Erleada (Apalutamide)

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Dosage & administration

ERLEADA 240 mg administered orally once daily. Swallow tablets whole. ERLEADA can be taken with or without food. (

2.1 Recommended Dosage

The recommended dose of ERLEADA is 240 mg administered orally once daily. This could be administered as one 240 mg tablet or four 60 mg tablets. Swallow the tablet(s) whole. Do not crush or split tablet(s). 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.

2.3 Alternate Methods of Administration

Disperse Tablet(s) in Water and Administer with Orange Juice, Applesauce, or Additional Water

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

Place the entire prescribed dose of ERLEADA tablet(s) in a cup. Do not crush or split the tablet(s).

For one 240 mg tablet:

Add about 2 teaspoons (10 mL) of non-carbonated water to make sure that the tablet is completely immersed in water.

For 60 mg tablets (prescribed dose of 240 mg, 180 mg, or 120 mg):

Add about 4 teaspoons (20 mL) of non-carbonated water to make sure that the tablets are completely immersed in water.

Wait 2 minutes until the tablet(s) are broken up and spread out, then stir the mixture.

Add 2 tablespoons (30 mL) of either orange juice, applesauce, or additional water and stir the mixture.

Swallow the mixture immediately.

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 Tablet(s) Through a Feeding Tube

ERLEADA tablet(s) can be administered through a feeding tube 8 French or greater as follows:

For one 240 mg tablet:

Place the 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.

For 60 mg tablets (prescribed dose of 240 mg, 180 mg, or 120 mg):

Place the entire prescribed dose of ERLEADA tablets in the barrel of the syringe (use at least a 50 mL syringe) and draw up 20 mL of non-carbonated water into the syringe.

Wait 10 minutes and then shake vigorously to disperse contents completely.

Administer immediately through the feeding tube.

Refill the syringe with non-carbonated water and administer. Repeat until no tablet residue is left in the syringe or feeding tube.

)

Patients should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy. (

2.1 Recommended Dosage

Patients should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had a bilateral orchiectomy.

)

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Erleada prescribing information

Dosage and Administration, Recommended Dosage ( 2.1 Recommended Dosage The recommended dose of ERLEADA is 240 mg administered orally once daily. This could be administered as one 240 mg tablet or four 60 mg tablets. Swallow the tablet(s) whole. Do not crush or split tablet(s). 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. )	8/2024
Dosage and Administration, Dosage Modification ( 2.2 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 severe ILD/pneumonitis or if no other potential causes of ILD/pneumonitis are identified, or confirmed SCARs, or for other Grade 4 skin reactions [see Warnings and Precautions (5.5, 5.6)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. )	8/2024
Dosage and Administration, Alternate Methods of Administration ( 2.3 Alternate Methods of Administration Disperse Tablet(s) in Water and Administer with Orange Juice, Applesauce, or Additional Water For patients who cannot swallow tablets whole, the recommended dose of ERLEADA tablet(s) can be dispersed in non-carbonated water and then administered with either orange juice, applesauce, or additional water as follows: Place the entire prescribed dose of ERLEADA tablet(s) in a cup. Do not crush or split the tablet(s). For one 240 mg tablet: Add about 2 teaspoons (10 mL) of non-carbonated water to make sure that the tablet is completely immersed in water. For 60 mg tablets (prescribed dose of 240 mg, 180 mg, or 120 mg): Add about 4 teaspoons (20 mL) of non-carbonated water to make sure that the tablets are completely immersed in water. Wait 2 minutes until the tablet(s) are broken up and spread out, then stir the mixture. Add 2 tablespoons (30 mL) of either orange juice, applesauce, or additional water and stir the mixture. Swallow the mixture immediately. 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 Tablet(s) Through a Feeding Tube ERLEADA tablet(s) can be administered through a feeding tube 8 French or greater as follows: For one 240 mg tablet: Place the 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. For 60 mg tablets (prescribed dose of 240 mg, 180 mg, or 120 mg): Place the entire prescribed dose of ERLEADA tablets in the barrel of the syringe (use at least a 50 mL syringe) and draw up 20 mL of non-carbonated water into the syringe. Wait 10 minutes and then shake vigorously to disperse contents completely. Administer immediately through the feeding tube. Refill the syringe with non-carbonated water and administer. Repeat until no tablet residue is left in the syringe or feeding tube. )	8/2024
Warnings and Precautions, Interstitial Lung Disease (ILD) ( 5.6 Interstitial Lung Disease (ILD)/Pneumonitis Fatal and life-threatening interstitial lung disease (ILD) or pneumonitis can occur in patients treated with ERLEADA. Post-marketing cases of ILD/pneumonitis, including fatal cases, occurred in patients treated with ERLEADA. Across clinical trials (TITAN and SPARTAN, n=1327), 0.8% of patients treated with ERLEADA experienced ILD/pneumonitis, including 0.2% who experienced Grade 3 events [see Adverse Reactions (6.1, 6.2)]. Monitor patients for new or worsening symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). Immediately withhold ERLEADA if ILD/pneumonitis is suspected. Permanently discontinue ERLEADA in patients with severe ILD/pneumonitis or if no other potential causes of ILD/pneumonitis are identified [see Dosage and Administration (2.2)] . )	8/2024

