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Fludarabine phosphate 50 mg/2mL Injection, Powder, Lyophilized, For Solution — NDC 45963-609-55 (Billing 45963-0609-55)

by Actavis Pharma, Inc. · 1 VIAL, GLASS in 1 CARTON / 2 mL in 1 VIAL, GLASS

This is a package of Fludarabine phosphate 50 mg/2mL Injection, Powder, Lyophilized, For Solution from Actavis Pharma, Inc., marketed since Jan 2015 and currently FDA-listed. It is this product's only package size.

NDC 45963-0609-55
🏷️ FDA NDC (as labeled) 45963-609-55 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
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NDC database record

One package, one record: these facts belong to NDC 45963-609-55 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
45963 labeler · 609 product · 55 package
Package marketed since
Jan 5, 2015
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0345963609557
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 45963-609-55
Product NDC 45963-609
11-digit billing NDC 45963060955
NCPDP billing unit EA — each (per item)
RxCUI 1740864
UNII 1X9VK9O1SC
UPC 0345963609557
Application # ANDA078610
SPL Set ID 3adca34b-4f65-4e21-8058-3c01fc7fc9bb
Established class (EPC) Nucleoside Metabolic Inhibitor
Mechanism of action Nucleic Acid Synthesis Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-01-05
Route INTRAVENOUS
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Substance FLUDARABINE PHOSPHATE
TE code (Orange Book) AP · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 21300025102120
GPI class Fludarabine Phosphate
GCN Seq No 016551
GCN 32981
HICL code 006308
Ingredient (HICL) Fludarabine Phosphate
HIC1 code V
Therapeutic class — broad (HIC1) Neoplasms
HIC2 code V1
Therapeutic class — intermediate (HIC2) Antineoplastic Drugs
HIC3 code V1B
Therapeutic class — specific (HIC3) Antineoplastic - Antimetabolites
AHFS code 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name FLUDARABINE 50 MG VIAL
FDB brand name Fludarabine Phosphate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 016551
  • GCN: 32981
  • GPI-14 (Medi-Span): 21300025102120
  • HICL (First Databank): 006308
  • AHFS class code: 10:00.00.00
  • RxCUI (RxNorm): 1740864
Why two NDCs? The FDA registers this code as 45963-609-55 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 45963-0609-55. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Nucleoside Metabolic Inhibitor class.

Pharmacologic class Nucleoside Metabolic Inhibitor
Drug family (ATC) Purine analogues
How it works Nucleic Acid Synthesis Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name FLUDARABINE 50 MG VIAL Ingredient Fludarabine Phosphate
📗 Our plain-language guide HelloPharmacist
  • It treats adults with B-cell chronic lymphocytic leukemia (CLL) that didn’t respond to, or got worse during, treatment with at least one standard alkylating-agent chemotherapy. Its...
  • A healthcare professional gives it through a vein over about 30 minutes, once a day for five days. A new course starts about every 28 days. Your doctor may delay or adjust doses ba...
  • Common ones include low blood counts, fever, chills, infections, nausea, vomiting, tiredness and weakness. Your team will check your blood counts regularly. Tell them about any fev...
  • Call for confusion, seizures, vision changes, trouble breathing, unusual bleeding or bruising, yellow skin or eyes, dark urine, or flank pain with blood in the urine. These can be...
📖 Read our full Fludarabine Injection guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J9185 $206.299 / J9185 unit —
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Billing & reimbursement

FDA NDC (as labeled)45963-609-55
11-digit billing NDC45963-0609-55
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ9185
DescriptorINJECTION, FLUDARABINE PHOSPHATE, 50 MG
Billing units / pkg1 units
How the units are derivedThis package is 1 EA; the HCPCS unit is 50 MG, so one package = 1 billing unit.
Medicare Part B spend (2026 (Q1))$13,618 · 113 claims · $120.51 per claim (all NDCs under J9185)
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
45963-0609-55 You're viewing this Main listing 1 VIAL, GLASS in 1 CARTON / 2 mL in 1 VIAL, GLASS 2015-01-05 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Fludarabine phosphate 50 mg/2mLthis 45963-0609-55 Actavis 1 vial — AP FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2015
On the market since
Jan 2015
📍
2026
Currently FDA-listed
11 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

🧪 Avoiding an ingredient? See Fludarabine Injection inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.

