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Panitumumab Dosage

Applies to the following strength(s): 20 mg/mL

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

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.

Comments:
-Evidence of KRAS mutational status in colorectal tumors using an FDA-approved test indicated for this use is necessary for selection of patients for treatment. This drug is indicated only for the treatment of patients with KRAS wild-type mCRC; it is not indicated for the treatment of patients with colorectal cancer that harbor somatic mutations in codons 12 and 13 (exon 2) as determined by an FDA-approved test.
-Treatment should be supervised by a physician experienced in the use of anti-cancer therapy.
-Appropriate medical resources for the treatment of severe infusion reactions should be available during infusions.
-See Dose Adjustments for dosage modifications in patients experiencing infusion reactions or dermatologic toxicity.

Uses: Treatment of patients with wild-type KRAS (exon 2 in codons 12 or 13) metastatic colorectal cancer (mCRC) as determined by an FDA-approved test for this use:
1) As first-line therapy in combination with FOLFOX
2) 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 Adjustments

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.

Precautions

US BOXED WARNINGS:
-DERMATOLOGIC TOXICITY: Dermatologic toxicities occurred in 90% of patients and were severe (NCI-CTC grade 3 and higher) in 15% of patients receiving panitumumab monotherapy. The clinical manifestations 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 while on therapy 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.

Dialysis

Data not available

Other Comments

Administration advice:
-Panitumumab should not be administered as an IV push or bolus.
-Doses should be administered as an IV infusion over approximately 60 minutes by an IV infusion pump, using a low protein-binding 0.2 or 0.22 micrometer in-line filter, and through a peripheral line or indwelling catheter.
-Provided that the initial infusion is tolerated, subsequent infusions may be administered over 30 to 60 minutes.
-Doses greater than 1000 mg should be infused over 90 minutes via an infusion pump.
-Lines must be flushed with 0.9% sodium chloride pre- and post-infusion.

Storage requirements:
-Unused vials should be stored in their original carton, protected from direct sunlight, at 2 to 8 degrees Celsius 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 2 C to 8 C
-Unused vials should not be shaken.

Reconstitution/preparation techniques: The manufacturer product information should be consulted.

General:
-Prior to initiation of treatment with, assess KRAS mutational status in colorectal tumors and confirm the absence of a KRAS mutation using an FDA-approved test. Information on FDA-approved tests for the detection of KRAS mutations in patients with metastatic colorectal cancer is available at: http://www.fda.gov/CompanionDiagnostics.
-Acute renal failure has been reported in patients that develop severe diarrhea and dehydration.

Patient advice:
-Report any adverse reactions, including dermatologic reactions, to their prescriber.
-Wear sunscreen and a hat, and to limit sun exposure while on panitumumab therapy as sunlight may worsen potential skin reactions.

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