ERLEADA 240 mg administered orally once daily. Swallow tablets whole. ERLEADA can be taken with or without food. (

2.1 Recommended Dosage

Patients should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had a bilateral orchiectomy.

2.3 Alternate Methods of Administration

Disperse Tablet(s) in Water and Administer with Orange Juice, Applesauce, or Additional Water

Place the entire prescribed dose of ERLEADA tablet(s) in a cup. Do not crush or split the tablet(s).
For one 240 mg tablet:
Add about 2 teaspoons (10 mL) of non-carbonated water to make sure that the tablet is completely immersed in water.

For 60 mg tablets (prescribed dose of 240 mg, 180 mg, or 120 mg):
Add about 4 teaspoons (20 mL) of non-carbonated water to make sure that the tablets are completely immersed in water.
Wait 2 minutes until the tablet(s) are broken up and spread out, then stir the mixture.
Add 2 tablespoons (30 mL) of either orange juice, applesauce, or additional water and stir the mixture.
Swallow the mixture immediately.
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 Tablet(s) Through a Feeding Tube

ERLEADA tablet(s) can be administered through a feeding tube 8 French or greater as follows:

For one 240 mg tablet:
Place the 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.

For 60 mg tablets (prescribed dose of 240 mg, 180 mg, or 120 mg):
Place the entire prescribed dose of ERLEADA tablets in the barrel of the syringe (use at least a 50 mL syringe) and draw up 20 mL of non-carbonated water into the syringe.
Wait 10 minutes and then shake vigorously to disperse contents completely.
Administer immediately through the feeding tube.
Refill the syringe with non-carbonated water and administer. Repeat until no tablet residue is left in the syringe or feeding tube.

)

Patients should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy. (

2.1 Recommended Dosage

Patients should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had a bilateral orchiectomy.

)

Risk Summary

The safety and efficacy of ERLEADA have not been established in females. Based on findings from animals and its mechanism of action, ERLEADA can cause fetal harm and loss of pregnancy when administered to a pregnant female

[see

12.1 Mechanism of Action

Apalutamide is an Androgen Receptor (AR) inhibitor that binds directly to the ligand-binding domain of the AR. Apalutamide inhibits AR nuclear translocation, inhibits DNA binding, and impedes AR-mediated transcription. A major metabolite, N-desmethyl apalutamide, is a less potent inhibitor of AR, and exhibited one-third the activity of apalutamide in an

in vitro

transcriptional reporter assay. Apalutamide administration caused decreased tumor cell proliferation and increased apoptosis leading to decreased tumor volume in mouse xenograft models of prostate cancer.

]

. There are no available data on ERLEADA use in pregnant women to inform a drug-associated risk. In an animal reproduction study, oral administration of apalutamide to pregnant rats during and after organogenesis resulted in fetal abnormalities and embryo-fetal lethality at maternal exposures ≥ 2 times the human clinical exposure (AUC) at the recommended dose

(see

Data

Animal Data

In a pilot embryo-fetal developmental toxicity study in rats, apalutamide caused developmental toxicity when administered at oral doses of 25, 50 or 100 mg/kg/day throughout and after the period of organogenesis (gestational days 6–20). Findings included embryo-fetal lethality (resorptions) at doses ≥50 mg/kg/day, decreased fetal anogenital distance, misshapen pituitary gland, and skeletal variations (unossified phalanges, supernumerary short thoracolumbar rib(s), and small, incomplete ossification, and/or misshapen hyoid bone) at ≥25 mg/kg/day. A dose of 100 mg/kg/day caused maternal toxicity. The doses tested in rats resulted in systemic exposures (AUC) approximately 2, 4 and 6 times, respectively, the AUC in patients.

Erleada (Apalutamide)

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