Patient Profiles

Explore typical patient profiles to discover how Trulance may be able to help your adult patients with IBS-C and CIC1,a
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  • Patient profile:Jennifer

    Jennifer, 42 Jenny

    IBS-C patient

    • Complains of constipation
    • Moderate abdominal pain accompanied by bloating
  • Patient profile:Sandy

    Carol, 65 Carol

    IBS-C patient

    • Bloating and abdominal pain
    • “Not feeling empty” after bowel movements
  • Patient profile:Carol

    Sandy, 48 Lisa

    CIC patient

    • “Pebble-like” stools
    • Long time on the toilet with “no success”
  • Patient profile:John

    John, 54 John

    CIC patient

    • <1 spontaneous bowel movement per week
    • Some straining but no abdominal pain

aThese scenarios are for illustrative purposes only.

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Meet Jennifer

Patient profile:Jennifer Patient profile:Jennifer

Presentation

  • 42-year-old customer service supervisor
  • Presents with complaints of constipation with moderate abdominal pain accompanied by the feeling of bloating for the past year (abdominal pain 5/10 on pain scale)
  • Typically has a bowel movement once every 3-4 days with feelings of incomplete evacuation
  • Hard, lumpy stools (2 on the Bristol Stool Form Scale) that require some straining to pass
  • Reports having tried multiple therapies, including OTC and dietary modifications
  • Diagnosed with IBS-C after physical and rectal exam with no red flags or alarm symptoms
  • Reports that OTCs were mildly effective but did not provide any relief of her abdominal pain

Treatment

  • Prescribed Trulance 3 mg once daily to treat IBS-C, to be taken at any time of day, with or without food1

Results

MORE regular, well-formed bowel movements

  • Moved from a 2 to a 4 on the Bristol Stool Form Scale
  • Improved from 2 spontaneous bowel movements per week before treatment to 5 spontaneous bowel movements
  • Improved from 1 complete spontaneous bowel movement per week before treatment to 3 complete spontaneous bowel movements

LESS IBS-C–related abdominal pain

  • Improvement in abdominal pain and bloating from a 5 on pain scale before treatment to a 2 (60% reduction)

LOW incidence of diarrhea

  • Jennifer did not report any treatment-related diarrhea

After 12 weeks of treatment, Jennifer reported that her results were maintained.

This profile is not an actual patient, and results may vary.

Meet Carol

Patient profile:Sandy Patient profile:Sandy

Presentation

  • 65-year-old retired high school math teacher
  • Presents with constipation associated with abdominal pain
  • Experiences an average of 2 spontaneous bowel movements per week; reports bloating, hard/lumpy stool that she identifies as a 1 on the Bristol Stool Form Scale, and “not feeling empty” after bowel movements
  • Recently diagnosed with IBS-C after clinical interview, physical exam, and absence of alarm features
  • Reports that IBS-C symptoms are unpredictable, causing her to leave work early or miss work with short notice
  • Previously tried OTC laxatives that didn’t provide enough relief from constipation and IBS-related pain

Treatment

  • Prescribed Trulance 3 mg once daily to treat IBS-C, to be taken at any time of day, with or without food1

Results

MORE regular, well-formed bowel movements

  • Moved from a 1 to a 4 on the Bristol Stool Form Scale
  • Improved from 2 spontaneous bowel movements per week before treatment to 5 spontaneous bowel movements
  • Improved from 0 complete spontaneous bowel movements per week before treatment to 3 complete spontaneous bowel movements

LESS IBS-C–related abdominal pain and bloating

  • Improvement in abdominal pain from a 6 on pain scale before treatment to a 3 (50% reduction)

After 12 weeks of treatment, Sandy reported that her results were maintained.

This profile is not an actual patient, and results may vary.

Meet Sandy

Patient profile:Carol Patient profile:Carol

Presentation

  • 48-year-old real estate agent
  • Experiences only 4 bowel movements per week, with hard, “pebble-like” stools that are difficult to pass
  • Reports straining but no abdominal pain associated with bowel movements
  • Often feels like she “hasn’t completely finished going” and spends long periods on the toilet with “no success,” which interrupts her work
  • Has tried OTC medications for constipation with minimal improvement and unwanted adverse events
  • Diagnosed with CIC based on medical history and clinical exam

Treatment

  • Prescribed Trulance 3 mg once daily to treat CIC, to be taken at any time of day, with or without food1

Results

MORE regular, well-formed bowel movements

  • Moved from a 1 to a 4 on the Bristol Stool Form Scale
  • Improved from 2 spontaneous bowel movements per week before treatment to 5 spontaneous bowel movements
  • Improved from 1 complete spontaneous bowel movement per week before treatment to 3 complete spontaneous bowel movements

LESS straining

  • Straining score reduced by 40%

After 12 weeks of treatment, Carol reported that her results were maintained.

