Duvelisib
Duvelisib is a kinase inhibitor taken by mouth to treat adults with relapsed or refractory chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL) and follicular lymphoma (FL) after other treatments have been tried.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 2 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Duvelisib (Copiktra), on the U.S. market since about 2018, blocks PI3K delta and gamma, enzymes that cancerous B-cells use to grow and survive. It is a less commonly used, later-line option for CLL, SLL or follicular lymphoma that has come back or stopped responding after at least two earlier treatments. Many people find it hard going, with diarrhea, rash, tiredness and fever the most common side effects. Its boxed warning covers treatment-related deaths and serious or fatal infections, diarrhea or colitis (bowel inflammation), skin reactions and pneumonitis (lung inflammation), so report fever, worsening diarrhea, rash or breathlessness right away, and keep up with blood counts, liver tests and the preventive medicines prescribed alongside it.
Clinical pearls
- Expect a preventive antibiotic for Pneumocystis pneumonia (PJP), and possibly an antiviral for CMV, throughout treatment, and do not skip them.
- Swallow the capsules whole, with or without food, and never open, break or chew them.
- Ketoconazole-type antifungals raise duvelisib levels and call for a lower dose, while rifampin lowers them and should be avoided.
- Women who could become pregnant, and men with such partners, need effective contraception during treatment and for one month after.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Copiktra can cause serious and sometimes fatal side effects. Treatment-related deaths occurred in 15% of people treated.
- Serious or fatal infections occurred in 31%. Watch for signs of infection.
- Serious or fatal diarrhea or colitis occurred in 18%. Watch for severe diarrhea.
- Serious or fatal skin reactions occurred in 5%.
- Serious or fatal lung inflammation (pneumonitis) occurred in 5%. Watch for cough or breathing problems.
Your doctor will hold treatment if these problems occur. Report symptoms promptly.
Patient information guide A plain-language walkthrough of Duvelisib, written from its FDA label.
What Duvelisib is used for
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Duvelisib treats certain blood cancers in adults after other treatments.
- Copiktra capsules: relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies.
- Copiktra capsules: relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. This is an accelerated approval based on response rate.
How Duvelisib works
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Duvelisib blocks PI3K, mainly the delta and gamma forms found in normal and cancerous B-cells. This shuts down signals that help malignant B-cells grow and survive.
It also affects signals that guide cell movement, including B-cell receptor signaling and certain T cell and macrophage activity.
Duvelisib dosage
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Copiktra is taken by mouth as a capsule twice a day, with or without food, in 28-day cycles.
- Swallow the capsules whole. Do not open, break or chew them.
- If you miss a dose by fewer than 6 hours, take it right away, then take the next dose as usual.
- If you miss it by more than 6 hours, wait and take the next dose at the usual time.
Your prescriber may adjust your dose for side effects or certain interacting medicines.
Dosing details from the FDA-approved label
From the Duvelisib prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Recommended dosage (all patients)
- 25 mg administered as oral capsules twice daily (BID) with or without food
- A cycle consists of 28 days
- Capsules swallowed whole
- Do not open, break, or chew capsules; if a dose is missed by fewer than 6 hours, take it right away, if by more than 6 hours, wait and take the next dose at the usual time
- Dose reduction for adverse reactions
- 15 mg twice daily
- Discontinue COPIKTRA if patient is unable to tolerate 15 mg twice daily
- Concomitant use with strong CYP3A4 inhibitors (e.g., ketoconazole)
- Reduce COPIKTRA dose to 15 mg twice daily
- Concomitant use with moderate CYP3A4 inducers, initial dosage 25 mg orally twice daily (if coadministration cannot be avoided)
- 40 mg orally twice daily, increased on Day 12 of coadministration
- After the inducer has been discontinued for at least 14 days, resume the dose taken prior to the inducer
- Concomitant use with moderate CYP3A4 inducers, initial dosage 15 mg orally twice daily (if coadministration cannot be avoided)
- 25 mg orally twice daily, increased on Day 12 of coadministration
- After the inducer has been discontinued for at least 14 days, resume the dose taken prior to the inducer
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION 25 mg orally, twice daily. Modify dosage for toxicity. ( 2.1 , 2.2 ) 2.1 Recommended 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. 2.2 Recommended 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. 2.3 Dosage Modifications for Adverse Reactions Manage toxicities per Table 1 with dose reduction, treatment hold, or discontinuation of COPIKTRA. Table 1.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Duvelisib side effects
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The most common side effects include:
Common side effects
- Diarrhea or colitis (bowel inflammation)
- Low white blood cell count (neutropenia)
- Rash
- Fatigue
- Fever
- Cough
- Nausea
- Upper respiratory infection, pneumonia, muscle or bone pain, and anemia
When to get medical help
- Call your doctor right away for any signs of infection, such as fever, chills or cough.
- Report any new or worsening diarrhea, belly pain, or stool with blood or mucus.
- Report any new or worsening rash, peeling skin or blistering.
- Seek help for new cough, shortness of breath or trouble breathing, which can signal lung inflammation (pneumonitis).
- Tell your doctor about signs of liver problems, since liver tests are monitored.
- Report any bleeding or bruising problems, since blood counts can drop.
Call your doctor promptly for signs of infection, severe or bloody diarrhea, worsening rash or skin peeling, or new cough or breathing trouble.
Duvelisib warnings and precautions
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- Fatal and serious infections are the biggest risk, including pneumonia, sepsis, PJP and CMV. Preventive medicines are used.
