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Copiktra duvelisib 25 mg Capsule, 56-count — NDC 73116-0225-56 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Copiktra duvelisib 25 mg Capsule, 56-count — NDC 73116-225-56 (Billing 73116-0225-56)

by Secura Bio, Inc · 56 CAPSULE in 1 PACKAGE

This is a package of 56 capsules of Copiktra duvelisib 25 mg Capsule from Secura Bio, Inc, marketed since Sep 2018 and currently FDA-listed.

NDC 73116-0225-56
🏷️ FDA NDC (as labeled) 73116-225-56 billing pads the product segment with a zero
This package
Contains56-count Pack sizes2 compare ↓
Also priced by: Part D plans $501.91/unit — full pricing hub ↓
Product page 73116-0225-28 Also comes in: 28 capsules 73116-225-28
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

NDC database record

One package, one record: these facts belong to NDC 73116-225-56 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
73116 labeler · 225 product · 56 package
Package marketed since
Sep 28, 2018
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
56 EA per package
Barcode (UPC-A, from the NDC)
3 7311622556 9
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 73116-225-56
Product NDC 73116-225
11-digit billing NDC 73116022556
NCPDP billing unit EA — each (per item)
RxCUI 2058514, 2058520, 2058523, 2058525
UNII 610V23S0JI
Application # NDA211155
SPL Set ID e3c5ac56-e1f6-473a-bc73-687836534780
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-09-25
Route ORAL
Dosage form CAPSULE
Substance DUVELISIB

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 21538030000130
GPI class Copiktra
GCN Seq No 078972
GCN 45425
HICL code 045269
Ingredient (HICL) Duvelisib
HIC1 code V
Therapeutic class — broad (HIC1) Neoplasms
HIC2 code V1
Therapeutic class — intermediate (HIC2) Antineoplastic Drugs
HIC3 code V1Q
Therapeutic class — specific (HIC3) Antineoplastic Systemic Enzyme Inhibitors
AHFS code 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name COPIKTRA 25 MG CAPSULE
FDB brand name Copiktra
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 078972
  • GCN: 45425
  • GPI-14 (Medi-Span): 21538030000130
  • HICL (First Databank): 045269
  • AHFS class code: 10:00.00.00
  • RxCUI (RxNorm): 2058514
Why two NDCs? The FDA registers this code as 73116-225-56 — 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 → 73116-0225-56. 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 Phosphatidylinositol-3-kinase (Pi3K) inhibitors class.

Drug family (ATC) Phosphatidylinositol-3-kinase (Pi3K) inhibitors
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.

Clinical

Label name COPIKTRA 25 MG CAPSULE Ingredient Duvelisib
📖 What it is MedlinePlus · NLM

Duvelisib is used to treat chronic lymphocytic leukemia (CLL; a type of cancer that begins in the white blood cells) or small lymphocytic lymphoma (SLL; a type of cancer that begins mostly in the lymph nodes) that has returned or is unresponsive to at least two other treatments. Duvelisib is in a class of medications called kinase inhibitors. It works by blocking the signals that cause cancer cells to multiply. This helps to stop the spread of cancer cells.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats adults with CLL, SLL or follicular lymphoma that has come back or stopped responding after at least two earlier treatments. It is not recommended as a first- or second-li...
  • Swallow the capsule whole twice a day, with or without food. Don't open, break or chew it. If you're less than 6 hours late on a dose, take it right away. If it's more than 6 hours...
  • Diarrhea, low white blood cells, rash, tiredness, fever, cough and nausea are common. Call us or your doctor if you have diarrhea that is new or worsening, a rash, a fever or infec...
  • Duvelisib raises infection risk, so your doctor will give you preventive medicine for Pneumocystis pneumonia and may consider antivirals for CMV. You'll also have regular blood and...
📖 Read our full Duvelisib 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.

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 $501.91 $28,106.82 / 56 capsules
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
73116-0225-28 73116-225-28 Main listing 28 CAPSULE in 1 PACKAGE 2018-09-25 — Active
73116-0225-56 You're viewing this 56 CAPSULE in 1 PACKAGE 2018-09-25 — Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 56-count package — 56 capsule in 1 package.
How does this package differ from NDC 73116-0225-28?
Both are Copiktra duvelisib 25 mg Capsule — the drug itself is identical. This page's package is the 56-count one, while NDC 73116-0225-28 is the 28 capsules package.
What NDC number is used to bill for this package of Copiktra duvelisib 25 mg Capsule?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Copiktra 25 mgthis 73116-0225-56 Secura 56 capsules — — 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

🏛️
2018
First FDA approval
Sep 2018
📍
2026
Currently FDA-listed
8 years listed
🛡️
2035
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 Apr 2035. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Sep 24, 2018 RLD RS ⏳ ~8.6 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 9840505 — method of use (U-2413)
US 9216982 — method of use (U-2413)
US 9840505 — method of use (U-2412)
US 9840505 — method of use (U-2412)
US 9216982 — method of use (U-2412)
US 9840505 — method of use (U-2413)
US 9216982 — method of use (U-2413)
US 12213983 — method of use (U-2412)
US 12213983 — method of use (U-2412)
US 9216982 — method of use (U-2412)
US 11312718 — drug product
US 11312718 — drug product
US RE46621 — drug substance
US RE46621 — drug substance
US 8193182 — drug substance
US 8193182 — drug substance
2018 2020 2022 2024 2026 2028 2030 2032 2034
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 (16)
PatentTypeUse codeExpires
US 9840505 ↗ Method of use U-2413 Jan 10, 2032
US 9216982 ↗ Method of use U-2413 Jan 5, 2029
US 9840505 ↗ Method of use U-2412 Jan 10, 2032
US 9840505 ↗ Method of use U-2412 Jan 10, 2032
US 9216982 ↗ Method of use U-2412 Jan 5, 2029
US 9840505 ↗ Method of use U-2413 Jan 10, 2032
US 9216982 ↗ Method of use U-2413 Jan 5, 2029
US 12213983 ↗ Method of use U-2412 Apr 26, 2035
US 12213983 ↗ Method of use U-2412 Apr 26, 2035
US 9216982 ↗ Method of use U-2412 Jan 5, 2029
US 11312718 ↗ Drug product — Jan 10, 2032
US 11312718 ↗ Drug product — Jan 10, 2032
US RE46621 ↗ Drug substance — May 17, 2032
US RE46621 ↗ Drug substance — May 17, 2032
US 8193182 ↗ Drug substance — Sep 24, 2032
US 8193182 ↗ Drug substance — Sep 24, 2032
Common questions
Is there a generic version of COPIKTRA 25 MG CAPSULE?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for COPIKTRA 25 MG CAPSULE. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Apr 2035 — 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.

