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CLOFARABINE 1 mg/mL Injection — NDC 72266-108-01 (Billing 72266-0108-01)

by Fosun Pharma USA Inc. · 1 VIAL, SINGLE-DOSE in 1 CARTON / 20 mL in 1 VIAL, SINGLE-DOSE

This is a package of CLOFARABINE 1 mg/mL Injection from Fosun Pharma USA Inc., marketed since Aug 2019 and currently FDA-listed. It is this product's only package size.

NDC 72266-0108-01
🏷️ FDA NDC (as labeled) 72266-108-01 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 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
📋 All sources & update times →

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

NDC database record

One package, one record: these facts belong to NDC 72266-108-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
72266 labeler · 108 product · 01 package
Package marketed since
Aug 19, 2019
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 7226610801 2
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 72266-108-01
Product NDC 72266-108
11-digit billing NDC 72266010801
NCPDP billing unit ML — per mL (volume)
RxCUI 486419
UNII 762RDY0Y2H
Application # ANDA207831
SPL Set ID e956b1e0-2829-4872-8c09-99462d60e922
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 2019-08-19
Route INTRAVENOUS
Dosage form INJECTION
Substance CLOFARABINE
TE code (Orange Book) AP · RLD · RS

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

GPI-14 21300008002020
GPI class Clofarabine
GCN Seq No 058571
GCN 24037
HICL code 026816
Ingredient (HICL) Clofarabine
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 CLOFARABINE 20 MG/20 ML VIAL
FDB brand name Clofarabine
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 058571
  • GCN: 24037
  • GPI-14 (Medi-Span): 21300008002020
  • HICL (First Databank): 026816
  • AHFS class code: 10:00.00.00
  • RxCUI (RxNorm): 486419
Why two NDCs? The FDA registers this code as 72266-108-01 — 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 → 72266-0108-01. 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.

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 CLOFARABINE 20 MG/20 ML VIAL Ingredient Clofarabine
📗 Our plain-language guide HelloPharmacist
  • Clofarabine Injection is a chemotherapy medicine specifically approved for children and young adults (ages 1 to 21) who have a type of blood cancer called acute lymphoblastic leuke...
  • What exactly is clofarabine being used for, and why does my child need it?
  • Clofarabine is given at the hospital or infusion center through an IV drip — it goes directly into the vein over about 2 hours, once a day, for 5 days in a row. That 5-day course i...
  • How will my child receive this medicine, and how often?
📖 Read our full Clofarabine 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 eachPer 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 · J9027 $16.245 / J9027 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)72266-108-01
11-digit billing NDC72266-0108-01
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ9027
DescriptorINJECTION, CLOFARABINE, 1 MG
Billing units / pkg1 units
How the units are derivedThis package is 20 ML; the HCPCS unit is 1 MG, so one package = 1 billing unit.
Medicare Part B spend (2026 (Q1))$4,129 · 14 claims · $294.90 per claim (all NDCs under J9027)
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
72266-0108-01 You're viewing this Main listing 1 VIAL, SINGLE-DOSE in 1 CARTON / 20 mL in 1 VIAL, SINGLE-DOSE 2019-08-19 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Clofarabine 1 mg/mL 43598-0309-20 Dr.Reddy's 1 vial — AP FDA listed —
Clofarabine 1 mg/mL 49315-0003-06 Zydus 1 vial — — FDA listed —
Clofarabine 1 mg/mL 55150-0326-01 Eugia 1 vial — — FDA listed —
Clofarabine 1 mg/mL 63323-0572-70 Fresenius 1 vial — — FDA listed —
Clofarabine 1 mg/mL 68083-0386-01 Gland 1 vial — AP FDA listed —
Clofarabine 1 mg/mL 70121-1236-01 Amneal 1 vial — AP FDA listed —
Clofarabine 1 mg/mL 71288-0128-20 Meitheal 1 vial — AP FDA listed —
Clofarabine 1 mg/mLthis 72266-0108-01 Fosun 1 vial — AP FDA listed —
Clofarabine 1 mg/mL 72205-0394-01 Novadoz 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

🏛️
2019
On the market since
Aug 2019
📍
2026
Currently FDA-listed
7 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 Clofarabine 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerFosun Pharma USA Inc.
Application holderGLAND PHARMA LTD
FDA applicationANDA207831 (ANDA)
Labeler code72266
First marketedAug 2019
Product typeHuman Prescription Drug
Portfolio26 products on file

More NDCs from Fosun Pharma USA Inc. labeler code 72266

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.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 🍼 Nursing Mothers 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 65 words ▾

1 INDICATIONS AND USAGE Clofarabine Injection is indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens. Clofarabine Injection is a nucleoside metabolic inhibitor indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens. (1)

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Administer the recommended pediatric dose of 52 mg/m2 as an intravenous infusion over 2 hours daily for 5 consecutive days of a 28-day cycle. Repeat cycles every 2-6 weeks. (2.1) Provide supportive care, such as intravenous infusion fluids,antihyperuricemic treatment, and alkalinization of urine throughout the 5 days of Clofarabine Injection administration to reduce the risk of tumor lysis and other adverse events.

