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)
Real-life efficacy and safety of idelalisib in 55 double-refractory follicular lymphoma patients.
Isidori Alessandro, Loscocco Federica, Visani Giuseppe et al. · Br J Haematol · 2022
PMID: 36002151Trial
Obinutuzumab and idelalisib in symptomatic patients with relapsed/refractory Waldenström macroglobulinemia.
Tomowiak Cécile, Poulain Stéphanie, Herbaux Charles et al. · Blood Adv · 2021
PMID: 33961019TrialFull text (PMC)
Phase 1b study of tirabrutinib in combination with idelalisib or entospletinib in previously treated B-cell lymphoma.
Morschhauser Franck, Dyer Martin J S, Walter Harriet S et al. · Leukemia · 2021
PMID: 33328591TrialFull text (PMC)
Outcomes of patients with up to 6 years of follow-up from a phase 2 study of idelalisib for relapsed indolent lymphomas.
Wagner-Johnston Nina D, Schuster Stephen J, deVos Sven et al. · Leuk Lymphoma · 2021
PMID: 33300385Trial

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 Ltrl knowledge graph.

2
Conditions
0
Biomarkers
0
Specialists
0
Symptoms
2
Clinical Trials

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