What it looks like

Color White / Orange / Pink
ShapeCapsule
Imprintduv;15;mg
Size15 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 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 2S7830E561
    Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
  • 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 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.

4 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.

Manufacturer & labeler

LabelerSecura Bio, Inc
Application holderSECURA BIO INC
FDA applicationNDA211155 (NDA)
Labeler code73116
First marketedSep 2018
Product typeHuman Prescription Drug
Portfolio2 products on file

More NDCs from Secura Bio, Inc labeler code 73116

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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 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 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🚨 Boxed Warning ~1 min read ▾

WARNING: TREATMENT-RELATED MORTALITY AND SERIOUS TOXICITIES: INFECTIONS, DIARRHEA OR COLITIS, CUTANEOUS REACTIONS, AND PNEUMONITIS Treatment-related mortality occurred in 15% of COPIKTRA-treated patients [see Warnings and Precautions ( 5.1 )] . Fatal and/or serious infections occurred in 31% of COPIKTRA-treated patients. Monitor for signs and symptoms of infection.

Withhold COPIKTRA if infection is suspected [see Warnings and Precautions ( 5.2 )]. Fatal and/or serious diarrhea or colitis occurred in 18% of COPIKTRA-treated patients. Monitor for the development of severe diarrhea or colitis.

Withhold COPIKTRA [see Warnings and Precautions ( 5.3 )] . Fatal and/or serious cutaneous reactions occurred in 5% of COPIKTRA-treated patients. Withhold COPIKTRA [see Warnings and Precautions ( 5.4 )] .

Fatal and/or serious pneumonitis occurred in 5% of COPIKTRA-treated patients. Monitor for pulmonary symptoms and interstitial infiltrates. Withhold COPIKTRA [see Warnings and Precautions ( 5.5 )].

WARNING: TREATMENT-RELATED MORTALITY AND SERIOUS TOXICITIES: INFECTIONS, DIARRHEA OR COLITIS, CUTANEOUS REACTIONS, and PNEUMONITIS See full prescribing information for complete boxed warning Treatment-related mortality occurred in 15% of COPIKTRA-treated patients. ( 5.1 ) Fatal and/or serious infections occurred in 31% of COPIKTRA-treated patients. Monitor for signs and symptoms of infection.

Withhold COPIKTRA if infection is suspected. ( 5.2 ) Fatal and/or serious diarrhea or colitis occurred in 18% of COPIKTRA-treated patients. Monitor for the development of severe diarrhea or colitis.

Withhold COPIKTRA. ( 5.3 ) Fatal and/or serious cutaneous reactions occurred in 5% of COPIKTRA-treated patients. Withhold COPIKTRA.

( 5.4 ) Fatal and/or serious pneumonitis occurred in 5% of COPIKTRA-treated patients. Monitor for pulmonary symptoms and interstitial infiltrates. Withhold COPIKTRA.

( 5.5 )

🎯 Indications and Usage 143 words ▾

1 INDICATIONS AND USAGE COPIKTRA is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior lines of systemic therapy. Limitations of Use: COPIKTRA is not indicated or recommended for the treatment of any patients with CLL or SLL as initial or second line treatment due to an increased risk of treatment-related mortality. COPIKTRA is a kinase inhibitor indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior lines lines of systemic therapy.

( 1 ) Limitations of Use : COPIKTRA is not indicated or recommended for the treatment of any patients with CLL or SLL as initial or second line treatment due to an increased risk of treatment-related mortality. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION 25 mg orally, twice daily. Modify dosage for toxicity. ( 2.1 , 2.2 )

2.1Recommended Dosage The recommended dose of COPIKTRA is 25 mg administered as oral capsules twice daily (BID) with or without food. A cycle consists of 28 days. The capsules should be swallowed whole.

Advise patients not to open, break, or chew the capsules. Advise patients that if a dose is missed by fewer than 6 hours, to take the missed dose right away and take the next dose as usual. If a dose is missed by more than 6 hours, advise patients to wait and take the next dose at the usual time.

2.2Recommended Prophylaxis Provide prophylaxis for Pneumocystis jirovecii (PJP) during treatment with COPIKTRA. Following completion of COPIKTRA treatment, continue PJP prophylaxis until the absolute CD4+ T cell count is greater than 200 cells/µL. Withhold COPIKTRA in patients with suspected PJP of any grade, and discontinue if PJP is confirmed.

Consider prophylactic antivirals during COPIKTRA treatment to prevent cytomegalovirus (CMV) infection including CMV reactivation.

2.3Dosage Modifications for Adverse Reactions Manage toxicities per Table 1 with dose reduction, treatment hold, or discontinuation of COPIKTRA. Table 1. COPIKTRA Dose Modifications and Toxicity Management Abbreviations: ALT = alanine aminotransferase; ANC = absolute neutrophil count; AST = aspartate aminotransferase; CMV = cytomegalovirus; DRESS = drug reaction with eosinophilia and systemic systems; PCR = polymerase chain reaction; PJP = Pneumocystis jirovecii; pneumonia; SJS = Stevens-Johnson syndrome; TEN = toxic epidermal necrolysis; ULN = upper limit of normal Toxicity Adverse Reaction Grade Recommended Management Nonhematologic Adverse Reactions Infections Grade 3 or higher infection Withhold COPIKTRA until resolved Resume at the same or reduced dose (see Table 2 ) Clinical CMV infection or viremia (positive PCR or antigen test) Withhold COPIKTRA until resolved Resume at the same or reduced dose (see Table 2 ) If COPIKTRA is resumed, monitor patients for CMV reactivation (by PCR or antigen test) at least monthly PJP For suspected PJP, withhold COPIKTRA until evaluated For confirmed PJP, discontinue COPIKTRA Non-infectious Diarrhea or colitis Mild/moderate diarrhea (Grade 1-2, up to 6 stools per day over baseline) and responsive to antidiarrheal agents, OR Asymptomatic (Grade 1) colitis No change in dose Initiate supportive therapy with antidiarrheal agents as appropriate Monitor at least weekly until resolved Mild/moderate diarrhea (Grade 1-2, up to 6 stools per day over baseline) and unresponsive to antidiarrheal agents Withhold COPIKTRA until resolved Initiate supportive therapy with enteric acting steroids (e.g., budesonide) Monitor at least weekly until resolved Resume at a reduced dose (see Table 2 ) Abdominal pain, stool with mucus or blood, change in bowel habits, peritoneal signs, OR Severe diarrhea (Grade 3, >6 stools per day over baseline) Withhold COPIKTRA until resolved Initiate supportive therapy with enteric acting steroids (e.g., budesonide) or systemic steroids Monitor at least weekly until resolved Resume at a reduced dose (see Table 2 ) For recurrent Grade 3 diarrhea or recurrent colitis of any grade, discontinue COPIKTRA Life-threatening Discontinue COPIKTRA Cutaneous reactions Grade 1-2 No change in dose Initiate supportive care with emollients, anti-histamines (for pruritus), or topical steroids Monitor closely Grade 3 Withhold COPIKTRA until resolved Initiate supportive care with emollients, anti-histamines (for pruritus), or topical steroids Monitor at least weekly until resolved Resume at reduced dose (see Table 2 ) If severe cutaneous reaction does not improve, worsens, or recurs, discontinue COPIKTRA Life-threatening Discontinue COPIKTRA SJS, TEN, DRESS (any grade) Discontinue COPIKTRA Pneumonitis without suspected infectious cause Moderate (Grade 2) symptomatic pneumonitis Withhold COPIKTRA Treat with systemic steroid therapy If pneumo… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 47 words ▾

