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Litak is a brand name for Cladribine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: LITAK is indicated for the treatment of hairy cell leukaemia.
Verbatim from this product's EMA label. Tap a section to expand.
Therapy with LITAK should be initiated by a qualified physician with experience in cancer chemotherapy. 14 mg/kg body weight for 5 consecutive days. Deviations from the posology indicated above are not advised. Elderly 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. 4). Renal and hepatic impairment There are no data on the use of LITAK in patients with renal or hepatic impairment.
2). 3). Method of administration 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 The recommended dose is directly withdrawn by a syringe and injected as a subcutaneous bolus injection without dilution.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. 3 Self-administration by the patient LITAK can be self-administered by the patient. Patients should be instructed and trained appropriately. Detailed instructions are contained in the Package Leaflet.
Summary of the safety profile Very common adverse reactions observed during the three most relevant clinical trials with cladribine in 279 patients treated for various indications and in 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 following treatment with cladribine occurs in 10-40% of patients with hairy cell leukaemia and is rarely observed in patients with other neoplastic disorders. Skin rashes (2-31%) are mainly described in patients with other concomitantly administered medicinal products known to cause rash (antibiotics and/or allopurinol).
Gastrointestinal adverse reactions like nausea (5-28%), vomiting (1-13%), and diarrhoea (3-12%) as well as fatigue (2-48%), headache (1-23%), and decreased appetite (1-22%) have been reported during treatment with cladribine. Cladribine is unlikely to cause alopecia; mild and transient alopecia for a few days was observed in 4/523 patients during the treatment, but could not clearly be associated with cladribine.
Tabulated list of adverse reactions Adverse reactions that have been reported are listed in the table below by frequency category and system organ class.
The frequencies are defined as follows:
Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data). For severity, please see text below the table.
g. pneumonia *, septicaemia *) Neoplasms benign, malignant and unspecified (incl cysts and polyps) Common: second malignancies * Rare: tumour lysis syndrome * Blood and lymphatic system disorders Very common: pancytopenia/myelosuppression *, neutropenia, thrombocytopenia, anemia, lymphopenia Uncommon: haemolytic anaemia * Rare: hypereosinophilia Very rare: amyloidosis Immune system disorders Very common: immunosuppression * Rare: graft-versus-host disease * Metabolism and nutrition disorders Very common: decreased appetite Uncommon: cachexia Nervous system disorders Very common: headache, dizziness Common: insomnia, anxiety Uncommon: somnolence, paraesthesia, lethargy, polyneuropathy, confusion, ataxia Rare: apoplexy, neurological disturbances in speech and swallowing Very rare: depression, epileptic seizure Eye disorders Uncommon: conjunctivitis Very rare: blepharitis Cardiac disorders Common: tachycardia, heart murmur, hypotension, epistaxis, myocardial ischemia * Rare: Cardiac failure, atrial fibrillation, cardiac decompensation Vascular disorders Very common: purpura Common: petechiae, haemorrhages * Uncommon: phlebitis Respiratory, thoracic and mediastinal disorders Very common: abnormal breath sounds, abnormal chest sounds, cough Common: shortness of breath, pulmonary interstitial infiltrates mostly due to infectious aetiology, mucositis Uncommon: pharyngitis Very rare: lung embolism Gastrointestinal disorders Very common: nausea, vomiting, constipation, diarrhoea Common: gastrointestinal pain, flatulence Rare: ileus Hepato-biliary disorders Common: reversible, mostly mild increases in bilirubin and transaminases Rare: hepatic failure Very rare: cholecystitis Skin and subcutaneous tissue disorders Very common: rash, localised exanthema, diaphoresis Common: pruritus, skin pain, erythema, urticaria Rare: Stevens-Johnson syndrome/Lyell syndrome Musculoskeletal and connective tissue disorders Common: myalgia, arthralgia, arthritis, bone pain Renal and urinary disorders Rare: renal failure General disorders and administration site conditions Very common: injection site reactions, fever, fatigue, chills, asthenia Common: oedema, malaise, pain * see descriptive section below.
Cladribine is an antineoplastic and immunosuppressive substance that can induce considerable toxic adverse reactions, such as myelo- and immunosuppression, long-lasting lymphocytopenia, and opportunistic infections. Patients undergoing treatment with cladribine should be closely monitored for signs of haematologic and non-haematologic toxicities.
Particular caution is advised and risks/benefits should be carefully evaluated if administration of cladribine is considered in patients with increased infection risk, manifested bone marrow failure or infiltration, myelosuppressive pre-treatments, as well as in patients with suspected or manifested renal and hepatic insufficiency.
