Dosing & Uses
Dosage Forms & Strengths
injectable solution
- 1mg/mL (20mg vial)
Refractory or Relapsed Acute Lymphoblastic Leukemia
<21 years: 52 mg/m² IV over 2 hr qDay for 5 consecutive days
Treatment cycles repeated q2-6wk following recovery or return to baseline organ function
>21 years: Not indicated for this age group
Acute Myelogenous Leukemia (Orphan)
Orphan indication sponsor
- Genzyme Corporation; 4545 Horizon Hill Blvd; San Antonio, TX 78229-2263
Dosage Modifications
Discontinue if hypotension develops during 5 days of treatment
Hepatic impairment: Not studied
Renal impairment
- CrCl 30-60 mL/min: Decrease dose by 50%
- CrCl <30 mL/min: Insufficient data to make recommendation
Monitor
Respiratory status & BP during infusion
Renal & hepatic function during administration
Hematologic status
Dosage Forms & Strengths
injectable solution
- 1mg/mL (20mg vial)
Refractory or Relapsed Acute Lymphoblastic Leukemia
≥1 year: 52 mg/m² IV over 2 hr daily for 5 consecutive days
Treatment cycles repeated q2-6wk following recovery or return to baseline organ function
Dosage Modifications
Discontinue if hypotension develops during 5 days of treatment
Hepatic impairment: Not studied
Renal impairment
- CrCl 30-60 mL/min: Decrease dose by 50%
- CrCl <30 mL/min: Insufficient data to make recommendation
Monitor
Respiratory status & BP during infusion
Renal & hepatic function during administration
Hematologic status
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (10)
- axicabtagene ciloleucel
clofarabine, axicabtagene ciloleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- bacitracin
clofarabine and bacitracin both increase nephrotoxicity and/or ototoxicity. Avoid or Use Alternate Drug. Avoid concurrent use of bacitracin with other nephrotoxic drugs
- brexucabtagene autoleucel
clofarabine, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- ciltacabtagene autoleucel
clofarabine, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- idecabtagene vicleucel
clofarabine, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- lisocabtagene maraleucel
clofarabine, lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- palifermin
palifermin increases toxicity of clofarabine by Other (see comment). Avoid or Use Alternate Drug. Comment: Palifermin should not be administered within 24 hrbefore, during infusion of, or within 24 hr after administration of antineoplastic agents. Coadministration of palifermin within 24 hr of chemotherapy resulted in increased severity and duration of oral mucositis.
- ropeginterferon alfa 2b
ropeginterferon alfa 2b, clofarabine. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.
- tisagenlecleucel
clofarabine, tisagenlecleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- tofacitinib
clofarabine, tofacitinib. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
Monitor Closely (11)
- cholera vaccine
clofarabine decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to cholera vaccine.
- dengue vaccine
clofarabine decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.
- hydroxyurea
clofarabine, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- influenza A (H5N1) vaccine
clofarabine decreases effects of influenza A (H5N1) vaccine by Mechanism: pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.
- influenza virus vaccine (H5N1), adjuvanted
clofarabine decreases effects of influenza virus vaccine (H5N1), adjuvanted by Mechanism: pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.
- ofatumumab SC
ofatumumab SC, clofarabine. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.
- peramivir
clofarabine increases levels of peramivir by decreasing renal clearance. Use Caution/Monitor. Caution when peramivir coadministered with nephrotoxic drugs.
- siponimod
siponimod and clofarabine both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.
- trastuzumab
trastuzumab, clofarabine. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .
- trastuzumab deruxtecan
trastuzumab deruxtecan, clofarabine. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .
- zidovudine
clofarabine, zidovudine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of myelosuppression.
Minor (2)
- benazepril
clofarabine, benazepril. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May increase risk of hypotension.
- captopril
clofarabine, captopril. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May increase risk of hypotension.
