Vectibix維替比

Vectibix

panitumumab

Manufacturer:

Amgen

Distributor:

Zuellig
/
Agencia Lei Va Hong
Concise Prescribing Info
Contents
Panitumumab
Indications/Uses
Treatment of adult patients w/ wild-type RAS metastatic colorectal cancer (mCRC): 1st-line in combination w/ FOLFOX or FOLFIRI; 2nd-line in combination w/ FOLFIRI for patients who have received 1st-line fluoropyrimidine-based chemotherapy (excluding irinotecan); monotherapy after failure of fluoropyrimidine-, oxaliplatin-, & irinotecan-containing chemotherapy regimens.
Dosage/Direction for Use
Recommended dose: 6 mg/kg once every 2 wk by IV infusion over approx 60 min. Doses >1,000 mg should be infused over approx 90 min.
Contraindications
History of severe or life-threatening hypersensitivity to panitumumab or excipients. Interstitial pneumonitis or pulmonary fibrosis. Combination w/ oxaliplatin-containing chemotherapy for patients w/ mutant RAS mCRC or for whom RAS mCRC status is unknown.
Special Precautions
Dermatologic reactions & soft tissue toxicity; pulmonary complications; electrolyte disturbances; infusion-related reactions; acute renal failure; ocular toxicities. Monitor & replenish serum Mg & K levels including other electrolytes prior to treatment. Avoid concomitant treatment w/ irinotecan, bolus 5-fluorouracil & leucovorin (IFL) chemotherapy. Should not be administered w/ bevacizumab & chemotherapy regimens. Assess benefit-risk prior to initiation of treatment in patients w/ ECOG 2 performance status. Contains 3.45 mg Na per mL of conc. Do not administer as an IV push or bolus. Minor influence on the ability to drive & use machines. Women of childbearing potential must use appropriate contraceptive measures during treatment & for 2 mth following the last dose. May impact the ability of a woman to become pregnant. Potential risk for loss of pregnancy or potential hazard to the foetus when administered to pregnant women. Recommended for women not to breastfeed during treatment & for 2 mth after last dose. Elderly. The safety & efficacy of Vectibix have not been studied in patients w/ renal or hepatic impairment.
Adverse Reactions
Diarrhoea, nausea, vomiting, constipation, abdominal pain; fatigue, pyrexia; decreased appetite; paronychia; rash, dermatitis acneiform, pruritus, erythema, dry skin. Conjunctivitis; anaemia; hypokalaemia, hypomagnesaemia; insomnia; dyspnoea, cough; stomatitis; skin fissures, acne, alopecia; back pain; asthenia, mucosal inflammation, oedema peripheral, decreased wt.
Drug Interactions
High incidence of severe diarrhoea w/ IFL chemotherapy. Increased toxicity & deaths w/ bevacizumab & chemotherapy. Shortened progression-free survival & overall survival time w/ oxaliplatin-containing chemotherapy in patients w/ mutant RAS mCRC or for whom RAS mCRC status is unknown.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01FE02 - panitumumab ; Belongs to the class of EGFR (Epidermal Growth Factor Receptor) inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Vectibix conc for soln for infusion 20 mg/mL
Packing/Price
5 mL x 1's
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