Clofarabine

What is Clofarabine?

• Clofarabine (Clolar) is a nucleoside metabolic inhibitor used in the therapy of acute lymphoblastic leukemia (ALL) in children.

What are the uses of this medicine?

• 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.

How does this medicine work?

• Clofarabine (kloe far' a been) is a purine analogue that is used in the treatment of acute lymphoblastic leukemia (ALL) in children and is used off-label in other forms of leukemia and myelodysplastic syndromes. Clofarabine is a fluorinated arabinosyladenine derivative that is converted intracellularly to the active triphosphate, which is believed to compete with adenine triphosphate for uptake and use by DNA polymerase leading to inhibition of DNA synthesis.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• No formal drug interaction studies have been conducted with Clolar.

Is this medicine FDA approved?

• Clofarabine was found to have activity against acute leukemia and was approved for use as an antineoplastic agent in the United States in 2004. C
• urrent indications are therapy of acute lymphoblastic leukemia in children after failure of prior therapies.

How should this medicine be used?

Recommended dosage:

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

Administration:

• Administer the recommended pediatric dose as an intravenous infusion over 2 hours daily for 5 consecutive days of a 28-day cycle.
• Repeat cycles every 2-6 weeks.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 20 mg/20 mL (1 mg/mL) single-dose vial

This medicine is available in fallowing brand namesː

• Clolar

What side effects can this medication cause?

The most common side effects of this medicine include:

• vomiting
• nausea
• diarrhea
• febrile neutropenia
• pruritus
• headache
• bacteremia
• pyrexia
• rash
• tachycardia
• abdominal pain
• chills
• fatigue
• anorexia
• pain in extremity
• hypotension
• epistaxis
• petechiae

What special precautions should I follow?

• Clofarabine causes myelosuppression which may be severe and prolonged. May be severe and prolonged. Monitor complete blood counts and platelet counts during Clofarabine therapy.
• Serious and fatal hemorrhage, including cerebral, gastrointestinal and pulmonary hemorrhage, has occurred. Monitor platelets and coagulation parameters and treat accordingly.
• Clofarabine increases the risk of infection, including severe and fatal sepsis, and opportunistic infections. Monitor for signs and symptoms of infection; discontinue Clofarabine and treat promptly.
• Administration of Clofarabine may result in tumor lysis syndrome associated with the break-down metabolic products from peripheral leukemia cell death. Anticipate, monitor for signs and symptoms and treat promptly.
• Clofarabine 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 for and discontinue Clofarabine immediately if suspected.
• Patients who have previously received a hematopoietic stem cell transplant (HSCT) are at higher risk for veno-occlusive disease (VOD) of the liver following treatment with clofarabine. Monitor for and discontinue Clofarabine if suspected.
• Severe and fatal hepatotoxicity, including hepatitis and hepatic failure, has occurred with the use of Clofarabine. Severe and fatal hepatotoxicity. Monitor liver function, for signs and symptoms of hepatitis and hepatic failure. Discontinue Clofarabine immediately for Grade 3 or greater liver enzyme and/or bilirubin elevations.
• Clofarabine may cause acute renal failure. Increased creatinine and acute renal failure; monitor renal function and interrupt or discontinue Clofarabine.
• Fatal and serious cases of enterocolitis, including neutropenic colitis, cecitis, and C. difficile colitis, have occurred during treatment with clofarabine. 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.
• Serious and fatal cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported. Discontinue for exfoliative or bullous rash, or if SJS or TEN is suspected.
• Based on findings from animal reproductive studies and the drug's mechanism of action, Clofarabine can cause fetal harm when administered to a pregnant woman. Advise males with female partners of reproductive potential to use effective contraception during treatment with Clofarabine and for at least 3 months after the last dose.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• hyperbilirubinemia
• vomiting
• maculopapular rash
• hematologic malignancies

Management of overdosage:

• In the event of an overdose, appropriate supportive treatment should be initiated.

Can this medicine be used in pregnancy?

• There are no available data on Clofarabine use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
• Clofarabine should be used during pregnancy only if the potential benefits to the mother outweigh the potential risks, including those to the fetus.

Can this medicine be used in children?

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

What are the active and inactive ingredients in this medicine?

Active ingredient:

• CLOFARABINE

Inactive ingredients:

• SODIUM CHLORIDE
• WATER

Who manufactures and distributes this medicine?

Manufactured for:

• Fresenius
• Lake Zurich, IL
• www.fresenius-kabi.com/us
• Made in India

What should I know about storage and disposal of this medication?

• Vials containing undiluted Clofarabine Injection should be stored at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).
• Do not freeze.
• Retain in carton until contents are used.
• Clofarabine is a cytotoxic drug.
• Follow applicable special handling and disposal procedures.

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• Dailymed label info on Clofarabine
• FDA Clofarabine

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