Dosing and Administration

ERLEADA®: once-daily oral dosing1

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Tablets shown are not actual size.

The recommended dose of ERLEADA® is 240 mg (four 60 mg tablets) administered  orally once daily 1

Patients should also receive a GnRH analog concurrently or should have had a bilateral orchiectomy.1

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No need for
co-administration of a corticosteroid.1

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Can be taken with or without food. Tablets should be swallowed whole.1

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No initial dose adjustments for ERLEADA® are necessary for renal or hepatic impairment.*1

*ERLEADA® has not been evaluated in patients with severe renal or hepatic impairment.

Dose Modifications

If a patient experiences a ≥Grade 3 toxicity or an intolerable side effect, hold dosing until symptoms improve to ≤Grade 1 or original grade, and then resume at the same dose or a reduced dose (180 mg or 120 mg), if warranted.1

Alternate Method of Administration

For patients who have difficulty swallowing tablets, ERLEADA® may be taken by mixing the recommended dose in applesauce. The following instructions are included in Section 2.3 of the full Prescribing Information for ERLEADA®.

Alternate Method of Administration

1. Mix whole ERLEADA® tablets in 4 ounces (120 mL) of applesauce by stirring. Do not crush the tablets.

Alternate Method of Administration

2. Wait 15 minutes, stir the mixture.

3. Wait another 15 minutes, stir the mixture until tablets are dispersed (well mixed with no chunks remaining).

Alternate Method of Administration

4. Using a spoon, swallow the mixture right away.

Alternate Method of Administration

5. Rinse the container with 2 ounces (60 mL) of water and immediately drink the contents. Repeat the rinse with 2 ounces (60 mL) of water a second time to ensure the whole dose is taken.

Consume the mixture within 1 hour of preparation. Do not store ERLEADA® that is mixed with applesauce.

GnRH = gonadotropin-releasing hormone.

Reference

1. ERLEADA® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.