IMBRUVICA Rx

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IMBRUVICA

Leukemias, lymphomas, and other hematologic cancers
Miscellaneous immune disorders
Only 4 drugs may be compared at once

Generic Name and Formulations:

Ibrutinib 70mg, 140mg; caps.

Select 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. 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. 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.

Interactions:

Avoid concomitant strong CYP3A inhibitors (eg, boceprevir, clarithromycin, cobicistat, conivaptan, danoprevir/ritonavir, diltiazem, elvitegravir/ritonavir, idelalisib, indinavir/ritonavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, paritaprevir/ritonavir/ombitasvir ± dasabuvir, ritonavir, saquinavir/ritonavir, tipranavir/ritonavir, troleandomycin; if short-term use (eg, anti-infectives for ≤7days), interrupt ibrutinib therapy. Concomitant posaconazole, voriconazole, and moderate CYP3A inhibitors (eg, aprepitant, cimetidine, ciprofloxacin, clotrimazole, crizotinib, cyclosporine, dronedarone, erythromycin, fluconazole, fluvoxamine, imatinib, verapamil): adjust ibrutinib dose (see full labeling). 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 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 70mg—28; 140mg—90, 120

IMBRUVICA 90 capsules of 140mg bottles (Qty:1)

appx. price $11995.00

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. 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. 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.

Interactions:

Avoid concomitant strong CYP3A inhibitors (eg, boceprevir, clarithromycin, cobicistat, conivaptan, danoprevir/ritonavir, diltiazem, elvitegravir/ritonavir, idelalisib, indinavir/ritonavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, paritaprevir/ritonavir/ombitasvir ± dasabuvir, ritonavir, saquinavir/ritonavir, tipranavir/ritonavir, troleandomycin; if short-term use (eg, anti-infectives for ≤7days), interrupt ibrutinib therapy. Concomitant posaconazole, voriconazole, and moderate CYP3A inhibitors (eg, aprepitant, cimetidine, ciprofloxacin, clotrimazole, crizotinib, cyclosporine, dronedarone, erythromycin, fluconazole, fluvoxamine, imatinib, verapamil): adjust ibrutinib dose (see full labeling). 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 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 70mg—28; 140mg—90, 120

IMBRUVICA 90 capsules of 140mg bottles (Qty:1)

appx. price $11995.00