Zaltrap

Zaltrap

aflibercept

Manufacturer:

sanofi-aventis

Distributor:

DKSH
Concise Prescribing Info
Contents
Aflibercept
Indications/Uses
In combination w/ irinotecan/5-fluorouracil/folinic acid (FOLFIRI) chemotherapy for adults w/ metastatic colorectal cancer (MCRC) resistant to or has progressed after an oxaliplatin-containing regimen.
Dosage/Direction for Use
4 mg/kg IV infusion over 1 hr followed by irinotecan 180 mg/m2 IV infusion over 90 min & folinic acid 400 mg/m2 IV infusion over 2 hr at same time on day 1 using a Y-line, followed by 5-fluorouracil 400 mg/m2 IV bolus then by 2,400 mg/m2 continuous IV infusion over 46 hr repeated every 2 wk.
Contraindications
Hypersensitivity. Ophth/intravitreal use.
Special Precautions
Discontinue use if severe hypersensitivity reaction occurs. Not to be used as intravitreal inj. Not to be given in patients w/ severe haemorrhage; NYHA class III or IV CHF. Not to be initiated in patients w/ inadequately controlled HTN. Discontinue use if GI perforation, fistula formation, hypertensive crisis or encephalopathy, cardiac failure & decreased ejection fraction, arterial & grade 4 venous thromboembolic events, severe proteinuria, nephrotic syndrome or thrombotic microangiopathy, compromised wound healing, posterior reversible encephalopathy syndrome occurs. History of clinically significant CV disease eg, CAD or CHF; neutropenia & neutropenic complications. Ensure adequate hydration in patients w/ severe diarrhoea. Suspend treatment at least 4 wk prior to elective surgery. Osteonecrosis of the jaw (ONJ); avoid invasive dental procedures in patients on or have previously received or receiving IV biphosphonates. Perform dental exam & appropriate preventive dentistry prior to treatment. Monitor complete blood count w/ platelets & differential count at baseline prior to & as necessary. ECOG performance status ≥2 or w/ significant co-morbidities. May affect ability to drive & use machines. Severe renal & hepatic impairment. Women of childbearing potential & fertile men should use effective contraception during & up to min 6 mth after last dose. Pregnancy & lactation. Elderly ≥65 yr.
Adverse Reactions
Infection; leucopenia, neutropenia, thrombocytopenia; decreased appetite, wt loss; headache; HTN, haemorrhage; dyspnoea, epistaxis, dysphonia; diarrhoea, stomatitis, abdominal pain, upper abdominal pain; increased AST & ALT; palmar-plantar erythrodysaesthesia syndrome; proteinuria, increased serum creatinine; asthenia. Neutropenic infection/sepsis, UTI, nasopharyngitis; febrile neutropenia; hypersensitivity; dehydration; arterial & venous thromboembolism; oropharyngeal pain, rhinorrhoea; rectal haemorrhage, fistula, aphthous stomatitis, haemorrhoids, proctalgia, toothache; skin hyperpigmentation. Cardiac failure; ONJ; decreased ejection fraction.
ATC Classification
L01XX44 - aflibercept ; Belongs to the class of other antineoplastic agents. Used in the treatment of cancer.
Presentation/Packing
Form
Zaltrap infusion conc 25 mg/mL
Packing/Price
4 mL x 1's;4 mL x 3 × 1's;8 mL x 1's
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