RELUGOLIX TAB
Clinical Criteria Summary
Exclusion Criteria
- Unmanageable drug interaction identified
- End stage renal disease (with or without hemodialysis)
- Child-Pugh class C
- QTc > 470 msec, Q-wave infarction or congenital long QT syndrome
- Uncontrolled or symptomatic ventricular arrhythmias in the prior 6 months
- Congestive heart failure (NYHA Class 3 or 4) in the prior 6 months
- A thromboembolic event in the prior 6 months
- Gastrointestinal condition that may interfere with relugolix absorption or inability to swallow tablets whole
- Known history of non-adherence with oral medication, follow-up appointments or laboratory visits
Inclusion Criteria
- Care provided by a VA or VA Community Care provider of urology or hematology/oncology services
- Goals of care and role of Palliative Care consult have been discussed and documented
- Hormone-sensitive, advanced adenocarcinoma of the prostate
- Additional Inclusion Criteria (One must be fulfilled)
- Inability to maintain castrate levels of serum testosterone on LHRH agonist therapy (taking into consideration the initial time required to reach castrate level)
- Known hypersensitivity to LHRH agonist analogs or their components
- Rapid decrease in testosterone levels needed due to organ-threatening disease
- Cardiovascular benefit alone (i.e. reduction in Major Cardiovascular Events) is not an appropriate indication for use
Reproductive Safety Considerations
- Advise male patients with female partners of childbearing potential to use effective contraception during and for 2 weeks following the last dose of relugolix