Adverse Effects
>10%
Infection: bacterial, viral, & fungal (83%)
Vomiting (83%)
Nausea (75%)
Anemia (83%)
Leukopenia (88%)
Lymphopenia (82%)
Febrile neutropenia (57%)
Thrombocytopenia (81%)
Diarrhea (53%)
Abdominal pain (8-35%)
Anorexia (30%)
Dermatitis
Pruritus (43%)
Fatigue (34%)
Headache (43%)
Pyrexia (39%)
Edema (12%)
Flushing (19%)
HTN (13%)
Hypotension (29%)
Anxiety (21%)
Pain (15%)
Erythema (11%)
Petechiae (26%)
Palmar-plantar erythrodysesthesia syndrome (16%)
Gingival bleeding (14%)
Mucositis (16%)
Oral candidiasis (11%)
Cough
Dyspnea (13%)
Pleural effusion (12%)
Hepatobiliary disorder
Hematuria (13%)
Limb pain (30%)
Myalgia (14%)
Contusion
Injection site pain
Transfusion reaction
1-10%
Back pain (10%)
Bacteremia (10%)
Herpes simplex infections (10%)
Sepsis (10%)
Irritability (10%)
Lethargy (10%)
Somnolence (10%)
Cellulitis (8%)
Agitation (5%)
Postmarketing Reports
Gastrointestinal disorders: Gastrointestinal hemorrhage including fatalities
Skin and subcutaneous tissue disorders: Occurrences of Stevens-Johnson Syndrome and toxic epidermal necrolysis
Metabolism and nutrition disorders: Hyponatremia
Hepatitis and hepatic failure
Cardiovascular disorders: Tachycardia
Chills
Warnings
Contraindications
Hypersensitivity
Cautions
Expect typical chemotherapeutic adverse events (diarrhea, nausea/vomiting, bone marrow suppression, risk of tumor lysis syndrome)
Discontinue immediately if clinically significant systemic inflammatory response synd or capillary leak synd develops (may be prevented with prophylactic steroids)
Myelosuppression may be severe and prolonged; monitor complete blood and platelet counts
Serious and fatal cerebral, gastrointestinal and pulmonary hemorrhage; monitor platelets and coagulation parameters and treat accordingly
Monitor for signs and symptoms of infection; severe and fatal sepsis as a result of bone marrow suppression; discontinue therapy promptly if infection occur
Monitor for and discontinue promptly if systemic inflammatory response or capillary leak syndrome suspected
Anticipate and monitor for signs and symptoms of tumor lysis syndrome occur; treat promptly
Monitor for and discontinue if venous occlusive disease of the liver suspected
Monitor liver enzymes and discontinue therapy at first signs of severe hepatotoxicity; discontinue therapy, immediately, for Grade 3 or greater liver enzyme and/or bilirubin elevations; fatal hepatotoxicity may occur
Monitor renal function and interrupt or discontinue if creatinine levels increase or acute renal failure occur
Monitor for signs and symptoms of enterocolitis and treat promptly
Discontinue therapy if exfoliative or bullous rash suspected or if Stevens-Johnson syndrome or toxic epidermal necrolysis suspected
Patients with infection, sepsis, or tumor lysis syndrome may be at increased risk of renal toxicity when treated receiving therapy; monitor patients for renal toxicity and interrupt or discontinue therapy as necessary
Avoid pregnancy
Hepatitis and hepatic failure reported
Renal impairment
Pregnancy & Lactation
Pregnancy
In animal reproduction studies, intravenous administration to pregnant rats and rabbits during organogenesis at doses approximately 0.2 to 1-times maximum recommended human dose of 52 mg/m2 based on body surface area (BSA) resulted in embryo-fetal mortality, alterations to growth, and structural abnormalities
Advise pregnant women of potential risk to a fetus; there are no available data on use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes; drug should be used during pregnancy only if potential benefits to mother outweigh potential risks, including those to fetus
Pregnancy testing is recommended for females of reproductive potential prior to initiating treatment
Contraception
- Females: Fherapy can cause embryo-fetal harm when administered to pregnant women; advise female patients to use effective contraception during treatment and for 6 months after last dose
- Males: Based on genotoxicity findings, advise males with female partners of reproductive potential to use effective contraception during treatment and for at least 3 months after last dose
Infertility
- Females: Based on findings from animal studies, drug may impair female fertility; the reversibility of effect on fertility is unknown
- Males: Based on findings from animal studies, drug may impair male fertility; reversibility of effect on fertility is unknown
Lactation
There are no data on presence of clofarabine in human milk, effects on breastfed child, or on milk production; because of potential for serious adverse reactions in breastfed child including genotoxicity, advise patients not to breastfeed during treatment, and for at least 2 weeks after last dose
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Half-Life: 5.2 hr
Protein Bound: 47%
Vd: 172 L/sq.meter
Metabolism: metabolized intracellularly to active triphosphate derivative by kinases & phosphokinases
Clearance: 28.8 L/h/sq.meter
Excretion: urine 49-60%
Mechanism of Action
Purine nucleoside analog, inhibits ribonucleotide reductase & DNA polymerases
May also promote mitochondria-mediated apoptosis
Administration
IV Preparation
Filter through 0.2 micron syringe filter
Dilute in D5W or NS
May store at room temp for <24 hr
IV Administration
Infuse over 2 hr
Do not administer other drugs in same IV line
Continuous IV fluids are recommended during the 5 days of Tx to reduce effects of tumor lysis syndrome
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Clolar intravenous - | 1 mg/mL vial |  | |
| clofarabine intravenous - | 1 mg/mL vial |  | |
| clofarabine intravenous - | 1 mg/mL vial |  | |
| clofarabine intravenous - | 1 mg/mL vial |  | |
| clofarabine intravenous - | 1 mg/mL vial |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
clofarabine intravenous
CLOFARABINE - INJECTION
(kloe-FAR-a-been)
COMMON BRAND NAME(S): Clolar
USES: Clofarabine is used to treat a certain type of cancer (acute lymphoblastic leukemia-ALL). It works by slowing or stopping the growth of cancer cells.
