Home › NDC Lookup › Ingredients › Fludarabine Phosphate › 42658-0024-01
Fludarabine Phosphate 25 mg/mL Injection, Solution — NDC 42658-0024-01 package photo

Fludarabine Phosphate 25 mg/mL Injection, Solution

by Hisun Pharmaceuticals USA, Inc. · 1 VIAL, SINGLE-DOSE in 1 CARTON (42658-024-01) / 2 mL in 1 VIAL, SINGLE-DOSE
NDC 42658-0024-01
🏷️ FDA NDC (as labeled) 42658-024-01 billing pads the product segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Sep 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 42658-024-01
Product NDC 42658-024
11-digit billing NDC 42658002401
Application # ANDA220196
SPL Set ID 291f6ee2-f5d2-ae6c-e063-6294a90a5951
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 2026-09-01
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance FLUDARABINE PHOSPHATE
Why two NDCs? The FDA registers this code as 42658-024-01 — 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 → 42658-0024-01. 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.

🏭 Manufacturer & labeler

LabelerHisun Pharmaceuticals USA, Inc.
Application holderHISUN PHARMACEUTICAL (HANGZHOU) CO LTD
FDA applicationANDA220196 (ANDA)
Labeler code42658
First marketedSep 2026
Product typeHuman Prescription Drug
Portfolio9 products on file
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.

🩺 Clinical

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.

🧪 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.

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

  • 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.
  • 1.78 mg / 1 mL UNII 94255I6E2T
    Sodium phosphate dibasic dihydrate is a salt that helps control the acidity level of a medicine. It acts as a buffer and pH regulator to keep the medication stable and effective.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

3 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.

💲 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.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Fludarabine Phosphate 25 mg/mL 00527-1242-02 Lannett 1 vial — AP1 FDA listed —
Fludarabine Phosphate 25 mg/mL 25021-0242-02 Sagent 1 vial — AP1 FDA listed —
Fludarabine Phosphate 25 mg/mL 59923-0604-02 Areva 1 vial — AP1 FDA listed —
Fludarabine 25 mg/mL 63323-0192-02 Fresenius 1 vial — AP1 FDA listed —
Fludarabine Phosphate 25 mg/mLthis 42658-0024-01 Hisun 1 vial — — 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

🏛️
2026
On the market since
Sep 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Fludarabine Phosphate — the ingredient across all brands.

Top reported reactions

Pyrexia2,931
Cytokine Release Syndrome2,905
Febrile Neutropenia2,825
Neutropenia2,013
Cytomegalovirus Infection1,683
Thrombocytopenia1,635
Sepsis1,543

Age at onset

Neonate103
Infant461
Child1,477
Adolescent580
Adult5,220
Elderly1,585

Reporter sex

39,094 reports
Male · 58%
Female · 40%
Unknown · 2%

Serious outcomes

Life-threatening3,590
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 3,666 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
42658-0024-01 You're viewing this 1 VIAL, SINGLE-DOSE in 1 CARTON (42658-024-01) / 2 mL in 1 VIAL, SINGLE-DOSE 2026-09-01 Active

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 42658-024-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 42658-0024-01, written without dashes as 42658002401. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 42658-0024-01, the first segment (42658) is the labeler code FDA assigned to Hisun Pharmaceuticals USA, Inc.; the middle segment (0024) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Hisun Pharmaceuticals USA, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Hisun Pharmaceuticals USA, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 111 words ▾

Fludarabine Phosphate Injection is indicated: as a component of a combination regimen for the treatment of adults with B-cell chronic lymphocytic leukemia (CLL); for the treatment of adults with B-cell CLL who have not responded to or whose disease has progressed during treatment with at least one alkylating-agent containing regimen. Fludarabine Phosphate Injection is a nucleoside metabolic inhibitor indicated: as a component of a combination regimen for the treatment of adults with B-cell chronic lymphocytic leukemia (CLL); ( 1 ) for the treatment of adults with B-cell CLL who have not responded to, or whose disease has progressed during treatment with at least one alkylating- agent containing regimen.

