PLECANATIDE
Background and Date of Approval
Plecanatide is a medication approved for treating certain gastrointestinal disorders. It works by mimicking a naturally occurring peptide in the body that regulates fluid balance in the intestines, promoting bowel movements. The U.S. Food and Drug Administration (FDA) approved this drug on January 19, 2017, based on clinical trials demonstrating its efficacy and safety in treating chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C). The pivotal clinical trials included thousands of patients and showed significant improvement in bowel movement frequency and stool consistency compared to placebo.
Uses
FDA-approved uses of this drug include: Chronic idiopathic constipation (CIC) â Long-term constipation without an identifiable cause Irritable bowel syndrome with constipation (IBS-C) â A functional bowel disorder characterised by abdominal pain and constipation
How is it administered?
Plecanatide is available as an oral tablet and is typically prescribed in a 3 mg once-daily dose, which can be taken with or without food. The tablet should be swallowed whole and not crushed, split, or chewed to ensure proper release of the medication. It is approved for use in adults aged 18 years and older and is not recommended for children. The drug should be taken at the same time each day for consistent results. If a dose is missed, it should be taken as soon as remembered, but double dosing should be avoided.
Side Effects
Common Side Effects Diarrhea Bloating Gas Nausea Fatigue Upper respiratory tract infections Serious Side Effects Severe diarrhoea leading to dehydration Severe abdominal pain Allergic reactions (swelling, difficulty breathing, rash)
Warnings
Contraindicated in children under six years due to the risk of severe dehydration Should not be used in patients with known or suspected mechanical gastrointestinal obstruction Serious allergic reactions may occur; discontinue use if symptoms like swelling or breathing difficulties develop Potential drug interactions: Caution is advised when taken with other medications affecting bowel motility
Precautions
Before starting treatment, patients should inform their healthcare provider about any medical history related to gastrointestinal obstructions, severe diarrhoea, or hypersensitivity reactions. Since the medication increases fluid secretion in the intestines, dehydration is a potential risk, especially in elderly patients. Adequate hydration should be maintained throughout the treatment. Patients should also avoid splitting or crushing the tablet to ensure proper drug release and effectiveness.
Word of Advice
Treatment with plecanatide should commence under medical supervision, particularly for patients with a history of gastrointestinal issues. Should diarrhoea develop, discontinuation of the medication and consultation with a healthcare provider is advised. Pregnant or breastfeeding women should discuss potential risks with their doctor prior to use. As plecanatide is not approved for paediatric use, it must be kept out of children's reach.
References
https://clinicaltrials.gov/study/NCT02387359 https://go.drugbank.com/drugs/DB13170 https://pmc.ncbi.nlm.nih.gov/articles/PMC5871240/ https://pubchem.ncbi.nlm.nih.gov/compound/Plecanatide
Frequently Asked Questions
What is the best time to take Plecanatide?
Plecanatide can be taken at any time of the day, but taking it at the same time daily ensures consistency. It does not have stimulant properties, so timing does not affect its effectiveness. If a dose is missed, it should be taken when remembered unless it is close to the next scheduled dose.
Should Plecanatide be taken before or after meals?
Plecanatide can be taken before or after meals as food does not impact its effectiveness. Patients may choose a time that fits their routine to maintain consistency in dosing.
How long does Plecanatide take to work?
Relief from constipation can typically be noticed within 24 to 48 hours after taking the first dose. However, individual responses may vary, and full benefits may take a few days of consistent use.
Can Plecanatide cause diarrhoea?
Yes, diarrhoea is a commonly reported side effect. If it becomes severe, leading to dehydration or discomfort, it is important to discontinue the medication and seek medical advice. Staying hydrated can help reduce the risk of dehydration from diarrhoea.
Is Plecanatide safe for long-term use?
Clinical studies have shown that Plecanatide is safe for long-term use in patients with CIC and IBS-C. However, regular follow-ups with a healthcare provider are recommended to monitor its effectiveness and any potential side effects over time.