linaclotide

(redirected from Linzess)

linaclotide

(lin-a-kloe-tide) ,

Linzess

(trade name)

Classification

Therapeutic: anti irritable bowel syndrome agents
Pharmacologic: guanylate cyclase c agonists
Pregnancy Category: C

Indications

Treatment of irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC).

Action

Locally increases levels of cyclic guanosine monophosphate (cGMP); accelerates transit time, increases intestinal fluid and decreases pain sensation.

Therapeutic effects

Increased frequency of bowel movements with decreased pain associated with IBS-C or CIC.

Pharmacokinetics

Absorption: Minimally absorbed, action is primarily local.
Distribution: Stays within the GI tract with minimal distribution.
Metabolism and Excretion: Converted to its principal active metabolite within the GI tract; subsequently locally degraded to smaller peptides and amino acids; 3–5% found in stool, mostly as the active metabolite.
Half-life: Unknown.

Time/action profile (improvement in GI IBS-C or ICI symptoms)

ROUTEONSETPEAKDURATION
POunknown6–9 wk1 wk†
†Following discontinuation.

Contraindications/Precautions

Contraindicated in: Known/suspected mechanical GI obstruction; Pediatric: Children <17 yr.
Use Cautiously in: Lactation: Use cautiously in nursing women; Obstetric: Use during pregnancy only if potential maternal benefit justifies potential risk to the fetus.

Adverse Reactions/Side Effects

Central nervous system

  • fatigue

Gastrointestinal

  • diarrhea (most frequent)
  • abdominal distention
  • abdominal pain
  • flatulence
  • gastrointestinal reflux
  • vomiting

Interactions

Drug-Drug interaction

None noted.

Route/Dosage

Oral (Adults) IBS-C—290 mcg once daily; CIC—145 mcg once daily.

Availability

Capsules: 145 mcg, 290 mcg

Nursing implications

Nursing assessment

  • Assess patient for symptoms of IBS (abdominal pain or discomfort, bloating, constipation).

Potential Nursing Diagnoses

Constipation (Indications)
Diarrhea (Adverse Reactions)

Implementation

  • Oral: Administer once daily on an empty stomach 30 minutes before eating first meal of the day. Swallow capsules whole; do not open, break, dissolve, or chew.

Patient/Family Teaching

  • Instruct patient to take as directed. Keep capsules in original bottle with desiccant packet to help keep medication dry; keep bottle tightly closed.
  • Inform patient that diarrhea often begins within first 2 wks of therapy. Stop taking and notify health care professional if severe diarrhea occurs. Contact health care professional and go to nearest hospital emergency room immediately if bright red, bloody stools or black stools that look like tar occur.
  • Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
  • Advise patient to notify health care professional if pregnancy is planned or suspected, or if breastfeeding.

Evaluation/Desired Outcomes

  • Increased frequency of bowel movements with decreased pain associated with IBS-C or CIC.
References in periodicals archive ?
LINZESS continued to strengthen its branded prescription market leading position, ex-U.
Ironwood's (IRWD) Linzess was initially approved in 2012 for both IBS-C and CIC, noted Maris, who said he expected Trulance's approval in IBS-C and is not making any changes to his Ironwood model following the news.
M2 EQUITYBITES-January 30, 2017-Ironwood Pharmaceuticals receives US FDA approval for 72 mcg dose of LINZESS
M2 PHARMA-January 30, 2017-Ironwood Pharmaceuticals receives US FDA approval for 72 mcg dose of LINZESS
and has also reacquired rights to Linzess (linaclotide) in Mexico from Almirall, the company said.
Several newer medications, including Amitiza (lubiprostone) and Linzess (linaclotide), can help relieve chronic constipation.
The key growth drivers for the IBS market in the US are the anticipated increasing uptake of Ironwood/Actavis/Almirall/Astellas' Linzess, the potential label expansion of Salix/Alfa Wassermann/Norgine/Bama-Geve's Xifaxan for IBS-D, the potential introduction of four additional therapies, and the increasing prevalent cases of IBS during the forecast period.
These include the constipation-predominant IBS (IBS-C) therapies, Sucampo/Takeda/Abbott's Amitiza (lubiprostone) and Ironwood/Actavis/Almirall/Astellas' Linzess (linaclotide), and the diarrhea-predominant IBS (IBS-D) therapies, Prometheus' Lotronex (alosetron) and Astellas' Irribow (ramosetron).
which will be sold under the brand name Linzess, was approved to treat IBS with constipation as well as another condition called chronic idiopathic constipation, Fox News reported.
Ironwood Pharmaceuticals (IRWD) and Allergan (AGN) announced that the companies have reached an agreement with wholly-owned subsidiaries of Sun Pharmaceutical Industries, resolving patent litigation brought in response to Sun Pharma's abbreviated new drug application seeking approval to market a generic version of LINZESS prior to the expiration of the companies' applicable patents.
M2 PHARMA-January 27, 2017-Ironwood awarded US FDA approval for 72 mcg Dose of LINZESS (linaclotide) for treating CIC in adults