Brand Name
Erleada
Generic Name
Apalutamide
View Brand Information FDA approval date: February 14, 2018
Form: Tablet
What is Erleada (Apalutamide)?
ERLEADA is indicated for the treatment of patients with Metastatic castration-sensitive prostate cancer Non-metastatic castration-resistant prostate cancer ERLEADA is an androgen receptor inhibitor indicated for the treatment of patients with metastatic castration-sensitive prostate cancer. non-metastatic castration-resistant prostate cancer.
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Brand Information
ERLEADA (Apalutamide)
1INDICATIONS AND USAGE
ERLEADA is indicated for the treatment of patients with
- Metastatic castration-sensitive prostate cancer (mCSPC)
- Non-metastatic castration-resistant prostate cancer (nmCRPC)
2DOSAGE FORMS AND STRENGTHS
Tablets:
- 240 mg: bluish grey to grey, oval, film-coated and debossed with "E240" on one side.
- 60 mg: slightly yellowish to greyish green, oblong, film-coated and debossed with "AR 60" on one side.
3ADVERSE REACTIONS
The following are discussed in more detail in other sections of the labeling:
- Cerebrovascular and Ischemic Cardiovascular Events
- Fractures
- Falls
- Seizure
- Severe Cutaneous Adverse Reactions (SCARs)
- Interstitial Lung Disease (ILD)
3.1Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The most common adverse reactions (≥ 10%) that occurred more frequently in the ERLEADA-treated patients (≥ 2% over placebo) from the randomized placebo-controlled clinical trials (TITAN and SPARTAN) were fatigue, arthralgia, rash, decreased appetite, fall, weight decreased, hypertension, hot flush, diarrhea, and fracture.
3.2Post-Marketing Experience
The following additional adverse reactions have been identified during post-approval use of ERLEADA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure.
Respiratory, Thoracic and Mediastinal Disorders:interstitial lung disease/pneumonitis [see
Skin and Subcutaneous Tissue Disorders:Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS).
4OVERDOSAGE
There is no known specific antidote for apalutamide overdose. In the event of an overdose, stop ERLEADA, undertake general supportive measures until clinical toxicity has been diminished or resolved.
5DESCRIPTION
Apalutamide, the active ingredient of ERLEADA, is an androgen receptor inhibitor. Each ERLEADA tablet contains either 60 mg or 240 mg of apalutamide. The chemical name is (4-[7-(6-Cyano-5-trifluoromethylpyridin-3-yl)-8-oxo-6-thioxo-5,7-diazaspiro[3.4]oct-5-yl]-2-fluoro-N-methylbenzamide). Apalutamide is a white to slightly yellow powder. Apalutamide is practically insoluble in aqueous media over a wide range of pH values.
The molecular weight is 477.44 and molecular formula is C
ERLEADA
- 240 mg film-coated tablets: colloidal anhydrous silica, croscarmellose sodium, hydroxypropyl methylcellulose-acetate succinate, silicified microcrystalline cellulose, and magnesium stearate. The coating contains glyceryl monocaprylocaprate, iron oxide black, polyvinyl alcohol, talc, titanium dioxide, and vinyl alcohol grafted copolymer.
- 60 mg film-coated tablets: colloidal anhydrous silica, croscarmellose sodium, hydroxypropyl methylcellulose-acetate succinate, magnesium stearate, microcrystalline cellulose, and silicified microcrystalline cellulose. The coating contains iron oxide black, iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.
6CLINICAL STUDIES
The efficacy and safety of ERLEADA was established in two randomized placebo-controlled clinical trials.
7HOW SUPPLIED/STORAGE AND HANDLING
ERLEADA
- ERLEADA
Film coated, bluish grey to grey, oval-shaped tablets debossed with "E240" on one side.
NDC Number 59676‐604‐30 - 30 tablets available in bottles with a silica gel desiccant and has a child-resistant closure
- ERLEADA
Film coated, slightly yellowish to greyish green, oblong-shaped tablets debossed with "AR 60" on one side.
NDC Number 59676‐600‐12 - 120 tablets available in bottles with a silica gel desiccant and has a child-resistant closure
8PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
9PRINCIPAL DISPLAY PANEL - 60 mg Tablet Bottle Label
NDC 59676-600-12
Erleada
60 mg
Each film-coated tablet
This package is child-resistant.
Rx only
120 film-coated
10PRINCIPAL DISPLAY PANEL - 240 mg Tablet Bottle Label
NDC 59676-604-30
Erleada
240 mg
Each film-coated tablet contains
This package is child-resistant.
Rx only
30 film-coated tablets
