Imbruvica

Ibrutinib

Mantle cell lymphoma (MCL) in adults who have received at least 1 prior therapy. Chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL); CLL/SLL w/ 17p deletion in adults. Waldenström's macroglobulinemia (WM) in adults. Marginal zone lymphoma (MZL) in adults 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 in adults.

MCL & MZL 560 mg (4 cap/tab) once daily. Dose modification after recovery: 1st toxicity occurrence: Restart at 560 mg daily. 2nd toxicity occurrence: Restart at 420 mg daily. 3rd toxicity occurrence: Restart at 280 mg daily. CLL/SLL & WM 420 mg (3 cap/tab) 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 (3 cap/tab) once daily. CLL/SLL, WM & cGVHD Dose modification after recovery: 1st toxicity occurrence: Restart at 420 mg daily. 2nd toxicity occurrence: Restart at 280 mg daily. 3rd toxicity occurrence: Restart at 140 mg daily. Dose modifications in concomitant use w/ CYP3A inhibitors: B-cell malignancies patient 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 w/ water. Avoid grapefruit & Seville oranges. Tab: Do not cut/crush/chew. Cap: Do not open/break/chew.

Withhold treatment for at least 3-7 days pre- & post-surgery. Increased risk of major hemorrhage in concomitant use w/ anticoagulant or antiplatelet agents. Progressive multifocal leukoencephalopathy, Pneumocystis jirovecii pneumonia, hepatitis B reactivation, & hepatitis E, which may be chronic. Cytopenias; HTN. Non-skin carcinomas, non-melanoma skin cancer; tumor lysis syndrome. Loose stools or diarrhea. Patients w/ cardiac risk factors, HTN, acute infections & previous history of cardiac arrhythmias. Monitor for signs & symptoms of bleeding; cardiac arrhythmias & failure at baseline & then periodically. Consider prophylaxis in patients at increased risk for opportunistic infections. Monitor & evaluate patients for fever & infections, jaundice, abnormal LFTs. Monitor CBC mthly; BP. Obtain ECG in patients who develop arrhythmic symptoms or new onset of dyspnea. Assess the baseline risk eg, high tumor burden. Maintain adequate hydration. 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. Not to be used during lactation while on treatment & for 1 wk after the last dose. Ped patients.

Diarrhea, nausea, constipation, abdominal pain (& in upper), vomiting, stomatitis, dyspepsia, GERD; fatigue, peripheral edema, pyrexia, asthenia, chills; 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.

Increased plasma conc w/ strong or moderate CYP3A inhibitors. Decreased conc w/ strong CYP3A inducers. Concomitant use w/ other strong CYP3A inhibitors & inducers; 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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