This profile is not an actual patient, and results may vary.

Meet John

Patient profile:John Patient profile:John

Presentation

  • 54-year-old construction worker
  • Experiences only 1 to 2 bowel movements per week over the last 2 years, with hard stools that he identifies as a 1 or 2 on the Bristol Stool Form Scale
  • <1 spontaneous bowel movement per week over the last 6 months
  • Reports some straining but has no abdominal pain associated with bowel movements
  • Never feels like he’s “completely gone” after he’s had a bowel movement
  • Has taken several OTC medications, a stool softener, fiber, and laxatives—some of them in combination—with little to no results

Treatment

  • Prescribed Trulance 3 mg once daily to treat CIC, to be taken at any time of day, with or without food1
  • Prescription was covered by his commercial insurance plan. After presenting a Trulance Savings Card, his copay was reduced to $25

Results

MORE regular, well-formed bowel movements

  • Moved from a 2 to a 4 on the Bristol Stool Form Scale
  • Improved from <1 spontaneous bowel movement per week before treatment to 4 spontaneous bowel movements
  • Improved from 0 complete spontaneous bowel movements per week before treatment to 3 complete spontaneous bowel movements

After 12 weeks of treatment, John reported that his results were maintained.

This profile is not an actual patient, and results may vary.

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Indication

Trulance (plecanatide) 3 mg tablets is indicated in adults for the treatment of Chronic Idiopathic Constipation (CIC) and Irritable Bowel Syndrome with Constipation (IBS-C).

IMPORTANT SAFETY INFORMATION

WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS
Trulance® is contraindicated in patients less than 6 years of age; in nonclinical studies in young juvenile mice administration of a single oral dose of plecanatide caused deaths due to dehydration. Use of Trulance should be avoided in patients 6 years to less than 18 years of age. The safety and efficacy of Trulance have not been established in pediatric patients less than 18 years of age.

 

Contraindications
  • Trulance is contraindicated in patients less than 6 years of age due to the risk of serious dehydration.
  • Trulance is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction.
Warnings and Precautions
Risk of Serious Dehydration in Pediatric Patients
  • Trulance is contraindicated in patients less than 6 years of age. The safety and effectiveness of Trulance in patients less than 18 years of age have not been established. In young juvenile mice (human age equivalent of approximately 1 month to less than 2 years), plecanatide increased fluid secretion as a consequence of stimulation of guanylate cyclase-C (GC-C), resulting in mortality in some mice within the first 24 hours, apparently due to dehydration. Due to increased intestinal expression of GC-C, patients less than 6 years of age may be more likely than older patients to develop severe diarrhea and its potentially serious consequences.
  • Use of Trulance should be avoided in patients 6 years to less than 18 years of age. Although there were no deaths in older juvenile mice, given the deaths in young mice and the lack of clinical safety and efficacy data in pediatric patients, use of Trulance should be avoided in patients 6 years to less than 18 years of age.
Diarrhea
  • Diarrhea was the most common adverse reaction in the four placebo-controlled clinical trials for CIC and IBS-C. Severe diarrhea was reported in 0.6% of Trulance-treated CIC patients, and in 1% of Trulance-treated IBS-C patients.
  • If severe diarrhea occurs, the health care provider should suspend dosing and rehydrate the patient.
Adverse Reactions
  • In the two combined CIC clinical trials, the most common adverse reaction in Trulance-treated patients (incidence ≥2% and greater than in the placebo group) was diarrhea (5% vs 1% placebo).
  • In the two combined IBS-C clinical trials, the most common adverse reaction in Trulance-treated patients (incidence ≥2% and greater than in the placebo group) was diarrhea (4.3% vs 1% placebo).

Please also see the full Prescribing Information, including BOXED Warning, for additional risk information.