March 23, 2017
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Linzess

"The U.S. Food and Drug Administration today approved Viberzi (eluxadoline) and Xifaxan (rifaximin), two new treatments, manufactured by two different companies, for irritable bowel syndrome with diarrhea (IBS-D) in adult men and women.

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Linzess




Linzess Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 9/23/2016

Linzess (linaclotide) is a guanylate cyclase-C agonist used to treat irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in adults. Common side effects of Linzess include:

  • diarrhea,
  • stomach/abdominal pain or discomfort,
  • gas,
  • bloating,
  • heartburn,
  • vomiting,
  • headache, or
  • cold symptoms such as stuffy nose, sneezing, or sinus pain.

The recommended dose of Linzess for those with irritable bowel syndrome (IBS) is 290 mcg taken once a day on an empty stomach, at least 30 minutes before the first meal of the day. The same applies for those with chronic idiopathic constipation only the dosage is 145 mcg. Pediatric patients under the age of 17 should not take Linzess. Linzess may interact with other drugs. Tell your doctor all medications you use. Linzess should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution should be exercised when Linzess is administered to nursing women. Consult your doctor before breastfeeding.

Our Linzess (linaclotide) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Linzess in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using linaclotide and call your doctor at once if you have a serious side effect such as:

  • severe or ongoing diarrhea;
  • severe stomach pain; or
  • black, bloody, or tarry stools.

Other common side effects may include:

  • mild diarrhea;
  • mild stomach discomfort;
  • heartburn, vomiting, gas, bloating;
  • headache; or
  • cold symptoms such as stuffy nose, sneezing, sinus pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Linzess (Linaclotide Capsules)

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Linzess FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Exposure in clinical development included approximately 2570, 2040, and 1220 patients with either IBS-C or CIC treated with LINZESS for 6 months or longer, 1 year or longer, and 18 months or longer, respectively (not mutually exclusive).

Demographic characteristics were comparable between treatment groups in all studies [see Clinical Studies].

Irritable Bowel Syndrome With Constipation (IBS-C)

Most Common Adverse Reactions

The data described below reflect exposure to LINZESS in the two placebo-controlled clinical trials involving 1605 adult patients with IBS-C (Trials 1 and 2). Patients were randomized to receive placebo or 290 mcg LINZESS once daily on an empty stomach for up to 26 weeks. Table 1 provides the incidence of adverse reactions reported in at least 2% of IBS-C patients in the LINZESS treatment group and at an incidence that was greater than in the placebo group.

Table 1: Most Common Adverse Reactionsa in Two Placebo-Controlled Trials (1 and 2) in Patients with IBS-C

Adverse Reactions LINZESS
290 mcg
[N=807]
%
Placebo
[N=798]
%
Gastrointestinal
  Diarrhea 20 3
  Abdominal painb 7 5
  Flatulence 4 2
  Abdominal distension 2 1
Infections and Infestations
  Viral Gastroenteritis 3 1
Nervous System Disorders
  Headache 4 3
a: Reported in at least 2% of LINZESS-treated patients and at an incidence greater than placebo
b:“Abdominal pain” term includes abdominal pain, upper abdominal pain, and lower abdominal pain.

Diarrhea

Diarrhea was the most commonly reported adverse reaction of the LINZESS-treated patients in the pooled IBS-C pivotal placebo-controlled trials. In these trials, 20% of LINZESS-treated patients reported diarrhea compared to 3% of placebo-treated patients. Severe diarrhea was reported in 2% of the LINZESS-treated patients versus less than 1% of the placebo-treated patients, and 5% of LINZESS-treated patients discontinued due to diarrhea vs less than 1% of placebo-treated patients. The majority of reported cases of diarrhea started within the first 2 weeks of LINZESS treatment [see WARNINGS AND PRECAUTIONS].

Adverse Reactions Leading to Discontinuation

In placebo-controlled trials in patients with IBS-C, 9% of patients treated with LINZESS and 3% of patients treated with placebo discontinued prematurely due to adverse reactions. In the LINZESS treatment group, the most common reasons for discontinuation due to adverse reactions were diarrhea (5%) and abdominal pain (1%). In comparison, less than 1% of patients in the placebo group withdrew due to diarrhea or abdominal pain.

Adverse Reactions Leading to Dose Reductions

In the open-label, long-term trials, 2147 patients with IBS-C received 290 mcg of LINZESS daily for up to 18 months. In these trials, 29% of patients had their dose reduced or suspended secondary to adverse reactions, the majority of which were diarrhea or other GI adverse reactions.

