Imbruvica Tablets Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
See Also
How Supplied
Caps 70mg—28; 140mg—90, 120; Tabs—28 (2×14 blister cards)
Manufacturer
Generic Availability
Imbruvica Tablets Indications
Indications
Imbruvica Tablets Dosage and Administration
Adult
Children
Renal Impairment
Mild or moderate renal impairment: no influence on the exposure of ibrutinib
Severe renal impairment: no data available
Hepatic Impairment
See Dosing and Administration.
Mild or moderate hepatic impairment: reduce dose; monitor more frequently
Severe hepatic impairment: avoid use
Study data showed that the AUC and Cmax of ibrutinib increased 2.7-fold and 5.2-fold in patients with mild hepatic impairment, 8.2-fold and 8.8-fold in patients with moderate hepatic impairment and 9.8-fold and 7-fold in patients with severe hepatic impairment relative to patients with normal liver function.
Other Modifications
Females of reproductive potential: use effective contraception during treatment and for 1 month after the last dose. Verify pregnancy status prior to initiating treatment.
Males with female partners of reproductive age: use effective contraception during treatment and for 1 month after the last dose.
Plasmapheresis: Management of hyperviscosity in WM patients may include plasmapheresis before and during treatment with Imbruvica. Modifications to dosing are not required.
Imbruvica Tablets Contraindications
Not Applicable
Imbruvica Tablets Boxed Warnings
Not Applicable
Imbruvica Tablets Warnings/Precautions
Warnings/Precautions
Imbruvica Tablets Pharmacokinetics
Absorption
Ibrutinib is absorbed after oral administration with a median Tmax of 1 hour to 2 hours.
Distribution
Reversible binding of ibrutinib to human plasma protein in vitro was 97.3%
Elimination
The half-life of ibrutinib is 4 hours to 6 hours. Eliminated primarily via feces.
Imbruvica Tablets Interactions
Interactions
Imbruvica Tablets Adverse Reactions
Adverse Reactions
Imbruvica Tablets Clinical Trials
Imbruvica Tablets Note
Not Applicable
Imbruvica Tablets Patient Counseling
Cost Savings Program
Imbruvica Tablets Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
See Also
How Supplied
Caps 70mg—28; 140mg—90, 120; Tabs—28 (2×14 blister cards); Oral susp—108mL
Manufacturer
Generic Availability
Imbruvica Tablets Indications
Indications
Imbruvica Tablets Dosage and Administration
Adult
Swallow caps/tabs whole with water. Take at same time each day. ≥12yrs: 420mg once daily. Treat until disease progression, recurrence of an underlying malignancy, or unacceptable toxicity; discontinue when treatment for cGVHD no longer required. Hepatic impairment (total bilirubin level >1.5–3×ULN [unless of non-hepatic origin or due to Gilbert’s syndrome]): 140mg once daily; (total bilirubin level >3×ULN [unless of non-hepatic origin or due to Gilbert’s syndrome]): avoid. Dose modifications for toxicities or concomitant CYP3A inhibitors (eg, voriconazole, posaconazole): see full labeling.
Children
<1yr: not established. Can use caps/tabs or oral susp. Swallow caps/tabs whole with water. Take at same time each day. 1–<12yrs: 240mg/m2 once daily (based on BSA); max: up to 420mg once daily. Treat until disease progression, recurrence of an underlying malignancy, or unacceptable toxicity; discontinue when treatment for cGVHD no longer required. Hepatic impairment (total bilirubin level >1.5–3×ULN [unless of non-hepatic origin or due to Gilbert’s syndrome]): 80mg/m2 once daily; (total bilirubin level >3×ULN [unless of non-hepatic origin or due to Gilbert’s syndrome]): avoid. Recommended dose based on BSA, dose modifications for toxicities or concomitant CYP3A inhibitors (eg, voriconazole, posaconazole): see full labeling.
Renal Impairment
Mild or moderate renal impairment: no influence on the exposure of ibrutinib
Severe renal impairment: no data available
Hepatic Impairment
See Dosing and Administration.
Total bilirubin level >1.5 to 3x upper limit of normal (ULN) (unless of nonhepatic origin or due to Gilbert syndrome): reduce dose
Total bilirubin level >3x ULN (unless of nonhepatic origin or due to Gilbert syndrome): avoid use
Other Modifications
Females of reproductive potential: use effective contraception during treatment and for 1 month after the last dose. Verify pregnancy status prior to initiating treatment.
Males with female partners of reproductive age: use effective contraception during treatment and for 1 month after the last dose.
Imbruvica Tablets Contraindications
Not Applicable
Imbruvica Tablets Boxed Warnings
Not Applicable
Imbruvica Tablets Warnings/Precautions
Warnings/Precautions
Imbruvica Tablets Pharmacokinetics
Absorption
Ibrutinib is absorbed after oral administration with a median Tmax of 1 hour to 2 hours.
Distribution
Reversible binding of ibrutinib to human plasma protein in vitro was 97.3%
Elimination
The half-life of ibrutinib is 4 hours to 6 hours. Eliminated primarily via feces.
Imbruvica Tablets Interactions
Interactions
Imbruvica Tablets Adverse Reactions
Adverse Reactions
Imbruvica Tablets Clinical Trials
Imbruvica Tablets Note
Not Applicable