Agencia Lei Va Hong
Concise Prescribing Info
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 IV infusion over approx 60 min once every 2 wk. Doses >1,000 mg should be infused over approx 90 min.
History of severe or life-threatening hypersensitivity reactions to panitumumab or excipients. Interstitial pneumonitis or pulmonary fibrosis. Combination w/ oxalipatin-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 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 for patients w/ ECOG 2 performance status. Contains 0.15 mmol Na per mL of concentrate. Do not administer as an IV push or bolus. Renal or hepatic impairment. May impair ability to drive or operate machines. Pregnancy & lactation. Elderly.
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, wt decreased.
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.
ATC Classification
L01XC08 - panitumumab ; Belongs to the class of monoclonal antibodies, other antineoplastic agents. Used in the treatment of cancer.
Vectibix conc for soln for infusion 20 mg/mL
5 mL x 1's
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