CLADRIBINE – BELMED, Solution for injection, 1 mg/ml
Patient information leaflet
Trade name: Cladribine-Belmed
International nonproprietary name (INN): Cladribine
Dosage form: solution for injection 1 mg/ml
Description: a clear colorless solution
Composition per one vial:
active ingredient: cladribine – 10 mg;
excipients: potassium dihydrogen phosphate, sodium chloride, 1 M solution of sodium hydrox-ide, water for injection.
Pharmacotherapeutic group: Antineoplastic agents. Antimetabolites. Purine analogues.
ATC Code: L01BB04
Cladribine is a 2'-deoxyadenosine analogue, which is a component of DNA molecule. Lym-phoid cells are more sensitive to the drug product (due to higher activity of deoxycytidine ki-nase and low activity of 5'-nucleotidase in these cells) than non-lymphoid cells. 25% of cladribine penetrates into cerebrospinal fluid. The drug product is mainly eliminated by kid-neys (35 %), minute quantity (1 %) – by intestinal tract.
- Hairy Cell Leukemia;
- Chronic lymphatic leukemia (progressing forms and the ones resistant to first line poly-chemotherapy drugs);
- Low-grade and intermediate magliant non-Hodgkin's lymphomas.
Dosage and administration
Dosage and duration of treatment should be prescribed by attending doctor depending on pecu-liarities of disease state and severity of patient's condition.
The drug product is injected by drop infusion in a dose of 0.09 mg/kg/day. Administration in higher doses could lead to the development of toxic effects.
For treatment of Hairy Cell Leukemia a single course for 7 days by continuous 24-hours intra-venous infusion is recommended. In patients with chronic lymphocytic leukemia the recom-mended treatment consists of a continuous intravenous infusion of Cladribine-Belmed for 2 hours on days 1 to 5 of a 28 day cycle, from 1 to 6 cycles could be applied.
In a form of salt solutions the drug product is stable for 24-hours.
Hemopoietic system: leucopenia, neutropenia, thrombocytopenia, anemia, pancytopenia, aplas-tic and hemolytic anemia; very rare – myelodysplastic syndrome.
Gastro-intestinal system: dizziness, vomiting, anorexia, diarrhea, constipation, gastralgia, in-crease of bilirubin and/or transaminases level.
Nervous system: headache, dizziness, insomnia, peripheral sensory neuropathy.
Cardiovascular system: oedema, tachycardia.
Respiratory system: cough, rapid breathing, interstitial pneumonitis, change of percussion sound and auscultatory properties of breathing. BELMEDPREPARATY RUE, Belarus, Minsk CLADRIBINE – BELMED, Solution for injection, 1 mg/ml Page 2 of 3
Skin/subcutaneous tissue: rash, skin peeling, skin itch, nettle rash.
Local reactions: erythema, pain, oedema, thrombosis, phlebitis.
Other: hyperthermia, weakness, asthenia, undue fatiguability, diversely located pain, purpura, petechia, nasal hemorrhage, immune suppression, susceptibility to opportunistic infections, to the infections caused by Herpes simplex, Herpes zoster, cytomegalovirus.
In case of the above mentioned adverse reactions occurrence or developments of side effects not listed in the present leaflet consult your doctor.
Cladribine is contraindicated to those patients who are hypersensitive to this drug, suffer from moderate or severe renal insufficiency (creatinine clearance is less than 50 ml/min), moderate or severe liver insufficiency (4 and more according to Child – Pugh scores). Simultaneous ad-ministration of myelosuppressive drug products, administration during pregnancy and lactation are contraindicated.
With caution: pediatric use in children under 16 years of age (efficacy and safety are underin-vestigated). Suppression of bone marrow functions, infections.
Symptoms: irreversible neurologic toxicity (paraparesis/quadriparesis), acute nephrotoxicity, significant bone marrow suppression (neutropenia, anemia, thrombocytopenia).
Treatment: symptomatic, no specific antidote is available.
Cladribine should be administered under the supervision of a qualified physician experienced in the use of antineoplastic therapy. Myelosuppression caused by the drug product administra-tion is commonly occurs within a month from the moment of treatment start, it is usually re-versible and appears to be dose dependent. Blood values should be thoroughly controlled dur-ing treatment and at least during 4-8 weeks after.
Special care should be taken for the patients with initial suppression of bone marrow functions of any origin because of the risk of prolonged hypoplasia development. In some cases the treatment could cause severe forms of immunosuppression with decrease of CD4+-leucocytes quantity.
In case of hyperthermia development affected by neutropenia, general state of a patient should be controlled during the first month of treatment and, if necessary, prescribing of antibacterial therapy is required.
In case of neurotoxicity development administration of Cladribine-Belmed should be discon-tinued until neurological symptomatic is resolved.
Treatment of patients with renal and/or liver insufficiency should be performed under direct control of kidneys and liver function.
Treatment should be discontinued in case of nephrotoxicity or hepatoxicity development.
Careful monitoring of elderly patients should be performed (because of absence of pharmaco-kinetics data).
Administration during pregnancy and lactation. Administration during pregnancy and lactation is contraindicated. BELMEDPREPARATY RUE, Belarus, Minsk CLADRIBINE – BELMED, Solution for injection, 1 mg/ml Page 3 of 3
Effects on ability to drive and use potentially dangerous machines. A person should not drive and engage in potentially dangerous activities requiring increased attention and rapidity of psy-chomotor abilities.
Interaction with other drug products
Additive suppression of bone morrow functions is possible in case of other myelotoxic drug products prescription simultaneously or immediately after treatment with Cladribine-Belmed.
High doses of Cladribine-Belmed in combination with cyclophosphamide and radiation thera-py cause neurotoxicity (irreversible para- and tetraparesis) and nephrotoxicity (acute renal in-sufficiency). Allopurinol and antibiotics increase skin rash. Cladribine shows increased degra-dation when mixed with 5% solution of dextrose, therefore this diluent should not be used.
Store in protected from light place at temperature below 25 ºC.
Keep out of reach of children.
Do not use after the expiration date specified on the package.
10 ml in vials in package No. 1.
Republic of Belarus,
30 Fabritsius Str.