(2.1) Discontinue Clofarabine Injection if hypotension develops during the 5 days of administration. (2.1) Reduce the dose in patients with renal impairment. (2.1) Use dose modification for toxicity.

(2.3)

2.1Recommended Dosage Administer the recommended pediatric dose of 52 mg/m2 as an intravenous infusion over 2 hours daily for 5 consecutive days. Treatment cycles are repeated following recovery or return to baseline organ function, approximately every 2 to 6 weeks. The dosage is based on the patient’s body surface area (BSA), calculated using the actual height and weight before the start of each cycle.

To prevent drug incompatibilities, no other medications should be administered through the same intravenous line. Provide supportive care, such as intravenous fluids, antihyperuricemic treatment, and alkalinize urine throughout the 5 days of Clofarabine Injection administration to reduce the effects of tumor lysis and other adverse events. Discontinue Clofarabine Injection if hypotension develops during the 5 days of administration.

Monitor renal and hepatic function during the 5 days of Clofarabine Injection administration [see Warnings and Precautions (5.7, 5.8)]. Monitor patients taking medications known to affect blood pressure. Monitor cardiac function during administration of Clofarabine Injection.

Reduce the dose by 50% in patients with creatinine clearance (CrCL) between 30 and 60 mL/min. There is insufficient information to make a dosage recommendation in patients with CrCL less than 30 mL/min [see Use in Specific Populations (8.7)].

2.2Supportive Medications and Medications to Avoid Consider prophylactic anti-emetic medications as Clofarabine Injection is moderately emetogenic. Consider the use of prophylactic steroids to mitigate Systemic Inflammatory Response Syndrome (SIRS) or capillary leak syndrome (e.g., hypotension, tachycardia, tachypnea, and pulmonary edema). Minimize exposure to drugs with known renal toxicity during the 5 days of Clofarabine Injection administration since the risk of renal toxicity may be increased.

Consider avoiding concomitant use of medications known to induce hepatic toxicity.

2.3Dose Modifications and Reinitiation of Therapy Hematologic Toxicity Administer subsequent cycles no sooner than 14 days from the starting day of the previous cycle and provided the patient’s ANC is ≥0.75 × 10 9 /L. If a patient experiences a Grade 4 neutropenia (ANC <0.5 × 10 9 /L) lasting ≥4 weeks, reduce dose by 25% for the next cycle. Non-hematologic Toxicity Withhold Clofarabine Injection if a patient develops a clinically significant infection, until the infection is controlled, then restart at the full dose.

Withhold Clofarabine Injection for a Grade 3 non-infectious non-hematologic toxicity (excluding transient elevations in serum transaminases and/or serum bilirubin and/or nausea/vomiting controlled by antiemetic therapy). Re-institute Clofarabine Injection administration at a 25% dose reduction when resolution or return to baseline.

2.4Reconstitution/Preparation Clofarabine Injection should be filtered through a sterile 0.2 micron syringe filter and then diluted with 5% Dextrose Injection, USP, or 0.9% Sodium Chloride Injection, USP, prior to intravenous (IV) infusion to a final concentration between 0.15 mg/mL and 0.4 mg/mL. Use within 24 hours of preparation. Store diluted Clofarabine Injection at room temperature (15-30 º C).

2.5Incompatibility Do not administer any other medications through the same intravenous line.

💊 Dosage Forms and Strengths 18 words ▾

3 DOSAGE FORMS AND STRENGTHS 20 mg/20 mL (1 mg/mL) single-dose vial 20 mg/20 mL single-dose vial. (3)

⛔ Contraindications 5 words ▾

4 CONTRAINDICATIONS None None. (4)

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Myelosuppression: May be severe and prolonged. Monitor complete blood counts and platelet counts during Clofarabine Injection therapy. (5.1) Hemorrhage: Serious and fatal cerebral, gastrointestinal and pulmonary hemorrhage.

Monitor platelets and coagulation parameters and treat accordingly. (5.2) Infections: Severe and fatal sepsis as a result of bone marrow suppression. Monitor for signs and symptoms of infection; discontinue Clofarabine Injection and treat promptly.