2 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerActavis Pharma, Inc.
Application holderACTAVIS TOTOWA LLC
FDA applicationANDA078610 (ANDA)
Labeler code45963
First marketedJan 2015
Product typeHuman Prescription Drug
Portfolio324 products on file

More NDCs from Actavis Pharma, Inc. labeler code 45963

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 🍼 Nursing Mothers 🔬 Clinical Studies 📚 References 📄 Package Label / Principal Display Panel
🚨 Boxed Warning ~1 min read ▾

WARNING: Fludarabine Phosphate for Injection should be administered under the supervision of a qualified physician experienced in the use of antineoplastic therapy. Fludarabine Phosphate for Injection can severely suppress bone marrow function. When used at high doses in dose-ranging studies in patients with acute leukemia, Fludarabine Phosphate for Injection was associated with severe neurologic effects, including blindness, coma, and death.

This severe central nervous system toxicity occurred in 36% of patients treated with doses approximately four times greater (96 mg/m 2 /day for 5 to 7 days) than the recommended dose. Similar severe central nervous system toxicity, including coma, seizures, agitation and confusion, has been reported in patients treated at doses in the range of the dose recommended for chronic lymphocytic leukemia. Instances of life-threatening and sometimes fatal autoimmune phenomena such as hemolytic anemia, autoimmune thrombocytopenia/thrombocytopenic purpura (ITP), Evans syndrome, and acquired hemophilia have been reported to occur after one or more cycles of treatment with Fludarabine Phosphate for Injection.

Patients undergoing treatment with Fludarabine Phosphate for Injection should be evaluated and closely monitored for hemolysis. In a clinical investigation using Fludarabine Phosphate for Injection in combination with pentostatin (deoxycoformycin) for the treatment of refractory chronic lymphocytic leukemia (CLL), there was an unacceptably high incidence of fatal pulmonary toxicity. Therefore, the use of Fludarabine Phosphate for Injection in combination with pentostatin is not recommended.

🎯 Indications and Usage 62 words ▾

INDICATIONS AND USAGE Fludarabine Phosphate for 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 for Injection in previously untreated or non-refractory patients with CLL have not been established.

⏱️ Dosage and Administration ~2 min read ▾

DOSAGE AND ADMINISTRATION Usual Dose The recommended adult dose of Fludarabine Phosphate for 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 for 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 additional cycles of Fludarabine Phosphate for Injection be administered following the achievement of a maximal response and then the drug should be discontinued.

Renal Impairment Adjustments to the starting dose are recommended to provide appropriate drug exposure in patients with creatinine clearance 30 to 79 mL/min, as estimated by the Cockroft-Gault equations. These adjustments are based on a pharmacokinetic study in patients with renal impairment. Fludarabine Phosphate for Injection should not be administered to patients with creatinine clearance less than 30 mL/min.

Starting Dose Adjustment for Renal Impairment Creatinine Clearance Starting Dose ≥ 80 mL/min 25 mg/m 2 (full dose) 50 to 79 mL/min 20 mg/m 2 30 to 49 mL/min 15 mg/m 2 < 30 mL/min do not administer Renally impaired patients should be monitored closely for excessive toxicity and the dose modified accordingly. Preparation of Solutions Fludarabine Phosphate for Injection should be prepared for parenteral use by aseptically adding Sterile Water for Injection, USP. When reconstituted with 2 mL of Sterile Water for Injection, the solid cake should fully dissolve in 15 seconds or less; each mL of the resulting solution will contain 25 mg of fludarabine phosphate, 25 mg of mannitol, and sodium hydroxide to adjust the pH to 7.7.

The pH range for the final product is 7.2 to 8.2. In clinical studies, the product has been diluted in 100 cc or 125 cc of 5% Dextrose Injection, USP, or 0.9% Sodium Chloride, USP. Reconstituted Fludarabine Phosphate for Injection contains no antimicrobial preservative and thus should be used within 8 hours of reconstitution.

Care must be taken to assure the sterility of prepared solutions. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Fludarabine Phosphate for Injection should not be mixed with other drugs.

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.

1-4. Caution should be exercised in the handling and preparation of Fludarabine Phosphate for Injection solution. The use of latex gloves and safety glasses is recommended to avoid exposure in case of breakage of the vial or other accidental spillage.

