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Purine analogue / immunosuppressant Pregnancy: Contraindicated in pregnancy and breast-feeding (§4.3). §4.6 verbatim: 'Cladribine causes serious birth defects when administered during pregnancy. Animal studies and in vitro studies with human cell lines demonstrated the teratogenicity and mutagenicity of cladribine. Cladribine is contraindicated in pregnancy. Women of childbearing potential must use effective contraception during treatment with cladribine and for 6 months after the last cladribine dose.' Breast-feeding: 'Limited data from case reports have shown that cladribine is excreted in human milk. The quantity is not yet well established. Because of the potential for serious adverse reactions in nursing infants, lactation is contraindicated during treatment with cladribine and for 6 months after the last cladribine dose.' Fertility: 'Men being treated with cladribine should be advised not to father a child up to 6 months after treatment and to seek advice of cryoconservation of sperm prior to treatment because of the possibility of infertility due to therapy with cladribine.'

Cladribine

Brand names: Litak, Mavenclad

Cladribine is a purine nucleoside analogue cytotoxic agent used in hairy cell leukaemia and certain other lymphoid malignancies, and (as a separate oral preparation) in relapsing multiple sclerosis.

Adult dose

Dose: HAIRY CELL LEUKAEMIA (parenteral cladribine — LITAK 2 mg/ml solution for injection, subcutaneous): 0.14 mg/kg body weight per day (i.e. 0.14 mg/kg/day), given as a SINGLE COURSE on 5 consecutive days. §4.2 verbatim: 'The recommended posology for hairy cell leukaemia is a single course of LITAK given by subcutaneous bolus injection at a daily dose of 0.14 mg/kg body weight for 5 consecutive days. Deviations from the posology indicated above are not advised.' Therapy must be initiated by a qualified physician experienced in cancer chemotherapy. ⚠️ SCOPE, STATED DELIBERATELY: this covers ONLY the haematological (hairy cell leukaemia) indication by the SUBCUTANEOUS route. The ORAL multiple sclerosis regimen (Mavenclad / cladribine tablets), which this page's brand list also names, is NOT sourced here and must NOT be inferred from the figure above — it is a different product, route and dose scale, and the site carries it on its own page. Intravenous administration is likewise not covered by this source.
Route: Subcutaneous bolus injection, undiluted. §4.2 verbatim: 'LITAK is supplied as a ready-to-use solution for injection. The recommended dose is directly withdrawn by a syringe and injected as a subcutaneous bolus injection without dilution. LITAK should be inspected visually for particulate matter and discoloration prior to administration. LITAK should warm up to room temperature prior to administration.' §4.2 also states it 'can be self-administered by the patient. Patients should be instructed and trained appropriately.' The oral and intravenous routes this page also lists are NOT covered by this source.
Frequency: Once daily for 5 consecutive days, as a single course (§4.2). The SPC gives no repeat-course interval and states that 'Deviations from the posology indicated above are not advised.'
INDICATION CONFIRMED BY §4.1 (newly captured), verbatim and in full: 'LITAK is indicated for the treatment of hairy cell leukaemia.' A later matcher fix has done exactly that — the product in this bundle is now LITAK 2 mg/ml solution for injection (eMC product 6194), the parenteral haematology product. || ⚠️ NO MAXIMUM DOSE IS PUBLISHED, DELIBERATELY. §4.2 prints no ceiling for this indication — only the 0.14 mg/kg/day × 5 days regimen and the instruction that deviations are not advised. The 5-day course total has NOT been calculated and must not be: a multiplied figure would be an invented ceiling, not the label's own. maxDose is therefore left empty. || PAEDIATRIC: none published, and nothing scaled. §4.2 verbatim: 'Paediatric population LITAK is contraindicated in patients less than 18 years of age (see section 4.3).' §4.3 repeats it as an absolute contraindication. paedDose is null so the weight-based calculator does not mount. || ELDERLY, §4.2 verbatim: 'Experience with patients older than 65 years is limited. Elderly patients should be treated by individual assessment and careful monitoring of the blood counts and of the renal and hepatic function. The risk requires assessment on a case-by-case basis.' || TUMOUR LYSIS SYNDROME, §4.4: 'In patients with a high tumour burden, prophylactic allopurinol therapy to control serum levels of uric acid, together with adequate or increased hydration' is advised — the sentence is cut at the source-fetch limit, so the prophylaxis regimen beyond that point was NOT retrieved and is not reproduced here. || TRANSFUSION, §4.4 verbatim: 'It is recommended that patients receiving cladribine should receive irradiated cellular blood components/products to prevent transfusion-related graft-versus-host disease (Ta-GVHD).' || §4.4 (which also absorbs the §4.5 interaction text — eMC does not expose §4.5 as its own heading) and §4.8 are cut at the source-fetch limit, so the warnings and adverse-reaction lists below are partial, not exhaustive. || CROSS-CHECK NOT USED FOR DOSING: the openFDA record in this bundle is a US cladribine label from Apotex Corp. (label date 2026-06-08); no figure has been taken from it, because US labelling may differ from the UK SPC and the UK product above already covers this page's indication. The WHO provider is a link only (https://list.essentialmeds.org/medicines/903) with no dosing extracted.

