Physicians Academy
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Table Of Contents
Editorial :
 The Real Paradigm Shift in Management of T2DM
Article 1 :
 Introduction of DMS irrigation to heal Endo–Perio lesions and Cysts
Article 2 :
 Alagille Syndrome in a Neonate
Picture of The Month :
 POTM-April 2018
Drug Update :
 SEGLUROMET (ertugliflozin+metformin)
Abstracts from Other Journals :
 Abstracts from Other Journals-April 2018

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Feb 2018 ( Volume -12 Number -2)

Drug Update
XTANDI® (enzalutamide)
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DRUG UPDATE

FEBRUARY 2018

XTANDI® (enzalutamide)

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use XTANDI® safely and effectively.

See full prescribing information for XTANDI. XTANDI® (enzalutamide) capsules for oral use Initial U.S. Approval: 2012

INDICATIONS AND USAGE

XTANDI is an androgen receptor inhibitor indicated for the treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel. (1)

DOSAGE AND ADMINISTRATION

XTANDI 160 mg (four 40 mg capsules) administered orally once daily. Swallow capsules whole. XTANDI can be taken with or without food. (2.1)

DOSAGE FORMS AND STRENGTHS

Capsule 40 mg (3)

CONTRAINDICATIONS

Pregnancy (4, 8.1)

WARNINGS AND PRECAUTIONS

Seizure occurred in 0.9% of patients receiving XTANDI. There is no clinical trial experience with XTANDI in patients who have had a seizure, in patients with predisposing factors for seizure, or in patients using concomitant medications that may lower the seizure threshold. (5.1)

ADVERSE REACTIONS

The most common adverse reactions (≥ 5%) are asthenia/fatigue, back pain, diarrhea, arthralgia, hot flush, peripheral edema, musculoskeletal pain, headache, upper respiratory infection, muscular weakness, dizziness, insomnia, lower respiratory infection, spinal cord compression and cauda equina syndrome, hematuria, paresthesia, anxiety, and hypertension. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Astellas Pharma US, Inc. at 1-800-727-7003 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

· Avoid strong CYP2C8 inhibitors, as they can increase the plasma exposure to XTANDI. If co-administration is necessary, reduce the dose of XTANDI. (2.2, 7.1) · Avoid strong or moderate CYP3A4 or CYP2C8 inducers as they can alter the plasma exposure to XTANDI. (7.1, 7.2) · Avoid CYP3A4, CYP2C9 and CYP2C19 substrates with a narrow therapeutic index, as XTANDI may decrease the plasma exposures of these drugs. If XTANDI is co-administered with warfarin (CYP2C9 substrate), conduct additional INR monitoring. (7.3)

See 17 for PATIENT COUNSELING INFORMATION and FDA approved patient labeling.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Manufactured by: Catalent Pharma Solutions, LLC, St. Petersburg, FL 33716

Marketed by:

Astellas Pharma US, Inc., Northbrook, IL 60062 Medivation Inc., San Francisco, CA 94105

Issued: August 2012 12A005-ENZ

© 2012 Astellas Pharma US, Inc.

XTANDI® is a trademark of Astellas Pharma Inc. 

For Detailed Product Information CLICK HERE to download in PDF (487 KB). Or go back to TOCs and download. 

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