LINZESS linaclotide capsule gelatin coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

linaclotide (UNII: N0TXR0XR5X) (linaclotide - UNII:N0TXR0XR5X)

Available from:

Avera McKennan Hospital

INN (International Name):

linaclotide

Composition:

linaclotide 145 ug

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application

Summary of Product characteristics

LINZESS- LINACLOTIDE CAPSULE, GELATIN COATED
AVERA MCKENNAN HOSPITAL
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LINZESS SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR LINZESS.
LINZESS (LINACLOTIDE) CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2012
WARNING: PEDIATRIC RISK
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
LINZESS IS CONTRAINDICATED IN PEDIATRIC PATIENTS UP TO 6 YEARS OF AGE;
LINACLOTIDE CAUSED DEATHS DUE TO
DEHYDRATION IN YOUNG JUVENILE MICE. AVOID USE OF LINZESS IN PEDIATRIC
PATIENTS 6 THROUGH 17 YEARS OF AGE.
THE SAFETY AND EFFICACY OF LINZESS HAS NOT BEEN ESTABLISHED IN
PEDIATRIC PATIENTS UNDER 18 YEARS OF AGE
(4, 5.1, 8.4, 13.2).
RECENT MAJOR CHANGES
DOSAGE AND ADMINISTRATION (2.3)
11/2015
INDICATIONS AND USAGE
LINZESS is a guanylate cyclase-C agonist indicated in adults for
treatment of:
Irritable bowel syndrome with constipation (IBS-C) (1.1)
Chronic idiopathic constipation (CIC) (1.2)
DOSAGE AND ADMINISTRATION
IBS-C: Take 290 mcg orally once daily (2.1)
CIC: Take 145 mcg orally once daily (2.2)
Take on empty stomach at least 30 minutes prior to first meal of the
day (2.1, 2.2)
For patients who have difficulty swallowing capsules or those with a
nasogastric or gastrostomy tube, see full
prescribing information for instructions for opening the capsule and
administering with applesauce or water.
DOSAGE FORMS AND STRENGTHS
Capsules: 145 mcg and 290 mcg (3)
CONTRAINDICATIONS
Pediatric patients under 6 years of age (4)
Patients with known or suspected mechanical gastrointestinal
obstruction (4)
WARNINGS AND PRECAUTIONS
_Diarrhea:_ Patients may experience severe diarrhea. Hold or stop
LINZESS (5.2)
ADVERSE REACTIONS
Most common adverse reactions (incidence of at least 2%) reported in
IBS-C or CIC patients are diarrhea, abdominal pain,
flatulence and abdominal distension. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT FOREST PHARMACEUTICALS,
INC., AT 1- 800- 678-1605 OR
FDA AT 1-800-FDA-1088 OR