Monotherapy for adults w/ relapsed or refractory mantle cell lymphoma (MCL). Monotherapy or in combination w/ rituximab or obinutuzumab for adults w/ previously untreated chronic lymphocytic leukaemia (CLL). Monotherapy or in combination w/ bendamustine & rituximab for adults w/ CLL who have received at least 1 prior therapy. Monotherapy for adults w/ Waldenström's macroglobulinaemia (WM) who have received at least 1 prior therapy or in 1st-line treatment for patients unsuitable for chemo-immunotherapy. In combination w/ rituximab for WM. Chronic graft-versus-host disease (cGVHD) after failure of ≥1 lines of systemic therapy.
MCL Recommended dose: 560 mg once daily. CLL Recommended dose: 420 mg once daily. WM Recommended dose: 420 mg once daily. Continue treatment until disease progression or no longer tolerated by patient. cGVHD Recommended dose: 420 mg once daily until cGVHD progression, recurrence of an underlying malignancy or unacceptable toxicity. Concomitant administration w/ moderate CYP3A4 inhibitors 280 mg once daily. Concomitant administration w/ strong CYP3A4 inhibitors 140 mg once daily or withheld for up to 7 days. Toxicity occurrence Dose modification should be considered. Mild hepatic impairment 280 mg daily. Moderate hepatic impairment 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.
Contraindications
Hypersensitivity. Concomitant use w/ St. John's wort-containing prep.
Bleeding-related events, avoid co-administration w/ warfarin or other vit K antagonist, monitor signs & symptoms of bleeding, avoid supplements eg, fish oil & vit E prep, withhold therapy 3-7 days pre- & post-op. Monitor leukostasis closely, consider temporarily withholding therapy & administer supportive care. Splenic rupture, monitor disease status & spleen size. Infections, monitor for fever, abnormal LFT, neutropenia & infections, institute appropriate anti-infective therapy; monitor CBC mthly. Hepatic events, assess liver function & viral hepatitis before treatment, monitor periodically during treatment. Cytopenias, monitor CBC monthly. ILD, monitor for pulmonary symptoms. Cardiac arrhythmia & cardiac failure, monitor for cardiac manifestations. CVA, transient ischaemic attack, ischaemic stroke including fatalities. Closely monitor tumour lysis syndrome. Non-melanoma skin cancer, monitor for appearance. HTN, monitor BP. Haemophagocytic lymphohistiocytosis. Avoid concomitant use w/ strong CYP3A4 inhibitors & moderate or strong CYP3A4 inducers. May affect ability to drive & use machines. Not recommended in severe hepatic impairment (Child-Pugh C). Severe renal impairment (CrCl <30 mL/min) or on dialysis. Women of childbearing potential should use effective contraception during & for 3 mth after treatment. Not to be used during pregnancy & lactation. Childn & adolescents ≤18 yr. FC tab: Not to be taken by patients w/ galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.
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