Imbruvica

Adults w/ mantle cell lymphoma (MCL) who have received at least 1 prior therapy; chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL); CLL/SLL w/ 17p deletion; Waldenström's macroglobulinemia (WM); marginal zone lymphoma (MZL) who require systemic therapy & have received at least 1 prior anti-CD20-based therapy; chronic graft-versus-host disease (cGVHD) after failure of ≥1 lines of systemic therapy.

MCL & MZL 560 mg once daily. Dose modifications for adverse reactions after recovery: Grade 2 cardiac failure, other Grade 3 or 4 non-hematological toxicities or neutropenia w/ infection or fever, Grade 4 hematological toxicities 1st occurrence: Restart at 420 mg daily. 2nd occurrence: Restart at 280 mg daily. Grade 3 cardiac arrythmias 1st occurrence: Restart at 420 mg daily. CLL/SLL & WM 420 mg once daily as monotherapy or in combination w/ rituximab or obinutuzumab, or bendamustine & rituximab (for CLL/SLL) & in combination w/ rituximab (for WM). cGVHD 420 mg once daily. CLL/SLL, WM & cGVHD Dose modification for adverse reactions after recovery: Grade 2 cardiac failure, other Grade 3 or 4 non-hematological toxicities or neutropenia w/ infection or fever, Grade 4 hematological toxicities 1st occurrence: Restart at 280 mg daily. 2nd occurrence: Restart at 140 mg daily. Grade 3 cardiac arrythmias 1st occurrence: Restart at 280 mg daily. Dose modifications in concomitant use w/ CYP3A inhibitors: Patients w/ B-cell malignancies concomitantly using moderate CYP3A inhibitors 280 mg once daily, voriconazole 200 mg bid or posaconazole susp 100 mg once daily or bid, or 200 mg bid 140 mg once daily, posaconazole susp 200 mg tid or 400 mg bid, or as IV/DR tab 300 mg once daily 70 mg once daily. Patients w/ cGVHD concomitantly using moderate CYP3A inhibitors 420 mg once daily, voriconazole 200 mg bid or posaconazole susp 100 mg once daily or bid, or 200 mg bid 280 mg once daily, posaconazole susp 200 mg tid or 400 mg bid or as IV/DR tab 300 mg once daily 140 mg once daily. Mild hepatic impairment (Child-Pugh class A) 140 mg once daily. Moderate hepatic impairment (Child-Pugh class B) 70 mg once daily.

May be taken with or without food: Take at the same time each day. Swallow whole. Cap: Do not open/break/chew. Tab: Do not cut/crush/chew.

Withhold treatment for at least 3-7 days pre- & post-surgery. Fatal bleeding events; major & post-procedural hemorrhage, GI bleeding, hematuria. Progressive multifocal leukoencephalopathy, Pneumocystis jirovecii pneumonia, hepatitis B reactivation, hepatitis E. Fatal & serious cardiac arrhythmias & cardiac failure; Grade 3 or greater ventricular tachyarrhythmia; HTN; cytopenias; non-skin carcinomas, non-melanoma skin cancer; tumor lysis syndrome. Patients w/ cardiac risk factors including HTN, DM, acute infections & previous history of cardiac arrhythmias. Manage hyperviscosity in WM patients through plasmapheresis before & during treatment. Consider prophylaxis in patients at increased risk for opportunistic infections. Monitor for signs & symptoms of bleeding; cardiac arrhythmias & cardiac function; BP; mthly blood counts. Evaluate cardiac history & function at baseline. Monitor & evaluate patients for fever & infections, jaundice, abnormal LFTs. Obtain ECG, echocardiogram in patients who develop arrhythmic symptoms (eg, palpitations, lightheadedness, syncope, chest pain), new onset of dyspnea or other CV concerns. Assess baseline risk eg, high tumor burden. Increased risk of major hemorrhage w/ concomitant anticoagulant or antiplatelet agents. Avoid use in patients w/ severe hepatic impairment (Child-Pugh class C). Females & males w/ female partners of reproductive potential should use effective contraception during treatment & 1 mth after the last dose. Pregnancy. Not to breastfeed while on treatment & for 1 wk after the last dose. Ped patients.

Diarrhea, nausea, constipation, abdominal pain, upper abdominal pain, vomiting, stomatitis, dyspepsia, GERD; fatigue, peripheral edema, pyrexia, asthenia, chills, pain; musculoskeletal pain, muscle spasms, arthralgia; URTI & viral URTI, UTI, pneumonia, skin infections, sinusitis, bronchitis, nasopharyngitis, conjunctivitis, flu, sepsis; bruising, rash, petechiae, pruritus; dyspnea, cough, epistaxis, oropharyngeal pain; decreased appetite, dehydration, hyperuricemia, hypokalemia, hypoalbuminemia; dizziness, headache, peripheral neuropathy; HTN, hemorrhage; 2nd malignancies; contusion, infusion related reaction, fall; blurred vision, increased lacrimation, dry eye, reduced visual acuity; decreased wt; neutropenia, thrombocytopenia, anemia; atrial fibrillation; insomnia, anxiety; decreased platelets, neutrophils & Hb; increased creatinine, bilirubin & AST.

Increased plasma conc w/ strong or moderate CYP3A inhibitors. Decreased conc w/ strong CYP3A inducers. Concomitant use w/ grapefruit & Seville oranges.

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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