( 1 )

⏱️ Dosage and Administration ~3 min read ▾

The recommended dosage is: In Combination with Cyclophosphamide and Rituximab: The recommended dosage is 25 mg/m 2 administered intravenously over 30 minutes daily for the first three days (Days 1 to 3) of each 28-day cycle for 6 cycles in combination with cyclophosphamide 250 mg/m 2 administered intravenously daily for three days (Days 1 to 3), and rituximab 375 mg/m 2 administered intravenously on Day 1 of the first cycle, followed by rituximab 500 mg/m 2 on Day 1 of subsequent cycles. ( 2.1 ) Single Agent: The recommended dosage is 25 mg/m 2 administered intravenously over approximately 30 minutes daily for five consecutive days (Days 1 to 5) of each 28-day cycle.

( 2.1 ) Renal impairment: Reduce the dosage for patients with creatinine clearance (CLcr) 30 to 79 mL/min. ( 2.2 , 8.6 ) See the Full Prescribing Information for instructions for preparation and administration. ( 2.3 )

2.1Recommended Dosage In Combination with Cyclophosphamide and Rituximab The recommended dosage of Fludarabine Phosphate Injection is 25 mg/m 2 administered intravenously over 30 minutes daily for the first three days (Days 1 to 3) of each 28-day cycle for 6 cycles or until unacceptable toxicity or disease progression, in combination with cyclophosphamide 250 mg/m 2 administered intravenously daily for three days (Days 1 to 3), and rituximab 375 mg/m 2 administered intravenously on Day 1 of the first cycle, followed by rituximab 500 mg/m 2 on Day 1 of subsequent cycles.

Refer to the cyclophosphamide and rituximab prescribing information for additional dosing information as appropriate. Single Agent The recommended dosage of Fludarabine Phosphate Injection is 25 mg/m 2 administered intravenously over 30 minutes daily for five consecutive days (Days 1 to 5) of each 28-day cycle.

2.2Recommended Dosage for Patients with Renal Impairment Reduce the Fludarabine Phosphate Injection dosage for patients with renal impairment as shown in Table 1. Closely monitor patients with renal impairment for adverse reactions. Table 1: Dosage Modifications for Renal Impairment Cre atinine Clearance (Estimated by Cockcroft-Gault equation) Recommended Dosage ​50 – 79 mL/min ​20 mg/m 2 30 – 49 mL/min 15 mg/m 2 < 30 mL/min A dosage has not been established.

2.3Preparation and Administration Fludarabine Phosphate Injection is a hazardous drug. Follow applicable special handling and disposal procedures. 1 Dilute Fludarabine Phosphate Injection in 100 mL to 125 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Infuse diluted Fludarabine Phosphate Injection intravenously over 30 minutes. Fludarabine Phosphate Injection contains no antimicrobial preservative.

If not used immediately, discard the unused portion within 8 hours after opening the single-dose vial. Do not mix Fludarabine Phosphate Injection with other drugs.

2.1Recommended Dosage In Combination with Cyclophosphamide and Rituximab The recommended dosage of Fludarabine Phosphate Injection is 25 mg/m 2 administered intravenously over 30 minutes daily for the first three days (Days 1 to 3) of each 28-day cycle for 6 cycles or until unacceptable toxicity or disease progression, in combination with cyclophosphamide 250 mg/m 2 administered intravenously daily for three days (Days 1 to 3), and rituximab 375 mg/m 2 administered intravenously on Day 1 of the first cycle, followed by rituximab 500 mg/m 2 on Day 1 of subsequent cycles.

Refer to the cyclophosphamide and rituximab prescribing information for additional dosing information as appropriate. Single Agent The recommended dosage of Fludarabine Phosphate Injection is 25 mg/m 2 administered intravenously over 30 minutes daily for five consecutive days (Days 1 to 5) of each 28-day cycle.

