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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Jan 2018 ( Volume -12 Number -1)

Drug Update
INGREZZA (Valbenazine)
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DRUG UPDATE

JANUARY 2018

INGREZZATM (Valbenazine)

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use INGREZZA safely and effectively.

See full prescribing information for INGREZZA. INGREZZATM (valbenazine) capsules, for oral use Initial U.S.

Approval: 2017

INDICATIONS AND USAGE

INGREZZA is a vesicular monoamine transporter 2 (VMAT2) inhibitor indicated for the treatment of adults with tardive dyskinesia. (1)

DOSAGE AND ADMINISTRATION

The initial dose is 40 mg once daily. After one week, increase the dose to· the recommended dose of 80 mg once daily. (2.1)  Can be taken with or without food. (2.1)·  The recommended dose for patients with moderate or severe hepatic· impairment is 40 mg once daily. (2.2)  Consider dose reduction based on tolerability in known CYP2D6 poor· metabolizers. (2.2)

DOSAGE FORMS AND STRENGTHS

Capsules: 40 mg. (3)

CONTRAINDICATIONS

None. (4)

WARNINGS AND PRECAUTIONS

Somnolence: May impair patient’s ability to drive or operate hazardous· machinery. (5.1)  QT Prolongation: May cause an increase in QT interval. Avoid use in· patients with congenital long QT syndrome or with arrhythmias associated with a prolonged QT interval. (5.2)

ADVERSE REACTIONS

Most common adverse reaction (≥5% and twice the rate of placebo): somnolence. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Neurocrine Biosciences, Inc. at 877-641-3461 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Dose adjustments due to drug interactions (2.3, 7): Factors Dose Adjustments for INGREZZA Use of MAOIs with INGREZZA Avoid concomitant use with MAOIs. Use of strong CYP3A4 inducers with INGREZZA Concomitant use is not recommended. Use of strong CYP3A4 inhibitors with INGREZZA Reduce dose to 40 mg. Use of strong CYP2D6 inhibitors with INGREZZA Consider dose reduction based on tolerability.

USE IN SPECIFIC POPULATIONS

Pregnancy: May cause fetal harm. (8.1)·  Lactation: Advise not to breastfeed. (8.2)·  Renal Impairment: No dosage adjustment is necessary for patients with· mild to moderate renal impairment. Use is not recommended in patients with severe renal impairment. (8.8)

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

 

For Detailed Product Information CLICK HERE to download in PDF (638 KB). Or go back to TOCs and download.

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