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IMBRUVICA™ (ibrutinib) capsules

DESCRIPTION CLINICAL PHARMACOLOGY INDICATIONS AND USAGE
CONTRAINDICATIONS PRECAUTIONS ADVERSE REACTIONS
DOSAGE AND ADMINISTRATION HOW SUPPLIED WARNINGS
PRESCRIBING HIGHLIGHTS:  Please see package insert for additional information and possible updates to ensure safe and effective use of this medication. The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.  
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DRUG UPDATES

Drug:  IMBRUVICA ® (ibrutinib) capsules, for oral use
[Drug information  /  PDF]  
Dosing:  Click (+) next to Dosage and Administration section (drug info link)

Initial U.S. Approval:  2013

WARNINGS  top of page

See precautions below.

DESCRIPTION  top of page

IMBRUVICA™ (ibrutinib) capsules, for oral use
Initial U.S. Approval: 2013

Ibrutinib is an inhibitor of Bruton's tyrosine kinase (BTK). It is a white to off-white solid with the empirical formula C25H24N6O2 and a molecular weight 440.50. Ibrutinib is freely soluble in dimethyl sulfoxide, soluble in methanol and practically insoluble in water.
IMBRUVICA (ibrutinib) capsules for oral administration are supplied as white opaque capsules that contain 140 mg ibrutinib as the active ingredient. Each capsule also contains the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate. The capsule shell contains gelatin, titanium dioxide and black ink. Each white opaque capsule is marked with "ibr 140 mg" in black ink.

CLINICAL PHARMACOLOGY: top of page

Mechanism of Action:
Ibrutinib is a small-molecule inhibitor of BTK. Ibrutinib forms a covalent bond with a cysteine residue in the BTK active site, leading to inhibition of BTK enzymatic activity. BTK is a signaling molecule of the B-cell antigen receptor (BCR) and cytokine receptor pathways. BTK's role in signaling through the B-cell surface receptors results in activation of pathways necessary for B-cell trafficking, chemotaxis, and adhesion. Nonclinical studies show that ibrutinib inhibits malignant B-cell proliferation and survival in vivo as well as cell migration and substrate adhesion in vitro.

INDICATIONS AND USAGE  top of page

INDICATIONS AND USAGE:
IMBRUVICA is a kinase inhibitor indicated for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

This indication is based on overall response rate. An improvement in survival or disease-related symptoms has not been established

CONTRAINDICATIONS top of page

None.

PRECAUTIONS top of page

WARNINGS AND PRECAUTIONS

  1. Hemorrhage: Monitor for bleeding.
  2. Infections: Monitor patients for fever and infections and evaluate promptly.
  3. Myelosuppression: Check complete blood counts monthly.
  4. Renal Toxicity: Monitor renal function and maintain hydration.
  5. Second Primary Malignancies: Other malignancies have occurred in patients, including skin cancers, and other carcinomas.
  6. Embryo-Fetal Toxicity: Can cause fetal harm. Advise women of the potential risk to a fetus and to avoid pregnancy while taking the drug

ADVERSE REACTIONS top of page

ADVERSE REACTIONS
The most common adverse reactions (geq20%) in patients with MCL were thrombocytopenia, diarrhea, neutropenia, anemia, fatigue, musculoskeletal pain, peripheral edema, upper respiratory tract infection, nausea, bruising, dyspnea, constipation, rash, abdominal pain, vomiting and decreased appetite.

To report SUSPECTED ADVERSE REACTIONS, contact Pharmacyclics at 1-877-877-3536 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

DRUG INTERACTIONS
CYP3A Inhibitors: Avoid co-administration with strong and moderate CYP3A inhibitors. If a moderate CYP3A inhibitor must be used, reduce IMBRUVICA dose .

CYP3A Inducers: Avoid co-administration with strong CYP3A inducers.

USE IN SPECIFIC POPULATIONS
Hepatic Impairment: Avoid use of IMBRUVICA in patients with baseline hepatic impairment.

See PACKAGE INSERT for PATIENT COUNSELING INFORMATION and Medication Guide.

DOSAGE AND ADMINISTRATION  top of page

DOSAGE AND ADMINISTRATION:
560 mg taken orally once daily (four 140 mg capsules once daily.

Capsules should be taken orally with a glass of water. Do not open, break, or chew the capsules.

HOW SUPPLIED top of page

DOSAGE FORMS AND STRENGTHS

Capsule: 140 mg

REFERENCE

Package insert data:   [Accessed: Jan 2014].

Distributed and Marketed by:
Pharmacyclics, Inc.
Sunnyvale, CA USA 94085
and
Marketed by:
Janssen Biotech, Inc.
Horsham, PA USA 19044

Patent http://www.imbruvica.com
IMBRUVICA™ is a trademark owned by Pharmacyclics, Inc.

©Pharmacyclics, Inc. 2013 Issued: November 2013



DRUG UPDATES

Drug:  IMBRUVICA ® (ibrutinib) capsules, for oral use
[Drug information  /  PDF]  
Dosing:  Click (+) next to Dosage and Administration section (drug info link)

Initial U.S. Approval:  2013
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