Drug Detail:Relugolix (Relugolix [ rel-ue-goe-lix ])
Drug Class: Gonadotropin-releasing hormone antagonists
Usual Adult Dose for Prostate Cancer
Loading Dose: 300 mg orally once on the first day
Maintenance Dose: 120 mg orally once a day
Comment:
- Treatment is usually continued upon development of nonmetastatic or metastatic castration-resistant prostate cancer in patients treated with GnRH receptor agonists and antagonists.
Use: For the treatment of adult patients with advanced prostate cancer
Renal Dose Adjustments
Data not available.
Liver Dose Adjustments
Data not available.
Dose Adjustments
USE WITH P-GP INHIBITORS:
- Coadministration should be avoided.
- If unavoidable, take this drug and separate dosing 6 hours apart.
- If a short course with P-gp inhibitor is required, treatment with this drug may be interrupted for up to two weeks.
- If treatment is interrupted for more than 7 days, resume with a 360 mg loading dose on the first day and continue with 120 mg once a day.
USE WITH A COMBINED P-GP AND STRONG CYP450 3A INDUCERS:
- Coadministration Should be avoided.
- If unavoidable, increase the dose of this drug to 240 mg once a day.
- May resume at the recommended dose after discontinuation of the combined P-gp and strong CYP450 3A inducer.
Precautions
CONTRAINDICATIONS:
- None
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available.
Other Comments
Administration advice:
- The tablets should be swallowed whole.
- Do not to crush or chew tablets.
- This drug can be taken with or without food at approximately the same time each day.
- Take a missed dose as soon as possible.
- If a dose is missed and cannot be taken within 12 hours, skip that dose and take the next dose at the usual time.
- If treatment is interrupted for greater than 7 days, restart with a loading dose of 360 mg on the first day and continue with a dose of 120 mg once a day.
Storage Requirements:
- Store at room temperature.
- Do not store above 30C (86F).
Monitoring:
- Cardiovascular: ECG
- Endocrine: Prostate specific antigen levels
- Metabolic: Serum electrolytes
Patient advice:
- Advise the patient to read the FDA-approved patient labeling.
- Inform patients that this drug can be harmful to a developing fetus and can cause loss of pregnancy.
- Advise males with female partners of reproductive potential to use effective contraception during therapy and for at least 2 weeks after the last dose.
- Advise patients that this drug may prolong the QT interval and to report any signs of symptoms of QT prolongation.
- Inform patients that this drug may cause hot flashes, flushing of the skin, increased weight, decreased sex drive, and difficulties with erectile function.
- Inform patients that this drug may cause infertility.
