Bondronat

Look at the difference a week’s Leustatin treatment can make

Indicated for primary or secondary treatment of patients with Hairy Cell Leukemia (HCL)1

Leustatin and Leustat are exactly the same product but may be known by different names in different countries and markets.


Hairy Cell Leukemia (HCL)

Indicated for primary or secondary treatment of patients with HCL1

Prevalence

  • Around 1600 new cases of HCL are diagnosed in Europe each year2

  • More men than women have HCL – approximate ratio 4:12

Diagnosis

  • Symptomatic patients may experience: weight loss, weakness and breathlessness, frequent infections, anemia, pale complexion, enlarged spleen,3 lethargy or infection4

  • About 25% of patients are asymptomatic when diagnosed3,4

  • Usually, these patients are identified through abnormal results from a routine full blood count3

3D illustration of ‘Hairy Cell’ B-lymphocytes

Look at the difference a week can make

Leustatin is highly effective in HCL5

A review of eight recent studies confirms cladribine’s efficacy6

76–100%

1st line complete response (CR)

97–100%

1st line overall response rate (ORR)

In 1993, Leustatin revolutionized HCL treatment5,7

  • Until the early 1980s, median overall survival was around 4 years6

  • After treatment with Leustatin, about 50% are still in remission 15+ years later6

  • Treatments like Leustatin have helped patients stay alive 30 years later6
"[Cladribine’s] profound impact on the natural history of hairy cell leukaemia is well known and revolutionized the treatment..." 5

Sigal DS et al. 2010

The complete course in just one week



In HCL Patients1

  • Continuous intravenous infusion for 7 consecutive days

  • Dosage 0.09 mg/kg/day (3.6 mg/m2/day)
“Standard [Leustatin] dosing is generally well tolerated, mainly causing cytopenias and fevers.” 5

Sigal DS et al. 2010

Adverse reactions, contraindications and warnings with Leustatin in HCL treatment1

Very Common Administration site reaction, Fatigue, Pyrexia, Rash, Nausea, Headache.
Common Septic shock.
Secondary malignancies, Primary hematological malignancies.
Hypersensitivity, Hemolytic anaemia, Anemia, Febrile neutropenia, Confusion, Anxiety, Insomnia, Dizziness.
Conjunctivitis, Tachycardia, Myocardial ischemia.
Pulmonary interstitial infiltrates, Breath sounds abnormal, Cough, Dysponea, Rales.
Abdominal pain, Constipation, Diarrhea, Flatulence, Vomiting.
Urticaria, Ecchymosis, Hyperhidrosis, Petechiae, Pruritus.
Arthralgia, Myalgia, Pain.
Renal failure.
Asthenia, Chills, Decreased appetite, Malaise, Muscular weakness, Edema peripheral.
Contusion.
Contraindications Patients hypersensitive to cladribine or other components of this product.
Special warnings and precautions are advised in association with these conditions Progressive multifocal leukoencephalopathy (PML), Bone marrow suppression, Neurotoxicity, Fever/Infection, Tumour lysis syndrome, Effects on renal and hepatic function, Hematological profile, Potential carcinogenesis/mutagenesis, Extravasation.
Effects on fertility Treatment should not be given during pregnancy. Leustatin Injection is teratogenic in mice and rabbits. Breastfeeding should not be undertaken during treatment and for 6 months after the last dose. Men should be advised not to father a child up to 6 months after the last dose.


Physicians should consider delaying or discontinuing the drug if neurotoxicity or renal toxicity occurs. Careful hematological monitoring, especially during the first 4 to 8 weeks after treatment with Leustatin is recommended. See the Summary of Product Characteristics for more details.

Leustatin in B-cell chronic lymphocytic leukemia (CLL)



In CLL Patients1

Leustatin is also indicated for CLL in patients who have not responded to, or whose disease has progressed during or after, treatment with at least one standard alkylating-agent containing regimen1.

References

  1. Leustat Injection Summary of Product Characteristics.
  2. Robak T et al. Ann Oncol. 2015;26 Suppl 5:v100-7.
  3. Leukaemia Care. Hairy Cell Leukaemia. Available at: https://www.leukaemiacare.org.uk/support-and-information/information-about-blood-cancer/blood-cancer-information/leukaemia/hairy-cell-leukaemia/ [Last accessed November 2022].
  1. Parry-Jones N et al. Br J Haematol 2020;191:730-737.
  2. Sigal DS et al. Blood 2010;116(60):2884-2896.
  3. Else M et al. Best Pract Res Clin Haematol 2015;28:217-229.
  4. Tortorella C et al. Curr Opin Investig Drugs 2001;2(12):1751-6.



Downloads

Prescribing Information
Patient Information Leaflet
Summary of Product Characteristics

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Adverse events should be reported. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellowcard in the Google Play or Apple App Store. Adverse events should also be reported to ATNAHS Pharma UK Ltd on 00 44 (0) 1279 406759, or by email to athnahspv@diamondpharmaservices.com