INDICATION AND LIMITATION OF USE

Vectibix® is indicated for the treatment of patients with 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):Read More

Prescribing Information Indication Important Safety Information Patient Site
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VECTIBIX®: THE ONLY FDA-APPROVED, FULLY
HUMAN* ANTI-EGFR MONOCLONAL ANTIBODY1

*Correlation with efficacy or safety is unknown.

EGFR = epidermal growth factor receptor.

DOSING AND
ADMINISTRATION
OVERVIEW1

Recommended dose is 6mg/kg every 14 days

Recommended dose is 6 mg/kg every 14 days.1

No standard premedication

No standardized premedication was required in clinical trials. The utility of premedication in preventing infusional toxicity is unknown.1

Two separate vials

No loading dose is required.1

Vectibix® may be given during the same visit as chemotherapy.1

INFUSION TIME IS BASED ON DOSE AND HOW WELL PATIENTS TOLERATE INFUSION1

DOSES ≤ 1,000 MG

Initial Dose

Vectibix® (panitumumab) initial dose over 60 minutes

Vectibix® is given by IV infusion over 60 minutes.1

Subsequent Doses

If the first infusion is tolerated, subsequent infusions may be administered over 30 to 60 minutes

If the first infusion is tolerated, subsequent infusions may be administered over 30 to 60 minutes.1

DOSES > 1,000 MG

Vectibix® (panitumumab) doses should be administered over 90 minutes

Vectibix® should be administered over 90 minutes.1

VECTIBIX® PREPARATION1

Prepare the solution for infusion using aseptic technique, as follows:

Step 1: Inspect drug products

STEP 1: INSPECT

Parenteral drug products should be inspected visually prior to administration. The solution should be colorless and may contain a small amount of visible translucent-to-white, amorphous, proteinaceous particles (which will be removed by in-line filtration).1

  • Do not administer Vectibix® if its appearance is not as described above
Step 2: Withdraw Vectibix® (panitumumab) vial contents

STEP 2: WITHDRAW

Use a 21-gauge or larger (small-bore) hypodermic needle to withdraw the necessary amount of Vectibix® for a dose of 6 mg/kg.1

  • Do not use a hypodermic needle smaller than 21-gauge
  • Do not use needle-free devices (eg, vial adapters) to withdraw vial contents
Step 3: Dilute solution without exceeding concentration of 10 mg/mL

STEP 3: DILUTE

Doses ≤ 1,000 mg: Dilute to a total volume of 100 mL with 0.9% sodium chloride injection, USP.1

Doses > 1,000 mg: Dilute to a total volume of 150 mL with 0.9% sodium chloride injection, USP.1

  • Do not exceed a final concentration of 10 mg/mL
Step 4: Mix diluted solution by gentle inversion

STEP 4: MIX

Mix diluted solution by gentle inversion.1

  • Do not shake
  • Discard any unused portion of the vial

VECTIBIX®
ADMINISTRATION

Vectibix® must be administered via an infusion pump using a low-protein-binding 0.2 μm or 0.22 μm in-line filter1

No administering Vectibix® (panitumumab) as an intravenous push or bolus

Do not administer Vectibix® as an intravenous push or bolus.1

Flush line before and after Vectibix® administration

Flush line before and after Vectibix® administration with 0.9% sodium chloride injection, USP, to avoid mixing with other drug products or intravenous solutions.1

  • Do not mix Vectibix® with, or administer as an infusion with, other medicinal products
  • Do not add other medications to solutions containing panitumumab
Infuse Vectibix® over either 30 to 60 minutes or 90 minutes, depending on the dosage

Doses ≤ 1,000 mg: Infuse over 60 minutes through a peripheral intravenous line or indwelling intravenous catheter.1

  • If the first infusion is tolerated, administer subsequent infusions over 30 to 60 minutes

Doses > 1,000 mg: Administer over 90 minutes.1

Do not freezer

Use the diluted infusion solution of Vectibix® within 6 hours of preparation if stored at room temperature or within 24 hours of dilution if stored at 2° to 8°C (36° to 46°F). DO NOT FREEZE.1

