"The U.S. Food and Drug Administration today expanded the approved uses of Abraxane (paclitaxel protein-bound particles for injectable suspension, albumin-bound) to treat patients with late-stage (metastatic) pancreatic cancer.
Mantle Cell Lymphoma
IMBRUVICA is indicated for the treatment of 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 of clinical benefit in confirmatory trials [see Clinical Studies].
Chronic Lymphocytic Leukemia
Chronic Lymphocytic Leukemia With 17p Deletion
IMBRUVICA is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion [see Clinical Studies].
DOSAGE AND ADMINISTRATION
Administer IMBRUVICA orally once daily at approximately the same time each day. Swallow the capsules whole with water. Do not open, break, or chew the capsules.
Mantle Cell Lymphoma
The recommended dose of IMBRUVICA for MCL is 560 mg (four 140 mg capsules) orally once daily.
Chronic Lymphocytic Leukemia And Waldenstrom's Macroglobulinemia
The recommended dose of IMBRUVICA for CLL and WM is 420 mg (three 140 mg capsules) orally once daily.
Dose Modifications For Adverse Reactions
Interrupt IMBRUVICA therapy for any Grade 3 or greater non-hematological toxicities, Grade 3 or greater neutropenia with infection or fever, or Grade 4 hematological toxicities. Once the symptoms of the toxicity have resolved to Grade 1 or baseline (recovery), IMBRUVICA therapy may be reinitiated at the starting dose. If the toxicity reoccurs, reduce dose by one capsule (140 mg per day). A second reduction of dose by 140 mg may be considered as needed. If these toxicities persist or recur following two dose reductions, discontinue IMBRUVICA.
Recommended dose modifications are described below:
|Toxicity Occurrence||MCL Dose Modification After Recovery Starting Dose = 560 mg||CLL and WM Dose Modification After Recovery Starting Dose = 420 mg|
|First||Restart at 560 mg daily||Restart at 420 mg daily|
|Second||Restart at 420 mg daily||Restart at 280 mg daily|
|Third||Restart at 280 mg daily||Restart at 140 mg daily|
|Fourth||Discontinue IMBRUVICA||Discontinue IMBRUVICA|
Dose Modifications For Use With CYP3A Inhibitors
Avoid co-administration with strong or moderate CYP3A inhibitors and consider alternative agents with less CYP3A inhibition.
Concomitant use of strong CYP3A inhibitors which would be taken chronically (e.g., ritonavir, indinavir, nelfinavir, saquinavir, boceprevir, telaprevir, nefazodone) is not recommended. For short-term use (treatment for 7 days or less) of strong CYP3A inhibitors (e.g., antifungals and antibiotics) consider interrupting IMBRUVICA therapy until the CYP3A inhibitor is no longer needed [see DRUG INTERACTIONS].
Reduce IMBRUVICA dose to 140 mg if a moderate CYP3A inhibitor must be used (e.g., fluconazole, darunavir, erythromycin, diltiazem, atazanavir, aprepitant, amprenavir, fosamprevir, crizotinib, imatinib, verapamil, and ciprofloxacin) [see DRUG INTERACTIONS].
Patients taking concomitant strong or moderate CYP3A inhibitors should be monitored more closely for signs of IMBRUVICA toxicity.
Dose Modifications For Use In Hepatic Impairment
For patients with mild liver impairment (Child-Pugh class A), the recommended dose is 140 mg daily (one capsule). Avoid the use of IMBRUVICA in patients with moderate or severe hepatic impairment (Child-Pugh classes B and C) [see Use In Specific Populations and CLINICAL PHARMACOLOGY].
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 capsules of IMBRUVICA should not be taken to make up for the missed dose.
Dosage Forms And Strengths
140 mg capsules
Storage And Handling
The white opaque 140 mg capsules marked with “ibr 140 mg” in black ink are available in white HDPE bottles with a child-resistant closure:
90 capsules per bottle: NDC 57962-140-09
120 capsules per bottle: NDC 57962-140-12
Store bottles at room temperature 20°C to 25°C (68°F to 77°F). Excursions are permitted between 15°C and 30°C (59°F to 86°F). Retain in original package until dispensing.
Distributed and Marketed by: Pharmacyclics LLC Sunnyvale, CA USA 94085. Marketed by: Janssen Biotech, Inc. Horsham, PA USA 19044. For more information call 1-877-877-3536. Revised: Mar 2016This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 4/4/2016
Additional Imbruvica Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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