2.2Recommended Dosage for Patients with Renal Impairment Reduce the Fludarabine Phosphate Injection dosage for p…

💊 Dosage Forms and Strengths 33 words ▾

Injection: 50 mg/2 mL (25 mg/mL). Fludarabine Phosphate Injection, USP is supplied as a clear, colorless to almost colorless sterile solution in single-dose vials. Injection: 50 mg/2 mL (25 mg/mL) ( 3 )

⛔ Contraindications 5 words ▾

None. None. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

N eurological Toxicities : Coma, seizures, agitation and confusion can occur and are dose dependent. Monitor patients for signs and symptoms of neurologic toxicity. Consider delaying or discontinuing Fludarabine Phosphate Injection if neurotoxicity occurs.

( 5.1 , 10 ) M y elosuppression : Severe anemia, thrombocytopenia, neutropenia, or pancytopenia can occur and are dose dependent. Monitor blood counts before and during treatment. Consider dose delays, dose reductions, or permanent discontinuation if recovery has not occurred by the first day of the next scheduled cycle.

( 5.2 , 10 ) A u t o immune Cytopenias : Life-threatening and fatal autoimmune hemolytic anemia, autoimmune thrombocytopenia/ thrombocytopenic purpura (ITP), Evans syndrome, and acquired hemophilia can occur. Closely monitor patients for hemolysis and manage as clinically indicated. ( 5.3 ) Transfusion-Associated Graft-Versus-Host Disease : Use only irradiated blood products for transfusions.

( 5.4 ) Tumor Lysis Syndrome (TLS) : Closely monitor patients at risk for TLS, consider appropriate prophylaxis including hydration, and manage as clinically indicated. ( 5.5 ) P u lmonary Toxicity in Patients with CLL when Fludarabine Phosphate is Used with Pentostatin : Severe and sometimes fatal pulmonary toxicity when used concomitantly with pentostatin. Concomitant use is not recommended.

( 5.6 , 7.1 ) V accination : Avoid live attenuated vaccines during or after treatment with Fludarabine Phosphate Injection. ( 5.7 ) Embryo-Fetal Toxicity : Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception.

( 5.8 , 8.1 )

5.1Neurologic Toxicities Severe central nervous system (CNS) adverse reactions, including coma, seizures, agitation and confusion, can occur in patients treated with Fludarabine Phosphate Injection. CNS adverse reactions may occur either early or late after the initiation of Fludarabine Phosphate Injection (range 7 to 225 days). CNS adverse reactions are dose dependent and occur at greater incidence and severity in patients treated at doses higher than the recommended dose of Fludarabine Phosphate Injection [see Overdosage ( 10 )] .

Monitor patients for signs and symptoms of neurologic toxicity during and after treatment with Fludarabine Phosphate Injection. Consider delaying or discontinuing Fludarabine Phosphate Injection if neurotoxicity occurs. Do not administer Fludarabine Phosphate Injection at doses higher than the recommended dose.

Advise patients that Fludarabine Phosphate Injection may reduce the ability to drive or use mechanical equipment, since fatigue, weakness, visual disturbances, confusion, agitation, or seizures may occur.

5.2Myelosuppression Fludarabine phosphate can cause severe and fatal myelosuppression, which may include neutropenia, thrombocytopenia, or anemia. Cases of trilineage bone marrow hypoplasia or aplasia resulting in pancytopenia, sometimes resulting in death, have been reported. The median time to nadir of counts was approximately 13 days (range, 3 to 25 days) for granulocytes and 16 days (range, 2 to 32 days) for platelets.

The duration of the cytopenia in reported cases has ranged from approximately 2 months to approximately 1 year. Monitor complete blood counts at baseline, prior to and during each treatment cycle, and as clinically needed. Consider dosage delays, dose reductions, or permanent discontinuation if recovery has not occurred by the first day of the next scheduled cycle.

