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. In combination w/ venetoclax, administer as single agent for 3 cycles (28 days/cycle) followed by 12 cycles of Imbruvica + venetoclax. In combination w/ anti-CD20 therapy, administer prior to anti-CD20 therapy when given on the same day. 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. Fatal & serious cardiac arrhythmias or cardiac failure. 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. Reports of fatigue, dizziness & asthenia during treatment which may affect patient's ability to drive or operate machines. Not recommended in severe hepatic impairment (Child-Pugh class C). Severe renal impairment or patients on dialysis. Maintain hydration & periodically monitor creatinine levels in mild or moderate renal impairment (CrCl >30 mL/min). Women of childbearing potential should use highly effective contraception during treatment. Men should not father a child or donate sperm during treatment, & for 3 mth following completion of treatment. Not to be used during pregnancy; women should avoid becoming pregnant during treatment & for up to 1 mth after treatment. Discontinue breast-feeding during treatment. Childn ≤18 yr.

Diarrhea, hemorrhage (eg, bruising), musculoskeletal pain, nausea, rash. MCL: Fatigue, URTI, cough. CLL/SLL: Thrombocytopenia, arthralgia, headache, 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, rifampin, 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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