3 DOSAGE FORMS AND STRENGTHS Strength Description 25 mg White to off-white opaque and Swedish orange opaque capsule printed in black ink with "duv 25 mg" 15 mg Pink opaque capsule printed in black ink with "duv 15 mg" Capsules: 25 mg, 15 mg. ( 3 )

⛔ Contraindications 4 words ▾

4 CONTRAINDICATIONS None. None.

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Hepatotoxicity: Monitor hepatic function. ( 5.6 ) Neutropenia: Monitor blood counts. ( 5.7 ) Embryo-Fetal toxicity: COPIKTRA can cause fetal harm. Advise females of reproductive potential and males with female partners of reproductive potential of potential risk to a fetus and to use effective contraception. ( 5.8 )

5.1Treatment-related Mortality In a randomized controlled study in patients with relapsed or refractory CLL or SLL, treatment with COPIKTRA caused increased treatment-related mortality [see Clinical Studies ( 14 )] . With extended follow-up with a median of 63 months, treatment-related deaths occurred in 15% (23/158) of those patients in the overall population. In the indicated patient population, patients with relapsed or refractory CLL or SLL after at least two prior lines of systemic therapy, treatment-related deaths following treatment with COPIKTRA occurred in 14% (13/93) of patients.

The most common cause of the treatment-related deaths were infections, which occurred in 9% and 11% of patients with relapsed or refractory CLL following at least one or two prior systemic therapies, respectively [see Adverse Reactions ( 6.1 )] . COPIKTRA is not indicated and is not recommended for any patients in the initial or second-line treatment setting [see Indications and Usage ( 1 )] .

5.2Infections Serious, including fatal (18/442; 4%), infections occurred in 31% of patients receiving COPIKTRA 25 mg BID (N = 442). The most common serious infections were pneumonia, sepsis, and lower respiratory infections. Median time to onset of any grade infection was 3 months (range: 1 day to 32 months), with 75% of cases occurring within 6 months.

Treat infections prior to initiation of COPIKTRA. Advise patients to report any new or worsening signs and symptoms of infection. For grade 3 or higher infection, withhold COPIKTRA until infection has resolved.

Resume COPIKTRA at the same or reduced dose [see Dosage and Administration ( 2.3 )] . Serious, including fatal, Pneumocystis jirovecii pneumonia (PJP) occurred in 1% of patients taking COPIKTRA. Provide prophylaxis for PJP during treatment with COPIKTRA.

Following completion of COPIKTRA treatment, continue PJP prophylaxis until the absolute CD4+ T cell count is greater than 200 cells/µL. Withhold COPIKTRA in patients with suspected PJP of any grade, and permanently discontinue if PJP is confirmed. CMV reactivation/infection occurred in 1% of patients taking COPIKTRA.

Consider prophylactic antivirals during COPIKTRA treatment to prevent CMV infection including CMV reactivation. For clinical CMV infection or viremia, withhold COPIKTRA until infection or viremia resolves. If COPIKTRA is resumed, administer the same or reduced dose and monitor patients for CMV reactivation by PCR or antigen test at least monthly [see Dosage and Administration ( 2.3 )] .

5.3Diarrhea or Colitis Serious, including fatal (1/442; 0.2%), diarrhea or colitis occurred in 18% of patients receiving COPIKTRA 25 mg BID (N = 442). The median time to onset of any grade diarrhea or colitis was 4 months (range: 1 day to 33 months), with 75% of cases occurring by 8 months. The median event duration was 0.5 months (range: 1 day to 29 months; 75 th percentile: 1 month).

Advise patients to report any new or worsening diarrhea. For non-infectious diarrhea or colitis, follow the guidelines below: For patients presenting with mild or moderate diarrhea (Grade 1-2) (i.e., up to 6 stools per day over baseline) or asymptomatic (Grade 1) colitis, initiate supportive care with antidiarrheal agents as appropriate, continue COPIKTRA at the current dose, and monitor the patient at least weekly until the event resolves. If the diarrhea is unresponsive to antidiarrheal therapy, withhold COPIKTRA and initiate supportive therapy with enteric acting steroids (e.g., budesonide).

Monitor the patient at least weekly. Upon resolution of the diarrhea, consider restarting COPIKTRA at a reduced dose. For patients prese… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions have been associated with COPIKTRA in clinical trials and are discussed in greater detail in other sections of the prescribing information: Treatment-related Mortality [see Warnings and Precautions ( 5.1 )] Infections [see Warnings and Precautions ( 5.2 )] Diarrhea or Colitis [see Warnings and Precautions ( 5.3 )] Cutaneous Reactions [see Warnings and Precautions ( 5.4 )] Pneumonitis [see Warnings and Precautions ( 5.5 )] Hepatotoxicity [see Warnings and Precautions ( 5.6 )] Neutropenia [see Warnings and Precautions ( 5.7 )] The most common adverse reactions ( > 20%) are diarrhea or colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain, and anemia.

( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Secura Bio, Inc. (Secura Bio) at 1-844-973-2872, or U.S. Food and Drug Administration (FDA) at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trial Experience Because clinical trials are conducted under widely variable conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared with rates in clinical trials of another drug and may not reflect the rates observed in practice. Summary of Clinical Trial Experience in B-cell Malignancies The data described below reflect exposure to COPIKTRA in two single-arm, open-label clinical trials, one open-label extension clinical trial, and one randomized, open-label, actively controlled clinical trial totaling 442 patients with previously treated hematologic malignancies primarily including CLL/SLL (69%) and FL (22%).

