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ERLEADA Apalutamide 60 mg Tablet, Film Coated — NDC 59676-0600-56 package photo

ERLEADA Apalutamide 60 mg Tablet, Film Coated

by Janssen Products, LP · 2 BLISTER PACK in 1 CARTON (59676-600-56) / 28 TABLET, FILM COATED in 1 BLISTER PACK
NDC 59676-0600-56
🏷️ FDA NDC (as labeled) 59676-600-56 billing pads the product segment with a zero
This package
Contains28 tablet, film coated in 1 blister pack Pack sizes2 compare ↓
Also priced by: Part D plans $125.03/unit — full pricing hub ↓
Also comes in: 120 tablets 59676-0600-12
Rx only Brand On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 59676-600-56
Product NDC 59676-600
11-digit billing NDC 59676060056
RxCUI 1999581, 1999587, 2630215, 2630217
UNII 4T36H88UA7
Application # NDA210951
SPL Set ID d1cda4f7-cb33-46ea-b9ac-431f6452b1a5
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-02-14
Route ORAL
Dosage form TABLET, FILM COATED
Substance APALUTAMIDE
GPI-14 21402410000320
GCN Seq No 078163
GCN 44446
HICL code 044773
Ingredient (HICL) Apalutamide
HIC1 code V
Therapeutic class — broad (HIC1) Neoplasms
HIC2 code V1
Therapeutic class — intermediate (HIC2) Antineoplastic Drugs
HIC3 code V1J
Therapeutic class — specific (HIC3) Antineoplastic - Antiandrogenic Agents
AHFS code 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name ERLEADA 60 MG TABLET
FDB brand name Erleada
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 59676-600-56 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 59676-0600-56. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Anti-androgens class.

Drug family (ATC) Anti-androgens
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerJanssen Products, LP
Application holderJANSSEN BIOTECH INC
FDA applicationNDA210951 (NDA)
Labeler code59676
First marketedFeb 2018
Product typeHuman Prescription Drug
Portfolio17 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name ERLEADA 60 MG TABLET Ingredient Apalutamide
📖 What it is MedlinePlus · NLM

Apalutamide is used to treat certain types of prostate cancer (cancer in men that begins in the prostate [a male reproductive gland]) and has spread to other parts of the body or that has not spread to other parts of the body but has not been helped by other medical treatments. Apalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of cancer cells.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Those terms describe how your prostate cancer is responding to hormone therapy. 'Castration-sensitive' means the cancer is still being controlled by keeping testosterone levels low...
  • What exactly is Erleada treating in my case — my doctor mentioned 'castration-sensitive' and 'castration-resistant.' What does that mean?
  • Good news — it doesn't matter. You can take Erleada with or without food, whichever fits your routine. If you take it with a meal, it might take a little longer to reach peak level...
  • Can I take Erleada with food, or does it matter?
📖 Read our full Apalutamide guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color green / gray
ShapeOval
ImprintE240
Size21 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII 24P2YXD2PW
    A cellulose derivative used as a film-coating agent and binder in tablets and capsules. It helps protect the medicine from moisture, controls how quickly the drug dissolves, and holds ingredients together.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

