Fludara
Generic Name
Fludarabine Phosphate
Manufacturer
Bayer AG (original developer)
Country
Germany
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| fludara 10 mg tablet | ৳ 950.00 | ৳ 4,750.00 |
Description
Overview of the medicine
Fludarabine Phosphate is an antineoplastic agent belonging to the purine analog class. It is used in the treatment of certain leukemias and lymphomas.
Uses & Indications
Dosage
Adults
The usual recommended dose is 40 mg/m² orally once daily for 5 consecutive days, repeated every 28 days.
Elderly
Dose adjustment may be necessary in elderly patients, especially those with impaired renal function. Close monitoring of renal function is recommended.
Renal_impairment
For patients with creatinine clearance between 30 and 70 mL/min, the dose should be reduced by 50%. Fludarabine is contraindicated in patients with creatinine clearance less than 30 mL/min.
How to Take
Take orally with a glass of water, with or without food. Tablets should be swallowed whole and not chewed or crushed. If tablets are broken, avoid skin contact and inhalation of powder.
Mechanism of Action
Fludarabine is a purine analog that, after intracellular phosphorylation to its active metabolite 2-fluoro-ara-ATP, inhibits DNA synthesis and repair. It interferes with DNA polymerase, ribonucleotide reductase, and DNA primase, leading to apoptosis of cancer cells.
Pharmacokinetics
Onset
Not immediate, involves metabolic activation and incorporation into cellular nucleic acids.
Excretion
Primarily renal excretion of the active metabolite and its inactive products. Approximately 40-60% of an oral dose is excreted unchanged in urine.
Half life
The terminal plasma half-life of the active metabolite (2-fluoro-ara-A) is approximately 10-20 hours.
Absorption
Rapidly absorbed after oral administration; absolute bioavailability is approximately 50-65%.
Metabolism
Fludarabine is rapidly dephosphorylated to 2-fluoro-ara-adenine (FAra-A) in plasma. FAra-A then enters cells and is phosphorylated intracellularly to the active triphosphate, 2-fluoro-ara-ATP.
Side Effects
Contraindications
- Hypersensitivity to fludarabine or any excipients.
- Severe renal impairment (creatinine clearance < 30 mL/min).
- Decompensated hemolytic anemia.
- Pregnancy and lactation.
Drug Interactions
Cytarabine
Increased intracellular concentrations of the active metabolite (FAra-ATP) and enhanced cytotoxicity when combined with cytarabine.
Pentostatin
Concomitant use with pentostatin is not recommended due to severe, potentially fatal pulmonary toxicity.
Live vaccines
Avoid live vaccines due to immunosuppression; risk of severe or fatal infection.
Other myelosuppressive drugs
May increase the risk and severity of myelosuppression.
Storage
Store at room temperature (15-30°C or 59-86°F). Protect from light and moisture. Keep out of reach of children.
Overdose
High doses of fludarabine have been associated with irreversible central nervous system (CNS) toxicity, including delayed blindness, coma, and death. Severe myelosuppression and delayed severe neurotoxicity are also major concerns. There is no known specific antidote; management is supportive, including blood transfusions and hematopoietic growth factors.
Pregnancy & Lactation
Pregnancy Category D: Fludarabine can cause fetal harm. Women of childbearing potential should use effective contraception during treatment and for at least 6 months after. Contraindicated during lactation due to potential for serious adverse reactions in breastfed infants.
Side Effects
Contraindications
- Hypersensitivity to fludarabine or any excipients.
- Severe renal impairment (creatinine clearance < 30 mL/min).
- Decompensated hemolytic anemia.
- Pregnancy and lactation.
Drug Interactions
Cytarabine
Increased intracellular concentrations of the active metabolite (FAra-ATP) and enhanced cytotoxicity when combined with cytarabine.
Pentostatin
Concomitant use with pentostatin is not recommended due to severe, potentially fatal pulmonary toxicity.
Live vaccines
Avoid live vaccines due to immunosuppression; risk of severe or fatal infection.
Other myelosuppressive drugs
May increase the risk and severity of myelosuppression.
Storage
Store at room temperature (15-30°C or 59-86°F). Protect from light and moisture. Keep out of reach of children.
Overdose
High doses of fludarabine have been associated with irreversible central nervous system (CNS) toxicity, including delayed blindness, coma, and death. Severe myelosuppression and delayed severe neurotoxicity are also major concerns. There is no known specific antidote; management is supportive, including blood transfusions and hematopoietic growth factors.
Pregnancy & Lactation
Pregnancy Category D: Fludarabine can cause fetal harm. Women of childbearing potential should use effective contraception during treatment and for at least 6 months after. Contraindicated during lactation due to potential for serious adverse reactions in breastfed infants.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years, refer to the specific product packaging for exact expiry date.
Availability
Hospitals, oncology centers, specialized pharmacies
Approval Status
Approved (FDA for oral formulation in 1993)
Patent Status
Expired
Clinical Trials
Fludarabine continues to be evaluated in clinical trials for new indications, combination therapies, and in various populations to optimize its use and minimize toxicity. Many trials focus on its role in refractory or relapsed hematologic malignancies.
Lab Monitoring
- Complete Blood Count (CBC) with differential (prior to, during, and after treatment to monitor for myelosuppression)
- Renal function tests (serum creatinine, creatinine clearance)
- Liver function tests (LFTs)
- Serum uric acid levels (for risk of tumor lysis syndrome)
- Direct Coombs test (if hemolytic anemia is suspected)
Doctor Notes
- Crucial to monitor CBC with differential closely before, during, and after treatment for myelosuppression.
- Prophylaxis against *Pneumocystis jirovecii* pneumonia (PJP) and herpes simplex virus (HSV) may be considered, especially in heavily pretreated or prolonged lymphopenic patients.
- Educate patients on symptoms of infection, bleeding, and neurological changes and advise immediate reporting.
- Assess renal function carefully before and during therapy; adjust dose accordingly.
Patient Guidelines
- Report any signs of infection (fever, chills), unusual bleeding/bruising, or severe fatigue immediately.
- Use effective birth control during treatment and for at least 6 months after.
- Stay well-hydrated during treatment, especially to prevent tumor lysis syndrome.
- Avoid contact with people who are sick or have infections.
Missed Dose Advice
If a dose is missed, take it as soon as you remember, unless it is almost time for your next scheduled dose. In that case, skip the missed dose and continue with your regular dosing schedule. Do not double the dose. Contact your doctor for advice.
Driving Precautions
Fludarabine may cause fatigue, weakness, or visual disturbances. Patients should be cautioned against driving or operating machinery if they experience these side effects.
Lifestyle Advice
- Maintain good hygiene to reduce infection risk. Avoid crowded places during periods of low blood counts. Discuss all medications, supplements, and herbal products with your doctor.
- Avoid exposure to sunlight or tanning beds due to increased photosensitivity.
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