FDA-filed SPL labeling · retrieved through openFDA

Clofarabine Injection

Clofarabine Injection is a chemotherapy medicine used to treat relapsed or refractory acute lymphoblastic leukemia in patients aged 1 to 21 years.

Brand name Clolar
Drug class ⓘ Nucleoside Metabolic Inhibitor
Rx Form 1 Route Intravenous
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 9 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveNov 21, 2022
Clinical labels in scope ⓘ9
AvailabilityRx
Earliest approval/marketing year ⓘ2004
FDA-listed product records ⓘ23
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 29, 2026
⭐ Clofarabine Injection at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Clofarabine Injection is a targeted chemotherapy for children and young adults (ages 1–21) with acute lymphoblastic leukemia that has relapsed or stopped responding to at least two other treatments. It is given by IV infusion over 5 consecutive days per cycle, with close monitoring for serious risks including bone marrow suppression, infection, liver and kidney toxicity, and dangerous inflammatory reactions. If you or your child is receiving this treatment, your care team will watch for these risks closely — reach out to them immediately if any warning signs appear.
How we write & review this content — our editorial policy →

📖 Clofarabine Injection: Patient Information Guide

A plain-language walkthrough of Clofarabine Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

Clofarabine Injection is a chemotherapy medicine approved for a specific group of young patients with a blood cancer called acute lymphoblastic leukemia.

  • Clofarabine Injection (brands: Clofarabine, Clolar) — given intravenously — is approved to treat pediatric patients ages 1 to 21 with relapsed or refractory acute lymphoblastic leukemia (ALL) who have already tried at least two other treatment regimens without lasting success
  • Approval is based on the drug's ability to shrink or eliminate measurable disease (response rate); no clinical trials have confirmed that it improves leukemia-related symptoms or extends overall survival
  • Safety and effectiveness have not been established in adults 22 and older or in patients 65 and older
⚙️How it works▾

Clofarabine is a type of chemotherapy called a nucleoside metabolic inhibitor. Once inside cancer cells, the body converts it into an active form that attacks DNA on two fronts: it blocks an enzyme (ribonucleotide reductase) needed to build the raw materials for DNA, and it inserts itself directly into the DNA chain, halting replication and preventing the cell from repairing damage. The active form also disrupts the membranes of mitochondria — the cell's power source — causing the release of proteins that trigger programmed cell death (apoptosis). Importantly, clofarabine is toxic to cancer cells whether they are actively dividing or in a resting state.

💊How it's taken▾

Clofarabine Injection is given by a healthcare professional as an intravenous (IV) infusion — directly into a vein — over approximately 2 hours, once a day for 5 days in a row. This 5-day course makes up one treatment cycle.

  • Cycles are generally repeated every 2 to 6 weeks, once blood counts and organ function have recovered
  • IV fluids, anti-nausea medications, and other supportive treatments are provided alongside each cycle
  • The dose is adjusted based on the patient's body size and kidney function — your care team will determine the right amount
  • Never mix or infuse this medication through the same IV line as other drugs
🤒Side effects — in detail▾

The most common side effects seen in clinical trials include:

  • Nausea, vomiting, and diarrhea
  • Fever (pyrexia) and chills
  • Febrile neutropenia (fever combined with dangerously low white blood cell counts)
  • Skin rash and itching (pruritus)
  • Headache and fatigue
  • Low blood pressure (hypotension) and rapid heart rate (tachycardia)
  • Low appetite (anorexia) and abdominal pain
  • Nosebleeds (epistaxis) and small skin bleeds (petechiae)

Serious reactions — including life-threatening infections, severe liver or kidney damage, dangerous inflammatory responses, and fatal skin reactions — can also occur and require immediate medical attention.

⚠️Warnings & precautions▾
  • Bone marrow suppression (myelosuppression): Clofarabine severely lowers blood cell counts, raising the risk of serious infections, bleeding, and anemia. Blood counts are monitored throughout treatment.
  • Serious and fatal infections: Because the immune system is suppressed, bacterial, fungal, and viral infections — including life-threatening sepsis — are a major risk. More than 80% of patients in clinical trials experienced at least one infection during treatment.
  • Liver toxicity (hepatotoxicity): Severe liver inflammation and failure, including fatal cases, have occurred. Liver enzymes are checked regularly. The drug is stopped immediately if significant liver enzyme or bilirubin elevations are detected.
  • Kidney toxicity (renal toxicity): Acute kidney failure has been reported. Kidney function is monitored during treatment, and the drug may be paused or stopped if kidney damage occurs.
  • Systemic Inflammatory Response Syndrome (SIRS) / capillary leak syndrome: A dangerous whole-body inflammatory reaction causing rapid breathing, fast heart rate, low blood pressure, and fluid buildup can develop and be fatal. The infusion is stopped immediately if this is suspected.
  • Tumor lysis syndrome: Rapid breakdown of cancer cells can release substances into the bloodstream that harm the kidneys and other organs. IV fluids and other preventive measures are given routinely.
  • Serious skin reactions: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) — severe, life-threatening skin conditions — have been reported, including fatal cases. Discontinue immediately if these are suspected.
  • Embryo-fetal toxicity: This drug can seriously harm or kill an unborn baby. Effective contraception is required during and after treatment.
🔀What it interacts with▾

