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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Mar 2018 ( Volume -12 Number -3)

Drug Update
SYMDEKO (tezacaftor/ivacaftor)
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DRUG UPDATE

MARCH 2018

SYMDEKOTM (tezacaftor/ivacaftor)

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use SYMDEKO safely and effectively. See full prescribing information for SYMDEKO.

SYMDEKO™ (tezacaftor/ivacaftor) tablets; (ivacaftor) tablets, for oral use Initial U.S. Approval: 2018

INDICATIONS AND USAGE

SYMDEKO is a combination of tezacaftor and ivacaftor, indicated for the treatment of patients with cystic fibrosis (CF) aged 12 years and older who are homozygous for the F508del mutation or who have at least one mutation in the

cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence. (12.1, 14)

If the patient’s genotype is unknown, an FDA-cleared CF mutation test should be used to detect the presence of a CFTR mutation followed by verification with bi-directional sequencing when recommended by the mutation test instructions for use.

DOSAGE AND ADMINISTRATION

Adults and pediatric patients ages 12 years and older: one tablet (containing tezacaftor 100 mg/ivacaftor 150 mg) in the morning and one tablet (containing ivacaftor 150 mg) in the evening, approximately 12 hours apart. SYMDEKO

should be taken with fat-containing food. (2.1, 12.3)

Reduce dose in patients with moderate and severe hepatic impairment. (2.2, 8.6, 12.3)

Reduce dose when co-administered with drugs that are moderate or strong CYP3A inhibitors. (2.3, 7.2, 12.3)

DOSAGE FORMS AND STRENGTHS

Tablets:

SYMDEKO is co-packaged as tezacaftor 100 mg/ivacaftor 150 mg fixed dose combination tablets and ivacaftor 150 mg tablets. (3)

CONTRAINDICATIONS

None. (4)

WARNINGS AND PRECAUTIONS

Elevated transaminases (ALT or AST): Transaminases (ALT and AST) should be assessed prior to initiating SYMDEKO, every 3 months during the first year of treatment, and annually thereafter. In patients with a history of transaminase elevations, more frequent monitoring should be considered. Dosing should be interrupted in patients with significant

elevations of transaminases, e.g., patients with ALT or AST >5 x upper limit of normal (ULN), or ALT or AST >3 x ULN with bilirubin >2 x ULN. Following resolution of transaminase elevations, consider the benefits and risks of resuming treatment. (5.1, 6)

Use with CYP3A inducers: Concomitant use with strong CYP3A inducers (e.g., rifampin, St. John’s wort) substantially decrease exposure of ivacaftor and may decrease the exposure of tezacaftor, which may reduce therapeutic effectiveness. Therefore, co-administration is not recommended. (5.2, 7.1, 12.3)

Cataracts: Non-congenital lens opacities/cataracts have been reported in pediatric patients treated with SYMDEKO. Baseline and follow-up examinations are recommended in pediatric patients initiating SYMDEKO treatment. (5.3, 8.4)

ADVERSE REACTIONS

The most common adverse drug reactions to SYMDEKO (occurring in ≥3% of patients) were headache, nausea, sinus congestion, and dizziness. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Vertex Pharmaceuticals Incorporated at 1-877-634-8789 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

CYP3A inhibitors: Reduce SYMDEKO dose when co-administered with strong (e.g., ketoconazole) or moderate (e.g., fluconazole) CYP3A inhibitors.

Avoid food containing grapefruit or Seville oranges. (2.3, 7.2, 12.3)

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 for: Vertex Pharmaceuticals Incorporated; 50 Northern Avenue, Boston, MA 02210 VERTEX and the VERTEX triangle logo are registered trademarks and SYMDEKO is a trademark of Vertex Pharmaceuticals Incorporated.

All other trademarks referenced herein are the property of their respective owners.

©2018 Vertex Pharmaceuticals Incorporated

For more information, go to www.symdeko.com or call 1-877-752-5933.

For Detailed Product Information CLICK HERE to download in PDF (458 KB). Or go back to TOCs and download.

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