Sign Out
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.
Dosage Modification: If Grade 3 or greater adverse reactions, or other intolerable adverse reactions occur, withhold ERLEADA. Consider permanent discontinuation of ERLEADA for Grade 3 or 4 cerebrovascular and ischemic cardiovascular events [see Cerebrovascular and Ischemic Cardiovascular Events under Precautions]. Permanently discontinue ERLEADA for confirmed SCARs or for other Grade 4 skin reactions [see Severe Cutaneous Adverse Reactions under Precautions and Clinical Trial Experience under Adverse Reactions]. For other adverse reactions, when symptoms improve to less than or equal to Grade 1 or original grade, resume ERLEADA 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].
Continue with Google