Usual Adult Dose for Lymphoma

100 mg orally every 12 hours

Comments:

• Start treatment at cycle 1 (each cycle is 28 days) when use concomitantly with obinutuzumab.
• Start obinutuzumab at Cycle 2 for a total of 6 cycles and refer to the obinutuzumab prescribing information for recommended dosing; administer this drug prior to obinutuzumab when given on the same day.
• Treatment should be continued until disease progression or unacceptable toxicity.

• As monotherapy for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy
• As monotherapy or in combination with obinutuzumab for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)

Renal Dose Adjustments

Mild (CrCl 60 to less than 90 mL/min) to moderate (CrCl 30 to less than 60 mL/min renal impairment: No adjustment recommended.
Severe (CrCl 15 to less than 30 mL/min) or end-stage (CrCl less than 15 mL/min) renal impairment: Data not available.

Liver Dose Adjustments

Mild (Child-Pugh A) to moderate (Child-Pugh B) hepatic impairment: No adjustment recommended.
Severe (Child-Pugh C) hepatic impairment): Avoid use.

Dose Adjustments

RECOMMENDED DOSE ADJUSTMENTS FOR ADVERSE REACTIONS:
Grade 3 or greater nonhematologic toxicities, Grade 3 thrombocytopenia with bleeding, Grade 4 thrombocytopenia, or Grade 4 neutropenia lasting longer than 7 days:

• First and second occurrence: Temporarily interrupt this drug; when toxicity has resolved to Grade 1 or baseline, this drug may be resumed at 100 mg orally 2 times a day
• Third occurrence: Temporarily interrupt this drug; when toxicity has resolved to Grade 1 or baseline, this drug may be resumed at 100 mg orally once daily
• Fourth occurrence: Discontinue this drug

• Strong CYP450 3A inhibitor: Avoid concomitant use; if inhibitor will be used short-term (e.g., anti-infectives for up to 7 days), interrupt this drug
• Moderate CYP450 3A inhibitor: 100 mg orally once daily
• Strong CYP450 3A inducer: Avoid concomitant use. If these inducers cannot be avoided, increase dose to 200 mg approximately every 12 hours

• Proton pump inhibitors: Avoid concomitant use
• H2 receptor antagonist: Administer this drug 2 hours before or 10 hours after taking a H2-receptor antagonist
• Antacid: Separate dosing by at least 2 hours

Precautions

CONTRAINDICATIONS:

• None

Dialysis

Data not available

Other Comments

Administration Advice:

• This drug may be taken with or without food.
• Capsules should be swallowed whole; do not open, break, or chew.
• If a dose is missed by less than 3 hours, it should be taken as soon as remembered; if more than 3 hours have elapsed the dose should be skipped and taken at the next regularly scheduled time.

• Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F).

• Cardiovascular: Signs/symptoms of atrial fibrillation and atrial flutter; signs of bleeding
• Hematologic: Periodic blood counts
• Infections/Infestations: Signs/symptoms of infection

• During therapy, use sun protection whenever you're exposed to sunlight as there have been reports of some patients experiencing new cancers (including skin cancer) while taking this drug.

Frequently asked questions

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