(5.3) Tumor Lysis syndrome: Anticipate, monitor for signs and symptoms and treat promptly. (5.4) Systemic Inflammatory Response Syndrome (SIRS) or Capillary Leak Syndrome: Monitor for and discontinue Clofarabine Injection immediately if suspected. (5.5) Venous Occlusive Disease of the Liver: Monitor for and discontinue Clofarabine Injection if suspected.

(5.6) Hepatotoxicity: Severe and fatal hepatotoxicity. Monitor liver function, for signs and symptoms of hepatitis and hepatic failure. Discontinue Clofarabine Injection immediately for Grade 3 or greater liver enzyme and/or bilirubin elevations.

(5.7) Renal Toxicity: Increased creatinine and acute renal failure; monitor renal function and interrupt or discontinue Clofarabine Injection. (5.8) Enterocolitis: Serious and fatal enterocolitis, occurring more frequently within 30 days of treatment and with combination chemotherapy. Monitor patients for signs and symptoms of enterocolitis and treat promptly.

(5.9) Skin Reactions: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), including fatal cases. Discontinue for exfoliative or bullous rash, or if SJS or TEN is suspected. (5.10)

5.1Myelosuppression Clofarabine Injection causes myelosuppression which may be severe and prolonged. Febrile neutropenia occurred in 55% and non-febrile neutropenia in an additional 10% of pediatric patients in clinical trials. At initiation of treatment, most patients in the clinical studies had hematological impairment as a manifestation of leukemia.

Myelosuppression is usually reversible with interruption of Clofarabine Injection treatment and appears to be dose-dependent. Monitor complete blood counts [see Dosage and Administration (2.3)].

5.2Hemorrhage Serious and fatal hemorrhage, including cerebral, gastrointestinal and pulmonary hemorrhage, has occurred. The majority of the cases were associated with thrombocytopenia. Monitor platelets and coagulation parameters and treat accordingly [see Adverse Reactions (6.2)].

5.3Infections Clofarabine Injection increases the risk of infection, including severe and fatal sepsis, and opportunistic infections. At baseline, 48% of the pediatric patients had one or more concurrent infections. A total of 83% of patients experienced at least one infection after Clofarabine Injection treatment, including fungal, viral and bacterial infections.

Monitor patients for signs and symptoms of infection, discontinue Clofarabine Injection, and treat promptly.

5.4Hyperuricemia (Tumor Lysis) Administration of Clofarabine Injection may result in tumor lysis syndrome associated with the break-down metabolic products from peripheral leukemia cell death. Monitor patients undergoing treatment for signs and symptoms of tumor lysis syndrome and initiate preventive measures including adequate intravenous fluids and measures to control uric acid.

5.5Systemic Inflammatory Response Syndrome (SIRS) and Capillary Leak Syndrome Clofarabine Injection may cause a cytokine release syndrome (e.g., tachypnea, tachycardia, hypotension, pulmonary edema) that may progress to the systemic inflammatory response syndrome (SIRS) with capillary leak syndrome and organ impairment which may be fatal. Monitor patients frequently for these conditions. In clinical trials, SIRS was reported in two patients (2%); capillary leak syndrome was reported in four patients (4%).

Symptoms included rapid onset of respiratory distress, hypotension, pleural and pericardial effusion, and multi-organ failure.… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the label: Myelosuppression [ see Warnings and Precautions (5.1) ] Hemorrhage [ see Warnings and Precautions (5.2) ] Serious Infections [ see Warnings and Precautions (5.3) ] Hyperuricemia (Tumor Lysis) [ see Warnings and Precautions (5.4) ] Systemic Inflammatory Response Syndrome (SIRS) and Capillary Leak Syndrome [ see Warnings and Precautions (5.5) ] Venous Occlusive Disease of the Liver [ see Warnings and Precautions (5.6) ] Hepatotoxicity [ see Warnings and Precautions (5.7) ] Renal Toxicity [ see Warnings and Precautions (5.8) ] Enterocolitis [ see Warnings and Precautions (5.9) ] Skin Reactions [ see Warnings and Precautions (5.10) ] Most common adverse reactions (≥25%): vomiting, nausea, diarrhea, febrile neutropenia, pruritus, headache, bacteremia, pyrexia, rash, tachycardia, abdominal pain, chills, fatigue, anorexia, pain in extremity, hypotension, epistaxis, and petechiae.