Patients were treated with COPIKTRA 25 mg BID until unacceptable toxicity or progressive disease. The median duration of exposure was 9 months (range: 0.1 to 53 months), with 36% (160/442) of patients having at least 12 months of exposure. For the 442 patients, the median age was 67 years (range: 30 to 90 years), 65% were male, 92% were White, and 93% had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.

Patients had a median of 2 prior therapies. The trials required hepatic transaminases at least ≤ 3 times upper limit of normal (ULN), total bilirubin ≤ 1.5 times ULN, and serum creatinine ≤ 1.5 times ULN. Patients were excluded for prior exposure to a PI3K inhibitor within 4 weeks.

Fatal adverse reactions within 30 days of the last dose occurred in 36 patients (8%) treated with COPIKTRA 25 mg BID. Serious adverse reactions were reported in 289 patients (65%). The most frequent serious adverse reactions that occurred were infection (31%), diarrhea or colitis (18%), pneumonia (17%), rash (5%), and pneumonitis (5%).

Adverse reactions resulted in treatment discontinuation in 156 patients (35%), most often due to diarrhea or colitis, infection, and rash. COPIKTRA was dose reduced in 104 patients (24%) due to adverse reactions, most often due to diarrhea or colitis and transaminase elevation. The median time to first dose modification or discontinuation was 4 months (range: 0.1 to 27 months), with 75% of patients having their first dose modification or discontinuation within 7 months.

Common Adverse Reactions Table 4 summarizes common adverse reactions in patients receiving COPIKTRA 25 mg BID, and Table 5 summarizes the treatment-emergent laboratory abnormalities. The most common adverse reactions (reported in ≥ 20% of patients) were diarrhea or colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain, and anemia. Table 4.

Common Adverse Reactions (≥ 10% Incidence) in Patients with B-cell Malignancies Receiving COPIKTRA † Grouped term for reactions with multiple preferred terms a Diarrhea or colitis includes the preferred terms: colitis, enterocolitis, colitis microscopic, colitis ulcerative, diarrhea, diarrhea hemorrhagic b Transaminase elevation includes the preferred terms: alanine aminotransferase increased, aspartate aminotransfe… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS CYP3A4 inhibitors: Reduce COPIKTRA dose to 15 mg twice daily when co-administered with strong CYP3A4 inhibitors. ( 2.4 , 7.1 , 12.3 ) Strong CYP3A4 inducers: Avoid coadministration. ( 2.5 , 7.1 , 12.3 ) Moderate CYP3A4 inducers: Avoid coadministration.

If coadministration cannot be avoided, increase the dose of COPIKTRA. ( 2.5 , 7.1 , 12.3 ) CYP3A4 substrates: Monitor for signs of toxicities when co-administering COPIKTRA with sensitive CYP3A substrates. ( 7.2 )

7.1Effects of Other Drugs on COPIKTRA Strong CYP3A4 Inhibitors Coadministration with a strong CYP3A4 inhibitor increases duvelisib AUC [see Clinical Pharmacology ( 12.3 )] , which may increase the risk of COPIKTRA toxicities. Reduce COPIKTRA dosage when co-administered with a strong CYP3A4 inhibitor [see Dosage and Administration ( 2.4 )] . Strong and Moderate CYP3A4 Inducers Coadministration with a strong or moderate CYP3A4 inducer decreases duvelisib area under the curve (AUC) [see Clinical Pharmacology ( 12.3 )] , which may reduce COPIKTRA efficacy.

Avoid coadministration of strong or moderate CYP3A4 inducers with COPIKTRA. If coadministration with a moderate CYP3A4 inducer cannot be avoided, increase the COPIKTRA dose. [see Dosage and Administration ( 2.5 ), Clinical Pharmacology ( 12.3 )].

7.2Effects of COPIKTRA on Other Drugs CYP3A4 Substrates Coadministration with COPIKTRA increases AUC of a sensitive CYP3A4 substrate [see Clinical Pharmacology ( 12.3 )] which may increase the risk of toxicities of these drugs. Consider reducing the dose of the sensitive CYP3A4 substrate and monitor for signs of toxicities of the co-administered sensitive CYP3A4 substrate.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation: Advise women not to breastfeed. ( 8.2 )

8.1Pregnancy Risk Summary Based on findings from animal studies and the mechanism of action, COPIKTRA can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )] . There are no available data in pregnant women to inform the drug-associated risk. In animal reproduction studies, administration of duvelisib to pregnant rats and rabbits during organogenesis caused adverse developmental outcomes including embryo-fetal mortality (resorptions, post-implantation loss, and decreased viable fetuses), alterations to growth (lower fetal weights) and structural abnormalities (malformations) at maternal doses 10 times and 39 times the MRHD of 25 mg BID in rats and rabbits, respectively (see Data ) .

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Data Animal Data In an embryo-fetal development study in rats, pregnant animals received daily oral doses of duvelisib of 0, 10, 50, 150 and 275 mg/kg/day during the period of organogenesis. Administration of duvelisib at doses ≥ 50 mg/kg/day resulted in adverse developmental outcomes including reduced fetal weights and external abnormalities (bent tail and fetal anasarca), and doses ≥ 150 mg/kg/day resulted in maternal toxicity including mortality and no live fetuses (100% resorption) in surviving dams. In another study in pregnant rats receiving oral doses of duvelisib up to 35 mg/kg/day during the period of organogenesis, no maternal or embryo-fetal effects were observed.

The dose of 50 mg/kg/day in rats is approximately 10 -times the MRHD of 25 mg BID. In an embryo-fetal development study in rabbits, pregnant animals received daily oral doses of duvelisib of 0, 25, 100, and 200 mg/kg/day during the period of organogenesis. Administration of duvelisib at doses ≥ 100 mg/kg/day resulted in maternal toxicity (body weight losses or lower mean body weights and increased mortality) and adverse developmental outcomes (increased resorptions and post-implantation loss, abortion, and decreased numbers of viable fetuses).

In another study in pregnant rabbits receiving oral doses of duvelisib up to 75 mg/kg/day, no maternal or embryo-fetal effects were observed. The dose of 100 mg/kg/day in rabbits is approximately 39 times the MRHD of 25 mg BID.

8.2Lactation Risk Summary There are no data on the presence of duvelisib and/or its metabolites in human milk, the effects on the breastfed child, or on milk production. Because of the potential for serious adverse reactions from duvelisib in a breastfed child, advise lactating women not to breastfeed while taking COPIKTRA and for 1 month after the last dose.

8.3Females and Males of Reproductive Potential COPIKTRA can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations ( 8.1 )]. Pregnancy Testing Conduct pregnancy testing before initiation of COPIKTRA treatment. Contraception Females Based on animal studies, COPIKTRA can cause fetal harm when administered to a pregnant woman.

