Substance / Medication

Idelalisib

Overview

Active Ingredient
idelalisib
RxNorm CUI
1544460

Indications

Zydelig is indicated, in combination with rituximab, for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL) for whom rituximab alone would be considered appropriate therapy due to other co-morbidities.

Labeler: Gilead Sciences, Inc.Updated: 2025-02-20T00:00:00.000ZFull label on DailyMed

Boxed Warning

FDA Black Box Warning

Dosage and Administration (2.2) Warnings and Precautions (5.1) [see,] Fatal and/or serious hepatotoxicity occurred in 16% of Zydelig-treated patients. Monitor hepatic function prior to and during treatment. Interrupt and then reduce or discontinue Zydelig as recommended. Dosage and Administration (2

Contraindications

When this intervention should not be used

Warnings and Precautions (5.6 5.7) [see,] Zydelig is contraindicated in patients with a history of serious hypersensitivity reactions to idelalisib, including anaphylaxis, or patients with a history of toxic epidermal necrolysis with any drug.

Indications & Related Conditions

Conditions associated via SNOMED clinical relationships

Administration & Protocol

Dosing, route, and treatment protocol

Detailed dosage and administration information is available in the full FDA drug label.

View full prescribing information on DailyMed

Monitoring & Follow-Up

Biomarkers relevant to this intervention via related conditions

No monitoring biomarkers have been mapped yet. Biomarker-intervention linkages are derived through related conditions and will expand as the knowledge graph grows.

Clinical Trials

2 trials linked to this intervention

2
Total Trials
1
Recruiting
1
With Results

Research Evidence

Published studies and systematic reviews

Sort:
Clinical Trials Portfolio and Regulatory History of Idelalisib in Indolent Non-Hodgkin Lymphoma: A Systematic Review and Meta-analysis.
Banerjee Titas, Kim Myung Sun, Haslam Alyson et al. · JAMA Intern Med · 2023
PMID: 36939665Meta-AnalysisFull text (PMC)
Incidence and management of toxicity associated with ibrutinib and idelalisib: a practical approach.
de Weerdt Iris, Koopmans Suzanne M, Kater Arnon P et al. · Haematologica · 2017
PMID: 28775119Meta-AnalysisFull text (PMC)
Bendamustine, followed by obinutuzumab and idelalisib in chronic lymphocytic leukemia (CLL2-BCG): Final analysis of a multicenter, open-label phase-II-trial.
Cramer Paula, von Tresckow Julia, Fink Anna-Maria et al. · Am J Hematol · 2024
PMID: 38578022Observational
Treatment with idelalisib in patients with chronic lymphocytic leukemia - real world data from the registry of the German CLL Study Group.
von Tresckow Julia, Heyl Nikola, Robrecht Sandra et al. · Ann Hematol · 2023
PMID: 37358640ObservationalFull text (PMC)
Results of a Prospective Non-Interventional Post-Authorization Safety Study of Idelalisib in Germany.
Hoechstetter Manuela A, Knauf Wolfgang, Dambacher Silvia et al. · Clin Lymphoma Myeloma Leuk · 2022
PMID: 35624058Observational
DBS Assay with LC-MS/MS for the Determination of Idelalisib, A Selective PI3K-δ Inhibitor in Mice Blood and Its Application to a Pharmacokinetic Study.
Tripathy Harsha K, Manju Nair S V, Dittakavi Sreekanth et al. · Drug Res (Stuttg) · 2021
PMID: 32992346Observational
Validation of a survival-risk score (SRS) in relapsed/refractory CLL patients treated with idelalisib-rituximab.
Gentile Massimo, Martino Enrica Antonia, Visentin Andrea et al. · Blood Cancer J · 2020
PMID: 32938904ObservationalFull text (PMC)

Research data from MEDLINE/PubMed

Benefits & Expected Outcomes

Benefits, expected outcomes, efficacy data, and NNT (Number Needed to Treat) are pending physician authorship and evidence review.

Risks & Side Effects

Adverse reaction and safety data for this drug is sourced from the FDA-approved label.

View adverse reactions & drug interactions on DailyMed

Related Symptoms

Symptoms associated with conditions this intervention addresses

No related symptoms have been mapped yet. Symptom linkages are derived through associated conditions.

Alternatives & Comparisons

Alternative treatments, comparison data, and clinical decision support are pending physician authorship.

Medical Disclaimer

This information is for educational purposes only and does not constitute medical advice, diagnosis, or treatment. Always consult with a qualified healthcare provider regarding any medical condition or treatment plan.

Do not start, stop, or change any treatment without consulting your healthcare provider.

Quick Facts

Type
Substance / Medication
Fully Specified Name
Idelalisib (substance)
SNOMED CT
710278000
UMLS CUI
C2698692
RxNorm CUI
1544460
Labeler
Gilead Sciences, Inc.

Clinical Data

This intervention maps to 2 entities in the Healos knowledge graph.

2
Conditions
0
Biomarkers
0
Specialists
0
Symptoms
2
Clinical Trials

Data is sourced from SNOMED CT, UMLS, and the Healos clinical knowledge graph. Content sections marked as pending require physician authorship. Consult a healthcare provider before starting any treatment.