Prostatic Neoplasms

<section class="Section" data-sectioncode="34089-3"><a name="S11"></a><a name="section-10"></a><p></p><h1>11 DESCRIPTION</h1><p class="First">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.</p><p>The molecular weight is 477.44 and molecular formula is C <span class="Sub">21</span>H <span class="Sub">15</span>F <span class="Sub">4</span>N <span class="Sub">5</span>O <span class="Sub">2</span>S. The structural formula is: </p><div class="Figure"><img alt="Chemical Structure" src="erleada-01.jpg"/></div><p>ERLEADA <span class="Sup">®</span>(apalutamide) tablets are available in 240 mg tablets and 60 mg tablets with the following inactive ingredients: </p><ul class="Disc"><li>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.</li><li>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.</li></ul></section>

ERLEADA

Erleada

apalutamide

apalutamide 240 MG Oral Tablet

apalutamide 240 MG Oral Tablet [Erleada]

apalutamide 60 MG Oral Tablet

apalutamide 60 MG Oral Tablet [Erleada]

Androgen Receptor Antagonists

Androgen Receptor Inhibitor

Cytochrome P450 2C19 Inducers

Cytochrome P450 2C9 Inducers

Cytochrome P450 3A4 Inducers

<section class="Section" data-sectioncode="34089-3"><a name="i4i_description_id_19b4fdbd-4453-411a-b18c-234a57b1870c"></a><a name="section-10"></a><p></p><h1>11  DESCRIPTION</h1><p class="First">Enzalutamide is an androgen receptor inhibitor. The chemical name is 4-{3-[4-cyano-3-(trifluoromethyl)phenyl]-5,5-dimethyl-4-oxo-2-sulfanylideneimidazolidin-1-yl}-2-fluoro-<span class="Italics">N</span>-methylbenzamide.</p><p>The molecular weight is 464.44 and molecular formula is C<span class="Sub">21</span>H<span class="Sub">16</span>F<span class="Sub">4</span>N<span class="Sub">4</span>O<span class="Sub">2</span>S. The structural formula is:</p><div class="Figure"><a name="id449594699"></a><img alt="Structural formula of Enzalutamide" src="image-01.jpg"/></div><p>Enzalutamide is a white crystalline non-hygroscopic solid. It is practically insoluble in water.</p><p>XTANDI is available as liquid-filled soft gelatin capsules for oral administration. Each capsule contains 40 mg of enzalutamide as a solution in caprylocaproyl polyoxylglycerides. The inactive ingredients are caprylocaproyl polyoxylglycerides, butylated hydroxyanisole, butylated hydroxytoluene, gelatin, sorbitol sorbitan solution, glycerin, purified water, titanium dioxide, and black iron oxide.</p><p>XTANDI is also available as film-coated tablets for oral administration. Each tablet contains 40 mg or 80 mg of enzalutamide. The inactive ingredients are hypromellose acetate succinate, microcrystalline cellulose, colloidal silicon dioxide, croscarmellose sodium, and magnesium stearate. The tablet film-coat contains hypromellose, talc, polyethylene glycol, titanium dioxide, and ferric oxide.</p></section>

Xtandi

enzalutamide

enzalutamide 40 MG Oral Capsule

enzalutamide 40 MG Oral Capsule [Xtandi]

enzalutamide 40 MG Oral Tablet

enzalutamide 40 MG Oral Tablet [Xtandi]

enzalutamide 80 MG Oral Tablet

enzalutamide 80 MG Oral Tablet [Xtandi]

Erleada is prescribed for the treatment of metastatic prostate cancer that remains responsive to medical or surgical interventions aimed at reducing testosterone levels. It is also employed to address prostate cancer that has not extended to other body parts when prior treatments, including surgery, have been ineffective or ceased to be effective.

Erleada falls within the category of medications known as androgen receptor inhibitors. Its mechanism of action involves inhibiting the impact of androgen, a male reproductive hormone, to halt the proliferation and dissemination of cancer cells.

Please note that this medication is not authorized for use in women or children.

Report Adverse Event

Prescribing Information

Medication Guide 

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Pharmacy List 

Reimbursement & Access Guide 

Prior Authorization Checklist 

Coverage Authorization Request 

Coverage Authorization Appeals 

Letter of Medical Necessity 

Letter of Exception

Other HCP Resources - Forms 

Janssen CarePath Provider Portal

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Other HCP Resources 

Patient Reported Outcomes 

About Erleada

Taking Erleada

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Patient Resources 

Patient Brochure

Erleada Patient Support Guide 

Affordability Options for Erleada

Doctor Discussion Guide 

Instructions For Use: Prostate Cancer 

Xtandi is an anti-androgen that functions by blocking the effects of androgens, which are male hormones.

Xtandi is prescribed for the treatment of prostate cancer.

It can be employed when the cancer is unresponsive to treatment but remains localized without spreading to other areas.

Xtandi is also an option when the cancer responds to treatment and has metastasized to other parts of the body.

Erleada®(apalutamide)	Xtandi®(enzalutamide)

Prescription Only Erleada is prescribed for the treatment of metastatic prostate cancer that remains responsive to medical or surgical interventions aimed at reducing testosterone levels. It is...	Prescription Only Xtandi is an anti-androgen that functions by blocking the effects of androgens, which are male hormones. Xtandi is prescribed for the treatment of prostate cancer. It can be...
Dosage & Administration
Administration
Oral. Learn more.	Oral. Learn more.
Dosing
ERLEADA 240 mg administered orally once daily. Swallow tablets whole. ERLEADA can be taken with or without food.. Learn more.	160 mg administered orally once daily.. Learn more.
Latin Shorthand
ERLEADA: 240 mg PO qd. Swallow tabs whole. May take with or without food.. Learn more.	160mg PO qd. . Learn more.
Financial Assistance
Out-Of-Pocket Costs With Copay Card
$0. Learn more.	$0. Learn more.
Annual Cap
$15,000. Learn more.	Learn more.
Assistance Expiration
Calendar year. Learn more.	12 months. Learn more.
Generics
No lower-cost generic available	No lower-cost generic available
Physician Advisory
Adverse Reactions
The most common adverse reactions (≥10%) are fatigue, arthralgia, rash, decreased appetite, fall, weight decreased, hypertension, hot flush, diarrhea, and fracture. . Learn more.	The most common adverse reactions (≥ 10%) that occurred more frequently (≥ 2% over placebo) in the XTANDI-treated patients are asthenia/fatigue, back pain, hot flush, constipation, arthralgia, decreased appetite, diarrhea, and hypertension.. Learn more.
Mechanism of Actions (MoA)
Antiandrogens. Learn more.	Antiandrogens. Learn more.
Special Populations

Erleada® Alternatives