DA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
CYP3A Inhibitors: Dose adjustments may be recommended (2.4, 7.1).
CYP3A Inducers: Avoid coadministration with strong CYP3A inducers (7.2).
USE IN SPECIFIC POPULATIONS
Hepatic Impairment (based on Child-Pugh criteria): Avoid use of IMBRUVICA in patients with severe baseline hepatic impairment. In patients with mild or moderate impairment, reduce IMBRUVICA dose (2.5, 8.6).
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 2/2018
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.1 Mantle Cell Lymphoma
1.2 Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
1.3 Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma with 17p deletion
1.4 Waldenström's Macroglobulinemia
1.5 Marginal Zone Lymphoma
1.6 Chronic Graft versus Host Disease
2 DOSAGE AND ADMINISTRATION
2.1 Dosing Guidelines
2.2 Recommended Dosage
2.3 Dose Modifications for Adverse Reactions
2.4 Dose Modifications for Use with CYP3A Inhibitors
2.5 Dose Modifications for Use in Hepatic Impairment
2.6 Missed Dose
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Hemorrhage
5.2 Infections
5.3 Cytopenias
5.4 Cardiac Arrhythmias
5.5 Hypertension
5.6 Second Primary Malignancies
5.7 Tumor Lysis Syndrome
5.8 Embryo-Fetal Toxicity
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
7.1 Effect of CYP3A Inhibitors on Ibrutinib
7.2 Effect of CYP3A Inducers on Ibrutinib
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.3 Females and Males of Reproductive Potential
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Hepatic Impairment
8.7 Plasmapheresis
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Mantle Cell Lymphoma
14.2 Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma
14.3 Waldenström's Macroglobulinemia
14.4 Marginal Zone Lymphoma
14.5 Chronic Graft versus Host Disease
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information are not listed. CLOSE
1 INDICATIONS AND USAGE
1.1 Mantle Cell Lymphoma
IMBRUVICA is indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.
Accelerated approval was granted for this indication based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial [see Clinical Studies (14.1)].
1.2 Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
IMBRUVICA is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).
1.3 Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma with 17p deletion
IMBRUVICA is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) with 17p deletion.
1.4 Waldenström's Macroglobulinem |