5.3Autoimmune Cytopenias Life-threatening and fatal autoimmune hemolytic anemia, autoimmune thrombocytopenia/idiopathic thrombocytopenic purpura (ITP), Evans syndrome, and acquired hemophilia can occur in patients treated with fludarabine phosphate with or without a previous history of autoimmune hemolytic anemia or a positive Coombs’ test. The majority of patients rechallenged with fludarabine phosphate developed a recurrence in the hemolytic process. The mechanism(s) which predispose pati…

🤒 Adverse Reactions ~3 min read ▾

The following clinically significant adverse reactions are described elsewhere in the labeling: Neurologic Toxicities [see Warnings and Precautions ( 5.1 )] Myelosuppression [see Warnings and Precautions ( 5.2 )] Autoimmune Cytopenias [see Warnings and Precautions ( 5.3 )] Transfusion Associated Graft-Versus-Host Disease [see Warnings and Precautions ( 5.4 )] Tumor Lysis Syndrome [see Warnings and Precautions ( 5.5 )] The most common adverse reactions (≥ 20%) are myelosuppression (neutropenia, thrombocytopenia, or anemia), fever, infection, nausea and vomiting, weakness, and pain.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Hisun Pharmaceuticals USA, Inc. at 1-855-554-4786 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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. B-cell Chronic Lymphocytic Leukemia Combination with Cyclophosphamide and Rituximab The safety of Fludarabine Phosphate Injection for the treatment of adults with B-cell CLL as a component of a combination regimen was derived from the published literature [see Clinical Studies ( 14 )] .

The safety of Fludarabine Phosphate Injection for the treatment of adults with B-cell CLL as a component of a combination regimen was consistent with the known safety profile of fludarabine phosphate. Single Agent The safety of fludarabine phosphate was evaluated in two single-arm open-label studies (MDAH and SWOG) in adult patients (n=133) with CLL refractory to at least one prior alkylating-agent containing regimen [see Clinical Studies ( 14 )] . In these two clinical trials, 22% of the patients treated with fludarabine phosphate had fatal adverse reactions, with approximately 50% of these due to infection.

Serious and fatal infections, including opportunistic and reactivation of latent viral infections such as Varicella-Zoster Virus (VZV; herpes zoster), Epstein-Barr Virus (EPV), and John Cunningham (JC) virus (progressive multifocal leukoencephalopathy) occurred in patients treated with fludarabine phosphate. Hematologic adverse reactions, including neutropenia (Grade 4: 59%), thrombocytopenia (55%), and anemia (55%) occurred in a majority of the CLL patients treated with fludarabine phosphate. The most common adverse reactions (≥ 20%) occurring in patients treated with fludarabine in the MDAH and SWOG trials (n=133) were myelosuppression (neutropenia, thrombocytopenia, or anemia), fever, infection, nausea and vomiting, weakness, and pain.

Table 2 summarizes the non-hematologic adverse reactions in the MDAH and SWOG studies. Table 2: Non-Hematologic Adverse Reactions (≥ 5%) in CLL Patients Treated with Fludarabine in the MDAH and SWOG Studies Adverse Reactions MDAH (N=101) % SWOG (N=32) % General Fever 60 69 Pain 20 22 Fatigue 10 38 Chills 11 19 Malaise 8 6 Diaphoresis 1 13 Infection Infection 33 44 Pneumonia 16 22 Upper respiratory infection 2 16 Urinary infection 2 15 Sinusitis 5 0 Pharyngitis 0 9 Gastrointestinal Nausea/Vomiting 36 31 Anorexia 7 34 Diarrhea 15 13 Stomatitis 9 0 Gastrointestinal bleeding 3 13 Ne urological Weakness 9 65 Paresthesia 4 12 Visual disturbance 3 15 Hearing loss 2 6 P ulmonary Cough 10 44 Dyspnea 9 22 Allergic pneumonitis 0 6 Hemoptysis 1 6 Skin and Subcutaneous Rash 15 15 C ardiovascular Edema 8 19 Angina 0 6 M usculoskeletal Myalgia 4 16 Endocrine Hyperglycemia 1 6 Clinically relevant adverse reactions in < 5% of patients who received fludarabine phosphate included the following: General: Headache, hemorrhage, tumor lysis syndrome (hyperuricemia, hyperphosphatemia, hypocalcemia, metabolic acidosis, hyperkalemia, hematuria, urate crystalluria, flank pain, renal failure) Blood and Lymphatic: Bone marrow fibrosis, thrombocytopenia/ITP, Evans syndrome, acquired hemophilia Cardiovascular: Congestive heart failure, arrhythmia,…

