Generic name: Ibrutinib 140mg
Dosage form: capsule
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
Administer IMBRUVICA orally once daily at approximately the same time each day. Swallow the capsules whole with water. Do not open, break, or chew the capsules.
Mantle Cell Lymphoma and Marginal Zone Lymphoma
The recommended dose of IMBRUVICA for MCL and MZL is 560 mg (four 140 mg capsules) orally once daily until disease progression or unacceptable toxicity.
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma and Waldenström's Macroglobulinemia
The recommended dose of IMBRUVICA for CLL/SLL and WM is 420 mg (three 140 mg capsules) orally once daily until disease progression or unacceptable toxicity.
The recommended dose of IMBRUVICA for CLL/SLL when used in combination with bendamustine and rituximab (administered every 28 days for up to 6 cycles) is 420 mg (three 140 mg capsules) orally once daily until disease progression or unacceptable toxicity.
Chronic Graft versus Host Disease
The recommended dose of IMBRUVICA for cGVHD is 420 mg (three 140 mg capsules) orally once daily until cGVHD progression, recurrence of an underlying malignancy, or unacceptable toxicity. When a patient no longer requires therapy for the treatment of cGVHD, IMBRUVICA should be discontinued considering the medical assessment of the individual patient.
Dose Modifications for Adverse Reactions
Interrupt IMBRUVICA therapy for any Grade 3 or greater non-hematological toxicities, Grade 3 or greater neutropenia with infection or fever, or Grade 4 hematological toxicities. Once the symptoms of the toxicity have resolved to Grade 1 or baseline (recovery), IMBRUVICA therapy may be reinitiated at the starting dose. If the toxicity reoccurs, reduce dose by one capsule (140 mg per day). A second reduction of dose by 140 mg may be considered as needed. If these toxicities persist or recur following two dose reductions, discontinue IMBRUVICA.
Recommended dose modifications are described below:
|Toxicity Occurrence||Dose Modification for MCL and MZL After Recovery
Starting Dose = 560 mg
|Dose Modification for CLL/SLL, WM, and cGVHD After Recovery
Starting Dose = 420 mg
|First||Restart at 560 mg daily||Restart at 420 mg daily|
|Second||Restart at 420 mg daily||Restart at 280 mg daily|
|Third||Restart at 280 mg daily||Restart at 140 mg daily|
|Fourth||Discontinue IMBRUVICA||Discontinue IMBRUVICA|
Dose Modifications for Use with CYP3A Inhibitors
Recommended dose modifications are described below [see Drug Interactions (7.1)]:
|Patient Population||Coadministered Drug||Recommended IMBRUVICA Dose|
140 mg once daily
Avoid concomitant use.
|Chronic Graft versus Host Disease||
420 mg once daily
280 mg once daily
Avoid concomitant use.
Dose Modifications for Use in Hepatic Impairment
The recommended dose is 140 mg daily for patients with mild hepatic impairment (Child-Pugh class A). Avoid the use of IMBRUVICA in patients with moderate or severe hepatic impairment (Child-Pugh classes B and C) [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
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- Drug class: multikinase inhibitors