Contact Us

Thank you for your interest in PENTASA and Shire US Inc. We welcome your comments and questions.

US Headquarters

Shire US Inc.
725 Chesterbrook Blvd
Wayne, PA 19087
Toll free: (800) 828-2088

Patients and Caregivers

Call the Shire Customer Service Center toll free at 1-800-828-2088, M-F 8:30 AM - 5:30 PM ET.

Health Care Professionals

Clinical inquiries: For further clinical information on Shire products, US health care professionals may call toll free at 1-800-828-2088 or e-mail MedInfoGlobal@Shire.com

Shire Cares Patient Assistance & Support Program:
Shire is dedicated to assisting patients with demonstrated financial need. If your patients don’t have prescription insurance or are having trouble affording your PENTASA prescription, Shire Cares may be able to help. Shire Cares Counselors are available from 8 AM to 8 PM Eastern Time. Patients can call 1-888-CARES-55 (1-888-227-3755) to speak with a counselor or visit www.ShireCares.com

Please see Important Safety Information and Full Prescribing Information for details about PENTASA.

INDICATION

PENTASA is indicated for the induction of remission and for the treatment of patients with mildly to moderately active ulcerative colitis.

IMPORTANT SAFETY INFORMATION

PENTASA is contraindicated in patients with a hypersensitivity to mesalamine, any other components in this medication, or salicylates.

IMPORTANT SAFETY INFORMATION (CONTINUED)

Mesalamine has been associated with an acute intolerance syndrome (3% of patients in clinical trials with mesalamine or sulfasalazine) that may be difficult to distinguish from a flare of inflammatory bowel disease. Symptoms include cramping, acute abdominal pain and bloody diarrhea, sometimes fever, headache, and rash. If acute intolerance syndrome is suspected, prompt withdrawal is required.

Caution should be exercised if PENTASA is administered to patients with impaired hepatic or renal function. Single reports of nephrotic syndrome and interstitial nephritis associated with mesalamine therapy have been described in the foreign literature. There have been rare reports of interstitial nephritis in patients receiving PENTASA. Patients with preexisting renal disease, increased BUN or serum creatinine, or proteinuria should be carefully monitored, especially during the initial phase of treatment. Mesalamine-induced nephrotoxicity should be suspected in patients developing renal dysfunction during treatment.

The most common adverse events in US clinical trials (N=451) were diarrhea (3.5%), headache (2.2%), nausea (3.1%), abdominal pain (1.1%), rash (1.3%), anorexia (1.1%), and nausea and vomiting (1.1%). In combined domestic and foreign trials (N>2100), the most common adverse events were diarrhea (3.4%), headache (2.0%), nausea (1.8%), abdominal pain (1.7%), dyspepsia (1.6%), vomiting (1.5%), and rash (1.0%).

Safety and efficacy of PENTASA in pediatric patients have not been established.

For additional safety information, please see Full Prescribing Information.