🔄 Drug Interactions 58 words ▾

7.1Pentostatin Avoid use of Fludarabine Phosphate Injection in combination with pentostatin due to the risk of severe and fatal pulmonary toxicity [see Warnings and Precautions ( 5.6 )]

7.1Pentostatin Avoid use of Fludarabine Phosphate Injection in combination with pentostatin due to the risk of severe and fatal pulmonary toxicity [see Warnings and Precautions ( 5.6 )]

👥 Use in Specific Populations ~3 min read ▾

8.1Pregnancy Risk Summary Based on findings in animals and its mechanism of action [see Clinical Pharmacology ( 12.1 )] , Fludarabine Phosphate Injection can cause fetal harm when administered to a pregnant woman. There are no available data on Fludarabine Phosphate Injection use in pregnant women to evaluate for a drug-associated risk. In animal reproduction studies, administration of fludarabine phosphate to pregnant animals during organogenesis resulted in adverse developmental outcomes, including embryo-fetal mortality and structural abnormalities at maternal doses below (rabbits) and above (rats) those in patients at the recommended human dose (see Data).

Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In rats, repeated intravenous doses of fludarabine phosphate at 2.4 times and 7.2 times the recommended human intravenous 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 intravenous dose, and was limited to slight body weight decreases at 7.2 times the human intravenous dose. In rabbits, repeated intravenous doses of fludarabine phosphate at 3.8 times the human intravenous 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 intravenous dose).

8.2Lactation Risk Summary There are no data on the presence of fludarabine phosphate or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in the breastfed child, advise patients that breastfeeding is not recommended during treatment with Fludarabine Phosphate Injection, and for 1 week after the last dose.

8.3Females and Males of Reproductive Potential Fludarabine Phosphate Injection can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations ( 8.1 )] . Pregnancy Testing Verify pregnancy status in females of reproductive potential prior to initiation of Fludarabine Phosphate Injection [see Use in Specific Populations ( 8.1 )] . Contraception Females Advise female patients of reproductive potential to use effective contraception during treatment with Fludarabine Phosphate Injection and for 6 months after the last dose.

Males Based on genotoxicity findings, advise males with female partners of reproductive potential to use effective contraception during treatment with Fludarabine Phosphate Injection and for 3 months after the last dose [see Nonclinical Toxicology ( 13.1 )] . I n fer tility Males Based on findings in animals and humans, Fludarabine Phosphate Injection may impair male fertility. Fludarabine phosphate may damage testicular tissue and spermatozoa.

Possible sperm DNA damage raises concerns about loss of fertility and genetic abnormalities in fetuses. The reversibility of this effect is unknown [see Nonclinical Toxicology ( 13.1 )] .

8.4Pediatric Use The safety and effectiveness of Fludarabine Phosphate Injection have not been established in pediatric patients. Safety and effectiveness were assessed, but not established for Fludarabine Phosphate Injection in pediatric patients 1 year to < 17 years with refractory acute leukemia or solid tumors. No new safety signals were observed in pediatric patients across these studies.

