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Indications & Uses
Fludara is indicated for:
Pharmacology
Fludarabine phosphate is rapidly dephosphorylated to 2-fluoro-ara-A, which is then phosphorylated inside cells by the enzyme deoxycytidine kinase to form its active triphosphate, 2-fluoro-ara-ATP. This metabolite appears to work by inhibiting DNA polymerase alpha, ribonucleotide reductase, and DNA primase, thereby blocking DNA synthesis and leading to cell death. The exact mechanism of action of this antimetabolite has not been fully characterized and may involve multiple pathways.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Fludarabine injection should be given only under the supervision of a physician experienced in antineoplastic therapy. The recommended dose is 25 mg Fludarabinebine phosphate per square metre of body surface, given daily for 5 consecutive days, repeated every 28 days, administered by the intravenous route. Each vial is reconstituted with 2 ml of water for injection, giving a solution in which each ml contains 25 mg Fludarabinebine phosphate. The dose required, calculated from the patient's body surface area, is drawn up into a syringe. For a bolus intravenous injection, this dose is diluted further into 10 ml of 0.9% sodium chloride; alternatively, for an infusion, the dose drawn up in the syringe can instead be diluted into 100 ml of 0.9% sodium chloride and infused over approximately 30 minutes. How long treatment continues depends on how well it is working and how well the patient tolerates it. In patients with CLL, Fludarabine should be given until the best response is reached, whether complete or partial remission, usually around 6 cycles, after which the drug should be discontinued. In patients with Lg-NHL, treatment with Fludarabine is recommended until the best response is achieved, and two cycles of consolidation should be considered once that best response has been reached; in clinical trials in Lg-NHL, most patients received no more than 8 cycles in total.
Fludarabine tablets are usually started at a dose of 40 mg/m2 of Fludarabinebine phosphate, given once daily for five consecutive days, repeated every 28 days. As with the injection, the duration of treatment depends on how well it is working and how well the drug is tolerated. Fludarabine taken orally should be continued until the maximal response is reached, whether complete or partial remission, usually around 6 cycles, and then the drug should be discontinued.
Side Effects
Decreased blood cell production by the bone marrow (bone marrow suppression) is a possible serious side effect. This can affect the body's ability to fight infection, carry oxygen in the blood, and clot properly, and in some cases has resulted in death. At doses about four times higher than the recommended dose for chronic lymphocytic leukaemia (CLL), central nervous system effects such as blindness, coma, and death have occurred; such effects have only rarely been reported at the recommended CLL dose. A drop in red blood cells caused by their breakdown (haemolytic anaemia) may also occur and can be fatal. When fludarabine is combined with pentostatin (deoxycoformycin), lung toxicity leading to death has been reported.
Cautions & Contraindications
Warnings & Precautions
Fludara should be given only under the supervision of a physician who is experienced in antineoplastic therapy. Treatment with Fludara has been linked to serious, sometimes fatal, effects: bone marrow suppression, irreversible effects on the central nervous system (CNS), and auto-immune hemolytic anemia. A clinical trial that combined Fludara with pentostatin (deoxycoformycin) to treat refractory chronic lymphocytic leukemia (CLL) found an unacceptably high rate of fatal lung toxicity; for this reason, combining Fludara with pentostatin is contraindicated.
Contraindications
Hypersensitivity to the active substance or any of the excipients; renal impairment with creatinine clearance below 30 mL/min; decompensated hemolytic anemia.
Pregnancy & Breastfeeding
Pregnancy: Only very limited data exist on Fludarabine use during the first trimester. One case has been reported of a newborn with absent radii on both sides (though the thumbs were normal), a low platelet count, an aneurysm of the fossa ovalis, and a small patent ductus arteriosus. Early pregnancy loss has occurred with Fludarabine used alone and in combination with other agents, and premature delivery has also been reported.
Breastfeeding: Breastfeeding should not be started during Fludarabine treatment, and mothers who are already nursing should stop. Whether this drug passes into human breast milk is not known, but preclinical data suggest that fludarabine phosphate and/or its breakdown products can transfer from the mother's blood into milk.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Use in Special Populations
Renal impairment: if CrCl is 30 to 70, Fludarabine Phosphate doses may be reduced by up to 50%. In severe impairment, avoid it.
Storage
Store the Fludarabine Phosphate injection below 25°C. If it isn't used straight away, the user is responsible for the in-use storage times and conditions before use, and these should not be longer than 24 hours at 2 to 8°C or 8 hours at room temperature. The tablets should be stored between 15°C and 30°C. Do not freeze. Keep the medicine out of the sight and reach of children, and leave the contents in their protective packaging until you are ready to use them.
Drug Interactions
Common questions about Fludara 10 mg
What is Fludara 10 mg Tablet?
Fludara 10 mg Tablet is a medicine that contains Fludarabine Phosphate. It is made by Synovia Pharma PLC. It belongs to the Cytotoxic Chemotherapy group of medicines.
What is Fludara used for?
Fludara is used for: Cancer.
What are the side effects of Fludara?
Decreased blood cell production by the bone marrow (bone marrow suppression) is a possible serious side effect. This can affect the body's ability to fight infection, carry oxygen in the blood, and clot properly, and in some cases has resulted in death.
Can I take Fludara during pregnancy or while breastfeeding?
Pregnancy: Only very limited data exist on Fludarabine use during the first trimester. One case has been reported of a newborn with absent radii on both sides (though the thumbs were normal), a low platelet count, an aneurysm of the fossa ovalis, and a small patent ductus arteriosus. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
How should I store Fludara?
Store the Fludarabine Phosphate injection below 25°C. If it isn't used straight away, the user is responsible for the in-use storage times and conditions before use, and these should not be longer than 24 hours at 2 to 8°C or 8 hours at room temperature.
Can I take other medicines with Fludara?
Some medicines can interact with Fludarabine Phosphate, for example: Adenosine, Dipyridamole, Cytarabine, Obinutuzumab. Tell your doctor or pharmacist about every medicine you take.
Is there a cheaper medicine with the same ingredient?
Fludara is already among the lowest-priced brands of Fludarabine Phosphate at this strength.
Do I need a prescription for Fludara?
Fludara is a prescription (Rx) medicine. Take it as your doctor advises.