Dose adjustments

Renal

Contraindicated in moderate to severe renal impairment. §4.2 verbatim: 'There are no data on the use of LITAK in patients with renal or hepatic impairment. LITAK is contraindicated in patients with moderate to severe renal impairment (creatinine clearance ≤ 50 ml/min) or with moderate to severe hepatic impairment (Child-Pugh score > 6).' §4.4 adds: 'Careful treatment is required in patients with known or suspected renal or hepatic impairment. For all patients treated with LITAK, periodic assessment of renal and hepatic function is advised as clinically indicated.' No numeric dose reduction band is given.

Hepatic

Contraindicated in moderate to severe hepatic impairment (Child-Pugh score > 6) — §4.2 and §4.3. §4.4: 'There are no data on the use of LITAK in patients with renal or hepatic impairment. Clinical experience is very limited and safety of LITAK in these patients is not well established… Careful treatment is required in patients with known or suspected renal or hepatic impairment.' No numeric dose reduction band is given.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance or any of the excipients listed in section 6.1 (§4.3)
  • Pregnancy and lactation (§4.3)
  • Patients less than 18 years of age (§4.3, restated in §4.2 under Paediatric population)
  • Moderate to severe renal impairment — creatinine clearance ≤ 50 ml/min (§4.3)
  • Moderate to severe hepatic impairment — Child-Pugh score > 6 (§4.3)
  • Concomitant use of other myelosuppressive medicinal products (§4.3)

Side effects

  • §4.8 summary of the safety profile, verbatim: the very common reactions across 279 treated patients and 62 patients with hairy cell leukaemia (HCL) were 'myelosuppression, especially severe neutropenia (41% (113/279), HCL 98% (61/62)), severe thrombocytopenia (21% (58/279), HCL 50% (31/62)) and severe anaemia (14% (21/150), HCL 55% (34/62)), as well as severe immunosuppression/lymphopenia (63% (176/279), HCL 95% (59/62)), infections (39% (110/279), HCL 58% (36/62)) and fever (up to 64%)'
  • Culture-negative fever — §4.8: 'occurs in 10-40% of patients with hairy cell leukaemia and is rarely observed in patients with other neoplastic disorders'
  • Very common: infections (e.g. pneumonia, septicaemia); pancytopenia/myelosuppression, neutropenia, thrombocytopenia, anaemia, lymphopenia; immunosuppression; decreased appetite; headache, dizziness; purpura (§4.8)
  • Common: second malignancies; insomnia, anxiety; tachycardia, heart murmur, hypotension, epistaxis, myocardial ischaemia; petechiae, haemorrhages (§4.8)
  • Uncommon: haemolytic anaemia; cachexia; somnolence, paraesthesia, lethargy, polyneuropathy, confusion, ataxia; conjunctivitis; phlebitis (§4.8)
  • Rare: tumour lysis syndrome; hypereosinophilia; graft-versus-host disease; apoplexy, neurological disturbances in speech and swallowing; cardiac failure, atrial fibrillation, cardiac decompensation (§4.8)
  • Very rare: amyloidosis; depression, epileptic seizure; blepharitis (§4.8)
  • Skin rashes (2-31%), nausea (5-28%), vomiting (1-13%), diarrhoea (3-12%), fatigue (2-48%), headache (1-23%) and decreased appetite (1-22%) reported during treatment (§4.8). Rashes are 'mainly described in patients with other concomitantly administered medicinal products known to cause rash (antibiotics and/or allopurinol)'
  • Progressive multifocal leukoencephalopathy (PML), including fatal cases — §4.4: 'PML was reported 6 months to several years after treatment with cladribine. An association with prolonged lymphopenia has been reported in several of these cases… Patients with suspected PML should not receive further treatment with cladribine.'
  • Secondary malignancies — §4.4: 'Secondary malignancies are expected to occur in patients with hairy cell leukaemia. Their frequency varies widely, ranging from 2% to 21%… The frequency of second malignancy following treatment with LITAK was 3.4% in all 232 hairy cell leukaemia patients treated, during a 10-year period.'
  • ⚠️ LIST IS PARTIAL: the §4.8 tabulated list is cut at the source-fetch limit part-way through 'Vascular disorders', so system organ classes beyond that point were not retrieved

