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Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma and Waldenström's Macroglobulinemia: The recommended dose of IMBRUVICA for CLL/SLL and WM is 420 mg orally once daily until disease progression or unacceptable toxicity.
For CLL/SLL, IMBRUVICA can be administered as a single agent, in combination with rituximab or obinutuzumab, or in combination with bendamustine and rituximab (BR).
For WM, IMBRUVICA can be administered as a single agent or in combination with rituximab.
When administering IMBRUVICA in combination with rituximab or obinutuzumab, consider administering IMBRUVICA prior to rituximab or obinutuzumab when given on the same day.
Chronic Graft versus Host Disease: The recommended dose of IMBRUVICA for cGVHD is 420 mg 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.
Administration: Administer IMBRUVICA at approximately the same time each day with a glass of water. Swallow tablets or capsule whole. Do not open, break, or chew the capsules. Do not cut, crush, or chew the tablets.
If a dose of IMBRUVICA is not taken at the scheduled time, it can be taken as soon as possible on the same day with a return to the normal schedule the following day. Do not take extra doses of IMBRUVICA to make up for the missed dose.
Dose Modifications for Adverse Reactions: Interrupt IMBRUVICA therapy for any Grade 3 or 4 non-hematological toxicities, Grade 3 or 4 neutropenia with infection or fever, or Grade 4 hematological toxicities. Once the adverse reaction has improved to Grade 1 or baseline (recovery), IMBRUVICA may be reinitiated at the starting dose. If the adverse reaction reoccurs, reduce dose by 140 mg per day. Consider a second reduction of dose by 140 mg as needed. If these adverse reactions persist or recur following two dose reductions, discontinue IMBRUVICA.
Recommended dose modifications are described as follows: See Table 12.
Click on icon to see table/diagram/imageDose Modifications for Use with CYP3A Inhibitors: Recommended dose modifications are described as follows [see Effect of CYP3A Inhibitors on Ibrutinib under Interactions]: See Table 13.
Click on icon to see table/diagram/imageAfter discontinuation of a CYP3A inhibitor, resume previous dose of IMBRUVICA [see Recommended Dosage as previously mentioned and Interactions].
Dose Modifications for Use in Hepatic Impairment: The recommended dosage is 140 mg daily for patients with mild hepatic impairment (Child-Pugh class A).
The recommended dose is 70 mg daily for patients with moderate hepatic impairment (Child-Pugh class B)*.
Avoid the use of IMBRUVICA in patients with severe hepatic impairment (Child-Pugh class C) [see Use in Specific Populations: Hepatic Impairment as follows and Pharmacology under Actions].
* IMBRUVICA 70 mg is not available in Thailand.
Use in Specific Populations: Females and Males of Reproductive Potential: Pregnancy Testing: Verify pregnancy status in females of reproductive potential prior to initiating IMBRUVICA.
Contraception: Females: IMBRUVICA can cause fetal harm when administered to pregnant women [see Pregnancy under Use in Pregnancy & Lactation]. Advise females of reproductive potential to use effective contraception during treatment with IMBRUVICA and for 1 month after the last dose.
Males: Advise males with female partners of reproductive potential to use effective contraception during treatment with IMBRUVICA and for 1 month following the last dose.
Pediatric Use: The safety and effectiveness of IMBRUVICA in pediatric patients has not been established.
Geriatric Use: Of the 1,124 patients in clinical studies of IMBRUVICA, 64% were ≥ 65 years of age, while 23% were ≥75 years of age. No overall differences in effectiveness were observed between younger and older patients. Anemia (all grades), pneumonia (Grade 3 or higher), thrombocytopenia, hypertension, and atrial fibrillation occurred more frequently among older patients treated with IMBRUVICA.
Hepatic Impairment: Avoid use of IMBRUVICA in patients with severe hepatic impairment (Child-Pugh class C). The safety of IMBRUVICA has not been evaluated in patients with mild to severe hepatic impairment by Child-Pugh criteria.
Reduce the recommended dose when administering IMBRUVICA to patients with mild or moderate hepatic impairment (Child-Pugh class A and B). Monitor patients more frequently for adverse reactions of IMBRUVICA [see Dosage Modifications for Use in Hepatic Impairment as previously mentioned and Pharmacology under Actions].
Plasmapheresis: Management of hyperviscosity in WM patients may include plasmapheresis before and during treatment with IMBRUVICA. Modifications to IMBRUVICA dosing are not required.