Advise females of reproductive potential to use effective contraception during treatment with COPIKTRA and for 1 month after the last dose. Males Advise male patients with female partners of reproductive potential to use effective contraception during treatment with COPIKTRA and for 1 month after the last dose. Infertility Based on testicular findings in animals, male fertility may be impaired by treatment with COPIKTRA [see Nonclinical Toxicology ( 13.1 )] .

There are no data on the effect of COPIKTRA on human fertility.

8.4Pediatric Use Safety and effectiveness of COPIKTRA have not been established in pediatric pat… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Based on findings from animal studies and the mechanism of action, COPIKTRA can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )] . There are no available data in pregnant women to inform the drug-associated risk. In animal reproduction studies, administration of duvelisib to pregnant rats and rabbits during organogenesis caused adverse developmental outcomes including embryo-fetal mortality (resorptions, post-implantation loss, and decreased viable fetuses), alterations to growth (lower fetal weights) and structural abnormalities (malformations) at maternal doses 10 times and 39 times the MRHD of 25 mg BID in rats and rabbits, respectively (see Data ) .

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Data Animal Data In an embryo-fetal development study in rats, pregnant animals received daily oral doses of duvelisib of 0, 10, 50, 150 and 275 mg/kg/day during the period of organogenesis. Administration of duvelisib at doses ≥ 50 mg/kg/day resulted in adverse developmental outcomes including reduced fetal weights and external abnormalities (bent tail and fetal anasarca), and doses ≥ 150 mg/kg/day resulted in maternal toxicity including mortality and no live fetuses (100% resorption) in surviving dams. In another study in pregnant rats receiving oral doses of duvelisib up to 35 mg/kg/day during the period of organogenesis, no maternal or embryo-fetal effects were observed.

The dose of 50 mg/kg/day in rats is approximately 10 -times the MRHD of 25 mg BID. In an embryo-fetal development study in rabbits, pregnant animals received daily oral doses of duvelisib of 0, 25, 100, and 200 mg/kg/day during the period of organogenesis. Administration of duvelisib at doses ≥ 100 mg/kg/day resulted in maternal toxicity (body weight losses or lower mean body weights and increased mortality) and adverse developmental outcomes (increased resorptions and post-implantation loss, abortion, and decreased numbers of viable fetuses).

In another study in pregnant rabbits receiving oral doses of duvelisib up to 75 mg/kg/day, no maternal or embryo-fetal effects were observed. The dose of 100 mg/kg/day in rabbits is approximately 39 times the MRHD of 25 mg BID.

🧒 Pediatric Use 21 words ▾

8.4Pediatric Use Safety and effectiveness of COPIKTRA have not been established in pediatric patients. Pediatric studies have not been conducted.

🧓 Geriatric Use 55 words ▾

8.5Geriatric Use Clinical trials of COPIKTRA included 270 patients (61%) that were 65 years of age and older and 104 (24%) that were 75 years of age and older. No major differences in efficacy or safety were observed between patients less than 65 years of age and patients 65 years of age and older.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Duvelisib is an inhibitor of PI3K with inhibitory activity predominantly against PI3K-δ and PI3K-γ isoforms expressed in normal and malignant B-cells. Duvelisib induced growth inhibition and reduced viability in cell lines derived from malignant B-cells and in primary CLL tumor cells. Duvelisib inhibits several key cell-signaling pathways, including B-cell receptor signaling and CXCR12-mediated chemotaxis of malignant B-cells.

Additionally, duvelisib inhibits CXCL12-induced T cell migration and M-CSF and IL-4 driven M2 polarization of macrophages.

12.2Pharmacodynamics At the recommended dose of 25 mg BID, reductions in levels of phosphorylated AKT (a downstream marker for PI3K inhibition) were observed in patients treated with COPIKTRA. Cardiac Electrophysiology The effect of multiple doses of COPIKTRA 25 and 75 mg BID on the QTc interval was evaluated in patients with previously treated hematologic malignancies. Increases of > 20 ms in the QTc interval were not observed.

12.3Pharmacokinetics Duvelisib exposure increased in a dose-proportional manner over a dose range of 8 mg to 75 mg twice daily (0.3 to 3 times the recommended dosage). At steady state following 25 mg BID administration of duvelisib in patients, the geometric mean (CV%) maximum concentration (C max ) was 1.5 (64%) µg/mL and AUC was 7.9 (77%) µg•h/mL. Absorption The absolute bioavailability of 25 mg duvelisib after a single oral dose in healthy volunteers was 42%.

The median time to peak concentration (T max ) was observed at 1 to 2 hours in patients. Effect of Food COPIKTRA may be administered without regard to food. The administration of a single dose of COPIKTRA with a high-fat meal (fat accounted for approximately 50% of the total caloric content of the meal) decreased C max by approximately 37% and decreased the AUC by approximately 6%, relative to fasting conditions.

Distribution Protein binding of duvelisib is greater than 98% with no concentration dependence. The mean blood-to-plasma ratio was 0.5. The geometric mean (CV%) apparent volume of distribution at steady state (V ss /F) is

28.5L (62%). Duvelisib is a substrate of P-glycoprotein (P-gp) and BCRP in vitro. Elimination The geometric mean (CV%) apparent systemic clearance at steady-state is

4.2L/hr (56%) in patients with lymphoma or leukemia. The geometric mean (CV%) terminal elimination half-life of duvelisib is 4.7 hours (57%). Metabolism Duvelisib is primarily metabolized by cytochrome P450 CYP3A4.

Excretion Following a single 25 mg oral dose of radiolabeled duvelisib, 79% of the radioactivity was excreted in feces (11% unchanged) and 14% was excreted in the urine (< 1% unchanged). Specific Populations Age (18 to 90 years), sex, race, renal impairment (creatinine clearance 23 to 80 mL/ min), hepatic impairment (Child Pugh Class A, B, and C) and body weight (40 to 154 kg) had no clinically significant effect on the exposure of duvelisib. Drug Interaction Studies CYP3A4 Inhibitors Coadministration of a single COPIKTRA 10 mg dose with ketoconazole (strong CYP3A4 inhibitor) at 200 mg BID for 5 days in healthy adults increased duvelisib C max by 1.7-fold and AUC by 4-fold.

Based on physiologically-based pharmacokinetic (PBPK) modeling and simulation, the increase in duvelisib exposure at steady state is estimated to be ~2-fold when coadministered with strong CYP3A4 inhibitors [see Dosage and Administration ( 2.4 ) and Drug Interactions ( 7.1 )] . PBPK modeling and simulation estimated no effect on duvelisib exposures from concomitantly used mild or moderate CYP3A4 inhibitors. Strong and Moderate CYP3A4 Inducers Coadministration of a single COPIKTRA 25 mg dose with rifampin (strong CYP3A4 inducer) 600 mg once daily for 7 days in healthy adults decreased duvelisib C max by 66% and AUC by 82% [see Dosage and Administration ( 2.5 ) and Drug Interactions ( 7.1 )] .

