Usual Adult Dose for Lymphoma

160 mg orally 2 times a day until disease progression or unacceptable toxicity
OR
320 mg orally once a day until disease progression or unacceptable toxicity

Uses:

• For the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy
• For the treatment of adult patients with Waldenström's macroglobulinemia (WM)
• For the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen

Renal Dose Adjustments

Mild to severe renal dysfunction: No adjustment recommended.

Liver Dose Adjustments

Mild to moderate hepatic dysfunction: No adjustment recommended.
Severe hepatic dysfunction: Reduce dose to 80 mg orally 2 times a day.

Dose Adjustments

DOSE MODIFICATIONS FOR ADVERSE REACTIONS (starting dose of 160 mg 2 times a day OR 320 mg once a day):
FOR:
1) GRADE 3 OR HIGHER NONHEMATOLOGICAL TOXICITIES
OR
2) GRADE 3 FEBRILE NEUTROPENIA; GRADE 3 THROMBOCYTOPENIA WITH SIGNIFICANT BLEEDING
OR
3) GRADE 4 NEUTROPENIA (LASTING MORE THAN 10 CONSECUTIVE DAYS)
OR
4) GRADE 4 THROMBOCYTOPENIA (LASTING MORE THAN 10 CONSECUTIVE DAYS):
Below are dose modifications for the reactions 1 through 4 listed above:

• First Occurrence: Interrupt therapy; when toxicity has resolved to Grade 1 or less or baseline resume at 160 mg 2 times a day or 320 mg once a day
• Second Occurrence: Interrupt therapy; when toxicity has resolved to Grade 1 or less or baseline resume at 80 mg 2 times a day or 160 mg once a day
• Third Occurrence: Interrupt therapy; when toxicity has resolved to Grade 1 or less or baseline resume at 80 mg once a day
• Fourth Occurrence: Discontinue therapy

• Strong CYP450 3A inhibitor: 80 mg orally once a day; interrupt dose as recommended for adverse reactions
• Moderate CYP450 3A inhibitor: 80 mg orally 2 times a day; interrupt dose as recommended for adverse reactions
• Moderate or strong CYP450 3A inducer: Avoid concomitant use.
• After discontinuation of a CYP450 3A inhibitor, resume previous dose of this drug.

Precautions

CONTRAINDICATIONS:

• None

Dialysis

Dose adjustment(s) may be required; however, no specific guidelines have been suggested. Monitor for adverse reactions.

Other Comments

Administration advice:

• This drug may be taken with or without food.
• Swallow capsules whole with water; do not open, break, or chew.
• If a dose is missed, it should be taken as soon as possible on the same day with a return to the normal schedule the following day.

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

• Renal function
• Hepatic function
• Cardiac function
• Secondary primary malignancies

• Read the patient information for this drug each time you have your prescription filled.
• Advise females not to breastfeed during treatment and for at least 2 weeks after the last dose.
• If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
• Advise female patients of reproductive potential to use effective contraception during therapy and for at least 1 after.
• Advise men to avoid fathering a child while receiving this drug and for at least 1 week after.
• Advise patients to to report any signs of palpitations, lightheadedness, dizziness, fainting, shortness of breath, and chest discomfort.
• Advise patients to use sun protection.
• Inform patients to report signs or symptoms of severe bleeding and that this drug may need to be interrupted for major surgeries or procedures.
• Inform patients to report signs or symptoms suggestive of infection.
• Inform your healthcare provider of all medications you are taking (including over-the-counter medications, vitamins, and herbal products).

Frequently asked questions

• What are the names of the BTK inhibitors?