(redirected from Clolar)
Also found in: Wikipedia.


Clolar, Evoltra (UK)

Pharmacologic class: Purine nucleoside antimetabolite

Therapeutic class: Antineoplastic

Pregnancy risk category D


Inhibits DNA synthesis by decreasing cellular deoxynucleotide triphosphate pools through inhibitory action on ribonucleotide reductase, terminating DNA chain elongation, and inhibiting repair through incorporation into DNA chain by competitive inhibition of DNA polymerases. Drug is cytotoxic to rapidly proliferating and quiescent cancer cell types in vitro.


Solution for injection: 1 mg/ml (20 mg in 20-ml flint vials)

Indications and dosages

Relapsed or refractory acute lymphoblastic leukemia after at least two previous regimens

Children and adults ages 1 to 21: 52 mg/m2/day by I.V. infusion over 2 hours daily for 5 consecutive days every 2 to 6 weeks, depending on toxicity and response

Dosage adjustment

• Hypotension
• Systemic inflammatory response syndrome (SIRS)
• Capillary leak syndrome (CLS)
• Substantial creatinine and bilirubin elevations




Use cautiously in:
• renal or hepatic impairment, active infection, dehydration, hypotension
• adults older than age 21
• pregnant or breastfeeding patients.


• Filter through sterile 0.2-micron syringe filter, and dilute further with D5W or normal saline solution for injection before I.V. infusion. Resulting admixture may be stored at room temperature but must be used within 24 hours of preparation.
• To prevent incompatibilities, don't give other drugs through same I.V. line.
• Administer continuous I.V. fluids throughout 5 days of treatment to reduce effects of tumor lysis and other adverse events. Give allopurinol, as ordered, if hyperuricemia is expected.
• Prophylactic steroids (such as 100 mg/m2 hydrocortisone on days 1 through 3) may help prevent SIRS and CLS. If early signs or symptoms of these life-threatening syndromes occur, stop drug immediately and start appropriate supportive measures.
• Withdraw drug immediately if patient develops significant signs or symptoms of SIRS or CLS (such as hypotension); consider giving steroids, diuretics, and albumin. Drug may be reinstituted (generally at lower dosage) when patient is stable.
• Stop drug if hypotension occurs during 5 days of treatment. If hypotension is transient and resolves without pharmacologic intervention, reinstitute drug (generally at lower dosage).
• If creatinine or bilirubin level rises substantially, discontinue drug. Drug may be reinstituted (possibly at lower dosage) when patient is stable and organ function returns to baseline.
• Know that after recovery or return to baseline organ function, treatment cycles are repeated about every 2 to 6 weeks. Dosage is based on body surface area, calculated using actual height and weight before start of each cycle.
• Avoid concurrent administration of hepatotoxic or renotoxic drugs during 5 days of treatment.

Adverse reactions

CNS: dizziness, headache, somnolence, tremor, anxiety, depression, lethargy, fatigue, irritability, rigors

CV: tachycardia, flushing, hypertension, hypotension

EENT: sore throat, epistaxis

GI: nausea, vomiting, diarrhea, constipation, abdominal pain, anorexia, gingival bleeding, oral candidiasis

GU: hematuria

Hematologic: febrile neutropenia, neutropenia, anemia, thrombocytopenia

Hepatic: hepatomegaly, jaundice

Musculoskeletal: arthralgia, back pain, myalgia, limb pain

Respiratory: pneumonia, cough, dyspnea, pleural effusion, respiratory distress

Skin: contusion, dermatitis, herpes simplex, dry skin, erythema, palmarplantar erythrodysesthesia, petechiae, pruritus, cellulitis

Other: decreased appetite, weight loss, edema, injection site pain, mucosal inflammation, pain, fever, bacteremia, sepsis, staphylococcal infection, transfusion reaction


Drug-drug.Hepatotoxic or renotoxic drugs: additive toxicity

Drug-diagnostic tests.Alanine aminotransferase, aspartate aminotransferase, bilirubin: increased

Drug-herbs.Alpha-lipoic acid, coenzyme Q10: decreased chemotherapeutic efficacy

Glutamine: possible increase in tumor growth

Patient monitoring

• Assess hepatic and renal function before and during therapy.
• Closely monitor respiratory status and blood pressure during infusion.
• Monitor hematologic status carefully during therapy; drug may cause severe bone marrow depression, resulting in neutropenia, anemia, and thrombocytopenia.
• Monitor for signs and symptoms of tumor lysis syndrome or cytokine release (such as tachypnea, tachycardia, hypotension, and pulmonary edema), which could progress to SIRS, CLS, or organ dysfunction.
• Closely monitor patients receiving drugs that affect blood pressure or cardiac function.