Co-administration of etravirine (moderate CYP3A4 inducer) 200 mg twice daily of etraviri… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 77 words ▾

12.1Mechanism of Action Duvelisib is an inhibitor of PI3K with inhibitory activity predominantly against PI3K-δ and PI3K-γ isoforms expressed in normal and malignant B-cells. Duvelisib induced growth inhibition and reduced viability in cell lines derived from malignant B-cells and in primary CLL tumor cells. Duvelisib inhibits several key cell-signaling pathways, including B-cell receptor signaling and CXCR12-mediated chemotaxis of malignant B-cells.

Additionally, duvelisib inhibits CXCL12-induced T cell migration and M-CSF and IL-4 driven M2 polarization of macrophages.

📦 How Supplied / Storage and Handling 132 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING COPIKTRA (duvelisib) capsules are supplied as follows: Abbreviations: HDPE = high-density polyethylene; NDC = National Drug Code; No. = number Capsule Strength Description Package Configuration NDC No 25 mg White to off-white and Swedish orange opaque capsules marked with "duv 25 mg" in black ink 14-day (28ct) single blister pack 28-day (56ct) carton (2 × 28ct blister packs per carton) 73116-225-28 73116-225-56 15 mg Pink opaque capsules marked with "duv 15 mg" in black ink 14-day (28ct) single blister pack 28-day (56ct) carton (2 × 28ct blister packs per carton) 73116-215-28 73116-215-56 Store at 20° to 25°C (68° to 77°F), with excursions permitted at 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Retain in original package until dispensing. Dispense blister packs in original container.

📋 Description 137 words ▾

11 DESCRIPTION COPIKTRA (duvelisib) is a kinase inhibitor. Duvelisib is a white-to-off-white crystalline solid with the empirical formula C 22 H 17 ClN 6 O•H 2 O and a molecular weight of 434.88 g/mol. Hydration can vary with relative humidity.

Duvelisib contains a single chiral center as ( S ) enantiomer. Duvelisib is soluble in ethanol and practically insoluble in water. Duvelisib is described chemically as a hydrate of (S)-3-(1-(9H-purin-6-ylamino)ethyl)-8-chloro-2-phenylisoquinolin-1(2H)-one and has the following chemical structure: COPIKTRA capsules are for oral administration and are supplied as white to off-white opaque and Swedish orange opaque capsules (25 mg, on anhydrous basis) or pink opaque capsules (15 mg, on anhydrous basis), and contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, and microcrystalline cellulose.

Capsule shells contain gelatin, titanium dioxide, black ink, and red iron oxide. Image

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Physicians and healthcare professionals are advised to discuss the following with patients prior to treatment with COPIKTRA: ● Treatment-related Mortality Advise patients that COPIKTRA has been associated with increased deaths due to side effects of therapy in a randomized study when compared to standard therapy. The main reason for death was infection [see Warnings and Precautions (5.1)] .

Infections Advise patients that COPIKTRA can cause serious infections that may be fatal. Advise patients to immediately report symptoms of infection (e.g., fever, chills) [see Warnings and Precautions ( 5.2 )] . ● Diarrhea or Colitis Advise patients that COPIKTRA can cause serious diarrhea or colitis (inflammation of the gut) that may be fatal, and to notify their healthcare provider immediately about any new or worsening diarrhea, stool with mucus or blood, or abdominal pain [see Warnings and Precautions ( 5.3 )] . ● Cutaneous Reactions Advise patients that COPIKTRA can cause a serious skin rash that may be fatal, and to notify their healthcare provider immediately if they develop a new or worsening skin rash [see Warnings and Precautions ( 5.4 )] . ● Pneumonitis Advise patients that COPIKTRA may cause pneumonitis (inflammation of the lungs) that may be fatal, and to report any new or worsening respiratory symptoms including cough or difficulty breathing [see Warnings and Precautions ( 5.5 )] . ● Hepatotoxicity Advise patients that COPIKTRA may cause significant elevations in liver enzymes, and that monitoring of liver tests is needed.

Advise patients to report symptoms of liver dysfunction including jaundice (yellow eyes or yellow skin), abdominal pain, bruising, or bleeding [see Warnings and Precautions ( 5.6 )] . ● Neutropenia Advise patients of the need for periodic monitoring of blood counts. Advise patients to notify their healthcare provider immediately if they develop a fever or any sign of infection [see Warnings and Precautions ( 5.7 )] . ● Embryo-Fetal Toxicity Advise females to inform their healthcare provider if they are pregnant or become pregnant.

Inform female patients of the risk to a fetus [see Use in Specific Populations ( 8.1 )] . Advise females of reproductive potential to use effective contraception during treatment and for 1 month after receiving the last dose of COPIKTRA [see Warnings and Precautions ( 5.8 ) and Use in Specific Populations ( 8.1 , 8.3 )] . Advise males with female partners of reproductive potential to use effective contraception during treatment with COPIKTRA and for 1 month after the last dose [see Warnings and Precautions ( 5.8 ) and Use in Specific Populations ( 8.1 , 8.3 )] . ● Lactation Advise lactating women not to breastfeed during treatment with COPIKTRA and for 1 month after the last dose [see Use in Specific Populations ( 8.2 )] . ● Instructions for Taking COPIKTRA Advise patients to take COPIKTRA exactly as prescribed.

COPIKTRA may be taken with or without food; the capsules should be swallowed whole [see Dosage and Administration ( 2.1 )] . Advise patients that if a dose is missed by fewer than 6 hours, to take the missed dose right away and take the next dose as usual. If a dose is missed by more than 6 hours, advise patients to wait and take the next dose at the usual time [see Dosage and Administration ( 2.3 )] .

Advise patients to inform their healthcare providers of all concomitant medications, including prescription medicines, over-the-counter drugs, vitamins, and herbal products, before and during treatment with COPIKTRA [see Drug Interactions ( 7 )] . Distributed by: Secura Bio, Inc. 200 Connell Drive, Suite 1100 Berkeley Heights, NJ 07922 © Secura Bio USCPR250042-1

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE COPIKTRA™ (co-PIK-trah) (duvelisib) capsules What is the most important information I should know about COPIKTRA? COPIKTRA can cause serious side effects, including: Death due to treatment side effects. COPIKTRA can cause severe, life-threatening side effects that can lead to death.

