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Ibrutinib Dosage

Medically reviewed on September 1, 2017.

Applies to the following strengths: 140 mg

Usual Adult Dose for Lymphoma

Mantle Cell Lymphoma (MCL) OR Marginal Zone Lymphoma (MZL): 560 mg orally once a day

Duration of Therapy: Until disease progression or unacceptable toxicity

Uses:
-Treatment of MCL patients who have received at least one prior therapy
-Treatment of MZL patients who require systemic therapy and have received at least one prior anti-CD20-based therapy

Usual Adult Dose for Chronic Lymphocytic Leukemia

Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL):
-Monotherapy: 420 mg orally once a day
-In Combination with Bendamustine and Rituximab: 420 mg orally once a day every 28 days for up to 6 cycles

Duration of Therapy: Until disease progression or unacceptable toxicity

Use: Treatment of CLL/SLL patients with or without 17p deletion

Usual Adult Dose for non-Hodgkin's Lymphoma

Waldenstrom's Macroglobulinemia (WM) OR Chronic Graft Versus Host Disease (cGVHD): 420 mg orally once a day

Duration of Therapy:
-WM: Until disease progression or unacceptable toxicity
-cGVHD: Until disease progression, recurrence of an underlying malignancy, or unacceptable toxicity

Comments:
-WM: Management of hyperviscosity may include plasmapheresis before and during treatment with this drug, which will not require dosing modifications.
-cGVHD: When a patient no longer requires treatment, discontinue this drug considering the medical assessment of the individual patient

Uses:
-Treatment of WM patients
-Treatment of cGVHD patients after failure of one or more lines of systemic therapy

Usual Adult Dose for Graft Versus Host Disease

Waldenstrom's Macroglobulinemia (WM) OR Chronic Graft Versus Host Disease (cGVHD): 420 mg orally once a day

Duration of Therapy:
-WM: Until disease progression or unacceptable toxicity
-cGVHD: Until disease progression, recurrence of an underlying malignancy, or unacceptable toxicity

Comments:
-WM: Management of hyperviscosity may include plasmapheresis before and during treatment with this drug, which will not require dosing modifications.
-cGVHD: When a patient no longer requires treatment, discontinue this drug considering the medical assessment of the individual patient

Uses:
-Treatment of WM patients
-Treatment of cGVHD patients after failure of one or more lines of systemic therapy

Renal Dose Adjustments

-Mild and Moderate Renal Impairment (CrCl 25 mL/min or greater): No dose adjustments recommended
-Severe Renal Impairment (CrCl less than 25 mL/min): Data not available

Liver Dose Adjustments

-Mild Hepatic Impairment (Child-Pugh A): Data not available
-Moderate or Severe Hepatic Impairment (Child-Pugh B or C): Not recommended

Dose Adjustments

ADVERSE REACTIONS:
Any Grade 3 or Greater Non-Hematological Toxicity, Grade 3 or Greater Neutropenia with Infection or Fever, OR Grade 4 Hematological Toxicity:
-Toxicity Occurs: Interrupt dosing of this drug.
-Once Toxicity Symptoms Resolve to Grade 1 or Baseline: Reinitiate this drug at the initial dose.
-If Toxicity Recurs: Reduce dose by 140 mg, and consider a second 140 mg dose reduction as needed.
-If Toxicity Persists or Recurs Following 2 Dose Reductions: Discontinue this drug.

CONCOMITANT USE WITH CYP450 3A4 INHIBITORS:
Patients with B-Cell Malignancies:
-Concomitant Administration of Moderate CYP450 3A Inhibitor, Posaconazole 200 mg Twice a Day or Less, OR Voriconazole at Any Dose: Reduce dose to 140 mg orally once a day; interrupt dose as recommended.
-Concomitant Administration of Strong CYP450 3A Inhibitor, Posaconazole at Doses Greater Than 200 mg Twice a Day, OR Voriconazole at Any Dose: Avoid concomitant use OR interrupt dosing of this drug IF concomitant inhibitors will be used short-term (e.g., anti-infectives for 7 days or less).

Patients with Chronic Graft Versus Host Disease:
-Concomitant Administration of Moderate CYP450 3A Inhibitor: Administer usual dose (420 mg orally once a day); modify dose as recommended.
-Concomitant Administration of Posaconazole Immediate-Release (IR) Tablet 200 mg Twice a Day or Posaconazole Delayed-Release (DR) Tablet 300 mg Every Day OR Voriconazole at Any Dose: Reduce dose to 280 mg orally once a day; modify dose as recommended.
-Concomitant Administration of Strong CYP450 3A Inhibitor OR Posaconazole at Doses Greater Than IR Tablet 200 mg Twice a Day/DR Tablet 300 mg Every Day: Avoid concomitant use OR interrupt dosing of this drug IF concomitant inhibitors will be used short-term (e.g., anti-infectives for 7 days or less).

Precautions

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration Advice:
-Administer this drug at approximately the same time each day.
-Instruct patients to swallow drug capsules whole with water, and not to open, break, or chew the capsules.
-Administer a missed dose as soon as possible on the same day with a return to the normal dosing schedule the following day; do not administer extra capsules to make up the missed dose.

Storage Requirements:
-Store drug bottles at room temperature (20 to 25 degrees Celsius/68 to 77 degrees Fahrenheit); excursions are permitted between 15 and 30 degrees Celsius/59 to 86 degrees Fahrenheit.
-Retain in original packaging until dispensing.

General:
-Accelerated approval was granted for treatment of mantle cell lymphoma and marginal zone lymphoma based on overall response rate. Continued approval for these treatment indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

Monitoring:
-Cardiovascular: Signs/symptoms of atrial fibrillation, atrial flutter, ventricular tachyarrhythmia, new onset hypertension or uncontrolled hypertension (during treatment)
-Embryofetal toxicity: Pregnancy status of females of reproductive potential (baseline and during treatment)
-General: Signs of bleeding (during treatment)
-Hematologic: Complete blood counts (monthly); signs/symptoms of leukostasis (during treatment)
-Hepatic: Liver function tests (during treatment)
-Infections/infestations: Fever and infections (during treatment)
-Metabolic: Signs/symptoms of tumor lysis syndrome (during treatment)
-Oncologic: Appearance of non-melanoma skin cancer (during treatment)
-Respiratory: Signs/symptoms of interstitial lung disease

Patient Advice:
-Avoid grapefruit, grapefruit juice, and Seville oranges (often used in marmalades) during treatment.
-This drug may cause side effects such as fatigue and dizziness; avoid driving or other potentially dangerous activities such as operating machinery until you know how this drug affects you.

Further information

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

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