If the solution contacts the skin or mucous membranes, wash thoroughly with soap and water; rinse eyes thoroughly with plain water. Avoid exposure by inhalation or by direct contact of the skin or mucous membranes.

⛔ Contraindications 19 words ▾

CONTRAINDICATIONS Fludarabine Phosphate for Injection is contraindicated in those patients who are hypersensitive to this drug or its components.

⚠️ Warnings ~3 min read ▾

WARNINGS (See BOXED WARNINGS ) Dose Dependent Neurologic Toxicities There are clear dose-dependent toxic effects seen with Fludarabine Phosphate for Injection. Dose levels approximately 4 times greater (96 mg/m 2 /day for 5 to 7 days) than that recommended for CLL (25 mg/m 2 /day for 5 days) were associated with a syndrome characterized by delayed blindness, coma and death. Symptoms appeared from 21 to 60 days following the last dose.

Thirteen of 36 patients (36%) who received Fludarabine Phosphate for Injection at high doses (96 mg/m 2 /day for 5 to 7 days) developed this severe neurotoxicity. Similar severe central nervous system toxicity, including coma, seizures, agitation and confusion, has been reported in patients treated at doses in the range of the dose recommended for chronic lymphocytic leukemia. In post-marketing experience neurotoxicity has been reported to occur either earlier or later than in clinical trials (range 7 to 225 days).

The effect of chronic administration of Fludarabine Phosphate for Injection on the central nervous system is unknown; however, patients have received the recommended dose for up to 15 courses of therapy. Bone Marrow Suppression Severe bone marrow suppression, notably anemia, thrombocytopenia and neutropenia, has been reported in patients treated with Fludarabine Phosphate for Injection. In a Phase I study in adult solid tumor patients, the median time to nadir counts was 13 days (range, 3 to 25 days) for granulocytes and 16 days (range, 2 to 32) for platelets.

Most patients had hematologic impairment at baseline either as a result of disease or as a result of prior myelosuppressive therapy. Cumulative myelosuppression may be seen. While chemotherapy-induced myelosuppression is often reversible, administration of Fludarabine Phosphate for Injection requires careful hematologic monitoring.

Several instances of trilineage bone marrow hypoplasia or aplasia resulting in pancytopenia, sometimes resulting in death, have been reported in adult patients. The duration of clinically significant cytopenia in the reported cases has ranged from approximately 2 months to approximately 1 year. These episodes have occurred both in previously treated or untreated patients.

Autoimmune Reactions Instances of life-threatening and sometimes fatal autoimmune phenomena such as hemolytic anemia, autoimmune thrombocytopenia/thrombocytopenic purpura (ITP), Evans syndrome, and acquired hemophilia have been reported to occur after one or more cycles of treatment with Fludarabine Phosphate for Injection in patients with or without a previous history of autoimmune hemolytic anemia or a positive Coombs' test and who may or may not be in remission from their disease. Steroids may or may not be effective in controlling these hemolytic episodes.

The majority of patients rechallenged with Fludarabine Phosphate for Injection developed a recurrence in the hemolytic process. The mechanism(s) which predispose patients to the development of this complication has not been identified. Patients undergoing treatment with Fludarabine Phosphate for Injection should be evaluated and closely monitored for hemolysis.

Discontinuation of therapy with Fludarabine Phosphate for Injection is recommended in case of hemolysis. Transfusion Associated Graft-Versus-Host Disease Transfusion-associated graft-versus-host disease has been observed after transfusion of non-irradiated blood in Fludarabine Phosphate for Injection treated patients. Fatal outcome as a consequence of this disease has been reported.

Therefore, to minimize the risk of transfusion-associated graft-versus-host disease, patients who require blood transfusion and who are undergoing, or who have received, treatment with Fludarabine Phosphate for Injection should receive irradiated blood only. Pulmonary Toxicity In a clinical investigation using Fludarabine Phosphate for Injection in combination with pentostatin (deoxycoformycin) for the treatment of refractory chronic lymphocyt… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~2 min read ▾

ADVERSE REACTIONS Very common adverse events 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 (such as latent viral reactivation, herpes zoster virus, Epstein-Barr virus, and progressive multifocal leukoencephalopathy) have occurred in CLL patients treated with Fludarabine Phosphate for Injection.