Less Common Adverse Reactions

Defecation urgency, fecal incontinence, vomiting, and gastroesophagal reflux disease were reported in <2% of patients in the LINZESS treatment group and at an incidence greater than in the placebo treatment group.

Chronic Idiopathic Constipation (CIC)

Most Common Adverse Reactions

The data described below reflect exposure to LINZESS in the two double-blind placebo-controlled clinical trials of 1275 adult patients with CIC (Trials 3 and 4). Patients were randomized to receive placebo or 145 mcg LINZESS or 290 mcg LINZESS once daily on an empty stomach, for at least 12 weeks. Table 2 provides the incidence of adverse reactions reported in at least 2% of CIC patients in the 145 mcg LINZESS treatment group and at an incidence that was greater than in the placebo treatment group.

Table 2: Most Common Adverse Reactionsa in the Two Placebo-controlled Trials (3 and 4) in Patients with CIC

Adverse Reactions LINZESS
145 mcg
[N=430]
%
Placebo
[N=423]
%
Gastrointestinal
  Diarrhea 16 5
  Abdominal painb 7 6
  Flatulence 6 5
  Abdominal distension 3 2
Infections and Infestations
  Upper respiratory tract infection 5 4
  Sinusitis 3 2
a: Reported in at least 2% of LINZESS-treated patients and at an incidence greater than placebo
b:“Abdominal pain” term includes abdominal pain, upper abdominal pain, and lower abdominal pain.

The safety of a 72 mcg dose was evaluated in an additional placebo-controlled trial in which 1223 patients were randomized to LINZESS 72 mcg, 145 mcg, or placebo once daily for 12 weeks (Trial 5).

In Trial 5, adverse reactions that occurred at a frequency of ≥ 2% in LINZESS-treated patients (n=411 in each LINZESS 72 mcg and 145 mcg group) and at a higher rate than placebo (n=401) were:

  • Diarrhea (LINZESS 72 mcg 19%; LINZESS 145 mcg 22%; placebo 7%)
  • Abdominal distension (LINZESS 72 mcg 2%; LINZESS 145 mcg 1%; placebo < 1%)

Diarrhea

This section summarizes information from Trials 3 and 4 (pooled) and Trial 5 regarding diarrhea, the most commonly reported adverse reaction reported in LINZESS-treated patients in CIC placebo-controlled studies.

In all trials, the majority of reported cases of diarrhea started within the first 2 weeks of LINZESS treatment.

Severe diarrhea was reported in less than 1% of the 72 mcg LINZESS-treated patients (Trial 5), in 2% of the 145 mcg LINZESS-treated patients (Trials 3 and 4; Trial 5), and less than 1% of the placebo-treated patients (Trials 3, 4, and 5) [see WARNINGS AND PRECAUTIONS].

Adverse Reactions Leading to Discontinuation

In placebo-controlled trials in patients with CIC, 3% of patients treated with 72 mcg (Trial 5) and between 5% (Trial 5) and 8% (Trials 3 and 4) of patients treated with 145 mcg of LINZESS discontinued prematurely due to adverse reactions compared to between less than 1% (Trial 5) and 4% (Trials 3 and 4) of patients treated with placebo.

In patients treated with 72 mcg LINZESS the most common reason for discontinuation due to adverse reactions was diarrhea (2% in Trial 5) and in patients treated with 145 mcg LINZESS, the most common reasons for discontinuation due to adverse reactions were diarrhea (3% in Trial 5 and 5% in Trials 3 and 4) and abdominal pain (1% in Trials 3 and 4). In comparison, less than 1% of patients in the placebo group withdrew due to diarrhea or abdominal pain (Trials 3 and 4; Trial 5).

Adverse Reactions Leading to Dose Reductions

In the open-label, long-term trials, 1129 patients with CIC received 290 mcg of LINZESS daily for up to 18 months. In these trials, 27% of patients had their dose reduced or suspended secondary to adverse reactions, the majority of which were diarrhea or other GI adverse reactions.

Less Common Adverse Reactions

Defecation urgency, fecal incontinence, dyspepsia, and viral gastroenteritis, were reported in less than 2% of patients in the LINZESS treatment group and at an incidence greater than placebo treatment group.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of LINZESS. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Hematochezia, rectal hemorrhage, nausea, and allergic reactions, urticaria or hives.

Read the entire FDA prescribing information for Linzess (Linaclotide Capsules)

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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