Fludarabine phosphate
(Redirected from Oforta)
What is Fludarabine phosphate?[edit | edit source]
- Fludarabine phosphate is a nucleotide metabolic inhibitor used to treat B-cell chronic lymphocytic leukemia (CLL) that has not responded to treatment with other anticancer drugs or that has gotten worse.
What are the uses of this medicine?[edit | edit source]
- Fludarabine phosphate is used as a single agent for the treatment of adult patients with B-cell chronic lymphocytic leukemia (CLL) whose disease has not responded to or has progressed during or after treatment with at least one standard alkylating-agent containing regimen.
How does this medicine work?[edit | edit source]
- Fludarabine phosphate (2F-ara-AMP) is a synthetic purine nucleotide antimetabolite agent.
- Upon administration, it is rapidly dephosphorylated in the plasma to 2F-ara-A, which then enters into the cell.
- Intracellularly, 2F-ara-A is converted to the 5'-triphosphate, 2-fluoro-ara-ATP (2F-ara-ATP).
- 2F-ara-ATP competes with deoxyadenosine triphosphate for incorporation into DNA.
- Once incorporated into DNA, 2F-ara-ATP functions as a DNA chain terminator, inhibits DNA polymerase alpha, gamma, and delta, and inhibits ribonucleoside diphosphate reductase.
- 2F-ara-A also inhibits DNA primase and DNA ligase I.
- Fludarabine is converted intracellularly to the active triphosphate, which competes with adenine triphosphate for use by DNA polymerase leading to inhibition of DNA synthesis.
- Therfore, fludarabine phosphate blocks cells from making DNA and may kill cancer cells.
Who Should Not Use this medicine ?[edit | edit source]
- This medicine have no usage limitations.
What drug interactions can this medicine cause?[edit | edit source]
- The use of fludarabine phosphate in combination with pentostatin is not recommended due to the risk of severe pulmonary toxicity.
Is this medicine FDA approved?[edit | edit source]
- Fludarabine was approved for medical use in the United States in 1991.
How should this medicine be used?[edit | edit source]
Recommended dosage: Chronic Lymphocytic Leukemia (CLL):
- The oral dose is different than the intravenous dose.
Fludarabine Phosphate tablets:
- The recommended adult dose is 40 mg/m2 administered daily for five consecutive days by the oral route.
- Begin each 5-day course of treatment every 28 days.
Renal Impairment:
- Reduce dose by 20% in patients with mild to moderate renal impairment (creatinine clearance 30 to 70 mL/min/1.73 m2).
- Reduce dose by 50% in patients with severe renal impairment (creatinine clearance < 30 mL/min/1.73 m2).
Fludarabine Phosphate Injection:
- The recommended adult dose of Fludarabine Phosphate Injection, USP is 25 mg/m 2 administered intravenously over a period of approximately 30 minutes daily for five consecutive days.
- Each 5 day course of treatment should commence every 28 days.
Renal Impairment:
- Adult patients with moderate impairment of renal function (creatinine clearance 30 to 70 mL/min/1.73 m 2) should have a 20% dose reduction of Fludarabine Phosphate Injection, USP.
Administration:
- Fludarabine phosphate film-coated tablets can be taken either on an empty stomach or with food.
- The tablets have to be swallowed whole with water; they should not be chewed or broken.
- Fludarabine Phosphate Injection, USP is administered intravenously over a period of approximately 30 minutes.
What are the dosage forms and brand names of this medicine?[edit | edit source]
This medicine is available in fallowing doasage form:
- Fludarabine is available as a powder or solution for injection.
- Oral formulations are also available as 10 milligram film-coated tablets.