(6) To report SUSPECTED ADVERSE REACTIONS, contact Fosun Pharma USA Inc. at 1-866-611-3762 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience 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. The data described below reflect exposure to Clofarabine Injection in 115 pediatric patients with relapsed or refractory Acute Lymphoblastic Leukemia (ALL) (70 patients) or Acute Myelogenous Leukemia (AML) (45 patients). In total, 115 pediatric patients treated in clinical trials received the recommended dose of Clofarabine Injection 52 mg/m2 daily × 5.

The median number of cycles was 2. The median cumulative amount of Clofarabine Injection received by pediatric patients during all cycles was 540 mg. Most common adverse reactions (≥25%): vomiting, nausea, diarrhea, febrile neutropenia, pruritus, headache, bacteremia, pyrexia, rash, tachycardia, abdominal pain, chills, fatigue, anorexia, pain in extremity, hypotension, epistaxis, and petechiae.

Table 1 lists adverse reactions by System Organ Class, including severe or life-threatening (NCI CTC Grade 3 or Grade 4), reported in ≥5% of the 115 patients in the 52 mg/m2/day dose group (pooled analysis of pediatric patients with ALL and AML). More detailed information and follow-up of certain events is given below. Table 1: Most Commonly Reported (≥5% Overall) Adverse Reactions by System Organ Class (N=115 pooled analysis) System Organ Class¹ Preferred Term¹ ALL/AM (N=115) Worst NCI Common Terminology Criteria Grade¹ 3 4 5 N % N % N % N % Blood and Lymphatic System Disorders Febrile neutropenia 63 55 59 51 3 3 Neutropenia 11 10 3 3 8 7 . .

Cardiac Disorders Pericardial effusion 9 8 . . 1 1 . . Tachycardia 40 35 6 5 . . . .

Gastrointestinal Disorders Abdominal pain 40 35 8 7 . . . . Abdominal pain upper 9 8 1 1 . . . . Diarrhea 64 56 14 12 . . . .

Gingival or mouth bleeding 20 17 8 7 1 1 . . Nausea 84 73 16 14 1 1 . . Oral mucosal petechiae 6 5 4 4 . . . .

Proctalgia 9 8 2 2 . . . . Stomatitis 8 7 1 1 . . . . Vomiting 90 78 9 8 1 1 . .

General Disorders and Administration Site Conditions Asthenia 12 10 1 1 1 1 . . Chills 39 34 3 3 . . . . Fatigue 39 34 3 3 2 2 . .

Irritability 11 10 1 1 . . . . Mucosal inflammation 18 16 2 2 . . . . Edema 14 12 2 2 . . . .

Pain 17 15 7 6 1 1 . . Pyrexia 45 39 16 14 . . . . Hepatobiliary Disorder Jaundice 9 8 2 2 . . . .

Infections and Infestations Bacteremia 10 9 10 9 . . . . Candidiasis 8 7 1 1 . . . . Catheter related infection 14 12 13 11 . . . .

Cellulitis 9 8 7 6 . . . . Clostridium colitis 8 7 6 5 . . . . Herpes simplex 11 10 6 5 . . . .

Herpes zoster 8 7 6 5 . . . . Oral candidiasis 13 11 2 2 . . . . Pneumonia 11 10 6 5 1 1 1 1 ¹ Patients with more than one preferred term within a SOC are counted only once in the SOC totals.

Patients… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS Embryo-fetal Toxicity: fetal harm can occur when administered to a pregnant woman. Women should be advised to avoid becoming pregnant when receiving Clofarabine Injection. (5.11, 8.1) See 17 for PATIENT COUNSELING INFORMATION

8.1Pregnancy Pregnancy Category D Clofarabine Injection may cause fetal harm when administered to a pregnant woman. Clofarabine was teratogenic in rats and rabbits. Developmental toxicity (reduced fetal body weight and increased post-implantation loss) and increased incidences of malformations and variations (gross external, soft tissue, skeletal and retarded ossification) were observed in rats receiving 54 mg/m 2 /day (approximately equivalent to the recommended clinical dose on a mg/m 2 basis), and in rabbits receiving 12 mg/m 2 /day (approximately 23% of the recommended clinical dose on a mg/m 2 basis).

There are no adequate and well-controlled studies in pregnant women using clofarabine. If this drug 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 while receiving treatment with clofarabine.

All patients should be advised to use effective contraceptive measures to prevent pregnancy.

8.3Nursing Mothers It is not known whether clofarabine or its metabolites are excreted in human milk. Because of the potential for tumorigenicity shown for clofarabine in animal studies and the potential for serious adverse reactions, women treated with clofarabine should not nurse. Female patients should be advised to avoid breastfeeding during treatment with Clofarabine Injection.