11 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $125.03 $7,001.58 / 56 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Erleada 60 mgthis 59676-0600-56 Janssen 28 tablets — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2023
First FDA approval
Feb 2023
📍
2026
Currently FDA-listed
3 years listed
🛡️
2041
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Jan 2041. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Feb 17, 2023 RLD RS ⏳ ~14.3 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 8802689 — method of use (U-2237)
US 9884054 — method of use (U-2237)
US 8802689 — method of use (U-2624)
US 8445507 — drug substance (U-2624)
US 8445507 — drug substance (U-2237)
US 12303497 — method of use (U-4448)
US 12303497 — method of use (U-4448)
US 11723898 — method of use (U-4449)
US 11723898 — method of use (U-4449)
US RE50642 — method of use (U-4450)
US RE50642 — method of use (U-4450)
US RE49353 — method of use (U-2381)
US 10849888 — method of use (U-3013)
US 10702508 — method of use (U-3012)
US RE49353 — method of use (U-2381)
US 8445507 — drug substance (U-2237)
US 8445507 — drug substance (U-2624)
US 10849888 — method of use (U-3013)
US 10702508 — method of use (U-3012)
US 9884054 — method of use (U-2237)
US 8802689 — method of use (U-2237)
US 8802689 — method of use (U-2624)
US 11963952 — method of use (U-3901)
US 11963952 — method of use (U-3901)
US 9481663 — drug substance (U-2624)
US 9481663 — drug substance (U-2237)
US 9481663 — drug substance (U-2624)
US 9481663 — drug substance (U-2237)
US 12303497 — method of use (U-4494)
US 12303497 — method of use (U-4494)
US 9987261 — drug product
US 9987261 — drug product
US 9388159 — drug substance
US 12303493 — drug product
US 9388159 — drug substance
US 12303493 — drug product
2023 2025 2027 2029 2031 2033 2035 2037 2039 2041
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (36)
PatentTypeUse codeExpires
US 8802689 ↗ Method of use U-2237 Mar 27, 2027
US 9884054 ↗ Method of use U-2237 Sep 23, 2033
US 8802689 ↗ Method of use U-2624 Mar 27, 2027
US 8445507 ↗ Drug substance U-2624 Feb 14, 2032
US 8445507 ↗ Drug substance U-2237 Feb 14, 2032
US 12303497 ↗ Method of use U-4448 Jan 30, 2040
US 12303497 ↗ Method of use U-4448 Jan 30, 2040
US 11723898 ↗ Method of use U-4449 Jan 14, 2041
US 11723898 ↗ Method of use U-4449 Jan 14, 2041
US RE50642 ↗ Method of use U-4450 Sep 23, 2033
US RE50642 ↗ Method of use U-4450 Sep 23, 2033
US RE49353 ↗ Method of use U-2381 Sep 23, 2033
US 10849888 ↗ Method of use U-3013 Sep 23, 2033
US 10702508 ↗ Method of use U-3012 Apr 30, 2038
US RE49353 ↗ Method of use U-2381 Sep 23, 2033
US 8445507 ↗ Drug substance U-2237 Feb 14, 2032
US 8445507 ↗ Drug substance U-2624 Feb 14, 2032
US 10849888 ↗ Method of use U-3013 Sep 23, 2033
US 10702508 ↗ Method of use U-3012 Apr 30, 2038
US 9884054 ↗ Method of use U-2237 Sep 23, 2033
US 8802689 ↗ Method of use U-2237 Mar 27, 2027
US 8802689 ↗ Method of use U-2624 Mar 27, 2027
US 11963952 ↗ Method of use U-3901 Jan 30, 2040
US 11963952 ↗ Method of use U-3901 Jan 30, 2040
US 9481663 ↗ Drug substance U-2624 Jun 4, 2033
US 9481663 ↗ Drug substance U-2237 Jun 4, 2033
US 9481663 ↗ Drug substance U-2624 Jun 4, 2033
US 9481663 ↗ Drug substance U-2237 Jun 4, 2033
US 12303497 ↗ Method of use U-4494 Jan 30, 2040
US 12303497 ↗ Method of use U-4494 Jan 30, 2040
US 9987261 ↗ Drug product — Mar 27, 2027
US 9987261 ↗ Drug product — Mar 27, 2027
US 9388159 ↗ Drug substance — Mar 27, 2027
US 12303493 ↗ Drug product — Dec 3, 2035
US 9388159 ↗ Drug substance — Mar 27, 2027
US 12303493 ↗ Drug product — Dec 3, 2035
Common questions
Is there a generic version of ERLEADA 60 MG TABLET?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for ERLEADA 60 MG TABLET. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Jan 2041 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
120 tablets59676-0600-12 1,384 Rx · $20,754,517
28 tablets this page59676-0600-56 No Medicaid data
Drug total (last 4 qtrs): 1,384 Rx · 164,880 units · $20,754,517 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Erleada — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Erleada. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$536.6M
Claims incl. refills
35.8K
Beneficiaries
14.6K
Spend / beneficiary
$36,852.15
Spend / claim
$15,009.91
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
59676-0600-12 120 TABLET, FILM COATED in 1 BOTTLE (59676-600-12) 2018-02-14 Active
59676-0600-56 You're viewing this 2 BLISTER PACK in 1 CARTON (59676-600-56) / 28 TABLET, FILM COATED in 1 BLISTER PACK 2019-04-01 Active