- Diarrhea or colitis can be severe and may need steroid treatment.
- Serious skin reactions, including SJS, TEN and DRESS, can occur.
- Pneumonitis (lung inflammation) can occur.
- Liver injury and low neutrophils require regular lab monitoring.
- Fetal harm is possible.
Duvelisib interactions
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Duvelisib is broken down mainly by the CYP3A4 enzyme, so some medicines change its levels.
- Strong CYP3A4 inhibitors (such as ketoconazole) raise duvelisib levels, so the dose is lowered.
- Strong CYP3A4 inducers (such as rifampin) lower levels and should be avoided.
- Moderate CYP3A4 inducers should be avoided. If needed, the dose is increased.
- Sensitive CYP3A4 substrates (such as midazolam) may reach higher levels, so their doses may need lowering.
Interactions listed in the FDA-approved label
From the Duvelisib prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Strong CYP3A4 inhibitors (e.g., ketoconazole): Coadministration increases duvelisib AUC, which may increase the risk of COPIKTRA toxicities. Reduce COPIKTRA dose to 15 mg twice daily.
- Strong CYP3A4 inducers: Coadministration decreases duvelisib AUC, which may reduce COPIKTRA efficacy. Avoid coadministration.
- Moderate CYP3A4 inducers: Coadministration decreases duvelisib AUC, which may reduce COPIKTRA efficacy. Avoid coadministration; if it cannot be avoided, increase the COPIKTRA dose.
- Sensitive CYP3A4 substrates: Coadministration with COPIKTRA increases AUC of a sensitive CYP3A4 substrate, 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.
Read the label’s full interactions text
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 ) 7.1 Effects 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 )]. 7.2 Effects 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.
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Duvelisib
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- Active infections should be treated before starting.
- Pregnancy: duvelisib can harm a fetus. A pregnancy test is done first.
- Use effective contraception during treatment and for at least 1 month after the last dose (women, and men with partners who could become pregnant).
- Do not breastfeed during treatment and for at least 1 month after the last dose.
- Male fertility may be affected.
- Not studied in children.
- Older adults had no major differences in safety or effectiveness.
- Kidney or liver impairment did not clinically change drug exposure, but liver tests are monitored during treatment.
What Duvelisib does in the body
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At the usual dose, duvelisib lowered levels of phosphorylated AKT, a marker that PI3K is being blocked. Studies of heart rhythm (QTc interval) did not show increases of more than 20 milliseconds.
How your body processes Duvelisib
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About 42% of an oral dose is absorbed, with peak levels in 1 to 2 hours. Food does not meaningfully change overall exposure, so it can be taken with or without food. Duvelisib is mostly broken down by CYP3A4 and has a half-life of about 4.7 hours. Most is cleared in the stool, with a smaller amount in urine.
How to store Duvelisib
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Store at 20° to 25°C (68° to 77°F), with excursions permitted at 15° to 30°C (59° to 86°F) .
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Duvelisib
143 supplements and herbal products have documented interactions with Duvelisib in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 3
- Moderate · 100
- Minor · 40
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Duvelisib: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Duvelisib — the kind of thing our pharmacy team would talk through with you at the counter.
What is duvelisib for?
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How do I take it?
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What side effects should I expect?
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Why will I take other medicines with it?
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Can I take it with my other medicines?
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Is it safe in pregnancy?
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Is Duvelisib available over the counter?
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When was Duvelisib first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Duvelisib on HelloPharmacist
Duvelisib forms and strengths (how it comes)
Duvelisib is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Duvelisib inactive ingredients by manufacturer.
Capsule
How this form is used
- Copiktra is used for relapsed or refractory CLL or SLL after at least two prior therapies.
- Copiktra is used for relapsed or refractory follicular lymphoma after at least two prior systemic therapies.
- Copiktra capsules are taken by mouth twice daily with or without food.
- Swallow Copiktra capsules whole. Do not open, break or chew them.
- If a Copiktra dose is missed by fewer than 6 hours, take it right away. If more than 6 hours, skip it and take the next dose at the usual time.
Duvelisib on the U.S. market: products, makers and brands
How Duvelisib appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
1 company lists 2 Duvelisib product records with the FDA, mostly as capsule; the earliest marketing or approval year on record is 2018. Brand names on the directory include Copiktra; the rest are generics.
Compare Duvelisib products
A representative set of FDA-listed product records for Duvelisib — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Capsule | ||||
| 15 mg | Oral | Secura Bio, Inc | NDA | View NDC → |
| 25 mg | Oral | Secura Bio, Inc | NDA | View NDC → |
Showing 2 of 2 products — FDA National Drug Code Directory. See every product, package size and price: browse all 2 Duvelisib NDCs →
Duvelisib side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Duvelisib — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Duvelisib in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Duvelisib FDA approval history
How Duvelisib went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Duvelisib recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Duvelisib recalls since July 2021.
✅No Duvelisib recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 2058509 1 dose form · 2 strengths
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Dose form (SCDF) Oral Capsule RxCUI 2058513In current FDA listings
Look up RxCUI 2058509 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Duvelisib supply and shortage status
Whether Duvelisib is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Duvelisib brand names
Duvelisib is sold under one brand name in the FDA directory — Copiktra. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Duvelisib: manufacturers and labelers
One company lists Duvelisib products with the FDA. By number of product records, the largest are Secura Bio, Inc. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Duvelisib drug class (RxNorm)
Duvelisib belongs to the Phosphatidylinositol-3-kinase (Pi3K) inhibitors class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Duvelisib page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Secura Bio, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →