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XTANDI
Prostate and other male cancers
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Drug Name:

XTANDI Rx

Generic Name and Formulations:
Enzalutamide 40mg; caps.

Company:
Astellas Pharma US, Inc.



Therapeutic Use:

Indications for XTANDI:

Treatment of metastatic castration-resistant prostate cancer in patients who have previously received docetaxel.

Adult Dose for XTANDI:

Swallow whole. 160mg once daily. Dose modifications: ≥Grade 3 toxicity or intolerable side effect: withhold dosing for 1 week or until symptoms improve to ≤Grade 2, then resume at same or reduced dose, if warranted. Concomitant strong CYP2C8 inhibitors: avoid if possible. If co-administration necessary, reduce Xtandi dose to 80mg once daily; if inhibitor is discontinued, return Xtandi dose to dose used prior to initiation of inhibitor.

Children's Dose for XTANDI:

Not established.

Pharmacological Class:

Androgen receptor inhibitor.

Contraindications:

Pregnancy (Cat.X).

Warnings/Precautions:

Seizure risk. Severe renal or hepatic impairment. Nursing mothers.

Interactions:

Potentiated by strong CYP2C8 inhibitors (eg, gemfibrozil), CYP3A4 inhibitors (itraconazole). May be antagonized by CYP2C8 inducers (eg, rifampin), CYP3A4 inducers (eg, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, bosentan, efavirenz, etravirine, modafinil, nafcillin, St. John’s Wort). Antagonizes midazolam (CYP3A4 substrate), warfarin (CYP2C9 substrate), and omeprazole (CYP2C19 substrate). Avoid concomitant drugs with narrow therapeutic indexes metabolized by CYP3A4 (eg, alfentanil, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus), CYP2C9 (eg, phenytoin, warfarin), CYP2C19 (eg, S-mephenytoin); enzalutamide may decrease their exposure. Caution with concomitant drugs that may lower the seizure threshold. Monitor INR if concomitant warfarin cannot be avoided.

Adverse Reactions:

Asthenia/fatigue, back pain, diarrhea, arthralgia, hot flush, peripheral edema, musculoskeletal pain, headache, upper respiratory infection, muscular weakness, dizziness, insomnia, lower respiratory infection, spinal cord compression and cauda equina syndrome, hematuria, paresthesia, anxiety, hypertension, neutropenia; seizures.

Metabolism:

Hepatic (CYP2C8, 3A4); 98% protein bound.

Elimination:

Renal, fecal.

Generic Availability:

NO

How Supplied:

Caps—120

XTANDI

  • 40mg capsules (Qty:120)
  • appx. price $8836.00
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