Plenvu Approved as Bowel Cleanser
May 4, 2018 – The U.S. FDA has approved Plenvu® (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride and potassium chloride for oral solution), manufactured by Salix, a subsidiary of Valeant Pharmaceuticals. The product is indicated to prepare the bowels prior to colonoscopy.
Compared to other products indicated for bowel preparation, Plenvu uses less active solution (one liter) per dose. It can also be taken in two stages. The patient first mixes one packet of Plenvu with a glass of water and consumes the solution either between 4:00 PM and 8:00 PM the night before their procedure, or on the morning of the procedure. The second dose consists of two packets of Plenvu mixed with water and taken between two and 12 hours after the first. Other bowel preparations may require the patient to drink as many as 17 eight-ounce doses every 15 minutes. The final dose of Plenvu must be taken at least two hours before the procedure. As with other bowel preparations, patients should only consume clear fluids once they have begun Plenvu, and avoid food and alcohol.
Plenvu is expected to launch during the third quarter of 2018. Salix has not yet announced pricing plans.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.