TELOTRISTAT TAB
Clinical Criteria Summary
Inclusion Criteria
- Diagnosis of neuroendocrine tumor
- Diarrhea secondary to carcinoid syndrome, inadequately managed with somatostatin analog (SSA) therapy alone; can be used in combination with short-acting SSA
Exclusion Criteria
- Patient has not been on a stable sandostatin analog (SSA) regimen defined as a long-acting release, depot or infusion pump for > 3 months
- More than 12 watery BMs per day associated with volume contraction, dehydration or hypotension
- Evidence of enteric infection
- Eastern Cooperative Oncology Group Performance Status > 2
- History of short bowel syndrome
- Moderate to severe hepatic impairment (Child-Pugh class B or C)
- Unmanageable drug-drug interaction
- Known pregnancy
Additional Inclusion Criteria
- For females who can become pregnant: Pregnancy should be excluded prior to receiving telotristat
- For females who can become pregnant and males with partners who can become pregnant: Counseling provided on potential risks vs benefits of treatment and the use of effective contraception during therapy