This pack shows little to no recent Medicaid volume — the 120 tablets pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 59676-0600-56?
NDC 59676-0600-56 is listed by the FDA — 2 blister pack in 1 carton / 28 tablet, film coated in 1 blister pack.
What NDC number is used to bill for this package of ERLEADA Apalutamide 60 mg Tablet, Film Coated?
Bill NDC 59676-0600-56 — the 11-digit billing format is 59676060056. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 59676-600-56, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 59676-0600-56, written without dashes as 59676060056. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 59676-0600-56, the first segment (59676) is the labeler code FDA assigned to Janssen Products, LP; the middle segment (0600) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (56) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Janssen Products, LP. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 120 tablets (59676-0600-12). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Janssen Products, LP is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 50 words ▾

1 INDICATIONS AND USAGE ERLEADA is indicated for the treatment of patients with Metastatic castration-sensitive prostate cancer (mCSPC) Non-metastatic castration-resistant prostate cancer (nmCRPC) ERLEADA is an androgen receptor inhibitor indicated for the treatment of patients with metastatic castration-sensitive prostate cancer. ( 1 ) non-metastatic castration-resistant prostate cancer. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION ERLEADA 240 mg orally once daily. Swallow tablets whole. ERLEADA can be taken with or without food. ( 2.1 ) The recommended ERLEADA dosage in patients with severe hepatic impairment is 120 mg orally once daily. ( 2.3 ) Patients should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy. ( 2.1 )

2.1Recommended Dosage The recommended dosage of ERLEADA is 240 mg orally once daily. ERLEADA can be taken with or without food [see Clinical Pharmacology (12.3) ] . Swallow the tablet(s) whole. Do not crush or split tablet(s). Patients should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had a bilateral orchiectomy.

2.2Dosage Modifications for Adverse Reactions If Grade 3 or 4 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, including those that may be related to increased exposure to ERLEADA due to drug interactions [see Drug Interactions (7.1) ] , resume ERLEADA at the same dose or at a reduced dose (180 mg or 120 mg) when symptoms improve to less than or equal to Grade 1 or original grade, if warranted. If the ERLEADA dose was reduced for an adverse reaction while receiving a drug that increases exposure to ERLEADA, consider resuming the previously tolerated dose after the drug has been discontinued for at least 3 half-lives.

2.3Recommended Dosage in Patients with Severe Hepatic Impairment The recommended dosage of ERLEADA for patients with severe hepatic impairment (Child-Pugh Class C) is 120 mg orally once daily [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3) ] .

2.4Alternate 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 wi…

💊 Dosage Forms and Strengths 50 words ▾

3 DOSAGE 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. Tablets: 240 mg ( 3 ) Tablets: 60 mg ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. ( 4 ) None.

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Cerebrovascular and ischemic cardiovascular events occurred in patients receiving ERLEADA. Monitor for signs and symptoms of cerebrovascular disorders and ischemic heart disease. Optimize management of cardiovascular risk factors.

( 5.1 ). Fractures occurred in patients receiving ERLEADA. Evaluate patients for fracture risk and treat patients with bone-targeted agents according to established guidelines.

( 5.2 ) Falls occurred in patients receiving ERLEADA with increased incidence in the elderly. Evaluate patients for fall risk. ( 5.3 ) Seizure occurred in 0.4% of patients receiving ERLEADA.

Permanently discontinue ERLEADA in patients who develop a seizure during treatment. ( 5.4 ) Severe Cutaneous Adverse Reactions (SCARs), including Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS), occurred in patients treated with ERLEADA. Interrupt ERLEADA if signs or symptoms of SCARs develop.

Permanently discontinue if SCARs are confirmed. ( 5.5 ) Interstitial Lung Disease (ILD)/pneumonitis occurred in patients treated with ERLEADA. Withhold ERLEADA for suspected ILD/pneumonitis.

Permanently discontinue ERLEADA in patients with severe ILD/pneumonitis or if no other potential causes of ILD/pneumonitis are identified. ( 2.2 , 5.6 ) Embryo-Fetal Toxicity: ERLEADA can cause fetal harm. Advise males with female partners of reproductive potential to use effective contraception.

( 5.7 , 8.1 , 8.3 ) Interference with Immunoassay Measurement of Digoxin: ERLEADA can interfere with certain digoxin immunoassays, resulting in falsely elevated digoxin plasma concentration results. ( 5.8 , 7.3 )

5.1Cerebrovascular and Ischemic Cardiovascular Events Cerebrovascular and ischemic cardiovascular events, including events leading to death, occurred in patients receiving ERLEADA. Monitor for signs and symptoms of ischemic heart disease and cerebrovascular disorders. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia.