Example dose calculation1 400 mg 100 mg
Patient weight 76 kg
Vectibix ® (panitumumab) 20 mL vial size

(20 mL vial size)
Vectibix ® (panitumumab) 5 mL vial size

(5 mL vial size)
Dose 6 mg/kg
Dose calculation 6 mg/kg x 76 kg =
456 mg (22.8 mL)

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 Vectibix®.
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LEARN ABOUT DERMATOLOGIC TOXICITY ASSOCIATED WITH VECTIBIX®

IMPORTANT SAFETY INFORMATION

BOXED WARNING:
DERMATOLOGIC TOXICITY

Dermatologic Toxicity: Dermatologic toxicities occurred in 90% of patients and were severe (NCI-CTC grade 3 and higher) in 15% of patients receiving Vectibix® monotherapy [see Dosage and Administration (2.3), Warnings and Precautions (5.1), and Adverse Reactions (6.1)].

  • In Study 20020408, dermatologic toxicities occurred in 90% of patients and were severe (NCI0CTC grade 3 and higher) in 15% of patients with mCRC receiving Vectibix®. The clinical manifestations included, but were not limited to, acneiform dermatitis, pruritus, erythema, rash, skin exfoliation, paronychia, dry skin, and skin fissures.
  • Monitor patients who develop dermatologic or soft tissue toxicities while receiving Vectibix® for the development of inflammatory or infectious sequelae. Life-threatening and fatal infectious complications including necrotizing fasciitis, abscesses, and sepsis have been observed in patients treated with Vectibix®. Life-threatening and fatal bullous mucocutaneous disease with blisters, erosions, and skin sloughing has also been observed in patients treated with Vectibix®. It could not be determined whether these mucocutaneous adverse reactions were directly related to EGFR inhibition or to idiosyncratic immune-related effects (eg, Stevens Johnson syndrome or toxic epidermal necrolysis). Withhold or discontinue Vectibix® for dermatologic or soft tissue toxicity associated with severe or life-threatening inflammatory or infectious complications. Dose modifications for Vectibix® concerning dermatologic toxicity are provided in the product labeling.
  • Vectibix® is not indicated for the treatment of patients with colorectal cancer that harbor somatic RAS mutations in exon 2 (codons 12 and 13), exon 3 (codons 59 and 61), and exon 4 (codons 117 and 146) of either KRAS or NRAS and hereafter is referred to as “RAS.”
  • Retrospective subset analyses across several randomized clinical trials were conducted to investigate the role of RAS mutations on the clinical effects of anti-EGFR-directed monoclonal antibodies (panitumumab or cetuximab). Anti-EGFR antibodies in patients with tumors containing RAS mutations resulted in exposing those patients to anti-EGFR related adverse reactions without clinical benefit from these agents. Additionally, in Study 20050203, 272 patients with RAS-mutant mCRC tumors received Vectibix® in combination with FOLFOX and 276 patients received FOLFOX alone. In an exploratory subgroup analysis, OS was shorter (HR = 1.21, 95% CI: 1.01-1.45) in patients with RAS-mutant mCRC who received Vectibix® and FOLFOX versus FOLFOX alone.
  • Progressively decreasing serum magnesium levels leading to severe (grade 3-4) hypomagnesemia occurred in up to 7% (in Study 20080763) of patients across clinical trials. Monitor patients for hypomagnesemia and hypocalcemia prior to initiating Vectibix® treatment, periodically during Vectibix® treatment, and for up to 8 weeks after the completion of treatment. Other electrolyte disturbances, including hypokalemia, have also been observed. Replete magnesium and other electrolytes as appropriate.
  • In Study 20020408, 4% of patients experienced infusion reactions and 1% of patients experienced severe infusion reactions (NCI-CTC grades 3-4). Infusion reactions, manifesting as fever, chills, dyspnea, bronchospasm, and hypotension, can occur following Vectibix® administration. Fatal infusion reactions occurred in postmarketing experience. Terminate the infusion for severe infusion reactions.
