Xtandi Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Mechanism of Action
Xtandi Indications
Indications
Castration-resistant prostate cancer (CRPC). Metastatic castration-sensitive prostate cancer (mCSPC). Non-metastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis.
Xtandi Dosage and Administration
Adult
Swallow whole. 160mg once daily until disease progression or unacceptable toxicity. CRPC or mCSPC: give concurrent GnRH analog or patient should have had bilateral orchiectomy. nmCSPC: may treat with or without a GnRH analog; can suspend treatment if PSA is undetectable (<0.2ng/mL) after 36 weeks; reinitiate treatment when PSA is ≥2.0ng/mL in those who had prior radical prostatectomy or ≥5.0ng/mL in those who had prior primary radiation therapy. Dose modifications: ≥Grade 3 toxicity or intolerable side effect: withhold dose for 1 week or until improvement to ≤Grade 2, then resume at same or reduced dose (120mg or 80mg), if warranted. Concomitant strong CYP2C8 inhibitors, if unavoidable: reduce to 80mg once daily. Concomitant strong CYP3A4 inducers, if unavoidable: increase to 240mg once daily. When CYP2C8 inhibitor or CYP3A4 inducer is discontinued, return enzalutamide dose to the dose used prior to initiation of the inhibitor or inducer.
Children
Administration
Nursing Considerations
Xtandi Contraindications
Not Applicable
Xtandi Boxed Warnings
Not Applicable
Xtandi Warnings/Precautions
Warnings/Precautions
Xtandi Pharmacokinetics
Absorption
Median Tmax: 1 hour (range: 0.5–3 hours) after a single dose of 160mg capsule; 2 hours (range: 0.5–6 hours) after a single dose of 160mg tablet.
Distribution
Mean volume of distribution: 110 L. Plasma protein bound: 97–98%.
Elimination
Renal (71%), fecal (14%). Half-life: 5.8 days (after a single oral dose).
Xtandi Interactions
Interactions
Xtandi Adverse Reactions
Adverse Reactions
Xtandi Clinical Trials
See Literature
Xtandi Note
Not Applicable
Xtandi Patient Counseling
See Literature