Adverse events and those reactions which are more clearly related to the drug are arranged below according to body system. Hematopoietic Systems Hematologic events (neutropenia, thrombocytopenia, and/or anemia) were reported in the majority of CLL patients treated with Fludarabine Phosphate for Injection. During Fludarabine Phosphate for Injection treatment of 133 patients with CLL, the absolute neutrophil count decreased to less than 500/mm 3 in 59% of patients, hemoglobin decreased from pretreatment values by at least 2 grams percent in 60%, and platelet count decreased from pretreatment values by at least 50% in 55%.

Myelosuppression may be severe, cumulative, and may affect multiple cell lines. Bone marrow fibrosis occurred in one CLL patient treated with Fludarabine Phosphate for Injection. Several instances of trilineage bone marrow hypoplasia or aplasia resulting in pancytopenia, sometimes resulting in death, have been reported in post marketing surveillance.

The duration of clinically significant cytopenia in the reported cases has ranged from approximately 2 months to approximately 1 year. These episodes have occurred both in previously treated or untreated patients. Life-threatening and sometimes fatal autoimmune phenomena such as hemolytic anemia, autoimmune thrombocytopenia/thrombocytopenic purpura (ITP), Evans syndrome, and acquired hemophilia have been reported to occur in patients receiving Fludarabine Phosphate for Injection (see WARNINGS section).

The majority of patients rechallenged with Fludarabine Phosphate for Injection developed a recurrence in the hemolytic process. In postmarketing experience, cases of myelodysplastic syndrome and acute myeloid leukemia, mainly associated with prior, concomitant or subsequent treatment with alkylating agents, topoisomerase inhibitors, or irradiation have been reported. Infections Serious and sometimes fatal infections, including opportunistic infections and reactivations of latent viral infections such as VZV (herpes zoster), Epstein-Barr virus and JC virus (progressive multifocal leukoencephalopathy) have been reported in patients treated with Fludarabine Phosphate for Injection.

Rare cases of Epstein Barr virus (EBV) associated lymphoproliferative disorders have been reported in patients treated with Fludarabine Phosphate for Injection. In postmarketing experience, cases of progressive multifocal leukoencephalopathy have been reported. Most cases had a fatal outcome.

Many of these cases were confounded by prior and/or concurrent chemotherapy. The time to onset has ranged from a few weeks to approximately one year after initiating treatment. Of the 133 adult CLL patients in the two trials, there were 29 fatalities during study, approximately 50% of which were due to infection.

Metabolic Tumor lysis syndrome has been reported in CLL patients treated with Fludarabine Phosphate for Injection. This complication may include hyperuricemia, hyperphosphatemia, hypocalcemia, metabolic acidosis, hyperkalemia, hematuria, urate crystalluria, and renal failure. The onset of this syndrome may be heralded by flank pain and hematuria.

Nervous System (see WARNINGS section) Objective weakness, agitation, confusion, seizures, visual disturbances, optic neuritis, optic neuropathy, blindness and coma have occurred in CLL patients treated with Fludarabine Phosphate for Injection at the recommended dose. Peripheral neuropathy has been observed in patients treated with Fludarabin… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 27 words ▾

Drug Interactions The use of Fludarabine Phosphate for Injection in combination with pentostatin is not recommended due to the risk of fatal pulmonary toxicity (see WARNINGS section).

🤰 Pregnancy ~1 min read ▾

Pregnancy (See WARNINGS section). Based on its mechanism of action, fludarabine phosphate can cause fetal harm when administered to a pregnant woman. There are not adequate and well-controlled studies of fludarabine phosphate in pregnant women.

Fludarabine phosphate was embryolethal and teratogenic in rats and rabbits. If Fludarabine Phosphate for Injection is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant.

In rats, repeated intravenous doses of fludarabine phosphate at 2.4 times and 7.2 times the recommended human IV dose (25 mg/m 2 ) administered during organogenesis caused an increase in resorptions, skeletal and visceral malformations (cleft palate, exencephaly, and fetal vertebrae deformities) and decreased fetal body weights. Maternal toxicity was not apparent at 2.4 times the human IV dose, and was limited to slight body weight decreases at 7.2 times the human IV dose. In rabbits, repeated intravenous doses of fludarabine phosphate at 3.8 times the human IV dose administered during organogenesis increased embryo and fetal lethality as indicated by increased resorptions and a decrease in live fetuses.

