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Linzess: A new option for IBS with constipation and Chronic Idiopathic Constipation
Jul 10, 2013

Date & Time: July 23rd, 2013, 6:30pm

Location: Sitar Indian Cuisine

Address: 420 Jordan Ln NW Huntsville, AL 35805 (256) 536-3360

Hosted By: Ironwood Pharmaceuticals (Sedric Barnett) and aAPI

Message: Please register for this program today. 
  
3 WAYS TO REGISTER: 
  
1. RSVP thru the pingg e-mail you received. 
2. Contact Shashi Kumar at shashikumaram@yahoo.com or Call Joann Johnson 256-468-9822
3. Click the link below to register on our aAPI website. 
http://www.alabamaapi.org/calendar_detail.asp?id=5703

Shashi Kumar MD 
  
In accordance with the PhRMA code on interactions with healthcare professionals, attendance at this educational program is limited to healthcare professionals. Accordingly, attendance by spouses and guests is not appropriate and associated expenses will not be reimbursed. 

LINZESS (linaclotide) is indicated in adults for the treatment of both irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC).

IMPORTANT SAFETY INFORMATION

CONTRAINDICATION
LINZESS is contraindicated in pediatric patients up to 6 years of age.

  • LINZESS is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction.

WARNINGS AND PRECAUTIONS

Pediatric Risk

  • LINZESS is contraindicated in pediatric patients up to 6 years of age. In nonclinical studies, deaths occurred within 24 hours in young juvenile mice (1 to 3 week‑old mice; approximately equivalent to human pediatric patients less than 2 years of age) following administration of one or two daily oral doses of linaclotide.
  • Use of LINZESS should be avoided in pediatric patients 6 through 17 years of age. Linaclotide did not cause deaths in older juvenile mice (approximately equivalent to humans age 12 to 17 years). Although there were no deaths in older juvenile mice, given the deaths in young juvenile mice and the lack of clinical safety and efficacy data in pediatric patients, use of LINZESS should be avoided in pediatric patients 6 through 17 years of age.

Diarrhea

  • Diarrhea was the most common adverse reaction of LINZESS‑treated patients in the pooled IBS‑C and CIC double‑blind placebo‑controlled trials. Severe diarrhea was reported in 2% of LINZESS‑treated patients. The incidence of diarrhea was similar in the IBS‑C and CIC populations.
  • Patients should be instructed to stop LINZESS if severe diarrhea occurs and to contact their healthcare provider, who should consider dose suspension.

ADVERSE REACTIONS

  • In IBS‑C clinical trials, the most common adverse reactions in LINZESS‑treated patients (incidence ≥2% and greater than placebo) were diarrhea (20% vs 3% placebo), abdominal pain (7% vs 5%), flatulence (4% vs 2%), headache (4% vs 3%), viral gastroenteritis (3% vs 1%) and abdominal distension (2% vs 1%).
  • In CIC clinical trials, the most common adverse reactions in LINZESS‑treated patients (incidence ≥2% and greater than placebo) were diarrhea (16% vs 5% placebo), abdominal pain (7% vs 6%), flatulence (6% vs 5%), upper respiratory tract infection (5% vs 4%), sinusitis (3% vs 2%) and abdominal distension (3% vs 2%).
Please also see the full Prescribing Information for LINZESS.