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Imbruvica Dosage

Generic name: IBRUTINIB 70mg
Dosage form: capsule
Drug class: BTK inhibitors

Medically reviewed by Drugs.com. Last updated on May 18, 2023.

2.1 Recommended Dosage

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 patients age 12 years and older with cGVHD is 420 mg orally once daily, and for patients 1 to less than 12 years of age with cGVHD is 240 mg/m2 orally once daily (up to a dose of 420 mg), 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.

Table 1: Recommended dosage based on body surface area (BSA) for patients 1 to less than 12 years of age using either IMBRUVICA capsules/tablets or oral suspension
Recommended dose to achieve 240 mg/m2
BSA* (m2) Range Dose (mg) of IMBRUVICA Capsules/Tablets to Administer Volume (mL) of IMBRUVICA Oral Suspension (70 mg/mL) to Administer
> 0.3 to 0.4 - 1.2 mL
> 0.4 to 0.5 - 1.5 mL
> 0.5 to 0.6 - 1.9 mL
> 0.6 to 0.7 - 2.2 mL
> 0.7 to 0.8 210 mg 2.6 mL
> 0.8 to 0.9 210 mg 2.9 mL
> 0.9 to 1.0 210 mg 3.3 mL
> 1.0 to 1.1 280 mg 3.6 mL
> 1.1 to 1.2 280 mg 4 mL
> 1.2 to 1.3 280 mg 4.3 mL
> 1.3 to 1.4 350 mg 4.6 mL
> 1.4 to 1.5 350 mg 5 mL
> 1.5 to 1.6 350 mg 5.3 mL
> 1.6 420 mg 6 mL

*BSA = body surface area.

Administration

Administer IMBRUVICA at approximately the same time each day.

Swallow tablets or capsules whole with a glass of water. Do not open, break, or chew the capsules. Do not cut, crush, or chew the tablets.

Follow Instructions for Use for further administration details of IMBRUVICA oral suspension.

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.

2.2 Dosage Modifications for Adverse Reactions

For adverse reactions listed in Table 2, interrupt IMBRUVICA therapy. Once the adverse reaction has improved to Grade 1 or baseline (recovery), follow the recommended dosage modifications (see Table 2).

Table 2: Recommended Dosage Modifications for Adverse Reactions
Adverse Reactiona,b Occurrence Dose Modification for CLL/SLL, WM, and Patients 12 Years or older with cGVHD After Recovery
Starting Dose = 420 mg
Dose Modification for Patients 1 Year to less than 12 Years with cGVHD After Recovery
Starting Dose = 240 mg/m2
Grade 2 cardiac failure First Restart at 280 mg dailyc Restart at 160 mg/m2 dailyc
Second Restart at 140 mg dailyc Restart at 80 mg/m2 dailyc
Third Discontinue IMBRUVICA Discontinue IMBRUVICA
Grade 3 cardiac arrhythmias First Restart at 280 mg dailyc Restart at 160 mg/m2 dailyc
Second Discontinue IMBRUVICA Discontinue IMBRUVICA
Grade 3 or 4 cardiac failure
Grade 4 cardiac arrhythmias
First Discontinue IMBRUVICA Discontinue IMBRUVICA
Other Grade 3 or 4 non-hematological toxicitiesd
Grade 3 or 4 neutropenia with infection or fever
Grade 4 hematological toxicities
First Restart at 280 mg daily Restart at 160 mg/m2 dailyc
Second Restart at 140 mg daily Restart at 80 mg/m2 dailyc
Third Discontinue IMBRUVICA Discontinue IMBRUVICA

a [see Warnings and Precautions (5)].

b Grading based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria, or International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria for hematologic toxicities in CLL/SLL.

c Evaluate the benefit-risk before resuming treatment.

d For Grade 4 non-hematologic toxicities, evaluate the benefit-risk before resuming treatment.

Table 3: Recommended dosage modifications based on BSA using either IMBRUVICA capsules/tablets or oral suspension
Recommended dose to achieve 160 mg/m2 Recommended dose to achieve 80 mg/m2
BSA* (m2) Range Dose (mg) of IMBRUVICA Capsules/Tablets to Administer Volume (mL) of IMBRUVICA Oral Suspension (70 mg/mL) to Administer Dose (mg) of IMBRUVICA Capsules/Tablets to Administer Volume (mL) of IMBRUVICA Oral Suspension (70 mg/mL) to Administer
> 0.3 to 0.4 - 0.8 mL - 0.4 mL
> 0.4 to 0.5 - 1 mL - 0.5 mL
> 0.5 to 0.6 - 1.3 mL - 0.6 mL
> 0.6 to 0.7 - 1.5 mL - 0.7 mL
> 0.7 to 0.8 140 mg 1.7 mL 70 mg 0.9 mL
> 0.8 to 0.9 140 mg 1.9 mL 70 mg 1 mL
> 0.9 to 1.0 140 mg 2.2 mL 70 mg 1.1 mL
> 1.0 to 1.1 140 mg 2.4 mL 70 mg 1.2 mL
> 1.1 to 1.2 210 mg 2.6 mL - 1.3 mL
> 1.2 to 1.3 210 mg 2.9 mL - 1.4 mL
> 1.3 to 1.4 210 mg 3.1 mL - 1.5 mL
> 1.4 to 1.5 210 mg 3.3 mL 140 mg 1.7 mL
> 1.5 to 1.6 280 mg 3.5 mL 140 mg 1.8 mL
> 1.6 280 mg 4 mL 140 mg 2 mL

*BSA = body surface area.

2.3 Dosage Modifications for Use with CYP3A Inhibitors

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

Table 4: Recommended Dosage Modifications for Use with CYP3A Inhibitors
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.
Patients 12 years and older with cGVHD
  • 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.
Patients 1 year to less than 12 years of age with cGVHD
  • Moderate CYP3A inhibitors
240 mg/m2 once daily
Modify dose as recommended [see Dosage and Administration (2.2)].
  • Voriconazole for suspension 9 mg/kg (maximum dose: 350 mg) twice daily
160 mg/m2 once daily
  • Posaconazole at any dosage
80 mg/m2 once daily
  • 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)].

2.4 Dosage Modifications for Use in Hepatic Impairment

Adult Patients with B-cell Malignancies

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)].

Patients with cGVHD

The recommended dosage is 140 mg daily for patients 12 years of age and older with total bilirubin level >1.5 to 3 x upper limit of normal (ULN) (unless of non-hepatic origin or due to Gilbert’s syndrome).

The recommended dosage is 80 mg/m2 daily for patients 1 to less than 12 years of age with total bilirubin level >1.5 to 3 x ULN (unless of non-hepatic origin or due to Gilbert’s syndrome).

Avoid the use of IMBRUVICA in these patients with total bilirubin level > 3 x ULN (unless of non-hepatic origin or due to Gilbert’s syndrome) [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

Frequently asked questions

Further information

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