  • Severe diarrhea and dehydration, leading to acute renal failure and other complications, have been observed in patients treated with Vectibix® in combination with chemotherapy.
  • Fatal and nonfatal cases of interstitial lung disease (ILD) (1%) and pulmonary fibrosis have been observed in patients treated with Vectibix®. Pulmonary fibrosis occurred in less than 1% (2/1467) of patients enrolled in clinical studies of Vectibix®. In the event of acute onset or worsening of pulmonary symptoms interrupt Vectibix® therapy. Discontinue Vectibix® therapy if ILD is confirmed.
  • In patients with a history of interstitial pneumonitis or pulmonary fibrosis, or evidence of interstitial pneumonitis or pulmonary fibrosis, the benefits of therapy with Vectibix® versus the risk of pulmonary complications must be carefully considered.
  • Exposure to sunlight can exacerbate dermatologic toxicity. Advise patients to wear sunscreen and hats and limit sun exposure while receiving Vectibix®.
  • Serious cases of keratitis, ulcerative keratitis, and corneal perforation have occurred with Vectibix® use. Monitor for evidence of keratitis, ulcerative keratitis, or corneal perforation. Interrupt or discontinue Vectibix® therapy for acute or worsening keratitis, ulcerative keratitis, or corneal perforation.
  • In an interim analysis of an open-label, multicenter, randomized clinical trial in the first-line setting in patients with mCRC, the addition of Vectibix® to the combination of bevacizumab and chemotherapy resulted in decreased OS and increased incidence of NCI-CTC grade 3-5 (87% vs 72%) adverse reactions. NCI-CTC grade 3-4 adverse reactions occurring at a higher rate in Vectibix®-treated patients included rash/acneiform dermatitis (26% vs 1%), diarrhea (23% vs 12%), dehydration (16% vs 5%), primarily occurring in patients with diarrhea, hypokalemia (10% vs 4%), stomatitis/mucositis (4% vs < 1%), and hypomagnesemia (4% vs 0).
  • NCI-CTC grade 3-5 pulmonary embolism occurred at a higher rate in Vectibix®-treated patients (7% vs 3%) and included fatal events in three (< 1%) Vectibix®-treated patients. As a result of the toxicities experienced, patients randomized to Vectibix®, bevacizumab, and chemotherapy received a lower mean relative dose intensity of each chemotherapeutic agent (oxaliplatin, irinotecan, bolus 5-FU, and/or infusional 5-FU) over the first 24 weeks on study compared with those randomized to bevacizumab and chemotherapy.
  • Vectibix® can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment, and for at least 2 months after the last dose of Vectibix®.
  • In monotherapy, the most commonly reported adverse reactions (≥ 20%) in patients with Vectibix® were skin rash with variable presentations, paronychia, fatigue, nausea, and diarrhea.
  • The most commonly reported adverse reactions (≥ 20%) with Vectibix® + FOLFOX were diarrhea, stomatitis, mucosal inflammation, asthenia, paronychia, anorexia, hypomagnesemia, hypokalemia, rash, acneiform dermatitis, pruritus, and dry skin. The most common serious adverse reactions (≥ 2% difference between treatment arms) were diarrhea and dehydration.

Please see Vectibix® full Prescribing Information, including Boxed WARNING.

INDICATION

Vectibix® is indicated for the treatment of patients with 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):

  • As first-line therapy in combination with FOLFOX.
  • As monotherapy following disease progression after prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy.

LIMITATION OF USE

Vectibix® is not indicated for the treatment of patients with RAS-mutant mCRC or for whom RAS mutation status is unknown.

IMPORTANT SAFETY INFORMATION

BOXED WARNING:
DERMATOLOGIC TOXICITY

Dermatologic Toxicity: Dermatologic toxicities occurred in 90% of patients and were severe (NCI-CTC grade 3 and higher) in 15% of patients receiving Vectibix® monotherapy [see Dosage and Administration (2.3), Warnings and Precautions (5.1), and Adverse Reactions (6.1)].

Reference 1. Vectibix® (panitumumab) prescribing information, Amgen.

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