Antiandrogens
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Erleada Dosage

Drug Detail:Erleada (Apalutamide [ ap-a-loot-a-mide ])

Generic Name: APALUTAMIDE 60mg

Dosage Form: tablet, film coated

Drug Class: Antiandrogens Hormones / antineoplastics

Contents
Uses Warnings Before Taking Dosage Side effects Interactions FAQ

Recommended Dosage

​The recommended dose of ERLEADA is 240 mg administered orally once daily. Swallow the tablets whole. Do not crush or split tablets. 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 Warnings and Precautions (5.1)] . Permanently discontinue ERLEADA for confirmed SCARs or for other Grade 4 skin reactions [see Warnings and Precautions (5.5) and Adverse Reactions (6.1)] . 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 Methods of Administration

​Disperse 240 mg Tablet in Water and Administer with Orange Juice, Applesauce, or Additional Water

​For patients who cannot swallow the tablet whole, the recommended dose of one ERLEADA 240 mg tablet can be dispersed in non-carbonated water and then administered with either orange juice, applesauce, or additional water as follows:

  1. ​Place the whole ERLEADA 240 mg tablet in a cup. Do not crush or split the tablet.
  2. ​Add about 2 teaspoons (10 mL) of non-carbonated water to make sure that the tablet is completely immersed in water.
  3. ​Wait 2 minutes until the tablet is broken up and spread out, then stir the mixture.
  4. ​Add 2 tablespoons (30 mL) of either orange juice, applesauce, or additional water and stir the mixture.
  5. ​Swallow the mixture immediately.
  6. ​Rinse the cup with enough water to make sure the whole dose is taken and drink it immediately.

​Do not store ERLEADA that is mixed with non-carbonated water, orange juice, or applesauce for later use.

​Administer 240 mg Tablet Through a Feeding Tube

​ERLEADA 240 mg tablet can be administered through a feeding tube 8 French or greater as follows:

  1. ​Place one 240 mg tablet in the barrel of the syringe (use at least a 20 mL syringe) and draw up 10 mL of non-carbonated water into the syringe.
  2. ​Wait 10 minutes and then shake vigorously to disperse contents completely.
  3. ​Administer immediately through the feeding tube.
  4. ​Refill the syringe with non-carbonated water and administer. Repeat until no tablet residue is left in the syringe or feeding tube.

Administer 60 mg Tablets with Applesauce

​For patients who have difficulty swallowing tablets whole, the recommended dose of ERLEADA 60 mg tablets may be mixed in applesauce.

  1. ​Mix whole ERLEADA 60 mg tablets in 4 ounces (120 mL) of applesauce by stirring. Do not crush or split 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.

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