A significant increase in malformations including cleft palate, hydrocephaly, adactyly, brachydactyly, fusions of the digits, diaphragmatic hernia, heart/great vessel defects, and vertebrae/rib anomalies were seen in all dose levels (≥0.5 times the human IV dose).

🧒 Pediatric Use 192 words ▾

Pediatric Use Data submitted to the FDA was insufficient to establish efficacy in any childhood malignancy. Fludarabine Phosphate for Injection was evaluated in 62 pediatric patients (median age 10, range 1 to 21) with refractory acute leukemia (45 patients) or solid tumors (17 patients). The Fludarabine Phosphate for Injection regimen tested for pediatric acute lymphocytic leukemia (ALL) patients was a loading bolus of 10.5 mg/m 2 /day followed by a continuous infusion of 30.5 mg/m 2 /day for 5 days.

In 12 pediatric patients with solid tumors, dose-limiting myelosuppression was observed with a loading dose of 8 mg/m 2 /day followed by a continuous infusion of 23.5 mg/m 2 /day for 5 days. The maximum tolerated dose was a loading dose of 7 mg/m 2 /day followed by a continuous infusion of 20 mg/m 2 /day for 5 days. Treatment toxicity included bone marrow suppression.

Platelet counts appeared to be more sensitive to the effects of Fludarabine Phosphate for Injection than hemoglobin and white blood cell counts. Other adverse events included fever, chills, asthenia, rash, nausea, vomiting, diarrhea, and infection. There were no reported occurrences of peripheral neuropathy or pulmonary hypersensitivity reaction.

🆘 Overdosage 63 words ▾

OVERDOSAGE High doses of Fludarabine Phosphate for Injection (see WARNINGS section) have been associated with an irreversible central nervous system toxicity characterized by delayed blindness, coma and death. High doses are also associated with severe thrombocytopenia and neutropenia due to bone marrow suppression. There is no known specific antidote for Fludarabine Phosphate for Injection overdosage.

Treatment consists of drug discontinuation and supportive therapy.

🧬 Clinical Pharmacology ~1 min read ▾

CLINICAL PHARMACOLOGY Fludarabine phosphate is rapidly dephosphorylated to 2-fluoro-ara-A and then phosphorylated intracellularly by deoxycytidine kinase to the active triphosphate, 2-fluoro-ara-ATP. This metabolite appears to act by inhibiting DNA polymerase alpha, ribonucleotide reductase and DNA primase, thus inhibiting DNA synthesis. The mechanism of action of this antimetabolite is not completely characterized and may be multi-faceted.

Phase I studies in humans have demonstrated that fludarabine phosphate is rapidly converted to the active metabolite, 2-fluoro-ara-A, within minutes after intravenous infusion. Consequently, clinical pharmacology studies have focused on 2-fluoro-ara-A pharmacokinetics. After the five daily doses of 25 mg 2-fluoro-ara-AMP/m 2 to cancer patients infused over 30 minutes, 2-fluoro-ara-A concentrations show a moderate accumulation.

During a 5-day treatment schedule, 2-fluoro-ara-A plasma trough levels increased by a factor of about 2. The terminal half-life of 2-fluoro-ara-A was estimated as approximately 20 hours. In vitro , plasma protein binding of fludarabine ranged between 19% and 29%.

A correlation was noted between the degree of absolute granulocyte count nadir and increased area under the concentration x time curve (AUC). Special Populations Pediatric Patients Limited pharmacokinetic data for Fludarabine Phosphate for Injection are available from a published study of children (ages 1 to 21 years) with refractory acute leukemias or solid tumors (Children's Cancer Group Study 097 1 ). When Fludarabine Phosphate for Injection was administered as a loading dose over 10 minutes immediately followed by a 5-day continuous infusion, steady-state conditions were reached early.

Patients with Renal Impairment The total body clearance of the principal metabolite 2-fluoro-ara-A correlated with the creatinine clearance, indicating the importance of the renal excretion pathway for the elimination of the drug. Renal clearance represents approximately 40% of the total body clearance. Patients with creatinine clearance 30 to 79 mL/min should have their Fludarabine Phosphate for Injection dose reduced and be monitored closely for excessive toxicity.

