Evoltra

Evoltra

clofarabine

Manufacturer:

Sanofi

Distributor:

DCH Auriga - Healthcare
/
Four Star
Concise Prescribing Info
Contents
Clofarabine
Indications/Uses
Acute lymphoblastic leukaemia in paed patients who have relapsed or are refractory after receiving at least 2 prior regimens & where there is no other treatment option anticipated to result in a durable response.
Dosage/Direction for Use
Childn & adolescents (≥1 yr) Monotherapy 52 mg/m2 administered by IV infusion over 2 hr daily for 5 consecutive days. Repeat treatment cycles every 2-6 wk following recovery of normal haematopoiesis & return to baseline organ function. Childn <20 kg Consider infusion time of >2 hr.
Contraindications
Hypersensitivity. Severe renal insufficiency or severe hepatic impairment. Lactation.
Special Precautions
Closely monitor complete blood & platelet counts at regular intervals, more frequently in patients who develop cytopaenias; renal & hepatic function prior to, during active treatment & following therapy; resp status, BP, fluid balance & wt throughout & immediately after the 5-day administration period. Discontinue immediately if substantial increases in creatinine, liver enzymes &/or bilirubin are observed. Severe bone marrow suppression. Haemorrhage. Monitor for signs & symptoms of infection, enterocolitis, or tumour lysis syndrome & cytokine release. Discontinue if exfoliative or bullous rash or if Stevens-Johnson syndrome or toxic epidermal necrolysis is suspected. Discontinue immediately if systemic inflammatory response syndrome, capillary leak syndrome, substantial organ dysfunction, or hypotension occurs. Patients w/ cardiac disease & those taking medicinal products known to affect BP or cardiac function. Mild to moderate renal & hepatic insufficiency. Avoid dehydration. Reduce dose if grade 4 neutropenia occurs. Hepatotoxic adverse reactions. Higher risk of hepatotoxicity suggestive of veno-occlusive disease in patients who previously received a hematopoietic stem cell transplant. Patients on a controlled Na diet. May impair ability to drive or operate machinery. Females of childbearing potential & sexually active males must use effective methods of contraception during treatment. Pregnancy. Childn <1 yr, adult including elderly.
Adverse Reactions
Nausea, vomiting, febrile neutropenia, headache, rash, diarrhoea, pruritus, pyrexia, palmar-plantar erythrodysaethesia syndrome, fatigue, anxiety, mucosal inflammation, flushing.
Drug Interactions
Avoid concomitant use w/ medicinal products associated w/ renal toxicity & those eliminated by tubular secretion eg, NSAIDs, amphotericin B, methotrexate, aminosides, organoplatines, foscarnet, pentamidine, cyclosporine, tacrolimus, acyclovir & valganciclovir. Avoid concomitant use w/ medicinal products associated w/ hepatic toxicity. Close monitoring when co-administered w/ medicinal products known to affect BP or cardiac function.
MIMS Class
Immunosuppressants
ATC Classification
L01BB06 - clofarabine ; Belongs to the class of antimetabolites, purine analogues. Used in the treatment of cancer.
Presentation/Packing
Form
Evoltra soln for infusion 20 mg/20 mL (1 mg/mL)
Packing/Price
1's
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