The serious side effects are listed below. Infections were the most common cause of death. If you develop any of these or any new or worsening side effects, tell your healthcare provider right away.

Infections . Infections are common during COPIKTRA treatment, and can be serious and can lead to death. Tell your healthcare provider right away if you have a fever, chills, or other signs of an infection during treatment with COPIKTRA.

Diarrhea or inflammation of your intestine. Diarrhea or inflammation of your intestine (colitis) is common during COPIKTRA treatment, and can be serious and can lead to death. Your healthcare provider may prescribe an anti-diarrhea medicine for your diarrhea.

Tell your healthcare provider right away if you have any new or worsening diarrhea, stool with mucus or blood, or if you have severe stomach-area (abdominal) pain. Your healthcare provider should prescribe medicine to help your diarrhea and check you at least weekly. If your diarrhea is severe or anti-diarrhea medicines did not work, you may need treatment with a steroid medicine.

Skin reactions. Rashes are common with COPIKTRA treatment. COPIKTRA can cause rashes and other skin reactions that can be serious and can lead to death.

Tell your healthcare provider right away if you get a new or worsening skin rash, or other skin reactions during treatment with COPIKTRA, including: painful sores or ulcers on your skin, lips, or in your mouth severe rash with blisters or peeling skin rash with itching rash with fever Your healthcare provider may need to prescribe medicines, including a steroid medicine, to help treat your skin rash or other skin reactions. Inflammation of the lungs . COPIKTRA can cause inflammation of your lungs which can be serious and can lead to death.

Tell your healthcare provider right away if you get new or worsening cough or difficulty breathing. Your healthcare provider may do tests to check your lungs if you have breathing problems during treatment with COPIKTRA. Your healthcare provider may treat you with a steroid medicine if you develop inflammation of the lungs that is not due to an infection.

If you have any of the above serious side effects during treatment with COPIKTRA, your healthcare provider may stop your treatment for a period of time, change your dose of COPIKTRA, or completely stop your treatment with COPIKTRA. See "What are the possible side effects of COPIKTRA?" " for more information about side effects. What is COPIKTRA?

COPIKTRA is a prescription medicine used to treat adults with: Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least 2 prior therapies and they did not work or are no longer working. COPIKTRA should not be used as the first or second medicine to treat anyone, including people with CLL or SLL because of an increased risk of death due to treatment side effects. It is not known if COPIKTRA is safe and effective in children less than 18 years of age.

What should I tell my healthcare provider before taking COPIKTRA? Before taking COPIKTRA, tell your healthcare provider about all of your medical conditions, including if you: have intestinal problems have lung or breathing problems have an infection are pregnant or plan to become pregnant. COPIKTRA can harm your unborn baby.

Your healthcare provider should do a pregnancy test to see if you are pregnant before you start treatment with COPIKTRA. Females who are able to become pregnant should use effective birth control (contraception) during treatment with COPIKTRA and for at least 1 month after the last dose of COPIKTRA. Talk to your healthcare provider about birth control methods that may be right for you.

Tel… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Duvelisib exposure increased in a dose-proportional manner over a dose range of 8 mg to 75 mg twice daily (0.3 to 3 times the recommended dosage). At steady state following 25 mg BID administration of duvelisib in patients, the geometric mean (CV%) maximum concentration (C max ) was 1.5 (64%) µg/mL and AUC was 7.9 (77%) µg•h/mL. Absorption The absolute bioavailability of 25 mg duvelisib after a single oral dose in healthy volunteers was 42%.

The median time to peak concentration (T max ) was observed at 1 to 2 hours in patients. Effect of Food COPIKTRA may be administered without regard to food. The administration of a single dose of COPIKTRA with a high-fat meal (fat accounted for approximately 50% of the total caloric content of the meal) decreased C max by approximately 37% and decreased the AUC by approximately 6%, relative to fasting conditions.

Distribution Protein binding of duvelisib is greater than 98% with no concentration dependence. The mean blood-to-plasma ratio was 0.5. The geometric mean (CV%) apparent volume of distribution at steady state (V ss /F) is

28.5L (62%). Duvelisib is a substrate of P-glycoprotein (P-gp) and BCRP in vitro. Elimination The geometric mean (CV%) apparent systemic clearance at steady-state is

4.2L/hr (56%) in patients with lymphoma or leukemia. The geometric mean (CV%) terminal elimination half-life of duvelisib is 4.7 hours (57%). Metabolism Duvelisib is primarily metabolized by cytochrome P450 CYP3A4.

Excretion Following a single 25 mg oral dose of radiolabeled duvelisib, 79% of the radioactivity was excreted in feces (11% unchanged) and 14% was excreted in the urine (< 1% unchanged). Specific Populations Age (18 to 90 years), sex, race, renal impairment (creatinine clearance 23 to 80 mL/ min), hepatic impairment (Child Pugh Class A, B, and C) and body weight (40 to 154 kg) had no clinically significant effect on the exposure of duvelisib. Drug Interaction Studies CYP3A4 Inhibitors Coadministration of a single COPIKTRA 10 mg dose with ketoconazole (strong CYP3A4 inhibitor) at 200 mg BID for 5 days in healthy adults increased duvelisib C max by 1.7-fold and AUC by 4-fold.

Based on physiologically-based pharmacokinetic (PBPK) modeling and simulation, the increase in duvelisib exposure at steady state is estimated to be ~2-fold when coadministered with strong CYP3A4 inhibitors [see Dosage and Administration ( 2.4 ) and Drug Interactions ( 7.1 )] . PBPK modeling and simulation estimated no effect on duvelisib exposures from concomitantly used mild or moderate CYP3A4 inhibitors. Strong and Moderate CYP3A4 Inducers Coadministration of a single COPIKTRA 25 mg dose with rifampin (strong CYP3A4 inducer) 600 mg once daily for 7 days in healthy adults decreased duvelisib C max by 66% and AUC by 82% [see Dosage and Administration ( 2.5 ) and Drug Interactions ( 7.1 )] .

Co-administration of etravirine (moderate CYP3A4 inducer) 200 mg twice daily of etravirine for 12 days with a single COPIKTRA 25 mg dose in healthy adults decreased duvelisib C max by 16% and AUC by 35%. [see Dosage and Administration ( 2.5 ) and Drug Interactions ( 7.1 )] . CYP3A4 Substrates Coadministration of multiple doses of COPIKTRA 25 mg BID for 5 days with a single midazolam (sensitive CYP3A4 substrate) 2 mg dose in healthy adults increased the midazolam AUC by 4.3-fold and C max by 2.2-fold [see Drug Interactions ( 7.2 )] .

