Imbruvica

Ibrutinib

Adults w/ mantle cell lymphoma (MCL) who have received at least 1 prior therapy. Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). CLL/SLL w/ deletion 17p. Waldenström's macroglobulinemia (WM).

MCL 560 mg once daily. CLL/SLL 420 mg once daily as single agent or in combination w/ anti-CD20 therapy (rituximab or obinutuzumab) or w/ bendamustine & rituximab. WM 420 mg once daily as single agent or in combination w/ rituximab. Continue treatment in all indications until disease progression or no longer tolerated by the patient. Hepatic impairment: Mild (Child-Pugh class A) 280 mg daily, moderate (Child-Pugh class B) 140 mg daily.

May be taken with or without food: Take at the same time each day. Swallow whole w/ water, do not open/break/chew. Do not take w/ grapefruit juice or Seville oranges.

Hypersensitivity.

Interrupt treatment if symptoms of ILD develop. Bleeding events w/ or w/o thrombocytopenia. Isolated cases of leukostasis. Infections including sepsis, neutropenic sepsis, bacterial, viral or fungal infections; cases of progressive multifocal leukoencephalopathy & hepatitis B reactivation; cases of hepatitis E (which may be chronic). Cytopenias. Atrial fibrillation & flutter & cases of ventricular tachyarrhythmia & cardiac failure including some fatal events particularly in patients w/ cardiac risk factors, HTN, acute infections & previous history of cardiac arrhythmia. Tumor lysis syndrome. Non-melanoma skin cancers. HTN. Patients w/ congenital bleeding diathesis. Hold treatment at least 3 to 7 days pre- & post‑surgery. Avoid supplements eg, fish oil & vit E prep. Increased risk of major bleeding in concomitant use w/ anticoagulant or antiplatelet agents. Not recommended in severe hepatic impairment (Child-Pugh class C). Severe renal impairment or patients on dialysis. Childn ≤18 yr.

Diarrhea, hemorrhage (eg, bruising), musculoskeletal pain, nausea, rash. MCL: Fatigue, URTI, cough. CLL/SLL: Thrombocytopenia, pyrexia. CLL/SLL & WM: Neutropenia.

Increased exposure w/ strong (eg, ketoconazole, indinavir, nelfinavir, ritonavir, saquinavir, clarithromycin, telithromycin, itraconazole, nefazadone, cobicistat, voriconazole, posoconazole) & moderate (eg, fluconazole, erythromycin, amprenavir, aprepitant, atazanavir, ciprofloxacin, crizotinib, diltiazem, fosamprenavir, imatinib, verapamil, amiodarone, dronedarone) CYP3A inhibitors; grapefruit & Seville oranges. Decreased plasma conc w/ strong CYP3A inducers eg, carbamazepine, rifampicin, phenytoin & St. John's wort. Potential interaction w/ P-gp or BCRP substrates eg, digoxin or MTX. May increase exposure of drugs that undergo BCRP-mediated hepatic efflux eg, rosuvastatin.

Targeted Cancer Therapy

L01EL01 - ibrutinib ; Belongs to the class of Bruton's tyrosine kinase (BTK) inhibitors. Used in the treatment of cancer.

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