Patient teaching

• Teach patient about appropriate measures to avoid dehydration caused by vomiting and diarrhea. Tell patient to seek medical advice if signs and symptoms of dehydration occur (such as dizziness, light-headedness, fainting spells, or decreased urine output).
• Advise female with childbearing potential to avoid pregnancy during therapy.
• Caution breastfeeding patient to discontinue breastfeeding during therapy.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and herbs mentioned above.


(klo-far-a-been) ,


(trade name)


Therapeutic: antineoplastics
Pharmacologic: antimetabolites
Pregnancy Category: D


Refractory/relapsed acute lymphoblastic leukemia in children 1–21 yr.


Converted intracellularly to the active 5'-triphosphate metabolite which acts as a purine nucleoside antimetabolite; net result is inhibition of DNA synthesis.
Produces a rapid reduction of peripheral leukemia cells.

Therapeutic effects

Death of rapidly replicating cells, particularly malignant ones.


Absorption: IV administration results in complete bioavailability.
Distribution: Unknown.
Metabolism and Excretion: 46–60% excreted unchanged in urine.
Half-life: 5.2 hr.

Time/action profile (effect on WBCs)

IVrapidunknown2–6 wk


Contraindicated in: None; Obstetric / Lactation: Pregnancy or lactation.
Use Cautiously in: Hepatic or renal impairment;Concurrent use of nephrotoxic or hepatotoxic drugs.

Adverse Reactions/Side Effects

Central nervous system

  • fatigue


  • pharyngitis


  • pericardial effusion (most frequent)
  • tachycardia (most frequent)
  • edema


  • hepatotoxicity (life-threatening)
  • diarrhea (most frequent)
  • nausea (most frequent)
  • abdominal pain
  • constipation
  • mucositis
  • vomiting

Fluid and Electrolyte

  • dehydration


  • neutropenia
  • anemia
  • thrombocytopenia


  • injection site pain


  • systemic inflammatory response syndrome (life-threatening)
  • tumor lysis syndrome (life-threatening)
  • infections (most frequent)
  • fever
  • chills


Drug-Drug interaction

Concurrent use of hepato- or nephrotoxic drugs ↑ risk of hepato- and nephrotoxicity and should be avoided for the 5-day treatment period.


Intravenous (Children 1–21 yr) 52 mg/m2 daily for 5 days; cycle may be repeated every 2–6 wk.


Solution for injection : 20 mg/20 mL vials

Nursing implications

Nursing assessment

  • Monitor respiratory status and BP during clofabarine infusion.
  • Monitor for bone marrow depression. Assess for bleeding (bleeding gums, bruising, petechiae, guaiac stools, urine, and emesis) and avoid IM injections and rectal temperatures if platelet count is low. Apply pressure to venipuncture sites for 10 min. Assess for signs of infection during neutropenia. Anemia may occur. Monitor for increased fatigue, dyspnea, and orthostatic hypotension.
  • Monitor for signs and symptoms of tumor lysis syndrome and cytokine release (tachypnea, tachycardia, hypotension, pulmonary edema) that could develop into systemic inflammatory response syndrome (SIRS), capillary leak syndrome (pleural and pericardial effusions) and organ dysfunction. Administer continuous IV fluids throughout the 5 days of therapy to reduce effects of tumor lysis syndrome and other adverse drug reactions. Administer prophylactic corticosteroids (hydrocortisone 100 mg/m2 of Days 1 and 3) and allopurinol if hyperuricemia is expected. If significant signs or symptoms of SIRS or capillary leak syndrome occur, discontinue clofarabine immediately; diuretics and albumin may be used; may be fatal. Clofarabine may be reinstituted, usually at a lower dose, when the patient is stable.
  • Assess for nausea and diarrhea. Prevent dehydration. Discontinue clofarabine administration if hypotension occurs during 5 days of therapy. If hypotension resolves without pharmacological intervention, clofarabine may be reinstituted, usually at a lower dose.
  • Lab Test Considerations: Monitor CBC and platelet counts at regular intervals during therapy and more frequently if levels are abnormal. May cause anemia, leukopenia, thrombocytopenia, neutropenia, febrile neutropenia, and infection.
    • Monitor hepatic and renal function frequently during therapy. May cause ↑ AST, ALT, and bilirubin; usually occur within 1 wk of administration and return to baseline within several days. May cause ↑ serum creatinine.