While clofarabine undergoes very limited liver metabolism and does not strongly affect most drug-metabolizing enzymes, some interactions still matter:

  • Kidney-toxic drugs: Using other medications known to harm the kidneys at the same time increases the risk of serious kidney damage — minimize exposure to these during the 5-day treatment window
  • Liver-toxic drugs: Concurrent use of medications that stress the liver increases the risk of serious liver injury — these should be avoided during treatment
  • Blood pressure medications: Patients on drugs affecting blood pressure require extra monitoring, as clofarabine itself can lower blood pressure
  • Drugs sharing kidney transport proteins (OAT1, OAT3, OCT1, OCT2): Clofarabine is transported by these kidney proteins; drugs that compete for or block these transporters (such as cimetidine) may reduce how quickly clofarabine is cleared, raising the risk of toxicity

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it▾
  • Kidney disease: The dose must be reduced in patients with moderately reduced kidney function; there is not enough information to guide dosing in those with severely reduced kidney function or on dialysis
  • Pregnancy: Clofarabine can cause serious harm or death to an unborn baby — effective contraception is required during treatment and for 6 months after the last dose for females; for males with partners who could become pregnant, contraception is required during treatment and for at least 3 months after the last dose
  • Breastfeeding: Do not breastfeed during treatment or for at least 2 weeks after the last dose, as the drug could seriously harm the nursing infant
  • Fertility: Based on animal studies, this drug may impair fertility in both males and females; discuss with your doctor before starting treatment if preserving fertility is important
  • Age (pediatric): Approved specifically for patients ages 1 to 21 with ALL; safety and effectiveness in adults 22 and older or adults 65 and older have not been established
  • Liver impairment: Clofarabine has not been formally studied in patients with pre-existing liver impairment; use with extra caution and close monitoring
  • Prior stem cell transplant: Patients who have had a hematopoietic stem cell transplant (bone marrow transplant) are at higher risk of a serious liver condition called veno-occlusive disease (blockage of liver blood vessels)
🚑If you take too much▾

There are no confirmed overdose cases with Clofarabine Injection reported to date. The highest doses given to pediatric patients in studies caused severe liver enzyme elevations, vomiting, and a serious skin rash. If an overdose is suspected, contact your care team or a poison control center immediately so symptoms can be monitored and managed.

📡Pharmacodynamics — effects in the body▾

Clofarabine is cytotoxic — meaning it kills cancer cells — both when they are actively dividing and when they are in a resting state. It works by blocking the enzymes and processes cancer cells need to make and repair DNA, ultimately triggering programmed cell death (apoptosis). These effects are directed at rapidly proliferating cells, which is why bone marrow suppression (lowering of normal blood cell production) is one of the main measurable effects in the body.

🔬Pharmacokinetics — how your body processes it▾

After an IV infusion, clofarabine distributes widely throughout the body (volume of distribution ~172 L/m²) and is about 47% bound to blood proteins, mainly albumin. The drug has a terminal half-life of roughly 5.2 hours — meaning it takes about 5 hours for the body to clear half the drug. Between 49% and 60% of the dose is excreted unchanged in the urine, making the kidneys the primary route of elimination; only a tiny fraction (~0.2%) is broken down by the liver. Because the kidneys do most of the work clearing this drug, reduced kidney function significantly raises drug levels in the blood and requires dose adjustment.

📦How to store it▾

Vials containing undiluted Clofarabine Injection should be stored at 25°C (77°F); excursions permitted between 15° to 30°C (59° to 86°F). Do not freeze.

📄 Written from Clofarabine Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Clofarabine Injection — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is clofarabine being used for, and why does my child need it? ▾
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 leukemia (ALL) that has either come back (relapsed) or stopped responding to at least two other treatments. It's used in this situation because other options haven't worked, and the goal is to get the leukemia back under control. Your child's oncologist chose it because the evidence shows it can reduce the amount of detectable cancer in the body.
How will my child receive this medicine, and how often? ▾
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 is one cycle of treatment. After that, the team waits for blood counts and organ function to recover — usually about 2 to 6 weeks — before starting the next cycle. Your child will also receive IV fluids and other supportive medications during those 5 days to help protect the body.
What side effects should I expect, and which ones mean I need to call the doctor right away? ▾
Common side effects include nausea, vomiting, diarrhea, fever, headache, skin rash, itching, fatigue, and low blood pressure. These are real but manageable with supportive care your team will provide. However, call your doctor or go to the emergency room immediately if you notice signs of serious infection (high fever, extreme weakness), unusual bleeding, rapid breathing or racing heartbeat, yellowing of the skin or eyes, a severe or blistering rash, or significant decrease in urination. These could be signs of serious complications that need prompt treatment.
Is this medicine safe during pregnancy, and what about fertility? ▾
Clofarabine can cause serious harm to an unborn baby — it caused birth defects and pregnancy loss in animal studies, even at doses well below those used in humans. Females who could become pregnant must use effective birth control during treatment and for 6 months after the last dose. Males with partners who could become pregnant should use contraception during treatment and for at least 3 months after the last dose. Also, based on animal studies, clofarabine may affect the ability to have children in the future — talk to your doctor before starting if fertility is a concern.
Are there any medicines or supplements I should avoid while my child is on this treatment? ▾
Yes — it's important to minimize the use of any medicines known to be hard on the kidneys or liver during the 5 treatment days, because clofarabine already puts stress on those organs. Drugs that affect blood pressure also need extra monitoring since clofarabine can lower blood pressure. Some medicines that share the kidney's transport system — including certain common drugs like cimetidine — may affect how clofarabine is cleared from the body. Always give your care team a full list of every medication, supplement, and herbal product your child is taking before treatment starts.
Can I breastfeed while my child (or I) am receiving this treatment? ▾
No — breastfeeding is not safe during clofarabine treatment or for at least 2 weeks after the last dose. The drug could pass into breast milk and cause serious harm to a nursing infant. Your care team can help you plan for this if breastfeeding is something you were doing or planning to do.
Is Clofarabine Injection available over the counter? ▾
Clofarabine Injection is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Clofarabine Injection first available? ▾
Clofarabine Injection has been available in the United States since at least 2004, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Clofarabine Injection? ▾
Clofarabine Injection is supplied by 14 manufacturers listed in the FDA NDC Directory, including Fosun Pharma USA Inc., Amneal Pharmaceuticals LLC, Apotex Corp..

💬 Answers drafted from Clofarabine Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

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💊 How Clofarabine Injection comes

Clofarabine Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Injection

Into a vein
Brands Clolar
How this form is used
What it may be used for
  • Clofarabine and Clolar are used intravenously to treat relapsed or refractory acute lymphoblastic leukemia (ALL) in patients ages 1 to 21 after at least two prior treatment regimens
  • This intravenous form is approved based on response rate; no studies have confirmed improvement in symptoms or survival
Important instructions
  • Clofarabine Injection and Clolar are given as an IV infusion over approximately 2 hours, once daily for 5 consecutive days per treatment cycle
  • Cycles are repeated approximately every 2 to 6 weeks, based on recovery of blood counts and organ function
  • Clofarabine Injection and Clolar must not be infused through the same IV line as other medications to prevent incompatibilities
  • IV fluids and other supportive treatments are given alongside Clofarabine Injection and Clolar to help reduce risks such as tumor lysis syndrome and kidney damage
Available strengths 1 strength
1 mg/mL
23 FDA-listed product records ⓘ

📊 Clofarabine Injection across the U.S. market

How Clofarabine Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms ⓘ
14
Manufacturers
2
Brand names
23
FDA-listed product records ⓘ
2004
First marketed ⓘ
Fosun Pharma USA Inc.13%
Amneal Pharmaceuticals LLC9%
Apotex Corp.9%
Dr.Reddy's Laboratories Inc9%
Gland Pharma Limited9%
Meitheal Pharmaceuticals Inc.9%
Other makers43%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

🔍 Compare Clofarabine Injection products

A representative set of FDA-listed product records for Clofarabine Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 23 of 23 products — FDA National Drug Code Directory. See every product, package size and price: browse all 23 Clofarabine Injection NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Clofarabine Injection RxCUI 44151 1 dose form · 1 strength
  1. Dose form (SCDF) Injection RxCUI 1806666 In current FDA listings
    Clinical drug / strength (SCD) 20 ML clofarabine 1 MG/ML RxCUI 486419

Look up RxCUI 44151 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Clolar

🏭 Manufacturers & labelers

Fosun Pharma USA Inc. 3 Amneal Pharmaceuticals LLC 2 Apotex Corp. 2 Dr.Reddy's Laboratories Inc 2 Gland Pharma Limited 2 Meitheal Pharmaceuticals Inc. 2 Mylan Institutional LLC 2 Sanofi-Aventis U.S. LLC 2 Eugia US LLC 1 Fresenius Kabi USA, LLC 1 Novadoz Pharmaceuticals LLC 1 Winthrop U.S, a business of sanofi-aventis U.S. LLC 1 Winthrop U.S. 1 Zydus Lifesciences Limited 1

RxNorm drug class

Clofarabine Injection belongs to the Nucleoside Metabolic Inhibitor class.

Pharmacologic class Nucleoside Metabolic Inhibitor
Drug family (ATC) Purine analogues
How it works Nucleic Acid Synthesis Inhibitors

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Nov 21, 2022
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Clofarabine Injection.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Clofarabine Injection after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
9
NDC products indexed
23
Distinct labelers/manufacturers represented
14
Linked representative label ⓘ
Gland Pharma Limited
Linked label effective
Nov 21, 2022
Composite sections available
22
Linked SPL Set ID
b7d3a96e-0280-4f14-b921-795996f75950
Linked SPL Document ID
e35a63ca-af60-4142-a5af-37640734e820
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 9 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Gland Pharma Limited is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.