Erleada Dosage/Direction for Use

Recommended Dosage: The recommended dose of ERLEADA is 240 mg (four 60 mg tablets) administered orally once daily. Swallow the tablets whole. ERLEADA can be taken with or without food.
Patients should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had a bilateral orchiectomy.
Dose Modification: If a patient experiences a greater than or equal to Grade 3 toxicity or an intolerable side effect, hold dosing until symptoms improve to less than or equal to Grade 1 or original grade, then resume at the same dose or a reduced dose (180 mg or 120 mg), if warranted.
Alternate Method of Administration: For patients who have difficulty swallowing tablets whole, the recommended dose of ERLEADA tablets may be mixed in applesauce.
1. Mix whole ERLEADA tablets in 4 ounces (120 mL) of applesauce by stirring. Do not crush the tablets.
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).
4. Using a spoon, swallow the mixture right away.
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 one hour of preparation. Do not store ERLEADA that is mixed with applesauce [see PHARMACOLOGY: Pharmacokinetics under Actions].
Pediatric Use: Safety and effectiveness of ERLEADA in pediatric patients have not been established.
Geriatric Use: Of the 1327 patients who received ERLEADA in clinical studies, 19% of patients were less than 65 years, 41% of patients were 65 years to 74 years, and 40% were 75 years and over.
No overall differences in effectiveness were observed between older and younger patients.
Of patients treated with ERLEADA (n=1073), Grade 3-4 adverse reactions occurred in 39% of patients younger than 65 years, 41% of patients 65-74 years, and 49% of patients 75 years or older. Falls in patients receiving ERLEADA with androgen deprivation therapy was elevated in the elderly, occurring in 8% of patients younger than 65 years, 10% of patients 65-74 years, and 19% of patients 75 years or older.