Patients with active infection should be treated for the underlying condition prior to receiving therapy with cladribine. Although anti-infective prophylaxis is not generally recommended, it may be beneficial for patients immunocompromised prior to therapy with cladribine or for patients with a pre-existing agranulocytosis.
If severe toxicity occurs, the physician should consider delaying or discontinuing the therapy with the medicinal product until serious complications resolve. In case of infections, antibiotic treatment should be initiated as required.
It is recommended that patients receiving cladribine should receive irradiated cellular blood components/products to prevent transfusion-related graft-versus-host disease (Ta-GVHD). Progressive multifocal leukoencephalopathy (PML) Cases of PML, including fatal cases, have been reported with cladribine.
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. Physicians should consider PML in the differential diagnosis in patients with new or worsening neurological, cognitive or behavioural signs or symptoms.
Suggested evaluation for PML includes 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.
1. Pregnancy and lactation. Patients less than 18 years of age. 4). Concomitant use of other myelosuppressive medicinal products.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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8 Description of selected adverse reactions Non-haematological adverse reactions Non-haematological adverse reactions are generally mild to moderate in severity. Treatment of nausea with antiemetics is usually not necessary. Adverse reactions related to skin and subcutaneous tissue are mostly mild or moderate and transient, usually resolving within a cycle interval of 30 days.
0 x 109/l). The use of haematopoietic growth factors neither improves the recovery of neutrophil counts nor decreases the incidence of fever. Severe thrombocytopenias (< 50 x 109/l) are observed in about 20% to 30% of all patients. Lymphocytopenia lasting for several months and immunosuppression with an increased risk of infections are expected.
The recovery of cytotoxic T-lymphocytes and natural killer cells occurs within 3 to 12 months. A complete recovery of T-helper cells and B-lymphocytes is delayed for up to 2 years. Cladribine induces a severe and prolonged reduction of CD4+ and CD8+ T-lymphocytes.
At present there exists no experience on possible long-term consequences of this immunosuppression. Infections Severe long-term lymphocytopenias have been reported rarely which, however, could not be associated with late infectious complications.
g. Pneumocystis carinii, Toxoplasma gondii, listeria, candida, herpes viruses, cytomegalovirus and atypical mycobacteria). 7 mg/kg body weight per cycle suffered from infections. 5 mg/kg body weight per cycle. Forty-three […]
A negative JCV PCR does not exclude PML. Additional follow- up and evaluation may be warranted if no alternative diagnosis can be established. Patients with suspected PML should not receive further treatment with cladribine. 4 Secondary malignancies Like other nucleoside analogues, treatment with cladribine is associated with myelosuppression and profound and prolonged immunosuppression.
Treatment with these agents is associated with the occurrence of second malignancies. Secondary malignancies are expected to occur in patients with hairy cell leukaemia. Their frequency varies widely, ranging from 2% to 21%. The peak risk is at 2 years after diagnosis with a median between 40 and 66 months.
The cumulative frequencies of second malignancy are 5%, 10-12% and 13-14% following 5, 10 and 15 years respectively after diagnosis of hairy cell leukaemia. 5 years. 4% in all 232 hairy cell leukaemia patients treated, during a 10-year period.
4 years. Therefore, patients treated with cladribine should be regularly monitored. Haematologic toxicity During the first month following treatment, myelosuppression is most notable and red blood cell or platelet transfusions may be required.
Patients with symptoms of bone marrow depression should be treated with caution, since further suppression of bone marrow function should be anticipated. Therapeutic risks and benefits should be carefully evaluated in patients with active or suspected infections.
The risk of severe myelotoxicity and long-lasting immunosuppression is increased in patients with a disease-related bone marrow infiltration or a previous myelosuppressive treatment. Dose reduction and regular monitoring of the patient is required in such cases.
Pancytopenia is normally reversible and the intensity of bone marrow aplasia is dose-dependent. An increased incidence of opportunistic infections is expected during, and for 6 months following, therapy with cladribine. 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.
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. In case of fever related to infections or agranulocytosis, an antibiotic treatment is indicated. Renal and hepatic impairment There are no data on the use of LITAK in patients with renal or hepatic impairment.
2). 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. Elderly Elderly patients should be treated by individual assessment and careful monitoring of the blood counts and of the renal and hepatic function.
2). Prevention of tumour lysis syndrome In patients with a high tumour burden, prophylactic allopurinol therapy to control serum levels of uric acid, together with adequate or increased hydration, should be commenced 24 hours before the start […]