8.5 Geriatric Use Among patients with CLL evalu…

🆘 Overdosage 96 words ▾

Severe myelosuppression, including thrombocytopenia, neutropenia, anemia, and pancytopenia has occurred in patients treated with doses that exceed the recommended dosage of Fludarabine Phosphate Injection [see Warnings and Precautions ( 5.3 )] . Severe, irreversible, central nervous system effects including blindness, coma, and death have occurred in patients treated at doses approximately four times greater (96 mg/m 2 /day for 5 to 7 days) than the recommended dose for fludarabine phosphate [see Warnings and Precautions ( 5.4 )] .

There is no known specific antidote for fludarabine phosphate overdosage. Treatment consists of drug discontinuation and supportive therapy.

🧬 Clinical Pharmacology 159 words ▾

Fludarabine phosphate is rapidly converted to active 2-fluoro-ara-ATP [see Clinical Pharmacology ( 12.3 )] , which appears to inhibit DNA synthesis through inhibition of DNA polymerase alpha, ribonucleotide reductase and DNA primase. The degree of absolute granulocyte count nadir is correlated with increased area under the concentration x time curve (AUC); however, the exposure-response relationship and time-course of pharmacodynamic response of fludarabine have not been fully characterized. Fludarabine phosphate is a prodrug.

It is rapidly converted to its active metabolite, 2-fluoro-ara-A which is the focus of the pharmacokinetic characterization. 2-fluoro-ara-A plasma trough concentration accumulated 2-fold. D istribution Plasma protein binding ranged between 19% and 29% in vitro.

E limination The terminal half-life of 2-fluoro-ara-A was approximately 20 hours. The total body clearance of 2-fluoro-ara-A correlated with the creatinine clearance. Renal clearance represents approximately 40% of the total body clearance.

Me tabolism Fludarabine phosphate is dephosphorylated to 2-fluoro-ara-A and then phosphorylated intracellularly by deoxycytidine kinase to the active triphosphate, 2-fluoro-ara-ATP.

🧬 Mechanism of Action 32 words ▾

Fludarabine phosphate is rapidly converted to active 2-fluoro-ara-ATP [see Clinical Pharmacology ( 12.3 )] , which appears to inhibit DNA synthesis through inhibition of DNA polymerase alpha, ribonucleotide reductase and DNA primase.

📦 How Supplied / Storage and Handling 139 words ▾

HOW SUPPLIED/STORAGE AND HANDLING H ow Supplied Fludarabine Phosphate Injection, USP is supplied as a clear, colorless to almost colorless sterile solution in a single- dose vial containing 50 mg/2 mL (25 mg/mL) of fludarabine phosphate. NDC 42658-024-01 one carton containing 1 vial of Fludarabine Phosphate Injection, USP. Storage Store in a refrigerator between 2˚ and 8˚C (36˚ to 46˚F).

Ha ndling and Disposal Fludarabine Phosphate Injection, USP is a hazardous drug. Follow applicable special handling and disposal procedures. 1 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.

📋 Description 105 words ▾

Fludarabine Phosphate Injection, USP contains fludarabine phosphate, a nucleoside metabolic inhibitor. The chemical name for fludarabine phosphate is 9H-Purin-6-amine, 2-fluoro-9-(5-0-phosphono-β-D-arabinofuranosyl) (2-fluoro-ara-AMP). The molecular formula of fludarabine phosphate is C 10 H 13 FN 5 O 7 P (MW 365.2) and has the following chemical structure: Each mL contains 25 mg of the active ingredient fludarabine phosphate (equivalent to 19.5 mg Fludarabine), 1.78 mg disodium phosphate dihydrate, water for injection and sodium hydroxide to adjust pH to 7.5.

The pH range for the final product is 7.3 to 7.7. Fludarabine Phosphate Injection, USP is a sterile solution intended for intravenous administration. Chemical structure of fludarabine phosphate

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 42658-0023-01 · Hisun 42658-0115-03 · Hisun →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.