Due to insufficient data, Fludarabine Phosphate for Injection should not be administered to patients with creatinine clearance less than 30 mL/min (see DOSAGE AND ADMINISTRATION section).

📦 How Supplied / Storage and Handling 100 words ▾

HOW SUPPLIED Fludarabine Phosphate for Injection, USP is a white, lyophilized solid cake. Each single-dose vial contains 50 mg of fludarabine phosphate USP, 50 mg of mannitol, and sodium hydroxide to adjust pH to 7.7. The pH range for the final product is 7.2 to 8.2.

Fludarabine Phosphate for Injection, USP, NDC 45963-609-55, is supplied in a clear glass single-dose vial and packaged in a carton. Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F), in the original package. The container closure is not made with natural rubber latex.

Sterile, Nonpyrogenic, Preservative-free

📋 Description 130 words ▾

DESCRIPTION Fludarabine Phosphate for Injection, USP contains fludarabine phosphate USP, a fluorinated nucleotide analog of the antiviral agent vidarabine, 9-β-D-arabinofuranosyladenine (ara-A) that is relatively resistant to deamination by adenosine deaminase. Each vial of sterile lyophilized solid cake contains 50 mg of the active ingredient fludarabine phosphate, 50 mg of mannitol, and sodium hydroxide to adjust pH to 7.7. The pH range for the final product is 7.2 to 8.2.

Reconstitution with 2 mL of Sterile Water for Injection, USP, results in a solution containing 25 mg/mL of fludarabine phosphate intended for intravenous administration. The chemical name for fludarabine phosphate is 9 H -Purin-6-amine, 2-fluoro-9-(5- 0 -phosphono-β-D-arabino-furanosyl) (2-fluoro-ara-AMP). The molecular formula of fludarabine phosphate is C 10 H 13 FN 5 O 7 P (MW 365.2) and the structure is: 9f8c17ab-figure-01

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General Fludarabine Phosphate for Injection is a potent antineoplastic agent with potentially significant toxic side effects. Patients undergoing therapy should be closely observed for signs of hematologic and nonhematologic toxicity. Periodic assessment of peripheral blood counts is recommended to detect the development of anemia, neutropenia and thrombocytopenia.

In patients with impaired state of health, Fludarabine Phosphate for Injection should be given with caution and after careful risk/benefit consideration. This applies especially for patients with severe impairment of bone marrow function (thrombocytopenia, anemia, and/or granulocytopenia), immunodeficiency or with a history of opportunistic infection. Prophylactic treatment should be considered in patients at increased risk of developing opportunistic infections.

Fludarabine Phosphate for Injection may reduce the ability to drive or use machines, since fatigue, weakness, visual disturbances, confusion, agitation and seizures have been observed. Tumor Cell Lysis Tumor lysis syndrome has been associated with Fludarabine Phosphate for Injection treatment. This syndrome has been reported in CLL patients with large tumor burden.

Since Fludarabine Phosphate for Injection can induce a response as early as the first week of treatment, precautions should be taken in those patients at risk of developing this complication. Renal Impairment Fludarabine Phosphate for Injection must be administered cautiously in patients with renal impairment. The total body clearance of 2-fluoro-ara-A has been shown to be directly correlated with creatinine clearance.

Patients with creatinine clearance 30 to 79 mL/min should have their Fludarabine Phosphate for Injection dose reduced and be monitored closely for excessive toxicity. Fludarabine Phosphate for Injection should not be administered to patients with creatinine clearance less than 30 mL/min. (See DOSAGE AND ADMINISTRATION section).

In patients aged 65 years or older, creatinine clearance should be measured before start of treatment. Laboratory Tests During treatment, the patient's hematologic profile (particularly neutrophils and platelets) should be monitored regularly to determine the degree of hematopoietic suppression. Drug Interactions The use of Fludarabine Phosphate for Injection in combination with pentostatin is not recommended due to the risk of fatal pulmonary toxicity (see WARNINGS section).

Carcinogenesis No animal carcinogenicity studies with Fludarabine Phosphate for Injection have been conducted. Mutagenesis Fludarabine phosphate was not mutagenic to bacteria (Ames test) or mammalian cells (HGRPT assay in Chinese hamster ovary cells) either in the presence or absence of metabolic activation. Fludarabine phosphate was clastogenic in vitro to Chinese hamster ovary cells (chromosome aberrations in the presence of metabolic activation) and induced sister chromatid exchanges both with and without metabolic activation.

