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Elunate

Elunate

fruquintinib

Manufacturer:

HUTCHMED

Distributor:

DCH Auriga - Healthcare
Concise Prescribing Info
Contents
Fruquintinib
Indications/Uses
Monotherapy in patients w/ metastatic CRC who have previously received fluoropyrimidine, oxaliplatin & irinotecan-based chemotherapy, & those who have previously received or are not suitable for receiving anti-VEGF therapy or anti-epidermal growth factor receptor therapy (RAS wild-type).
Dosage/Direction for Use
Recommended dose: 5 mg once daily for 3 consecutive wk followed by 1 wk of drug-free period (every 4 wk as 1 treatment cycle). Continue treatment cycle until disease progression or unacceptable toxicity.
Administration
May be taken with or without food: Swallow whole.
Contraindications
Hypersensitivity. Patients w/ severe active haemorrhage, active GI ulcer, unhealed GI perforation or fistula. Severe hepatic & renal impairment. Pregnancy & lactation.
Special Precautions
May increase risk of haemorrhage; infection (eg, URTI & UTI); HTN; hand-foot skin reaction; proteinuria. May cause increased transaminases, increased blood bilirubin, & abnormal hepatic function. May suppress or interfere wound healing. Reports of arterial thrombosis. Monitor CBC & coagulation indicators; increase monitoring frequency especially in patients taking anticoagulants (eg, warfarin) during treatment. Consider permanent discontinuation once signs of haemorrhage requiring urgent medical intervention occur. Use in patients w/ severe infections only after infection is effectively controlled. Interrupt treatment for patients who experience Grade ≥3 infection during treatment until infection is well under controlled. Conduct LFTs (eg, transaminase & bilirubin) before administration & routinely monitor liver function during treatment. Promptly interrupt, reduce dose or permanently discontinue in patients w/ Grade ≥3 increased transaminases. Routinely monitor BP during treatment, once a wk in the 1st 3 cycles & once per cycle thereafter; control BP at <140/90 mmHg before starting treatment. Regularly undergo routine urine test. Closely monitor urinary protein in patients w/ renal impairment. Closely monitor patients w/ GI infiltration, previous history of GI perforation; patients w/ high-risk factors of arterial thrombosis. Permanently discontinue in case of GI perforation; or suspected reversible posterior leukoencephalopathy syndrome (RPLS). Discontinue in patients who develop arterial thrombosis or stroke. Interrupt Elunate in patients who require major surgery. Caution in patients w/ moderate renal & hepatic impairment; elderly. Women of childbearing age & men should take effective contraceptive measures during treatment & up to 1 mth after treatment. Not recommended in childn or adolescents <18 yr.
Adverse Reactions
HTN, hand-foot skin reaction, proteinuria, decreased platelet count, abnormal hepatic function, increased blood bilirubin, abdominal pain/discomfort, diarrhoea, fatigue/asthenia, decreased appetite, haemorrhage.
Drug Interactions
Reduced exposure w/ moderate or strong CYP3A inducers; avoid concomitant use. Closely monitor patients concomitantly taking P-gp & BCRP substrates for any adverse reactions & make appropriate dose adjustments.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01EK04 - fruquintinib ; Belongs to the class of vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Elunate cap 1 mg
Packing/Price
21's
Form
Elunate cap 5 mg
Packing/Price
7's
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