8.4Pediatric Use Safety and effectiveness have been established in pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia.

8.5Geriatric Use Safety and effectiveness of Clofarabine Injection has not been established in geriatric patients aged 65 and older.

8.6Adults with Hematologic Malignancies Safety and effectiveness have not been established in adults.

8.7Renal Impairment Reduce the Clofarabine Injection starting dose by 50% in patients with CrCL of 30 to 60 mL/min. There is insufficient information to make a dosage recommendation in patients with CrCL less than 30 mL/min or in patients on dialysis. The pharmacokinetics of clofarabine in patients with renal impairment and normal renal function were obtained from a population pharmacokinetic analysis of three pediatric and two adult studies.

In patients with CrCL 60 to less than 90 mL/min (N=47) and CrCL 30 to less than 60 mL/min (N=30), the average AUC of clofarabine increased by 60% and 140%, respectively, compared to patients with normal (N=66) renal function (CrCL greater than 90 mL/min).

🤰 Pregnancy 160 words ▾

8.1Pregnancy Pregnancy Category D Clofarabine Injection may cause fetal harm when administered to a pregnant woman. Clofarabine was teratogenic in rats and rabbits. Developmental toxicity (reduced fetal body weight and increased post-implantation loss) and increased incidences of malformations and variations (gross external, soft tissue, skeletal and retarded ossification) were observed in rats receiving 54 mg/m 2 /day (approximately equivalent to the recommended clinical dose on a mg/m 2 basis), and in rabbits receiving 12 mg/m 2 /day (approximately 23% of the recommended clinical dose on a mg/m 2 basis).

There are no adequate and well-controlled studies in pregnant women using clofarabine. If this drug 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 while receiving treatment with clofarabine.

All patients should be advised to use effective contraceptive measures to prevent pregnancy.

🧒 Pediatric Use 24 words ▾

8.4Pediatric Use Safety and effectiveness have been established in pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia.

🧓 Geriatric Use 20 words ▾

8.5Geriatric Use Safety and effectiveness of Clofarabine Injection has not been established in geriatric patients aged 65 and older.

🆘 Overdosage 84 words ▾

10 OVERDOSAGE There were no known overdoses of Clofarabine Injection. The highest daily dose administered to a human to date (on a mg/m 2 basis) has been 70 mg/m 2 /day × 5 days (2 pediatric ALL patients). The toxicities included in these 2 patients included Grade 4 hyperbilirubinemia, Grade 2 and 3 vomiting, and Grade 3 maculopapular rash.

In a Phase 1 study of adults with refractory and/or relapsed hematologic malignancies, the recommended pediatric dose of 52 mg/m 2 /day was not tolerated.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Clofarabine is sequentially metabolized intracellularly to the 5’-monophosphate metabolite by deoxycytidine kinase and mono- and di-phospho-kinases to the active 5’-triphosphate metabolite. Clofarabine has affinity for the activating phosphorylating enzyme, deoxycytidine kinase, equal to or greater than that of the natural substrate, deoxycytidine. Clofarabine inhibits DNA synthesis by decreasing cellular deoxynucleotide triphosphate pools through an inhibitory action on ribonucleotide reductase, and by terminating DNA chain elongation and inhibiting repair through incorporation into the DNA chain by competitive inhibition of DNA polymerases.

The affinity of clofarabine triphosphate for these enzymes is similar to or greater than that of deoxyadenosine triphosphate. In preclinical models, clofarabine has demonstrated the ability to inhibit DNA repair by incorporation into the DNA chain during the repair process. Clofarabine 5’- triphosphate also disrupts the integrity of mitochondrial membrane, leading to the release of the pro-apoptotic mitochondrial proteins, cytochrome C and apoptosis-inducing factor, leading to programmed cell death.

Clofarabine is cytotoxic to rapidly proliferating and quiescent cancer cell types in vitro.

12.3Pharmacokinetics The population pharmacokinetics of Clofarabine Injection were studied in 40 pediatric patients aged 2 to 19 years (21 males/19 females) with relapsed or refractory acute lymphoblastic leukemia (ALL) or acute myelogenous leukemia (AML). At the given 52 mg/m 2 dose, similar concentrations were obtained over a wide range of body surface areas (BSAs). Clofarabine was 47% bound to plasma proteins, predominantly to albumin.

Based on non-compartmental analysis, systemic clearance and volume of distribution at steady-state were

28.8L/h/m 2 and 172 L/m 2 , respectively. The terminal half-life was 5.2 hours. No apparent difference in pharmacokinetics was observed between patients with ALL and AML or between males and females.

