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Imbruvica Dosage

Generic name: IBRUTINIB 140mg
Dosage form: capsule

Medically reviewed by Drugs.com. Last updated on Apr 23, 2020.

Recommended Dosage

Mantle Cell Lymphoma and Marginal Zone Lymphoma

The recommended dosage of IMBRUVICA for MCL and MZL is 560 mg orally once daily until disease progression or unacceptable toxicity.

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma and Waldenström's Macroglobulinemia

The recommended dosage 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 dosage 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.

Dosage 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 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 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

Dosage Modifications for Use with CYP3A Inhibitors

Recommended dosage modifications are described below [see Drug Interactions (7.1)]:

Patient Population Coadministered Drug Recommended IMBRUVICA Dosage
B-Cell Malignancies
  • Moderate CYP3A inhibitor
280 mg once daily
Modify dose as recommended [see Dosage and Administration (2.2)].
  • Voriconazole 200 mg twice daily
  • Posaconazole suspension 100 mg once daily, 100 mg twice daily, or 200 mg twice daily
140 mg once daily
Modify dose as recommended [see Dosage and Administration (2.2)].
  • Posaconazole suspension 200 mg three times daily or 400 mg twice daily
  • Posaconazole intravenously 300 mg once daily
  • Posaconazole delayed-release tablets 300 mg once daily
70 mg once daily
Interrupt dose as recommended [see Dosage and Administration (2.2)].
  • 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.
Chronic Graft versus Host Disease
  • Moderate CYP3A inhibitor
420 mg once daily
Modify dose as recommended [see Dosage and Administration (2.2)].
  • Voriconazole 200 mg twice daily
  • Posaconazole suspension 100 mg once daily, 100 mg twice daily, or 200 mg twice daily
280 mg once daily
Modify dose as recommended [see Dosage and Administration (2.2)].
  • Posaconazole suspension 200 mg three times daily or 400 mg twice daily
  • Posaconazole intravenously 300 mg once daily
  • Posaconazole delayed-release tablets 300 mg once daily
140 mg once daily
Interrupt dose as recommended [see Dosage and Administration (2.2)].
  • 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.

After discontinuation of a CYP3A inhibitor, resume previous dose of IMBRUVICA [see Dosage and Administration (2.1), Drug Interactions (7.1)].

Dosage 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 dosage 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 (8.6), Clinical Pharmacology (12.3)].

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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