In addition, fludarabine phosphate was clastogenic in vivo (mouse micronucleus assay) but was not mutagenic to germ cells (dominant lethal test in male mice). Impairment of Fertility Studies in mice, rats and dogs have demonstrated dose-related adverse effects on the male reproductive system. Observations consisted of a decrease in mean testicular weights in mice and rats with a trend toward decreased testicular weights in dogs and degeneration and necrosis of spermatogenic epithelium of the testes in mice, rats and dogs.

The possible adverse effects on fertility in humans have not been adequately evaluated. Pregnancy (See WARNINGS section). Based on its mechanism of action, fludarabine phosphate can cause fetal harm when administered to a pregnant woman.

There are not adequate and well-controlled studies of fludarabine phosphate in pregnant women. Fludarabine phosphate was embryolethal and teratogenic in rats and rabbits. If Fludarabine Phosphate for Injection is used during pregnancy, or if the pa… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 59 words ▾

Nursing Mothers It is not known whether fludarabine phosphate is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions including tumorgenicity in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

🔬 Clinical Studies ~2 min read ▾

CLINICAL STUDIES Two single-arm, open-label studies of Fludarabine Phosphate for Injection have been conducted in adult patients with CLL refractory to at least one prior standard alkylating-agent containing regimen. In a study conducted by M.D. Anderson Cancer Center (MDAH), 48 patients were treated with a dose of 22 to 40 mg/m 2 daily for 5 days every 28 days.

Another study conducted by the Southwest Oncology Group (SWOG) involved 31 patients treated with a dose of 15 to 25 mg/m 2 daily for 5 days every 28 days. The overall objective response rates were 48% and 32% in the MDAH and SWOG studies, respectively. The complete response rate in both studies was 13%; the partial response rate was 35% in the MDAH study and 19% in the SWOG study.

These response rates were obtained using standardized response criteria developed by the National Cancer Institute CLL Working Group and were achieved in heavily pretreated patients. The ability of Fludarabine Phosphate for Injection to induce a significant rate of response in refractory patients suggests minimal cross-resistance with commonly used anti-CLL agents. The median time to response in the MDAH and SWOG studies was 7 weeks (range of 1 to 68 weeks) and 21 weeks (range of 1 to 53 weeks), respectively.

The median duration of disease control was 91 weeks (MDAH) and 65 weeks (SWOG). The median survival of all refractory CLL patients treated with Fludarabine Phosphate for Injection was 43 weeks and 52 weeks in the MDAH and SWOG studies, respectively. Rai stage improved to Stage II or better in 7 of 12 MDAH responders (58%) and in 5 of 7 SWOG responders (71%) who were Stage III or IV at baseline.

In the combined studies, mean hemoglobin concentration improved from 9 g/dL at baseline to 11.8 g/dL at the time of response in a subgroup of anemic patients. Similarly, average platelet count improved from 63,500/mm 3 to 103,300/mm 3 at the time of response in a subgroup of patients who were thrombocytopenic at baseline.

📚 References 105 words ▾

REFERENCES Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings. NIOSH Alert 2004-165. OSHA Technical Manual, TED 1-0.

15A, Section VI: Chapter 2. Controlling Occupational Exposure to Hazardous Drugs. OSHA, 1999. http://www.osha.gov/dts/osta/otm/otm_vi_2.htm l American Society of Health-System Pharmacists.

ASHP guidelines on handling hazardous drugs. Am J Health-Syst Pharm . 2006: 63: 1172-1193.

Polvich, M., White, J.M., & Kelleher, L.O. (eds.) 2005. Chemotherapy and biotherapy guidelines and recommendations for practice (2nd ed.).

Pittsburgh, PA: Oncology Nursing Society Manufactured In Romania By: Sindan Pharma SRL 11 Ion Mihalache Blvd Bucharest 1, Romania 011171 Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. A 9/2022

📄 Package Label / Principal Display Panel 31 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 45963-609-55 Fludarabine Phosphate for Injection, USP (Lyophilized) 50 mg/ vial For Intravenous Use Only MUST BE RECONSTITUTED CAUTION: Cytotoxic Agent Rx only 1 Single-Dose Vial Carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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