Imbruvica Dosage/Direction for Use

Dosage: Ibrutinib (Imbruvica) should be administered orally once daily with a glass of water at approximately the same time each day. The capsules or tablets should be swallowed whole with water. Do not open, break, or chew the capsules. Ibrutinib (Imbruvica) must not be taken with grapefruit juice. Ibrutinib (Imbruvica) should continue until disease progression or no longer tolerated by the patient.
Mantle cell lymphoma: The recommended dose of Ibrutinib (Imbruvica) for the treatment of MCL is 560 mg once daily until disease progression or no longer tolerated by the patient.
Chronic lymphocytic leukemia/Small lymphocytic lymphoma (CLL/SLL) and Waldenström's macroglobulinemia (WM): The recommended dose of Ibrutinib (Imbruvica) for CLL/SLL or WM is 420 mg once daily. For CLL/SLL, Ibrutinib (Imbruvica) can be administered until disease progression or is no longer tolerated by the patient as a single agent or in combination with anti-CD20 therapy (rituximab or obinutuzumab), or in combination with bendamustine and rituximab (BR). In combination with venetoclax, Ibrutinib (Imbruvica) should be administered as a single agent for 3 cycles (1 cycle is 28 days), followed by 12 cycles of Ibrutinib (Imbruvica) plus venetoclax.
For WM, Ibrutinib (Imbruvica) can be administered until disease progression or no longer tolerated as a single agent or in combination with rituximab. For additional information concerning rituximab, BR, or obinutuzumab see the corresponding local rituximab, bendamustine or obinutuzumab prescribing information. When administering Ibrutinib (Imbruvica) in combination with anti-CD20 therapy, it is recommended to administer Ibrutinib (Imbruvica) prior to anti-CD20 therapy when given on the same day.
Dose modification guidelines: Dose modifications are required for the concomitant use of moderate and strong CYP3A inhibitors as these can increase the exposure of ibrutinib (see Interactions).
Ibrutinib (Imbruvica) therapy should be withheld for any new onset or worsening Grade ≥3 non-hematological toxicities, Grade 3 or greater neutropenia with infection or fever, or Grade 4 hematological toxicities.
Once the symptoms of the toxicity has resolved to Grade 1 or baseline (recovery), Ibrutinib (Imbruvica) therapy may be reinitiated at the starting dose. If the toxicity reoccurs, reduce dose by 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 Ibrutinib (Imbruvica).
Recommended dose modifications are described as follows: see Table 19.

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Missed dose: If a dose of Ibrutinib (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. The patient should not take extra capsules to make up the missed dose.
Special populations: Pediatrics (18 years of age and younger): The safety and efficacy of Ibrutinib (Imbruvica) in children have not been evaluated.
Elderly: No specific dose adjustment is required for elderly patients (aged ≥65 years).
Renal impairment: Ibrutinib has minimal renal clearance. No specific clinical studies have been conducted in patients with renal impairment. Patients with mild or moderate renal impairment were treated in Ibrutinib (Imbruvica) clinical studies. No dose adjustment is needed for patients with mild or moderate renal impairment (greater than 30 mL/min creatinine clearance). Hydration should be maintained and serum creatinine levels monitored periodically. There are no data in patients with severe renal impairment or patients on dialysis (see Pharmacology: Pharmacokinetics under Actions).
Hepatic Impairment: Ibrutinib is metabolized in the liver. In a hepatic impairment study, data showed an increase in ibrutinib exposure (see Pharmacology: Pharmacokinetics under Actions). For patients with mild liver impairment (Child‑Pugh class A), the recommended dose is 280 mg daily. For patients with moderate liver impairment (Child‑Pugh class B), the recommended dose is 140 mg daily (one capsule). Monitor patients for signs of Ibrutinib (Imbruvica) toxicity and follow dose modification guidance as needed. It is not recommended to administer Ibrutinib (Imbruvica) to patients with severe hepatic impairment (Child‑Pugh class C).