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Imbruvica Dosage

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.

Dosing Guidelines

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.

Dosage

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
B-Cell Malignancies
  • Moderate CYP3A inhibitor
  • Posaconazole at doses less than or equal to 200 mg BID
  • Voriconazole at any dose

140 mg once daily


Interrupt dose as recommended [see Dosage and Administration (2.3)].

  • Posaconazole at doses greater than 200 mg BID
  • Other strong CYP3A inhibitors
  • Voriconazole at any dose

Avoid concomitant use.


If these inhibitors will be used short-term (such as anti-infectives for seven days or less), interrupt IMBRUVICA.

Chronic Graft versus Host Disease
  • Moderate CYP3A inhibitor

420 mg once daily


Modify dose as recommended [see Dosage and Administration (2.3)].

  • Posaconazole immediate-release tablet 200 mg BID or delayed-release tablet 300 mg QD
  • Voriconazole at any dose

280 mg once daily


Modify dose as recommended [see Dosage and Administration (2.3)].

  • Posaconazole at other higher doses
  • Other strong CYP3A inhibitors

Avoid concomitant use.


If these inhibitors will be used short-term (such as anti-infectives for seven days or less), interrupt IMBRUVICA.

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)].

Missed Dose

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. Extra capsules of IMBRUVICA should not be taken to make up for the missed dose.

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