Enzter 160

Composition

Generic name: Enzalutamide

Dosage forms: 160 mg

Drug classes: Antiandrogens, Hormones

Indications

Castration-resistant prostate cancer (CRPC)
Metastatic castration-sensitive prostate cancer (CSPC)
Non-metastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR)

Dosage

160 mg PO Day
CRPC or CSPC: Patients should also receive a gonadotropic-releasing hormone (GnRH) an alog concurrently or should have had bilateral orchiectomy.
CSPC with high-risk BCR
- May be treated with enzalutamide with or without a GnRH analog
- Treatment can be suspended if PSA is undetectable (<0.2 ng/mL) after 36 weeks of therapy
- Reinitiate treatment when PSA increases to ≥2 ng/mL for patients who had prior radical prostatectomy or ≥5 ng/mL for patients who had prior primary radiation therapy

Dosage Modifications

Dosage modifications based on drug-related toxicities.

Grade ≥3 toxicity or an intolerable side effect: Withhold for 1 week or until symptoms improve to Grade ≤2, then resume at same or reduced dose (eg, 120 mg or 80 mg), if necessary

Concomitant Strong CYP2C8 Inhibitors

Avoid use
If coadministration is unavoidable, reduce enzalutamide dose to 80 mg qDay
If strong inhibitor discontinued, return enzalutamide to dose before initiating the strong CYP2C8 inhibitor

Concomitant Strong CYP3A4 Inducers

Avoid use
If coadministration unavoidable, increase enzalutamide dose from 160 mg to 240 mg Day
If strong inducer discontinued, return enzalutamide to dose before initiating the strong CYP3A4 inducer.

Renal Impairment

Mild-to-moderate (CrCl 30-89 mL/min): No dosage adjustment necessary
Severe (CrCl <30 mL/min) and end-stage renal disease: Not assessed

Hepatic Impairment

Mild-to-severe (Child Pugh A to C): No dosage adjustment necessary

How Should I Take Enzalutamide?

Take enzalutamide exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Take the medicine at the same time each day, with or without food.

You may need to take 1 tablet at a time to get a full dose.

Swallow the enzalutamide pill whole. Do not break, chew, or crush a tablet. Do not chew, open, or dissolve a capsule.

Use all medications as directed and read all medication guides you receive. Do not change your dose or dosing schedule without your doctor’s advice.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Comments

This drug can be taken with or without food.
Swallow capsules whole. Do not chew, dissolve, or open the capsules.
Patients receiving this drug should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy.

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