Sandostatin Patient Counseling Information

Recommendation for the management of patients during octreotide (Sandostatin) treatment with respect to the development of gallstones: 1. Patients should undergo a baseline ultrasound examination of the gallbladder prior to commencing octreotide treatment.
2. Periodic repeat ultrasound examination of the gallbladder should be performed, preferably at about 6-month intervals, throughout octreotide (Sandostatin) treatment.
3. If stones are already present before the start of therapy, the potential benefit of octreotide (Sandostatin) should be assessed against the potential risks associated with the gallstones. There is no evidence at present that octreotide (Sandostatin) adversely affects the course or prognosis of pre-existing gallstones.
4. Management of patients who develop gallstones in association with octreotide (Sandostatin): Asymptomatic gallstones: Octreotide (Sandostatin) may be continued, depending on re-assessment of the benefit/risk ratio. Either way, no action is required except to continue monitoring, with increased frequency if this is considered necessary.
Symptomatic gallstones: Octreotide (Sandostatin) may be either stopped or continued, depending on re-assessment of the benefit/risk ratio. Either way, the gallstones should be treated like any other symptomatic gallstones. Medically, this may include combined bile acid therapy (e.g. chenodeoxycholic acid [CDCA] together with ursodeoxycholic acid [UDCA] or monotherapy with ursodeoxycholic acid (UDCA) associated with ultrasound monitoring until the stones have completely disappeared. For posology and treatment duration, please consult the locally approved prescribing information for CDCA and/or UDCA.