Duvelisib: uses, dosing, side effects & brands
Duvelisib is a medicine sold in the U.S. under one brand, for b-cell chronic lymphocytic leukemia. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Treats
- B-Cell Chronic Lymphocytic Leukemia
- Available as
- Capsule
- Sold as
- Copiktra
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
- Boxed warning
- Boxed warning
How duvelisib is dosed
From the FDA label for Copiktra (application NDA211155). Other duvelisib products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
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. COPIKTRA Dose Modifications and Toxicity Management Abbreviations: ALT = alanine aminotransferase; ANC = absolute neutrophil count; AST = aspartate aminotransferase; CMV = cytomegalovirus; DRESS…
Duvelisib side effects
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. 6.1 Clinical 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…
Who shouldn’t take duvelisib
None. None.
Duvelisib 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.
Every duvelisib product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Copiktra.
What duvelisib pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
Can you crush or split duvelisib?
At least one duvelisibproduct is labelled to be swallowed whole — crushing an extended-release tablet releases the whole day’s dose at once. Which applies depends on the form you were given.
What each duvelisib label says about crushing, splitting and chewingDuvelisib and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for duvelisib: levels in milk, effects in breastfed infants, and the drugs it would consider insteadNo information is available on the clinical use of duvelisib during breastfeeding. Because duvelisib is 98% bound to plasma proteins, the amount in milk is likely to be low. However, because of its potential toxicity in the breastfed infant, the manufacturer recommends that breastfeeding be discontinued during duvelisib therapy and for at least 1 month after the last dose.
National Institute of Child Health and Human Development, record revised February 15, 2025. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about duvelisib
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 177 reports naming duvelisib, and the FDA flagged 92% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- diarrhoea17 reports
- febrile neutropenia17 reports
- fatigue14 reports
- pneumonia13 reports
- neutropenia11 reports
- rash10 reports
- mucosal inflammation9 reports
- acute kidney injury7 reports
Read these as a signal, not a rate. A report does not mean duvelisib caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
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Frequently asked questions
What is duvelisib?
Copiktra (Duvelisib) is a medication used to treat B-Cell Chronic Lymphocytic Leukemia.
Can you take duvelisib with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run duvelisib against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does duvelisib come in?
Across the brands we track, duvelisib is currently marketed as capsule, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic duvelisib?
We do not currently list a generic-labelled duvelisib product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Duvelisib: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/duvelisib
- MLA
- “Duvelisib: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/duvelisib.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for duvelisib on DailyMed (NIH) ↗ — including its boxed warning in full.