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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 70mg, 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. Take at same time each day. MCL and MZL: 560mg once daily. CLL/SLL (with or without bendamustine/rituximab) and WM (with or without rituximab): 420mg once daily. Combination therapy: consider giving ibrutinib prior to rituximab when given on same day. All: treat until disease progression or unacceptable toxicity. Hepatic impairment (mild): 140mg once daily; (moderate): 70mg once daily; (severe): avoid. Dose modifications for toxicities or concomitant CYP3A inhibitors (eg, voriconazole, posaconazole): 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. Consider prophylaxis for opportunistic infections in high risk patients. Monitor for myelosuppression; obtain CBCs monthly. Periodically monitor for cardiac arrhythmias (esp. in those with cardiac risk factors, hypertension, acute infections, history of cardiac arrhythmias); 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, non-melanoma skin cancer or others). Monitor for tumor lysis syndrome in patients at risk (eg, high tumor burden). Hepatic impairment. Maintain adequate hydration. Embryo-fetal toxicity. Pregnancy; avoid during and for 1 month after treatment cessation. Nursing mothers.

See Also:

IMBRUVICA TABLETS

Pharmacological Class:

Bruton tyrosine kinase (BTK) inhibitor.

Interactions:

Avoid concomitant strong CYP3A inhibitors (eg, ketoconazole); if short-term use (eg, anti-infectives for ≤7days), interrupt ibrutinib therapy. Concomitant posaconazole, voriconazole, and moderate CYP3A inhibitors (eg, erythromycin): adjust ibrutinib dose (see full labeling). Avoid grapefruit and Seville oranges during treatment. Avoid concomitant strong CYP3A inducers (eg, rifampin). Increased risk of hemorrhage with concomitant antiplatelets or anticoagulants; monitor.

Adverse Reactions:

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

Generic Availability:

NO

How Supplied:

Caps 70mg—28; 140mg—90, 120; Tabs—28 (2x14 blister cards)

Indications for IMBRUVICA:

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

Adult:

Swallow whole with water. Take at same time each day. 420mg once daily. Treat until disease progression, recurrence of an underlying malignancy, or unacceptable toxicity; discontinue when treatment for cGVHD no longer required. Hepatic impairment (mild): 140mg once daily; (moderate): 70mg once daily; (severe): avoid. Dose modifications for toxicities or concomitant CYP3A inhibitors (eg, voriconazole, posaconazole): 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. Consider prophylaxis for opportunistic infections in high risk patients. Monitor for myelosuppression; obtain CBCs monthly. Periodically monitor for cardiac arrhythmias (esp. in those with cardiac risk factors, hypertension, acute infections, history of cardiac arrhythmias); 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, non-melanoma skin cancer or others). Monitor for tumor lysis syndrome in patients at risk (eg, high tumor burden). Hepatic impairment. Maintain adequate hydration. Embryo-fetal toxicity. Pregnancy; avoid during and for 1 month after treatment cessation. Nursing mothers.

See Also:

IMBRUVICA TABLETS

Pharmacological Class:

Bruton tyrosine kinase (BTK) inhibitor.

Interactions:

Avoid concomitant strong CYP3A inhibitors (eg, ketoconazole); if short-term use (eg, anti-infectives for ≤7days), interrupt ibrutinib therapy. Concomitant posaconazole, voriconazole, and moderate CYP3A inhibitors (eg, erythromycin): adjust ibrutinib dose (see full labeling). Avoid grapefruit and Seville oranges during treatment. Avoid concomitant strong CYP3A inducers (eg, rifampin). Increased risk of hemorrhage with concomitant antiplatelets or anticoagulants; monitor.

Adverse Reactions:

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

Generic Availability:

NO

How Supplied:

Caps 70mg—28; 140mg—90, 120; Tabs—28 (2x14 blister cards)

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