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IMBRUVICA
Leukemias, lymphomas, and other hematologic cancers
Miscellaneous immune disorders
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Drug Name:

IMBRUVICA Rx

Generic Name and Formulations:
Ibrutinib 140mg; caps.

Company:
Pharmacyclics and Janssen Biotech

Therapeutic Use:

Indications for IMBRUVICA:

Mantle cell lymphoma (MCL) in patients who have received at least one prior therapy. Chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). CLL/SLL in patients with 17p deletion. Waldenstrom's macroglobulinemia (WM). Marginal zone lymphoma (MZL) in patients who require systemic treatment and have received at least one prior anti-CD20-based therapy.

Adult:

Swallow whole with water. MCL and MZL: 560mg once daily. CLL/SLL (with or without bendamustine/rituximab) and WM: 420mg once daily. Treat until disease progression or unacceptable toxicity. Concomitant moderate CYP3A inhibitors, posaconazole (≤200mg twice daily), voriconazole: 140mg once daily. Mild hepatic impairment (Child-Pugh Class A): 140mg once daily. Dose modifications for toxicities: see full labeling.

Children:

Not established.

Warnings/Precautions:

Risk of hemorrhage; consider the benefit/risk of withholding treatment for 3–7 days pre-and post-surgery. Monitor for fever and infections; evaluate promptly if occurs. Monitor for myelosuppression; obtain CBCs monthly. Periodically monitor for atrial fibrillation (esp. in those with cardiac risk factors, acute infections, history of atrial fibrillation); do ECG if arrhythmic symptoms or new onset dyspnea develop. Monitor for new onset or uncontrolled hypertension; adjust and/or initiate anti-hypertensives as appropriate. Risk of second primary malignancies (eg, skin cancer or other carcinomas). Monitor for tumor lysis syndrome in patients at risk (eg, high tumor burden). Moderate or severe hepatic impairment: not recommended. Maintain adequate hydration. Embryo-fetal toxicity. Pregnancy; avoid during and for 1 month after treatment cessation. Nursing mothers.

Interactions:

See Adult. Avoid concomitant strong CYP3A inhibitors (eg, boceprevir, clarithromycin, cobicistat, conivaptan, diltiazem, elvitegravir/ritonavir, idelalisib, indinavir/ritonavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, paritaprevir/ritonavir/ombitasvir ± dasabuvir, ritonavir, saquinavir/ritonavir, tipranavir/ritonavir, troleandomycin, posaconazole (at higher doses); if short-term use (eg, anti-infectives for ≤7days), consider interrupting ibrutinib therapy. Concomitant moderate CYP3A inhibitors (eg, aprepitant, cimetidine, ciprofloxacin, clotrimazole, crizotinib, cyclosporine, dronedarone, erythromycin, fluconazole, fluvoxamine, imatinib, verapamil): reduce ibrutinib dose (see Adult). Avoid grapefruit and Seville oranges during treatment. Avoid concomitant strong CYP3A inducers (eg, carbamazepine, enzalutamide, mitotane, rifampin, phenytoin, St. John’s Wort). Increased risk of hemorrhage with concomitant antiplatelets or anticoagulants; monitor.

Pharmacological Class:

Bruton’s tyrosine kinase (BTK) inhibitor.

Adverse Reactions:

Neutropenia, thrombocytopenia, diarrhea, anemia, musculoskeletal pain, rash, nausea, bruising, fatigue, hemorrhage, pyrexia, muscle spasms, stomatitis, pneumonia.

Generic Availability:

NO

How Supplied:

Caps—90, 120

Indications for IMBRUVICA:

Chronic graft-versus-host disease (cGVHD) after failure of one or more lines of systemic therapy.

Adult:

Swallow whole with water. 420mg once daily. Treat until disease progression, recurrence of an underlying malignancy, or unacceptable toxicity; discontinue when treatment for cGVHD no longer required. Concomitant moderate CYP3A inhibitors: 420mg once daily; adjust dose based on toxicity. Concomitant posaconazole (200mg twice daily or 300mg once daily), voriconazole: 280mg once daily; adjust dose accordingly. Mild hepatic impairment (Child-Pugh Class A): 140mg once daily. Dose modifications for toxicities: see full labeling.

Children:

Not established.

Warnings/Precautions:

Risk of hemorrhage; consider the benefit/risk of withholding treatment for 3–7 days pre-and post-surgery. Monitor for fever and infections; evaluate promptly if occurs. Monitor for myelosuppression; obtain CBCs monthly. Periodically monitor for atrial fibrillation (esp. in those with cardiac risk factors, acute infections, history of atrial fibrillation); do ECG if arrhythmic symptoms or new onset dyspnea develop. Monitor for new onset or uncontrolled hypertension; adjust and/or initiate anti-hypertensives as appropriate. Risk of second primary malignancies (eg, skin cancer or other carcinomas). Monitor for tumor lysis syndrome in patients at risk (eg, high tumor burden). Moderate or severe hepatic impairment: not recommended. Maintain adequate hydration. Embryo-fetal toxicity. Pregnancy; avoid during and for 1 month after treatment cessation. Nursing mothers.

Interactions:

See Adult. Avoid concomitant strong CYP3A inhibitors (eg, boceprevir, clarithromycin, cobicistat, conivaptan, diltiazem, elvitegravir/ritonavir, idelalisib, indinavir/ritonavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, paritaprevir/ritonavir/ombitasvir ± dasabuvir, ritonavir, saquinavir/ritonavir, tipranavir/ritonavir, troleandomycin, posaconazole (at higher doses); if short-term use (eg, anti-infectives for ≤7days), consider interrupting ibrutinib therapy. Concomitant moderate CYP3A inhibitors (eg, aprepitant, cimetidine, ciprofloxacin, clotrimazole, crizotinib, cyclosporine, dronedarone, erythromycin, fluconazole, fluvoxamine, imatinib, verapamil): reduce ibrutinib dose (see Adult). Avoid grapefruit and Seville oranges during treatment. Avoid concomitant strong CYP3A inducers (eg, carbamazepine, enzalutamide, mitotane, rifampin, phenytoin, St. John’s Wort). Increased risk of hemorrhage with concomitant antiplatelets or anticoagulants; monitor.

Pharmacological Class:

Bruton’s tyrosine kinase (BTK) inhibitor.

Adverse Reactions:

Neutropenia, thrombocytopenia, diarrhea, anemia, musculoskeletal pain, rash, nausea, bruising, fatigue, hemorrhage, pyrexia, muscle spasms, stomatitis, pneumonia.

Generic Availability:

NO

How Supplied:

Caps—90, 120

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