Fludarabine Phosphate 25 mg/mL
Fludarabine Phosphate · INJECTION · Areva Pharmaceuticals
Fludarabine Phosphate is a injection containing fludarabine phosphate at 25 mg/mL, taken intravenous. Manufactured by Areva Pharmaceuticals.
Key Facts
- Brand Name
- Fludarabine Phosphate
- Generic Name
- Fludarabine Phosphate
- NDC Code (Product)
59923-604- Manufacturer
- Areva Pharmaceuticals
- Strength
- 25 mg/mL
- Dosage Form
- INJECTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA090724
- Marketing Start
- 12/31/2019
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Fludarabine Phosphate Injection is a nucleotide metabolic inhibitor indicated for: The treatment of adult patients with B-cell chronic lymphocytic leukemia (CLL) who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen. Benefit in treatment-naïve or non-refractory CLL patients is not established. ( 1.1 ) 1.1 Indication Fludarabine Phosphate Injection is indicated for the treatment of adult patients with B-cell chronic lymphocytic leukemia (CLL) who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen. The safety and effectiveness of Fludarabine Phosphate Injection in previously untreated or non-refractory patients with CLL have not been established.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION The recommended adult dose 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. ( 2.1 ) Reduce dose in patients with creatinine clearance 30 to 70 mL/min/l.73 m 2 . Do not use in patients with severe renal impairment ( 2.2 ). 2.1 Recommended Dose The recommended adult dose of fludarabine phosphate injection 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. Dosage may be decreased or delayed based on evidence of hematologic or nonhematologic toxicity. Physicians should consider delaying or discontinuing the drug if neurotoxicity occurs. A number of clinical settings may predispose to increased toxicity from Fludarabine Phosphate Injection. These include advanced age, renal impairment, and bone marrow impairment. Such patients should be monitored closely for excessive toxicity and the dose modified accordingly. The optimal duration of treatment has not been clearly established. It is recommended that three add…
Contraindications
4 CONTRAINDICATIONS None None
Drug Interactions
7 DRUG INTERACTIONS Fludarabine phosphate injection in combination with pentostatin is not recommended due to the risk of severe pulmonary toxicity ( 5.5 and 7.1 ). 7.1 Pentostatin The use of Fludarabine Phosphate Injection in combination with pentostatin is not recommended due to the risk of fatal pulmonary toxicity [see Warnings and Precautions ( 5.5 )].
Adverse Reactions
6 ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Very common adverse reactions include myelosuppression (neutropenia, thrombocytopenia and anemia), fever and chills, fatigue, weakness, infection, pneumonia, cough, nausea, vomiting and diarrhea. Other commonly reported events include malaise, mucositis, and anorexia. Serious opportunistic infections have occurred in CLL patients treated with fludarabine phosphate. The most frequently reported adverse reactions and those reactions which are more clearly related to the drug are arranged below according to body system. Most common adverse reactions (incidence > 30%) include myelosuppression (neutropenia, thrombocytopenia and anemia), fever, infection, nausea and vomiting, fatigue, anorexia, cough and weakness ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Areva at 1-855-853-4760 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Hematopoietic Systems Hematologic events (neutropenia, thrombocytop…
Frequently Asked Questions
What is Fludarabine Phosphate used for?
Fludarabine Phosphate contains Fludarabine Phosphate. It is a injection taken intravenous. Consult your doctor for specific uses.
Is Fludarabine Phosphate a controlled substance?
Fludarabine Phosphate is not classified as a controlled substance by the DEA.
What is the generic name for Fludarabine Phosphate?
The generic name for Fludarabine Phosphate is Fludarabine Phosphate. There are 2 other brand versions of Fludarabine Phosphate.
What is the NDC code for Fludarabine Phosphate 25 mg/mL?
The NDC (National Drug Code) for Fludarabine Phosphate 25 mg/mL is 59923-604, listed by Areva Pharmaceuticals.