No relationship between clofarabine or clofarabine triphosphate exposure and toxicity or response was found in this population. Based on 24-hour urine collections in the pediatric studies, 49-60% of the dose is excreted in the urine unchanged. In vitro studies using isolated human hepatocytes indicate very limited metabolism (0.2%).

The pathways of non-hepatic elimination remain unknown. Clofarabine has not been studied in patients with hepatic impairment. Drug-Drug Interactions In vitro studies suggested that clofarabine undergoes limited metabolism and does not inhibit or induce major CYP enzymes.

CYP inhibitors and inducers are unlikely to affect the metabolism of clofarabine. Clofarabine is unlikely to affect the metabolism of CYP substrates. However, no in vivo drug interaction studies have been conducted.

An in vitro transporter study suggested that clofarabine is a substrate of human transporters OAT1, OAT3, and OCT1. A preclinical study using perfused rat kidney demonstrated that the renal excretion of clofarabine was decreased by cimetidine, an inhibitor of the hOCT2. Although the clinical implications of this finding have not been determined, signs of Clofarabine Injection toxicity should be monitored when administered with other hOAT1, hOAT3, hOCT1 and hOCT2 substrates or inhibitors.

🧬 Mechanism of Action 166 words ▾

12.1Mechanism of Action Clofarabine is sequentially metabolized intracellularly to the 5’-monophosphate metabolite by deoxycytidine kinase and mono- and di-phospho-kinases to the active 5’-triphosphate metabolite. Clofarabine has affinity for the activating phosphorylating enzyme, deoxycytidine kinase, equal to or greater than that of the natural substrate, deoxycytidine. Clofarabine inhibits DNA synthesis by decreasing cellular deoxynucleotide triphosphate pools through an inhibitory action on ribonucleotide reductase, and by terminating DNA chain elongation and inhibiting repair through incorporation into the DNA chain by competitive inhibition of DNA polymerases.

The affinity of clofarabine triphosphate for these enzymes is similar to or greater than that of deoxyadenosine triphosphate. In preclinical models, clofarabine has demonstrated the ability to inhibit DNA repair by incorporation into the DNA chain during the repair process. Clofarabine 5’- triphosphate also disrupts the integrity of mitochondrial membrane, leading to the release of the pro-apoptotic mitochondrial proteins, cytochrome C and apoptosis-inducing factor, leading to programmed cell death.

Clofarabine is cytotoxic to rapidly proliferating and quiescent cancer cell types in vitro.

📦 How Supplied / Storage and Handling 123 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Clofarabine Injection is supplied in single-dose flint vials containing 20 mg of clofarabine in 20 mL of solution. Each box contains one Clofarabine Injection vial (NDC 72266-108-01). The 20 mL flint vials contain 20 mL (20 mg) of solution.

The pH range of the solution is 4.5 to 7.5. Vials containing undiluted Clofarabine Injection should be stored at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). Diluted admixtures may be stored at room temperature, but must be used within 24 hours of preparation.

Procedures for proper handling and disposal should be utilized. Handling and disposal of Clofarabine Injection should conform to guidelines issued for cytotoxic drugs. Several guidelines on this subject have been published.

1

📋 Description 69 words ▾

11 DESCRIPTION Clofarabine Injection contains clofarabine, a purine nucleoside metabolic inhibitor. Clofarabine Injection (1 mg/mL) is supplied in a 20 mL, single-dose vial. The 20 mL vial contains 20 mg clofarabine formulated in 20 mL unbuffered normal saline (comprised of Water for Injection, USP, and Sodium Chloride, USP). The pH range of the solution is 4.5 to 7.5. The solution is sterile, clear and practically colorless, and is preservative-free.

🍼 Nursing Mothers 56 words ▾

8.3Nursing Mothers It is not known whether clofarabine or its metabolites are excreted in human milk. Because of the potential for tumorigenicity shown for clofarabine in animal studies and the potential for serious adverse reactions, women treated with clofarabine should not nurse. Female patients should be advised to avoid breastfeeding during treatment with Clofarabine Injection.

🧬 Pharmacokinetics ~1 min read ▾

12.3Pharmacokinetics The population pharmacokinetics of Clofarabine Injection were studied in 40 pediatric patients aged 2 to 19 years (21 males/19 females) with relapsed or refractory acute lymphoblastic leukemia (ALL) or acute myelogenous leukemia (AML). At the given 52 mg/m 2 dose, similar concentrations were obtained over a wide range of body surface areas (BSAs). Clofarabine was 47% bound to plasma proteins, predominantly to albumin.

