Clofarabine

Clofarabine is a prescription medication 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 is available under the following different brand names: Clolar

Common side effects of clofarabine include:

• pain at the injection site
• tiredness
• flushing
• headache
• dizziness
• light-headedness
• fainting
• drowsiness
• back pain
• stomach pain
• diarrhea
• rectal pain
• nausea or vomiting (may be severe)
• loss of appetite
• muscle or joint pain
• itching or skin rash
• anxiety
• irritability
• flushing (warmth, redness, or tingly feeling under the skin)

Serious side effects of clofarabine include:

• hives
• difficulty breathing
• swelling of the face, lips, tongue, or throat
• fever
• sore throat
• burning eyes
• skin pain
• red or purple skin rash with blistering and peeling
• flu-like symptoms
• sudden swelling
• shortness of breath
• rapid breathing
• light-headedness
• trouble breathing while lying down
• watery or bloody diarrhea
• little or no urination
• pain, blisters, bleeding, or severe rash on the palms of the hands or the soles of the feet
• upper stomach pain
• sudden swelling of the midsection
• dark urine
• yellowing of the skin or eyes (jaundice)
• chills
• mouth or throat ulcers
• skin sores
• easy bruising
• unusual bleeding
• pale skin
• cold hands and feet
• shallow breathing
• sudden numbness or weakness (especially on one side of the body)
• severe headache
• problems with vision or speech
• chest pain
• coughing up blood
• blood in the urine
• bloody or tarry stools
• tiredness
• weakness
• muscle cramps
• nausea
• vomiting
• diarrhea
• fast or slow heart rate
• tingling in the hands, feet, or around the mouth

Rare side effects of clofarabine include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, light-headedness, or passing out

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Injectable solution

• 1 mg/mL (20-mg vial)

Refractory or Relapsed Acute Lymphoblastic Leukemia

Adult dosage

• Adults younger than 21 years: 52 mg/m2 IV over 2 hours once a day for 5 consecutive days
• Treatment cycles repeated every 2-6 weeks following recovery or return to baseline organ function
• Adults older than 21 years: Not indicated for this age group

Pediatric dosage

• Children aged 1 year and older: 52 mg/m2 IV over 2 hours daily for 5 consecutive days
• Treatment cycles repeated every 2-6 weeks following recovery or return to baseline organ function

Dosage Considerations – Should be Given as Follows:

• See "Dosages"

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Clofarabine has severe interactions with no other drugs
• Clofarabine has serious interactions with the following drugs:
  • axicabtagene ciloleucel
  • bacitracin
  • brexucabtagene autoleucel
  • ciltacabtagene autoleucel
  • idecabtagene vicleucel
  • lisocabtagene maraleucel
  • palifermin
  • ropeginterferon alfa 2b
  • tisagenlecleucel
  • tofacitinib
• Clofarabine has moderate interactions with the following drugs:
  • cholera vaccine
  • dengue vaccine
  • hydroxyurea
  • influenza A (H5N1) vaccine
  • influenza virus vaccine (H5N1), adjuvanted
  • ofatumumab SC
  • peramivir
  • siponimod
  • trastuzumab
  • trastuzumab deruxtecan
  • zidovudine
• Clofarabine has minor interactions with the following drugs:
  • benazepril
  • captopril

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Clofarabine?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Clofarabine?”

Cautions

• Expect typical chemotherapeutic adverse events (diarrhea, nausea/vomiting, bone marrow suppression, risk for 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 because of bone marrow suppression; discontinue therapy promptly if infection occurs
• 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; 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 occurs
• Monitor for signs and symptoms of enterocolitis and treat it promptly
• Discontinue therapy if exfoliative or bullous rash is suspected or if Stevens-Johnson syndrome or toxic epidermal necrolysis is suspected
• Patients with infection, sepsis, or tumor lysis syndrome may be at an increased risk for 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 and Lactation

• In animal reproduction studies, intravenous administration to pregnant rats and rabbits during organogenesis at doses approximately 0.2-1 times the maximum recommended human dose of 52 mg/m2 based on body surface area resulted in embryo-fetal mortality, alterations to growth, and structural abnormalities
• Advise pregnant women of the potential risk to their fetus; there are no available data on use in pregnant women to evaluate for a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes; the drug should be used during pregnancy only if potential benefits to mother outweigh potential risks, including those to the fetus
• Pregnancy testing is recommended for women of reproductive potential before initiating treatment
• Contraception
  • Women: Therapy can cause embryo-fetal harm when administered to pregnant women; advise female patients to use effective contraception during treatment and for 6 months after the last dose
  • Men: Based on genotoxicity findings, advise men with female partners of reproductive potential to use effective contraception during treatment and for at least 3 months after the last dose
• Infertility
  • Women: Based on findings from animal studies, drugs may impair female fertility; the reversibility of effect on fertility is unknown
  • Men: Based on findings from animal studies, the drug may impair male fertility; the reversibility of its effect on fertility is unknown
• Lactation
  • There are no data on the presence of clofarabine in human milk, its effects on breastfed children, or milk production; because of the potential for serious adverse reactions in breastfed children including genotoxicity, advise patients not to breastfeed during treatment and for at least 2 weeks after last dose