This medicine is available in fallowing brand namesː
- Fludara; Oforta
What side effects can this medication cause?[edit | edit source]
The most common side effects of this medicine include:
- myelosuppression (neutropenia, thrombocytopenia and anemia)
- Fever
- weakness
- infection
- pain
- cough
- anorexia
What special precautions should I follow?[edit | edit source]
- Severe bone marrow suppression, notably anemia, thrombocytopenia and neutropenia, has been reported in patients treated with fludarabine phosphate. Monitor blood counts before and during treatment.
- Infections may occur. Monitor for signs or symptoms of infection.
- Dose-dependent neurotoxicity has been observed with fludarabine phosphate. Physicians should consider delaying or discontinuing the drug if neurotoxicity occurs.
- A high incidence of fatal pulmonary toxicity was observed in a clinical investigation using fludarabine phosphate in combination with pentostatin (deoxycoformycin). Therefore, the use of fludarabine phosphate in combination with pentostatin is not recommended.
- Tumor lysis syndrome associated with fludarabine phosphate treatment has been reported. precautions should be taken in those patients at risk of developing this complication.
- Transfusion-associated graft-versus-host disease has been observed rarely after transfusion of non-irradiated blood in fludarabine phosphate treated patients. Consideration should, therefore, be given to the use of irradiated blood products in those patients requiring transfusions while undergoing treatment with fludarabine phosphate.
- Fludarabine phosphate dose should be adjusted in patients with mild to moderate (creatinine clearance 30 to 70 mL/min/1.73 m2) or severe (creatinine clearance < 30 mL/min/1.73 m2) renal impairment.
- Based on its mechanism of action, fludarabine phosphate can cause fetal harm when administered to a pregnant woman. Women of childbearing potential and fertile males must take contraceptive measures during and at least for 6 months after the cessation of therapy.
What to do in case of emergency/overdose?[edit | edit source]
Symptoms of overdosage may include:
- delayed blindness
- coma
- death
- thrombocytopenia
- neutropenia
Management of overdosage:
- There is no known specific antidote for fludarabine phosphate overdosage.
- Treatment consists of drug discontinuation and supportive therapy.
Can this medicine be used in pregnancy?[edit | edit source]
- Based on its mechanism of action, fludarabine phosphate can cause fetal harm when administered to a pregnant woman.
- There are no adequate and well-controlled studies of fludarabine phosphate in pregnant women.
- Women of childbearing potential should be advised to avoid becoming pregnant.
- Women of childbearing potential and fertile males must take contraceptive measures during and at least for 6 months after the cessation of therapy.
Can this medicine be used in children?[edit | edit source]
- Safety and effectiveness in pediatric patients have not been established.
What are the active and inactive ingredients in this medicine?[edit | edit source]
Active ingredient:
- FLUDARABINE PHOSPHATE
Inactive ingredients:
- microcrystalline cellulose
- lactose monohydrate
- colloidal anhydrous silicon dioxide
- croscarmellose sodium
- magnesium stearate
- hypromellose
- talc
- titanium dioxide
- ferric oxide pigment
Who manufactures and distributes this medicine?[edit | edit source]
Fludarabine Phosphate tablets:
- Manufactured for: Antisoma Research Limited, Cambridge, MA 02139
- Manufactured by: Bayer Schering Pharma AG, Berlin, Germany
What should I know about storage and disposal of this medication?[edit | edit source]
Fludarabine Phosphate Injection:
- REFRIGERATE AT: 2° to 8°C (36° to 46°F).
- The container closure is not made with natural rubber latex.
Fludarabine phosphate tablets:
- Store under normal lighting conditions at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).
Handling and Disposal:
- Procedures for proper handling and disposal should be considered.
- Consideration should be given to handling and disposal according to guidelines issued for cytotoxic drugs.
- Several guidelines on this subject have been published.
- Caution should be exercised in the handling of fludarabine phosphate.
- Do not crush tablets.
- Avoid exposure by direct contact of the skin or mucous membranes or by inhalation.
- If contact occurs, wash thoroughly with soap and water or wash the eyes immediately with gently flowing water for at least 15 minutes.
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