In Vitro Studies Duvelisib is a substrate of P-glycoprotein (P-gp) and breast cancer-resistant protein (BCRP). Duvelisib does not inhibit OAT1, OAT3, OCT1, OCT2, OATP1B1, OATP1B3, BCRP, or P-gp.

🧬 Pharmacodynamics 68 words ▾

12.2Pharmacodynamics At the recommended dose of 25 mg BID, reductions in levels of phosphorylated AKT (a downstream marker for PI3K inhibition) were observed in patients treated with COPIKTRA. Cardiac Electrophysiology The effect of multiple doses of COPIKTRA 25 and 75 mg BID on the QTc interval was evaluated in patients with previously treated hematologic malignancies. Increases of > 20 ms in the QTc interval were not observed.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES DUO Study A randomized, multicenter, open-label trial (DUO Study; NCT02004522 ) compared COPIKTRA versus ofatumumab in 319 adult patients with CLL (N = 312) or SLL (N = 7) after at least one prior therapy. The trial excluded patients with prior autologous transplant within 6 months or allogeneic transplant, prior exposure to a PI3K inhibitor or a Bruton's tyrosine kinase (BTK) inhibitor. The trial required hepatic transaminases ≤ 3 times upper limit of normal (ULN), total bilirubin ≤ 1.5 times ULN, and serum creatinine ≤ 2 times ULN.

The study randomized patients with a 1:1 ratio to receive either COPIKTRA 25 mg BID until disease progression or unacceptable toxicity or ofatumumab for 7 cycles. Ofatumumab was administered intravenously at an initial dose of 300 mg, followed one week later by 2000 mg once weekly for 7 doses, and then 2000 mg once every 4 weeks for 4 additional doses. The approval of COPIKTRA was based on efficacy and safety analysis of patients with at least 2 prior lines of therapy, where the benefit:risk appeared greater in this more heavily pretreated population compared to the overall trial population.

In this subset (95 randomized to COPIKTRA, 101 to ofatumumab), the median patient age was 69 years (range: 40 to 90 years), 59% were male, and 88% had an ECOG performance status of 0 or 1. Forty-six percent received 2 prior lines of therapy, and 54% received 3 or more prior lines. At baseline, 52% of patients had at least one tumor ≥ 5 cm, and 22% of patients had a documented 17p deletion.

During randomized treatment, the median duration of exposure to COPIKTRA was 13 months (range: 0.2 to 37), with 80% of patients receiving at least 6 months and 52% receiving at least 12 months of COPIKTRA. The median duration of exposure to ofatumumab was 5 months (range: < 0.1 to 6). Efficacy was based on progression-free survival (PFS) as assessed by an Independent Review Committee (IRC).

Other efficacy measures included overall response rate. Efficacy of COPIKTRA compared to ofatumumab specifically in patients treated with at least two prior therapies is presented in Table 8 and Figure 1 . Table 8.

Efficacy in CLL or SLL After at Least Two Prior Therapies (DUO) Abbreviations: CI = confidence interval; CR = complete response; IRC = Independent Review Committee; PFS = progression-free survival; PR = partial response; SE = standard error a Kaplan-Meier estimate b Standard Error of ln(hazard ratio) = 0.2 c IWCLL or revised IWG response criteria, with modification for treatment-related lymphocytosis Outcome per IRC COPIKTRA N = 95 Ofatumumab N = 101 PFS Number of events, n (%) 55 (58) 70 (69) Progressive disease 44 62 Death 11 8 Median PFS (SE), months a 16.4 (2.1) 9.1 (0.5) Hazard Ratio (SE), b COPIKTRA/ofatumumab 0.40 (0.2) Response rate ORR, n (%) c 74 (78) 39 (39) CR 0 (0) 0 (0) PR 74 (78) 39 (39) Difference in ORR, % (SE) 39 (6.4) Figure 1.

Kaplan-Meier Curve of PFS per IRC In Patients with at Least 2 Prior Therapies (DUO) Increased Mortality in Patients with Relapsed or Refractory CLL or SLL Treated with COPIKTRA Final overall survival (OS) analysis was conducted with a median follow-up time of 63 months. Fifty percent (80/160) of patients in the overall population died in the COPIKTRA arm, and 44% (70/159) of patients died in the ofatumumab arm. Treatment of patients in the overall population with duvelisib compared with ofatumumab demonstrated an OS HR of 1.09 (95% CI: 0.79, 1.51) with a median OS of 52 months (95% CI: 42, 68) in those patients treated with COPIKTRA and a median OS of 63 months (95% CI: 41 mo, NE) in those treated with ofatumumab.

In the indicated population, those patients with relapsed or refractory CLL or SLL after at least 2 prior lines of systemic therapy, 56% (53/95) of patients died in the COPIKTRA arm and 49% (49/101) of patients died in the ofatumumab arm. Treatment of patients in the indicated population with duvelisib compared with ofatumumab demonstrated an OS HR of 1.06… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 78 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity studies have not been conducted with duvelisib. Duvelisib did not cause genetic damage in in vitro or in vivo assays. Fertility studies with duvelisib were not conducted.

Histological findings in male and female rats were observed in the repeat dose toxicity studies and included testis (seminiferous epithelial atrophy, decreased weight, soft testes), and epididymis (small size, oligo/aspermia) in males and ovary (decreased weight) and uterus (atrophy) in females.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 75 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity studies have not been conducted with duvelisib. Duvelisib did not cause genetic damage in in vitro or in vivo assays. Fertility studies with duvelisib were not conducted.

Histological findings in male and female rats were observed in the repeat dose toxicity studies and included testis (seminiferous epithelial atrophy, decreased weight, soft testes), and epididymis (small size, oligo/aspermia) in males and ovary (decreased weight) and uterus (atrophy) in females.

📄 Recent Major Changes 28 words ▾

Boxed Warning, Treatment Related Mortality added Indications and Usage, Limitations of Use added ( 1 ) Warnings and Precautions, Treatment Related Mortality ( 5.1 ) 7/2024 7/2024 7/2024

📄 Package Label / Principal Display Panel 35 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 25 mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 25 mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 25 mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 15 mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Desc

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 15 mg

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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

Medicare Part D (outpatient prescription) spending for Copiktra — 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 Copiktra. 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
$12.57M
Claims incl. refills
295
Beneficiaries
147
Spend / beneficiary
$85,524.62
Spend / claim
$42,617.35
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.

About this NDC listing & data coverage

Finished prescription product
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Active ingredient / dosage form / route ✓ Available
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Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
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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?
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Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 28 capsules (73116-0225-28). Each has its own NDC and its own page — see the package list near the top of this page.
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Secura Bio, Inc 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.
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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?
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← 73116-0215-28 · Secura 73117-0509-01 · Blue →
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.