Potential Nursing Diagnoses

Risk for infection (Adverse Reactions)


  • Administer under the supervision of a physician experienced in the use of cancer chemotherapeutic agents.
  • Intravenous Administration
  • pH: 4.5–7.5.
  • Intermittent Infusion: Diluent: Dilute with 50 mL of 5% D5W or 0.9% NaCl and filter through a sterile 0.2 micron syringe filter. Solution is clear and practically colorless. Concentration: 0.4 mg/mL. Store at room temperature; use within 24 hr of preparation.
  • Rate: Administer over 2 hr daily for 5 consecutive days.
  • Y-Site Incompatibility: Do not administer other medications through same IV line.

Patient/Family Teaching

  • Advise patient to consult health care professional if dizziness, fainting spells, or decreased urine output occur during therapy.
  • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking any other Rx, OTC, or herbal products.

Evaluation/Desired Outcomes

  • Rapid reduction in peripheral leukemia cells.
References in periodicals archive ?
This estimate reflects several factors: (1) the continued integration of Bioenvision and the expanded introduction of Clolar in Europe; (2) investments in late-stage clinical trials-particularly the phase 3 study of alemtuzumab for multiple sclerosis; and (3) product launches, including the U.
Genzyme has requested a meeting with the FDA to discuss a path forward for the potential use of Clolar in adult patients with acute myeloid leukemia, following the receipt of a complete response letter regarding the company's sNDA this month.
The agency recommended a randomized, controlled clinical study be conducted for label expansion of Clolar in this indication.
The existing regimes and drugs market currently includes three regimens (Hyper-CVAD, Linker, and CALGB 8811) and three monotherapy drugs (Oncaspar, Clolar, and Arranon).
The historic growth in major markets such as the US, the top five countries of Europe and Japan were driven mainly by the increasing prevalence and prescription population as well as launch of newer brands such as Sprycel, Tasigna, Clolar and Arranon with no major patent expirations.
Cambridge MA) said the FDA will not allow the company to market its leukemia drug Clolar to previously untreated older adults unless it completes an additional clinical trial.
and ILEX Oncology, serving as CEO in both, where he led teams that were responsible for the clinical development of numerous important therapeutic products, four of which are currently used in the practice of medicine: Betaseron, Fludara, CAMPATH, and Clolar.
Genzyme, a maker of drugs for rare genetic disorders, agreed to buy New York-based Bioenvision to get exclusive rights to the leukemia drug clofarabine, sold as Clolar.
The committee will also review Ilex/Enzon's liposomal vincristine formulation Marqibo NDA (21-600) for relapsed aggressive non-Hodgkin's lymphoma and Ilex' Clolar (clofarabine) NDA (21-673) for pediatric patients (1-21 years) with refractory or relapsed acute leukemias on Dec 1.
The revenue of the leukemia treatment market has increased at a Compound Annual Growth Rate (CAGR) of 21% during the past eight years, due to the launch of new therapies including Sprycel (dasatinib), Tasigna (nilotinib), Clolar (cloferabine) and Arranon (nelarabine), which will continue to enjoy patent protection throughout the next six years covered by the report's forecast period.
Clofarabine, sold as Clolar, is used in children with acute lymphoblastic leukemia who have had relapses or failed other treatment.
This growth is attributed to the entry of premium priced products, and the market will be dominated by metabolic inhibitors such as midostaurin, from Novartis, an inhibitor of FLT-3 receptor tyrosine kinase, as well as Clolar (clofarabine), from Genzyme (Sanofi), an inhibitor of DNA polymerase.