Consider discontinuation of ERLEADA for Grade 3 and 4 events. In a randomized study (SPARTAN) of patients with nmCRPC, ischemic cardiovascular events occurred in 3.7% of patients treated with ERLEADA and 2% of patients treated with placebo. In a randomized study (TITAN) in patients with mCSPC, ischemic cardiovascular events occurred in 4.4% of patients treated with ERLEADA and 1.5% of patients treated with placebo.

Across the SPARTAN and TITAN studies, 4 patients (0.3%) treated with ERLEADA, and 2 patients (0.2%) treated with placebo died from an ischemic cardiovascular event. In the SPARTAN study, cerebrovascular events occurred in 2.5% of patients treated with ERLEADA and 1% of patients treated with placebo [see Adverse Reactions (6.1) ] . In the TITAN study, cerebrovascular events occurred in 1.9% of patients treated with ERLEADA and 2.1% of patients treated with placebo.

Across the SPARTAN and TITAN studies, 3 patients (0.2%) treated with ERLEADA, and 2 patients (0.2%) treated with placebo died from a cerebrovascular event. Patients with history of unstable angina, myocardial infarction, congestive heart failure, stroke, or transient ischemic attack within six months of randomization were excluded from the SPARTAN and TITAN studies.

5.2Fractures Fractures occurred in patients receiving ERLEADA. Evaluate patients for fracture risk. Monitor and manage patients at risk for fractures according to established treatment guidelines and consider use of bone-targeted agents.

In a randomized study (SPARTAN) of patients with non-metastatic castration-resistant prostate cancer, fractures occurred in 12% of patients treated with ERLEADA and in 7% of patients treated with placebo. Grade 3–4 fractures occurred in 2.7% of patients treated with ERLEADA and in 0.8% of patients treated with placebo. The median time to onset of fracture was 314 days (range: 20 to 953 days) for patients treated with ERLEADA.…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling: Cerebrovascular and Ischemic Cardiovascular Events [see Warnings and Precautions (5.1) ] . Fractures [see Warnings and Precautions (5.2) ] . Falls [see Warnings and Precautions (5.3) ] .

Seizure [see Warnings and Precautions (5.4) ] . Severe Cutaneous Adverse Reactions (SCARs) [see Warnings and Precautions (5.5) ] . Interstitial Lung Disease (ILD) [see Warnings and Precautions (5.6) ] .

The most common adverse reactions (≥10%) are fatigue, arthralgia, rash, decreased appetite, fall, weight decreased, hypertension, hot flush, diarrhea, and fracture. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Janssen Products, LP at 1-800-526-7736 (1-800-JANSSEN) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical 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.

Metastatic Castration-sensitive Prostate Cancer (mCSPC) TITAN, a randomized (1:1), double-blind, placebo-controlled, multi-center clinical study, enrolled patients who had mCSPC. In this study, patients received either ERLEADA at a dose of 240 mg daily or placebo. All patients in the TITAN study received a concomitant gonadotropin-releasing hormone (GnRH) analog or had prior bilateral orchiectomy.

The median duration of exposure was 20 months (range: 0 to 34 months) in patients who received ERLEADA and 18 months (range: 0.1 to 34 months) in patients who received placebo. Ten patients (1.9%) who were treated with ERLEADA died from adverse reactions. The reasons for death were ischemic cardiovascular events (n=3), acute kidney injury (n=2), cardio-respiratory arrest (n=1), sudden cardiac death (n=1), respiratory failure (n=1), cerebrovascular accident (n=1), and large intestinal ulcer perforation (n=1).

ERLEADA was discontinued due to adverse reactions in 8% of patients, most commonly from rash (2.3%). Adverse reactions leading to dose interruption or reduction of ERLEADA occurred in 23% of patients; the most frequent (>1%) were rash, fatigue, and hypertension. Serious adverse reactions occurred in 20% of ERLEADA-treated patients and 20% in patients receiving placebo.

Table 1 shows adverse reactions occurring in ≥10% on the ERLEADA arm in TITAN that occurred with a ≥2% absolute increase in frequency compared to placebo. Table 2 shows laboratory abnormalities that occurred in ≥15% of patients, and more frequently (>5%) in the ERLEADA arm compared to placebo. Table 1: Adverse Reactions in TITAN (mCSPC) ERLEADA N=524 Placebo N=527 System/Organ Class Adverse reaction All Grades % Grade 3–4 % All Grades % Grade 3–4 % Musculoskeletal and connective tissue disorders Arthralgia Per the Common Terminology Criteria for Adverse Reactions (CTCAE), the highest severity for these events is Grade 3.

