Substance / Medication

Cladribine

Overview

Active Ingredient
cladribine
RxNorm CUI
44157

Indications

Cladribine Injection, USP is indicated for the treatment of active Hairy Cell Leukemia as defined by clinically significant anemia, neutropenia, thrombocytopenia or disease-related symptoms.

Labeler: Hisun Pharmaceuticals USA, Inc.Updated: 2025-12-23T00:00:00.000ZFull label on DailyMed

Boxed Warning

FDA Black Box Warning

Cladribine injection should be administered under the supervision of a qualified physician experienced in the use of antineoplastic therapy. Suppression of bone marrow function should be anticipated. This is usually reversible and appears to be dose dependent. Serious neurological toxicity (includin

Contraindications

When this intervention should not be used

Cladribine Injection, USP is contraindicated in those patients who are hypersensitive to this drug or any of its components.

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

Research Evidence

Published studies and systematic reviews

Sort:
Cladribine for people with multiple sclerosis.
Celani Maria Grazia, Orso Massimiliano, Melis Marta et al. · Cochrane Database Syst Rev · 2026
PMID: 41510790Meta-AnalysisFull text (PMC)
Safety and efficacy of oral cladribine in relapsing multiple sclerosis: a systematic review and meta-analysis.
Alnajashi Hind, Almohammed Hussain Ali J, Morad Ahmed Salah et al. · BMC Neurol · 2025
PMID: 41420217Meta-AnalysisFull text (PMC)
Real-world experience with cladribine in the two years since treatment start: A systematic review and meta-analysis.
Albanese Angela, Schiavetti Irene, Sormani Maria Pia · Mult Scler Relat Disord · 2025
PMID: 40752118Meta-Analysis
Expert opinion on the long-term use of cladribine tablets for multiple sclerosis: Systematic literature review of real-world evidence.
Oreja-Guevara Celia, Brownlee Wallace, Celius Elisabeth G et al. · Mult Scler Relat Disord · 2023
PMID: 36565573Meta-Analysis
Safety and efficacy of cladribine in multiple sclerosis: a systematic review and meta-analysis.
Nabizadeh Fardin, Mohamadi Mobin, Rahmani Shayan et al. · Neurol Sci · 2023
PMID: 37062787Meta-AnalysisFull text (PMC)
COVID-19 severity among patients with multiple sclerosis treated with cladribine: A systematic review and meta-analysis.
Albanese Angela, Sormani Maria Pia, Gattorno Giovanni et al. · Mult Scler Relat Disord · 2022
PMID: 36137347Meta-AnalysisFull text (PMC)
Systematic review and network meta-analysis (NMA) for cladribine tablets in achieving sustained disability improvement (SDI) in multiple sclerosis.
Piasecka-Stryczyńska Karolina, Kaczyński Łukasz, Rolka Mirosław et al. · Neurol Neurochir Pol · 2022
PMID: 36421066Meta-Analysis
Cladribine tablets versus other disease-modifying oral drugs in achieving no evidence of disease activity (NEDA) in multiple sclerosis-A systematic review and network meta-analysis.
Bartosik-Psujek Halina, Kaczyński Łukasz, Górecka Magdalena et al. · Mult Scler Relat Disord · 2021
PMID: 33516133Meta-Analysis

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.

Specialists

Providers who commonly manage this intervention

Health Goals

Goals connected through associated conditions

Quick Facts

Type
Substance / Medication
Fully Specified Name
Cladribine (substance)
SNOMED CT
386916009
UMLS CUI
C0092801
RxNorm CUI
44157
Labeler
Hisun Pharmaceuticals USA, Inc.

Clinical Data

This intervention maps to 9 entities in the Healos knowledge graph.

4
Conditions
3
Biomarkers
1
Specialists
0
Symptoms

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.