Based on non-compartmental analysis, systemic clearance and volume of distribution at steady-state were

28.8L/h/m 2 and 172 L/m 2 , respectively. The terminal half-life was 5.2 hours. No apparent difference in pharmacokinetics was observed between patients with ALL and AML or between males and females.

No relationship between clofarabine or clofarabine triphosphate exposure and toxicity or response was found in this population. Based on 24-hour urine collections in the pediatric studies, 49-60% of the dose is excreted in the urine unchanged. In vitro studies using isolated human hepatocytes indicate very limited metabolism (0.2%).

The pathways of non-hepatic elimination remain unknown. Clofarabine has not been studied in patients with hepatic impairment. Drug-Drug Interactions In vitro studies suggested that clofarabine undergoes limited metabolism and does not inhibit or induce major CYP enzymes.

CYP inhibitors and inducers are unlikely to affect the metabolism of clofarabine. Clofarabine is unlikely to affect the metabolism of CYP substrates. However, no in vivo drug interaction studies have been conducted.

An in vitro transporter study suggested that clofarabine is a substrate of human transporters OAT1, OAT3, and OCT1. A preclinical study using perfused rat kidney demonstrated that the renal excretion of clofarabine was decreased by cimetidine, an inhibitor of the hOCT2. Although the clinical implications of this finding have not been determined, signs of Clofarabine Injection toxicity should be monitored when administered with other hOAT1, hOAT3, hOCT1 and hOCT2 substrates or inhibitors.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES Seventy-eight (78) pediatric patients with ALL were exposed to Clofarabine Injection. Seventy (70) of the patients received the recommended pediatric dose of Clofarabine Injection 52 mg/m 2 daily for 5 days as an intravenous (IV) infusion. Dose Escalation Study in Pediatric Patients with Hematologic Malignancies The safety and efficacy of Clofarabine Injection were evaluated in pediatric patients with refractory or relapsed hematologic malignancies in an open-label, dose-escalation, noncomparative study.

The starting dose of Clofarabine Injection was 11.25 mg/m 2 /day IV infusion daily × 5 and escalated to 70 mg/m 2 /day IV infusion daily × 5. This dosing schedule was repeated every 2 to 6 weeks depending on toxicity and response. Nine of 17 ALL patients were treated with Clofarabine Injection 52 mg/m 2 daily for 5 days.

In the 17 ALL patients there were 2 complete remissions (12%) and 2 partial remissions (12%) at varying doses. Dose-limiting toxicities (DLTs) in this study were reversible hyperbilirubinemia and elevated transaminase levels and skin rash, experienced at 70 mg/m 2 . As a result of this study, the recommended dose for subsequent study in pediatric patients was determined to be 52 mg/m 2 /day for 5 days.

Single-Arm Study in Pediatric ALL Clofarabine Injection was evaluated in an open-label, single-arm study of 61 pediatric patients with relapsed/refractory ALL. Patients received a dose of 52 mg/m 2 over 2 hours for 5 consecutive days repeated every 2 to 6 weeks for up to 12 cycles. There was no dose escalation in this study.

All patients had disease that had relapsed after and/or was refractory to two or more prior therapies. Most patients, 38/61 (62%), had received >2 prior regimens and 18/61 (30%) of the patients had undergone at least 1 prior transplant. The median age of the treated patients was 12 years, 61% were male, 39% were female, 44% were Caucasian, 38% were Hispanic, 12% were African-American, 2% were Asian and 5% were Other race.

The overall remission (OR) rate (Complete Remission [CR] + CR in the absence of total platelet recovery [CRp]) was evaluated. CR was defined as no evidence of circulating blasts or extramedullary disease, an M1 bone marrow (≤5% blasts), and recovery of peripheral counts [platelets ≥100 × 10 9 /L and absolute neutrophil count (ANC) ≥1.0 × 10 9 /L]. CRp was defined as meeting all criteria for CR except for recovery of platelet counts to ≥100 × 10 9 /L.

Partial Response (PR) was also determined, defined as complete disappearance of circulating blasts, an M2 bone marrow (≥5% and ≤25% blasts), and appearance of normal progenitor cells or an M1 marrow that did not qualify for CR or CRp. Duration of remission was also evaluated. Transplantation rate was not a study endpoint.

Response rates for these studies were determined by an unblinded Independent Response Review Panel (IRRP). Table 3 summarizes results for the pediatric ALL study. Responses were seen in both pre-B and T-cell immunophenotypes of ALL.

The median cumulative dose was 530 mg (range 29-2815 mg) in 1 (41%), 2 (44%) or 3 or more (15%) cycles. The median number of cycles was 2 (range 1-12). The median time between cycles was 28 days with a range of 12 to 55 days.

