse reactions and concomitant use of CYP3A inhibitors. Important safety information includes warnings for hemorrhage, infections, cardiac arrhythmias, and hypertension, as well as contraindications and adverse reactions. Special population considerations include use during pregnancy, pediatric use, and geriatric use.

Key Clinical Findings and Indications

Treatment of adult patients with CLL/SLL
Treatment of adult patients with Waldenström’s macroglobulinemia (WM)
Treatment of adult and pediatric patients with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy

Important Safety Information

Warning

Hemorrhage, infections, cardiac arrhythmias, and hypertension

Contraindications

None

Adverse Reactions

Thrombocytopenia
Diarrhea
Fatigue
Musculoskeletal pain
Neutropenia
Rash
Anemia
Bruising
Nausea

Dosing Recommendations

General Guidance

Modify dose as described for adverse reactions and concomitant use of CYP3A inhibitors

CLL/SLL and WM

Adult Dose

420 mg orally once daily

Pediatric Dose

Not established

cGVHD

Adult Dose

420 mg orally once daily

Pediatric Dose

240 mg/m^2 orally once daily (up to a dose of 420 mg) for patients 1 to less than 12 years of age

Special Population Considerations

Pregnancy

Can cause fetal harm based on animal studies
Advise pregnant women of the potential risk to a fetus

Nursing Mothers

Not specified

Pediatric Use

Established for treatment of cGVHD in pediatric patients 1 year of age and older
Not established for CLL/SLL, CLL/SLL with 17p deletion, or WM

Geriatric Use

No overall differences in effectiveness were observed between younger and older patients
Anemia, pneumonia, thrombocytopenia, hypertension, and atrial fibrillation occurred more frequently among older patients