17 0.4 15

0.9Skin and subcutaneous tissue disorders Rash Includes rash, rash maculo-papular, rash generalized, urticaria, rash pruritic, rash macular, conjunctivitis, erythema multiforme, rash papular, skin exfoliation, genital rash, rash erythematous, stomatitis, drug eruption, lichenoid eruption, mouth ulceration, rash pustular, blister, papule, pemphigoid, skin erosion, dermatitis, and rash vesicular. 28 6 9

0.6Pruritus 11 0.2 4.6

0.2Vascular disorders Hot flush 23 0 16 0 Hypertension 18 8 16 9 Additional adverse reactions of interest occurring in less than 10% of patients treated with ERLEADA included diarrhea (9% versus 6% on placebo), m…

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Concomitant use with medications that are sensitive substrates of CYP3A4, CYP2C19, CYP2C9, UGT, P-gp, BCRP, or OATP1B1 may result in loss of activity of these medications. ( 7.2 )

7.1Effect of Other Drugs on ERLEADA Strong CYP2C8 or CYP3A4 Inhibitors Reduce the ERLEADA dose as recommended for adverse reactions [see Dosage and Administration (2.2) ] . Co-administration of a strong CYP2C8 or CYP3A4 inhibitor is predicted to increase the steady-state exposure of the active moieties (sum of unbound apalutamide plus the potency-adjusted unbound N-desmethyl-apalutamide).

7.2Effect of ERLEADA on Other Drugs Substrates of CYP3A4, CYP2C9, CYP2C19, P-gp, BCRP, or OATP1B1 Refer to the Prescribing Information for these substrates. Consider alternative agents when possible or evaluate for loss of activity of the substrate if concomitant use cannot be avoided. Apalutamide is a strong inducer of CYP3A4 and CYP2C19, a weak inducer of CYP2C9, and an inducer of P-gp, BCRP, and OATP1B1.

Apalutamide decreases exposure of substrates of CYP3A4, CYP2C19, CYP2C9, P-gp, BCRP, or OATP1B1 [see Clinical Pharmacology (12.3) ] , which may decrease the effectiveness of these substrates.

7.3Laboratory Test Interference ERLEADA can interfere with certain digoxin immunoassays (e.g., Chemiluminescent Microparticle Immunoassays), resulting in falsely elevated digoxin plasma concentration results. Notify the laboratory conducting the digoxin plasma concentration assay to use an appropriate method in patients receiving ERLEADA and digoxin [see Warnings and Precautions (5.8) ] .

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy 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 Clinical Pharmacology (12.1) ] . 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 ) . 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.

8.2Lactation Risk Summary The safety and efficacy of ERLEADA have not been established in females. There are no data on the presence of apalutamide or its metabolites in human milk, the effect on the breastfed child, or the effect on milk production.

8.3Females and Males of Reproductive Potential Contraception Males Based on the mechanism of action and findings in an animal reproduction study, advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of ERLEADA [see Use in Specific Populations (8.1) ] . Infertility Males Based on animal studies, ERLEADA may impair fertility in males of reproductive potential [see Nonclinical Toxicology (13.1) ] .

8.4Pediatric Use Safety and effectiveness of ERLEADA in pediatric patients have not been established.

8.5Geriatric Use Of the 1327 patients who received ERLEADA in clinical studies, 19% of patients were less than 65 years, 41% of patients were 65 years to 74 years, and 40% were 75 years and over. No overall differences in effectiveness were observed between older and younger patients. Of patients treated with ERLEADA (n=1073), Grade 3–4 adverse reactions occurred in 39% of patients younger than 65 years, 41% of patients 65–74 years, and 49% of patients 75 years or older.

Falls in patients receiving ERLEADA with androgen deprivation therapy was elevated in the elderly, occurring in 8% of patients younger than 65 years, 10% of patients 65–74 years, and 19% of patients 75 years or older.

8.6Hepatic Impairment The recommended ERLEADA dosage in patients with severe hepatic impairment (Child-Pugh C) is lower than the recommended dosage in patients with normal hepatic function [see Dosage and Administration (2.3) ] . No dosage modification is recommended for patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment [see Clinical Pharmacology (12.3) ] .

