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Fludalym Lyophilisate

Fludalym Lyophilisate

fludarabine

Manufacturer:

Teva

Distributor:

KLN Pharma
Concise Prescribing Info
Contents
Fludarabine phosphate
Indications/Uses
Chronic B-cell lymphocytic leukaemia (B-CLL) in patients w/ sufficient healthy blood cell production.
Dosage/Direction for Use
IV 25 mg/m2 once daily as inj or infusion for 5 consecutive days every 28 days.
Contraindications
Hypersensitivity. Haemolytic anaemia. Severe renal impairment. Lactation.
Special Precautions
Start treatment only in patients w/ advanced disease having disease-related symptoms or evidence of disease progression. Perform regular blood tests during treatment. Regularly check kidney function. Patients should receive irradiated blood if blood transfusion is needed. Monitor for unusual CNS effects & any changes to the skin. Risk of autoimmune disorder & autoimmune haemolysis; tumour lysis syndrome. Caution in patients whose bone marrow is not working properly or in patients who are susceptible to infections; patients who will undergo stem cell collection; patients w/ hepatic impairment; patients w/ any form of kidney disease. Avoid live vaccinations during & after treatment. May influence the ability to drive & use machines. Potential harm to fetus. Must not be given during pregnancy unless clearly necessary. Fertile men & women must use reliable contraception during treatment & for at least 6 mth after stopping treatment. Not recommended in childn & adolescents <18 yr. Caution in patients ≥75 yr.
Adverse Reactions
Serious infections; opportunistic infections; pneumonia; thrombocytopenia; neutropenia; anaemia; cough; vomiting, diarrhea, nausea; fever; fatigue; weakness. Myelodysplastic syndrome, AML; myelosuppression; anorexia; peripheral neuropathy; disturbed vision; stomatitis; skin rash; oedema; mucositis; chills; malaise.
Drug Interactions
Combination w/ pentostatin or deoxycoformycin is not recommended. Reduced effectiveness w/ dipyridamole.
MIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01BB05 - fludarabine ; Belongs to the class of antimetabolites, purine analogues. Used in the treatment of cancer.
Presentation/Packing
Form
Fludalym Lyophilisate powd for soln for inj/infusion 50 mg
Packing/Price
1's
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