Applies to the following strength(s): 20 mg/mL
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Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Colorectal Cancer
6 mg/kg IV over 60 minutes every 14 days; if the first infusion is tolerated, administer subsequent infusions over 30 to 60 minutes; administer doses higher than 1000 mg over 90 minutes
¬¬-Prior to initiation of therapy, assess RAS mutational status in colorectal tumors and confirm the absence of a RAS mutation in exon 2 (codons 12 and 13), exon 3 (codons 59 and 61), and exon 4 (codons 117 and 146) of both KRAS and NRAS.
-See Dose Adjustments for dosage modifications in patients experiencing infusion reactions or dermatologic toxicity.
Uses: For the treatment of wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use) metastatic colorectal cancer (mCRC):
-In combination with FOLFOX for first-line treatment.
-As monotherapy following disease progression after prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan-containing chemotherapy.
Renal Dose Adjustments
Data not available
Liver Dose Adjustments
Data not available
DOSE MODIFICATIONS FOR INFUSION REACTIONS:
-Reduce infusion rate by 50% in patients experiencing a mild or moderate (Grade 1 or 2) infusion reaction for the duration of that infusion.
-Terminate the infusion in patients experiencing severe infusion reactions.
-Depending on the severity and/or persistence of the reaction, permanently discontinue therapy.
DOSE MODIFICATIONS FOR DERMATOLOGIC TOXICITY:
-Upon first occurrence of a Grade 3 (NCI-CTC/CTCAE) dermatologic reaction, withhold 1 to 2 doses. If the reaction improves to less than Grade 3, reinitiate therapy at the original dose.
-Upon the second occurrence of a Grade 3 (NCI-CTC/CTCAE) dermatologic reaction, withhold 1 to 2 doses. If the reaction improves to less than Grade 3, reinitiate therapy at 80% of the original dose.
-Upon the third occurrence of a Grade 3 (NCI-CTC/CTCAE) dermatologic reaction, withhold 1 to 2 doses. If the reaction improves to less than Grade 3, reinitiate therapy at 60% of the original dose.
-Upon the fourth occurrence of a Grade 3 (NCI-CTC/CTCAE) dermatologic reaction, permanently discontinue therapy.
-Permanently discontinue therapy following the occurrence of a Grade 4 dermatologic reaction or for a Grade 3 (NCI-CTC/CTCAE) dermatologic reaction that does not recover after withholding 1 or 2 doses.
US BOXED WARNINGS:
-Dermatologic toxicities occurred in 90% of patients and were severe (NCI-CTC Grade 3 and higher) in 15% of patients receiving monotherapy. Symptoms included, but were not limited to, acneiform dermatitis, pruritus, erythema, rash, skin exfoliation, paronychia, dry skin, and skin fissures. Patients who develop dermatologic or soft tissue toxicities should be monitored for inflammatory or infectious sequelae.
-Life-threatening and fatal infectious complications including necrotizing fasciitis, abscesses, sepsis, and bullous mucocutaneous disease with blisters, erosions, and skin sloughing have been observed. It has not been determined whether these mucocutaneous adverse reactions were directly related to EGFR inhibition or to idiosyncratic immune-related effects (e.g., Stevens Johnson syndrome or toxic epidermal necrolysis).
-Modify dosing, withhold therapy, or discontinue therapy for dermatologic or soft tissue toxicity associated with severe or life-threatening inflammatory or infectious complications.
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Data not available
-Therapy should be supervised by a physician experienced in the use of anti-cancer therapy.
-Do not administer as an IV push or bolus.
-Administer by an IV infusion pump, using a low protein-binding 0.2 or 0.22 micrometer in-line filter, through a peripheral line or indwelling catheter.
-Flush lines with 0.9% sodium chloride pre- and post-infusion.
-Do not administer other medications in the same IV line with this drug.
-Store unused vials in the original carton, protected from direct light, at 2C to 8C until needed. Do not freeze.
-The diluted solution should be used within 6 hours of preparation if stored at room temperature, or within 24 hours of dilution if stored at 2C to 8 C.
-Unused vials should not be shaken.
-The manufacturer product information should be consulted.
-Resources for the treatment of severe infusion reactions should be available during infusions.
-Prior to initiation of therapy, assess KRAS mutational status in colorectal tumors and confirm the absence of a KRAS mutation using an approved test.
-Acute renal failure has been reported in patients that develop severe diarrhea and dehydration.
-This drug is not indicated for the treatment of patients with KRAS-mutant mCRC or for whom KRAS mutation status is unknown.
-Report any adverse reactions to the prescriber.
-Wear sunscreen and a hat, and limit sun exposure as sunlight may worsen potential skin reactions.
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