Wild-type RAS metastatic colorectal cancer (mCRC)

Indication for Panitumumab

Population group: Suitable for both men and women, only adults (18 years old or older)

Panitumumab is indicated for the treatment of adult patients with wild-type RAS metastatic colorectal cancer (mCRC):

  • in first-line in combination with FOLFOX or FOLFIRI.
  • in second-line in combination with FOLFIRI for patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan).
  • as monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.

For this indication, competent medicine agencies globally authorize below treatments:

6 mg/kg once every two weeks

Route of admnistration

Intravenous

Defined daily dose

6 - 6 mg per kg of body weight

Dosage regimen

From 6 To 6 mg per kg of body weight once every 14 day(s)

Detailed description

The recommended dose of panitumumab is 6 mg/kg of bodyweight given once every two weeks.

Modification of the dose of panitumumab may be necessary in cases of severe (≥ grade 3) dermatological reactions as follows:

Occurrence of skin symptom(s): ≥ grade 31Administration of panitumumabOutcomeDose regulation
Initial occurrenceWithhold 1 or 2 dosesImproved (< grade 3)Continuing infusion at 100% of original dose
Not recoveredDiscontinue
At the second occurrenceWithhold 1 or 2 dosesΒελτίωση (< βαθμού 3)Continuing infusion at 80% of original dose
Not recoveredDiscontinue
At the third occurrenceWithhold 1 or 2 dosesImproved (< grade 3)Continuing infusion at 60% of original dose
Not recoveredDiscontinue
At the fourth occurrenceDiscontinue- -

1 Greater than or equal to grade 3 is defined as severe or life-threatening

Dosage considerations

The recommended infusion time is approximately 60 minutes. If the first infusion is tolerated, then subsequent infusions may be administered over 30 to 60 minutes. Doses higher than 1.000 mg should be infused over approximately 90 minutes.

Active ingredient

Panitumumab is a recombinant, fully human IgG2 monoclonal antibody that binds with high affinity and specificity to the human EGFR. Panitumumab binds to the ligand binding domain of EGFR and inhibits receptor autophosphorylation induced by all known EGFR ligands. Binding of panitumumab to EGFR results in internalisation of the receptor, inhibition of cell growth, induction of apoptosis, and decreased interleukin 8 and vascular endothelial growth factor production.

Read more about Panitumumab

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