Table 3: Results in Single-Arm Pediatric ALL N=61 CR % [95% CI] 11.5 (4.7, 22.2) CRp % [95% CI] 8.2 (2.7, 18.1) Median Duration of CR plus CRp (range in weeks)1 10.7 (4.3 to 58.6) CR = Complete response CRp = Complete response without platelet recovery 1 Does not include 4 patients who were transplanted (duration of response, including response after transplant, in these 4 patients was 28.6 to 107.7 weeks). Six (9.8%) patients achieved a PR; the clinical relevance of a PR in this setting is unknown. Of 35 patients who were refractory to their immediately preceding induction regimen, 6 (17%) achieved a CR or CRp.

Of 18 patients who had at least 1 prior hematopoietic stem cell transplant (HSCT), 5 (28%) achieved a CR or CRp. Among the 12 pati… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Clofarabine has not been tested for carcinogenic potential. Clofarabine showed clastogenic activity in the in vitro mammalian cell chromosome aberration assay (CHO cells) and in the in vivo rat micronucleus assay. It did not show evidence of mutagenic activity in the bacterial mutation assay (Ames test).

Studies in mice, rats, and dogs have demonstrated dose-related adverse effects on male reproductive organs. Seminiferous tubule and testicular degeneration and atrophy were reported in male mice receiving intraperitoneal (IP) doses of 3 mg/kg/day (9 mg/m 2 /day, approximately 17% of clinical recommended dose on a mg/m 2 basis). The testes of rats receiving 25 mg/kg/day (150 mg/m 2 /day, approximately 3 times the recommended clinical dose on a mg/m 2 basis) in a 6-month IV study had bilateral degeneration of the seminiferous epithelium with retained spermatids and atrophy of interstitial cells.

In a 6-month IV dog study, cell degeneration of the epididymis and degeneration of the seminiferous epithelium in the testes were observed in dogs receiving 0.375 mg/kg/day (7.5 mg/m 2 /day, approximately 14% of the clinical recommended dose on a mg/m 2 basis). Ovarian atrophy or degeneration and uterine mucosal apoptosis were observed in female mice at 75 mg/kg/day (225 mg/m 2 /day, approximately 4-fold of recommended human dose on a mg/m 2 basis), the only dose administered to female mice. The effect on human fertility is unknown.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~1 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Clofarabine has not been tested for carcinogenic potential. Clofarabine showed clastogenic activity in the in vitro mammalian cell chromosome aberration assay (CHO cells) and in the in vivo rat micronucleus assay. It did not show evidence of mutagenic activity in the bacterial mutation assay (Ames test).

Studies in mice, rats, and dogs have demonstrated dose-related adverse effects on male reproductive organs. Seminiferous tubule and testicular degeneration and atrophy were reported in male mice receiving intraperitoneal (IP) doses of 3 mg/kg/day (9 mg/m 2 /day, approximately 17% of clinical recommended dose on a mg/m 2 basis). The testes of rats receiving 25 mg/kg/day (150 mg/m 2 /day, approximately 3 times the recommended clinical dose on a mg/m 2 basis) in a 6-month IV study had bilateral degeneration of the seminiferous epithelium with retained spermatids and atrophy of interstitial cells.

In a 6-month IV dog study, cell degeneration of the epididymis and degeneration of the seminiferous epithelium in the testes were observed in dogs receiving 0.375 mg/kg/day (7.5 mg/m 2 /day, approximately 14% of the clinical recommended dose on a mg/m 2 basis). Ovarian atrophy or degeneration and uterine mucosal apoptosis were observed in female mice at 75 mg/kg/day (225 mg/m 2 /day, approximately 4-fold of recommended human dose on a mg/m 2 basis), the only dose administered to female mice. The effect on human fertility is unknown.

📚 References 9 words ▾

15 REFERENCES 1. OSHA Hazardous Drugs. OSHA . http://www.osha.gov/SLTC/hazardousdrugs/index.html.

📄 Recent Major Changes 5 words ▾

Indications and Usage (1) 7/2022

📄 Package Label / Principal Display Panel 49 words ▾

NDC 72266-108-01 Clofarabine Injection 20 mg/20 mL (1 mg/mL) Must Be Diluted Prior To Intravenous Use Each 20 mL Single-Dose Vial contains 20 mg clofarabine dissolved in 20 mL of sodium chloride injection, USP 0.9% pH 4.5-7.5. Rx only 20 mL Single-Dose Vial FOSUN PHARMA Clofarabine Injection CRT jpg

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

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