• Prostate and other male cancers

Xtandi Generic Name & Formulations

General Description

Enzalutamide 40mg; soft gelatin caps; or 40mg, 80mg; tabs.

Pharmacological Class

Androgen receptor inhibitor.

How Supplied

Caps, tabs 40mg—120; Tabs 80mg—60

Generic Availability


Xtandi Indications


Castration-resistant prostate cancer (CRPC). Metastatic castration-sensitive prostate cancer (mCSPC).

Xtandi Dosage and Administration


Swallow whole. 160mg once daily. Give concurrent GnRH analog or patient should have had bilateral orchiectomy. 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.


Not established.

Xtandi Contraindications

Not Applicable

Xtandi Boxed Warnings

Not Applicable

Xtandi Warnings/Precautions


Risk of seizure; permanently discontinue if occurs. Discontinue if posterior reversible encephalopathy syndrome (PRES) develops. Monitor for ischemic heart disease; discontinue if Grade 3 or 4 develops. Manage CV risk factors (eg, hypertension, diabetes, dyslipidemia). Evaluate for fall and fracture risk; monitor and manage as per established guidelines. Severe renal impairment or ESRD: not studied. Embryo-fetal toxicity. Advise males (w. female partners of reproductive potential) to use effective contraception during and for 3 months after the last dose.

Xtandi Pharmacokinetics

See Literature

Xtandi Interactions


Avoid concomitant strong CYP2C8 inhibitors (eg, gemfibrozil); if unavoidable, reduce dose (see Adult dose). Avoid concomitant strong CYP3A4 inducers (eg, rifampin); if unavoidable, increase dose (see Adult dose). Antagonizes midazolam (CYP3A4 substrate) and omeprazole (CYP2C19 substrate). May antagonize certain CYP3A4, CYP2C9, or CYP2C19 substrates; increase dose of these substrates, if unavoidable. Caution with concomitant drugs that may lower the seizure threshold.

Xtandi Adverse Reactions

Adverse Reactions

Asthenia/fatigue, back pain, hot flush, constipation, arthralgia, decreased appetite, diarrhea, hypertension; seizure, PRES, ischemic heart disease, falls, fractures, hypersensitivity reactions (permanently discontinue if severe).

Xtandi Clinical Trials

See Literature

Xtandi Note

Not Applicable

Xtandi Patient Counseling

See Literature