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Panitumumab
Vectibix™
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FDA Approval: |
27 September 2006 |
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Indication: |
EGFR-expressing metastatic colorectal cancer that has progressed
during or after other treatment |
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Pharmacology: |
Recombinant human IgG2 kappa monoclonal antibody |
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Usual Dose: |
6 mg/kg by IV infusion once every 14 days. |
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Contraindications: |
None known |
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Warnings: |
Severe dermatologic toxicity (NCI-CTC grade 3 and higher) leading to
septic complications and death has been reported: Interrupt or
discontinue drug if severe dermatologic toxicity occurs. Severe
infusion reactions including anaphylaxis, bronchospasm, chills,
fever, and hypotension have been reported: Discontinue
infusion and/or permanently discontinue drug if reaction occurs.
Gastrointestinal mucosal and ocular toxicity have also occurred.
Drug should be discontinued in patients who develop interstitial
lung disease, pneumonitis, or lung infiltrates.
Concurrent use of panitumumab with irinotecan, 5-FU,
and leucovorin is not recommended because the
incidence and severity of diarrhea may be increased.
Hypomagnesemia (NCI-CTC grade 3/4) and hypocalcemia have been
reported: Monitor electrolytes during treatment and for 8
weeks afterward.
Patients should limit exposure to sunlight to prevent
exacerbation of skin reactions.
Testing for EGFR expression should be done at experienced
facilities with the appropriate assays, reagents, and procedures.
Benefit has not been demonstrated in patients with non-EGFR-expressing
tumors.
Breastfeeding should be discontinued during treatment and for 2
months after the last dose
May impair fertility in women
Women of childbearing potential should use
effective contraception during treament and for 6 months after the
last dose.
Safety and efficacy have not been established in pediatric
patients |
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Pregnancy Category: |
C |
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Side Effects: |
Common: Rash, hypomagnesemia, paronychia, fatigue, abdominal pain,
nausea, diarrhea Most severe: Pulmonary
fibrosis; skin toxicity complicated by infections, sepsis, and
death; infusion reactions, abdominal pain, hypomagnesemia, nausea,
vomiting, constipation |
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Drug Interactions: |
Data not available |
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