e CYP3A inhibitor
Voriconazole 200 mg twice daily
Posaconazole suspension 100 mg once daily, 100 mg twice daily, or 200 mg twice daily
140 mg once daily
Interrupt dose as recommended [see Dosage and Administration (2.3)].
Posaconazole suspension 200 mg three times daily or 400 mg twice daily
Posaconazole IV injection 300 mg once daily
Posaconazole delayed-release tablets 300 mg once daily
70 mg once dail
Interrupt dose as recommended [see Dosage and Administration (2.3).
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.
Chronic Graft versus Host Disease
Moderate CYP3A inhibitor
420 mg once daily
Modify dose as recommended [see Dosage and Administration (2.3)].
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 (2.3)].
Posaconazole suspension 200 mg three times daily or 400 mg twice daily
Posaconazole IV injection 300 mg once daily
Posaconazole delayed-release tablets 300 mg once daily
140 mg once daily
Interrupt dose as recommended [see Dosage and Administration (2.3).
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 (2.2) and Drug Interactions (7.1)].
2.5 Dose Modifications for Use in Hepatic Impairment
The recommended dose is 140 mg daily for patients with mild hepatic impairment (Child-Pugh class A).
The recommended dose 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) and Clinical Pharmacology (12.3)].
2.6 Missed Dose
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. Extra doses of IMBRUVICA should not be taken to make up for the missed dose.
3 DOSAGE FORMS AND STRENGTHS
Capsules:
Each 70 mg capsule is a yellow, opaque capsule marked with "ibr 70 mg" in black ink.
Each 140 mg capsule is a white, opaque capsule marked with "ibr 140 mg" in black ink.
Tablets:
Each 140 mg tablet is a yellow green to green round tablet debossed with "ibr" on one side and "140" on the other side.
Each 280 mg tablet is a purple oblong tablet debossed with "ibr" on one side and "280" on the other side.
Each 420 mg tablet is a yellow green to green oblong tablet debossed with "ibr" on one side and "420" on the other side.
Each 560 mg tablet is a yellow to orange oblong tablet debossed with "ibr" on one side and "560" on the other side.
4 CONTRAINDICATIONS
None
5 WARNINGS AND PRECAUTIONS
5.1 Hemorrhage
Fatal bleeding events have occurred in patients treated with IMBRUVICA. Grade 3 or higher bleeding events (intracranial hemorrhage [including subdural hematoma], gastrointestinal bleeding, hematuria, and post procedural hemorrhage) have occurred in up to 6% of patients. Bleeding events of a |