🤰 Pregnancy 207 words ▾

8.1Pregnancy 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 Clinical Pharmacology (12.1) ] . 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 ) . 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.

🧒 Pediatric Use 15 words ▾

8.4Pediatric Use Safety and effectiveness of ERLEADA in pediatric patients have not been established.

🧓 Geriatric Use 117 words ▾

8.5Geriatric Use Of the 1327 patients who received ERLEADA in clinical studies, 19% of patients were less than 65 years, 41% of patients were 65 years to 74 years, and 40% were 75 years and over. No overall differences in effectiveness were observed between older and younger patients. Of patients treated with ERLEADA (n=1073), Grade 3–4 adverse reactions occurred in 39% of patients younger than 65 years, 41% of patients 65–74 years, and 49% of patients 75 years or older.

Falls in patients receiving ERLEADA with androgen deprivation therapy was elevated in the elderly, occurring in 8% of patients younger than 65 years, 10% of patients 65–74 years, and 19% of patients 75 years or older.

🆘 Overdosage 31 words ▾

10 OVERDOSAGE 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.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism 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.

12.2Pharmacodynamics ERLEADA 240 mg daily in addition to ADT in patients with mCSPC (TITAN) reduced PSA to undetectable levels (<0.2 ng/mL) in 68% of patients compared to 32% of patients taking ADT alone. ERLEADA 240 mg daily in addition to ADT in patients with nmCRPC (SPARTAN) reduced PSA to undetectable levels (<0.2 ng/mL) in 38% of patients compared to no patients (0%) taking ADT alone. The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of apalutamide have not been fully characterized.

Cardiac Electrophysiology At the approved recommended dosage, the maximum mean QTcF change from baseline was 12.4 ms (2-sided 90% upper CI: 16.0 ms). An exposure-QT analysis suggested a concentration-dependent increase in QTcF for apalutamide and its active metabolite.

12.3Pharmacokinetics Apalutamide and N-desmethyl apalutamide pharmacokinetic parameters were observed at steady-state following the approved recommended dosage for ERLEADA and are presented as the mean [standard deviation (SD)] unless otherwise specified. Apalutamide maximum concentration (C max ) is 6 mcg/mL (1.7) and total systemic exposure (AUC) is 100 mcg∙h/mL (32). Apalutamide C max and AUC increases in a dose proportional manner following repeated once-daily dosing of 30 to 480 mg (0.125 to 2 times the recommended dosage).

Apalutamide steady-state is achieved after 4 weeks and the mean accumulation ratio is approximately 5-fold. The major active metabolite N-desmethyl apalutamide C max is 5.9 mcg/mL (1) and AUC is 124 mcg∙h/mL (23). Mean AUC metabolite/parent drug ratio for N-desmethyl apalutamide following repeat-dose administration is 1.3.

Based on systemic exposure, relative potency, and pharmacokinetic properties, N-desmethyl apalutamide likely contributes to the clinical activity of apalutamide. Absorption Apalutamide absolute oral bioavailability is approximately 100%. Apalutamide median (min, max) time to maximum plasma concentration (t max ) is 2 hours (1, 5 hours).

No clinically significant changes in C max and AUC were observed following oral administration of four 60 mg tablets dispersed in applesauce compared to administration of four intact 60 mg tablets under fasting condition. Effect of Food No clinically significant differences in apalutamide C max and AUC were observed following administration of a high-fat meal (approximately 500 to 600 fat calories, 250 carbohydrate calories, and 150 protein calories). Median time to reach t max was delayed approximately 2 hours with food.

Distribution Apalutamide apparent volume of distribution is approximately 276 L. Apalutamide is 96% and N-desmethyl apalutamide is 95% bound to plasma proteins with no concentration dependency. Elimination Apalutamide half-life is approximately 3 days.

The CL/F of apalutamide is

1.3 L/h after single dosing and increases to

2.0L/h at steady-state after once-daily dosing likely due to CYP3A4 auto-induction. Metabolism Apalutamide is primarily metabolized by CYP2C8 and CYP3A4 to form active metabolite, N-desmethyl apalutamide. The contribution of CYP2C8 and CYP3A4 in the metabolism of apalutamide is estimated to be 58% and 13% following single dose but changes to 40% and 37%, respectively at steady-state.