Interactions

  • Concomitant myelosuppressive medicinal products — an absolute contraindication in §4.3 ('Concomitant use of other myelosuppressive medicinal products')
  • Blood transfusion — §4.4: 'It is recommended that patients receiving cladribine should receive irradiated cellular blood components/products to prevent transfusion-related graft-versus-host disease (Ta-GVHD)'
  • NOTE ON COMPLETENESS: eMC does not expose §4.5 as a separate section heading — its interaction text is absorbed into the §4.4 block, and that block is cut at the source-fetch limit in this bundle, so this list is partial rather than a complete interaction profile

Monitoring

  • Peripheral blood counts — §4.4 verbatim: 'Careful and regular monitoring of peripheral blood counts is essential during, and for 2 to 4 months following, treatment with cladribine to detect potential adverse reactions and consequent complications (anaemia, neutropenia, thrombocytopenia, infections, haemolysis or bleedings), and to survey haematologic recovery.'
  • Myelosuppression — §4.4: 'During the first month following treatment, myelosuppression is most notable and red blood cell or platelet transfusions may be required.'
  • Infection surveillance — §4.4: 'An increased incidence of opportunistic infections is expected during, and for 6 months following, therapy with cladribine.' Patients with active infection should be treated for the underlying condition before receiving cladribine.
  • Fever — §4.4: 'Fever of unknown origin frequently occurs in patients treated for hairy cell leukaemia and is manifested predominantly during the first 4 weeks of therapy. The origin of febrile events should be investigated by appropriate laboratory and radiologic tests. Less than a third of febrile events are associated with a documented infection.'
  • Renal and hepatic function — §4.4: 'For all patients treated with LITAK, periodic assessment of renal and hepatic function is advised as clinically indicated.'
  • Neurological review for PML — §4.4: consider PML in the differential diagnosis in patients with new or worsening neurological, cognitive or behavioural signs or symptoms; suggested evaluation is 'neurology consultation, magnetic resonance imaging of the brain, and cerebrospinal fluid analysis for JC virus (JCV) DNA by polymerase chain reaction (PCR) or a brain biopsy with testing for JCV. A negative JCV PCR does not exclude PML.'
  • Second malignancy surveillance — §4.4: 'patients treated with cladribine should be regularly monitored'
  • Elderly — §4.2: individual assessment with 'careful monitoring of the blood counts and of the renal and hepatic function'
  • Pregnancy prevention — §4.6: effective contraception during treatment and for 6 months after the last dose (women of childbearing potential); men advised not to father a child up to 6 months after treatment

Clinical monograph

How it works

As a deoxyadenosine analogue it is phosphorylated intracellularly and accumulates particularly in lymphocytes, disrupting DNA synthesis and repair and causing selective lymphocyte depletion and apoptosis.

Prescribing in practice

  • Profound and prolonged myelosuppression and lymphopenia occur, with a consequent risk of serious and opportunistic infection requiring close haematological monitoring.
  • It is markedly immunosuppressive; consider infection prophylaxis and avoid live vaccines during and after treatment.
  • Verify the correct product and route, as haematology (parenteral) and multiple sclerosis (oral) preparations and regimens differ.

Monitoring

Monitor full blood count, including lymphocyte subsets, and watch closely for febrile neutropenia and opportunistic infection.

Counselling the patient

  • Report fever or any sign of infection without delay, as your white cell count may be very low.
  • Effective contraception is advised during and for a period after treatment.
  • Avoid live vaccines and discuss any planned immunisations with your team.

Evidence & guidelines

Cladribine produces durable complete responses in hairy cell leukaemia and is an established option supported by long-term cohort data; consult current prescribing references for malignancy regimens.

Reference: NICE TA616; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

Pathways