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 ?
Patients taking LINZESS experienced significant improvement in stool frequency and hardness of stool compared to placebo.
If successful in development, relamorelin could provide a significant addition to our GI family, which currently includes Linzess, Delzicol/Asacol, Carafate, Canasa, Pylera and Rectiv, and for which we are currently developing eluxadoline, the product opportunity acquired earlier this year with our acquisition of Furiex Pharmaceuticals.
Sales of Linzess are now expected to be $25 million compared with previous guidance of $60 million due to a delay in launch resulting from the extended three month FDA review of our NDA.
5% of net sales of LINZESS in the United States for the preceding quarter ("the synthetic royalty amount") and (ii) accrued and unpaid interest on the notes ("the required interest amount").
Food and Drug Administration (FDA) recently approved LINZESS as a once-daily oral capsule for adult men and women suffering from irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC).
This high growth rate is attributed to the strong pipeline dominated by First-In-Class (FIC) molecules such as recently launched Linzess (linaclotide).
Our first quarter performance was highlighted by strong revenue growth from Namenda XR, Linzess, Bystolic, Viibryd/ Fetzima, LoLoestrin Fe, Saphris, Estrace Cream as well as continued growth within our generics business, powered by strong sales of the generic versions of Concerta, Intuniv and the recent launch of our generic version of OxyContin.
NASDAQ: IRWD) today announced it will be hosting a webinar to provide an overview of how LINZESS will be reflected in Ironwood's quarterly income statements following its commercial availability in the U.
Ironwood/Actavis/Almirall/Astellas' Linzess is the only available product indicated for IBS-C in Germany, which was launched in 2013.
Peer-Reviewed Publications of LINZESS Phase 3 IBS-C Data in American Journal of Gastroenterology -
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).
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.