Apalutamide represented 45% and N-desmethyl apalutamide represented 44% of the total AUC following a single oral…

🧬 Mechanism of Action 81 words ▾

12.1Mechanism 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.

📦 How Supplied / Storage and Handling 144 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING ERLEADA ® (apalutamide) tablets are available in the strengths and packages listed below: ERLEADA ® 240 mg Tablets 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 ® 60 mg Tablets 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 Storage and Handling Store at 20 °C to 25 °C (68 °F to 77 °F); excursions permitted to 15 °C to 30 °C (59 °F to 86 °F) [see USP Controlled Room Temperature] .

Store in original package to protect from light and moisture. Do not discard desiccant.

📦 Storage and Handling 48 words ▾

Storage and Handling Store at 20 °C to 25 °C (68 °F to 77 °F); excursions permitted to 15 °C to 30 °C (59 °F to 86 °F) [see USP Controlled Room Temperature] . Store in original package to protect from light and moisture. Do not discard desiccant.

📋 Description 170 words ▾

11 DESCRIPTION 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 21 H 15 F 4 N 5 O 2 S.

The structural formula is: ERLEADA ® (apalutamide) tablets are available in 240 mg tablets and 60 mg tablets with the following inactive ingredients: 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. Chemical Structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Cerebrovascular and Ischemic Cardiovascular Events Inform patients that ERLEADA has been associated with cerebrovascular and ischemic cardiovascular events. Advise patients to seek immediate medical attention if any symptoms suggestive of a cardiovascular or a cerebrovascular event occur [see Warnings and Precautions (5.1) ] .

Falls and Fractures Inform patients that ERLEADA is associated with an increased incidence of falls and fractures [see Warnings and Precautions (5.2 , 5.3) ] . Seizures Inform patients that ERLEADA has been associated with an increased risk of seizure. Discuss conditions that may predispose to seizures and medications that may lower the seizure threshold.

Advise patients of the risk of engaging in any activity where sudden loss of consciousness could cause serious harm to themselves or others. Inform patients to contact their healthcare provider right away if they experience a seizure [see Warnings and Precautions (5.4) ] . Severe Cutaneous Adverse Reactions (SCARs) Inform patients that ERLEADA has been associated with SCARs (including SJS/TEN and DRESS), which can be fatal or life-threatening.

Advise patients to stop taking ERLEADA and contact their healthcare provider or seek medical attention right away if they experience signs or symptoms of SCARs [see Warnings and Precautions (5.5) ] . Interstitial Lung Disease (ILD)/Pneumonitis Inform patients of the risks of fatal or life-threatening ILD/pneumonitis. Advise patients to stop taking ERLEADA and contact their healthcare provider or seek medical attention immediately if they develop new or worsening respiratory symptoms [see Warnings and Precautions (5.6) ] .

Rash Inform patients that ERLEADA is associated with rashes and to inform their healthcare provider if they develop a rash [see Adverse Reactions (6.1 , 6.2) ] . Dosage and Administration Inform patients receiving concomitant gonadotropin-releasing hormone (GnRH) analog therapy that they need to maintain this treatment during the course of treatment with ERLEADA. Instruct patients to take their dose at the same time each day (once daily).

ERLEADA can be taken with or without food. Each tablet should be swallowed whole. Do not crush or split tablets [see Dosage and Administration (2.1) ] .

Instruct patients who cannot swallow tablets whole to follow the instructions for the prescribed strength of ERLEADA tablets for alternate methods of administration, including administration through a feeding tube [see Dosage and Administration (2.4) ] . Inform patients that in the event of a missed daily dose of ERLEADA, they should take their normal dose as soon as possible on the same day with a return to the normal schedule on the following day. The patient should not take extra tablets to make up the missed dose [see Dosage and Administration (2.1) ] .

Embryo-Fetal Toxicity Inform patients that ERLEADA can be harmful to a developing fetus. Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of ERLEADA. Advise male patients to use a condom if having sex with a pregnant woman [see Warnings and Precautions (5.7) ] .

Infertility Advise male patients that ERLEADA may impair fertility and not to donate sperm during therapy and for 3 months following the last dose of ERLEADA [see Use in Specific Populations (8.3) ] . Drug Interactions Advise patients to inform their healthcare providers of all concomitant medications, including prescription medicines, over-the-counter drugs, and herbal products [see Drug Interactions (7.1 , 7.2 , 7.3) ] .

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 59676-0578-30 · Janssen 59676-0604-14 · Janssen →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.