HOW TO USE: This medication is given by injection into a vein by a health care professional. It is given over 2 hours as directed by your doctor, usually once a day for 5 days in a row. A 5-day course of this medication is called a cycle. This cycle is repeated every 2 to 6 weeks depending on your response. The dosage is based on your medical condition, body size, and response to treatment.Drink plenty of fluids to prevent serious problems due to dehydration.Avoid getting the medication on the skin or in the eyes, mouth, or nose. If you do get the medication in those areas, flush with plenty of water and tell your doctor right away.
SIDE EFFECTS: Pain at the injection site, tiredness, flushing, headache, lightheadedness, drowsiness, back pain, diarrhea, nausea, vomiting, and loss of appetite may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If these effects last or get worse, tell your doctor or pharmacist promptly.People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.Treatment with clofarabine may sometimes cause your hands/feet to develop a skin reaction called hand-foot syndrome (palmar-plantar erythrodysesthesia). You can prevent or reduce these problems by protecting your hands and feet from a great deal of heat or pressure. Avoid unnecessary exposure to heat (such as hot dishwater, long hot baths). Avoid pressure on elbows, knees, and soles of feet (such as leaning on elbows, kneeling, taking long walks). Wear loose clothing. Depending on how severe your hand-foot syndrome is, your doctor may prescribe a medication to reduce the symptoms or decrease/delay your next dose of clofarabine. If you experience pain/swelling/redness, blisters, or numbness of the hands/feet that affects your usual activities, tell your doctor right away.Tell your doctor right away if you have any serious side effects, including: easy bleeding/bruising, muscle/joint pain, swelling feet/ankles, mental/mood changes (such as anxiety, depression), dark urine, yellowing skin/eyes, fast/difficult breathing, fast heartbeat.This medication can lower the body's ability to fight an infection. Tell your doctor right away if you develop any signs of an infection such as sore throat that doesn't go away, fever, or chills.This medication may rarely cause a serious bowel infection (enterocolitis). This infection is more likely to occur within 30 days of treatment and when clofarabine is used with other medications to treat cancer. Tell your doctor right away if you develop: diarrhea that doesn't stop, abdominal or stomach pain/cramping, mucus in your stool.Clofarabine sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, your doctor may add a medication and tell you to drink plenty of fluids. Tell your doctor right away if you have symptoms such as: low back/side pain (flank pain), signs of kidney problems (such as painful urination, pink/bloody urine, change in the amount of urine), muscle spasms/weakness.This drug may rarely cause serious (rarely fatal) bleeding in the brain or lungs, or bleeding from the stomach or intestines. If you notice any of the following unlikely but serious side effects, get medical help right away: nausea that doesn't stop, dizziness/fainting, sudden vision changes, seizures, confusion, trouble breathing, black/bloody stools, vomit that contains blood or looks like coffee grounds.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using clofarabine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood/bleeding problems, kidney disease, liver disease, recent/current infections.Clofarabine can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.Tell your health care professional that you are using clofarabine before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).To lower your risk of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using clofarabine. Clofarabine may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Women using this medication should ask about reliable forms of birth control during treatment and for 6 months after the last dose. Men using this medication should ask about reliable forms of birth control during treatment and for 3 months after the last dose. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this drug and for at least 2 weeks after the last dose. Consult your doctor before breastfeeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Lab and/or medical tests (such as complete blood count, kidney/liver function, bilirubin, blood pressure, lung function) should be done while you are using this medication. Keep all medical and lab appointments.
MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.
STORAGE: Not applicable. This medication is given in a clinic and will not be stored at home.
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
Information last revised October 2023. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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