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Vectibix® is available in 3 vial sizes.1
For more information, see the Dosing & Administration Pocket Guide.
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Preparation and administration1
Important considerations:
• Do not administer Vectibix® as an IV push or bolus. Vectibix® must be administered by an IV infusion pump using a low-protein-binding 0.2 µm or 0.22 µm inline filter.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Although Vectibix® should be colorless, the solution may contain a small amount of visible translucent-to-white amorphous, proteinaceous panitumumab particulates (which will be removed by filtration). Do not shake. Vectibix® should not be administered if discoloration is observed.
• Appropriate medical resources for the treatment of severe infusion reactions should be available during Vectibix® infusions.
Six steps to prepare and administer Vectibix®
1. Withdraw the necessary amount of Vectibix® for a dose of 6 mg/kg.
2. Dilute to a total volume of 100 mL with 0.9% sodium chloride injection, USP.* Final concentration should not exceed 10 mg/mL.
3. Mix diluted solution by gentle inversion. DO NOT SHAKE.
4. Administer using an IV infusion pump with a low-protein-binding 0.2 µm or 0.22 µm inline filter.
5. Infuse over approximately 60 minutes through a peripheral line or indwelling catheter. Doses higher than 1,000 mg should be infused over approximately 90 minutes.
6. Flush line before and after Vectibix® administration with 0.9% sodium chloride injection, USP, to avoid mixing with other drug products or IV solutions.
* Doses higher than 1,000 mg should be diluted in 150 mL 0.9% sodium chloride injection, USP.
• If a patient develops dermatologic toxicities related to Vectibix® that are grade 3 or higher or are considered intolerable, temporarily withhold Vectibix® administration until the toxicities have improved.
• If dermatologic toxicity improves to < grade 2, and the patient is symptomatically improved after withholding no more than 2 doses of Vectibix®, treatment may be resumed at 50% of the original dose.
• If toxicities do not recur, escalate each additional dose of Vectibix® by 25% increments of the original dose until the recommended starting dose is reached.
• If toxicities do not resolve after withholding 1 or 2 doses of Vectibix®, or if toxicities recur or become intolerable at 50% of the original dose level, permanently discontinue the use of Vectibix®.
• Reduce the infusion rate by 50% in patients experiencing a mild or moderate (grade 1 or 2) infusion reaction for the duration of that infusion.
• Immediately and permanently discontinue Vectibix® infusion in patients experiencing severe (grade 3 or 4) infusion reactions.
References
1. Vectibix® (panitumumab) package insert. Amgen; 2007.
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Vectibix® is indicated as a single agent for the treatment of EGFR-expressing, metastatic colorectal carcinoma (mCRC) with disease progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.
The effectiveness of Vectibix® as a single agent for the treatment of EGFR-expressing mCRC is based on progression-free survival. Currently no data are available that demonstrate an improvement in disease related symptoms or increased survival with Vectibix®.
Important Safety Information
Safety data are available from 15 clinical trials in which 1,467 patients received Vectibix®; of these, 1,293 received Vectibix® monotherapy and 174 received Vectibix® in combination with chemotherapy.
WARNING Infusion Reactions: Severe infusion reactions occurred with the administration of Vectibix® in approximately 1% of patients. Severe infusion reactions were identified by reports of anaphylactic reaction, bronchospasm, fever, chills, and hypotension. Although fatal infusion reactions have not been reported with Vectibix®, fatalities have occurred with other monoclonal antibody products. Stop infusion if a severe infusion reaction occurs. Depending on the severity and/or persistence of the reaction, permanently discontinue Vectibix®.
Dermatologic Toxicity:Dermatologic toxicities, related to Vectibix® blockade of EGF binding and subsequent inhibition of EGFR-mediated signaling pathways, were reported in 89% of patients and were severe (NCI-CTC grade 3 and higher) in 12% of patients receiving Vectibix® monotherapy. The clinical manifestations included, but were not limited to, dermatitis acneiform, pruritus, erythema, rash, skin exfoliation, paronychia, dry skin, and skin fissures. Severe dermatologic toxicities were complicated by infection including sepsis, septic death, and abscesses requiring incisions and drainage. Withhold or discontinue Vectibix® and monitor for inflammatory or infectious sequelae in patients with severe dermatologic toxicities.
Vectibix® is not indicated for use in combination with chemotherapy with or without bevacizumab. In an interim analysis of a randomized (1:1) clinical trial of patients with previously untreated metastatic colorectal cancer, the addition of Vectibix® to the combination of bevacizumab and chemotherapy resulted in decreased progression-free survival (n=947) and increased incidence of NCI-CTC grade 3-5 (87% vs. 72%) adverse reactions (n=926).
In a single-arm study of 19 patients receiving Vectibix® in combination with IFL, the incidence of NCI-CTC grade 3-4 diarrhea was 58%; in addition, grade 5 diarrhea occurred in 1 patient. In a single-arm study of 24 patients receiving Vectibix® plus FOLFIRI, the incidence of NCI-CTC grade 3 diarrhea was 25%.
Pulmonary fibrosis occurred in less than 1% (2/1,467) of patients in clinical trials of Vectibix®. Following the initial fatality, patients with a history of interstitial pneumonitis, pulmonary fibrosis, and evidence of interstitial pneumonitis were excluded from clinical studies. Therefore, the estimated risk in such patients is uncertain. Permanently discontinue Vectibix® therapy in patients developing interstitial lung disease, pneumonitis, or lung infiltrates.
In the randomized, controlled clinical trial, median magnesium levels decreased by 0.1 mmol/L in the Vectibix® arm. Additionally, hypomagnesemia (NCI-CTC grade 3 or 4) requiring electrolyte repletion occurred in 2% of patients 6 weeks or longer after the initiation of Vectibix®. In some patients, hypomagnesemia was associated with hypocalcemia. Patients should be periodically monitored, and treated appropriately, for hypomagnesemia and hypocalcemia during and for 8 weeks after the completion of Vectibix® therapy.
It is recommended that patients wear sunscreen and hats and limit sun exposure while receiving Vectibix®, since sunlight can exacerbate any skin reactions that may occur.
In women of childbearing potential, appropriate contraceptive measures must be used during, and for 6 months after, treatment with Vectibix®.
The most common adverse events observed in clinical studies of Vectibix® (n = 1,467) were skin rash with variable presentations, hypomagnesemia, paronychia, fatigue, abdominal pain, nausea, and diarrhea, including diarrhea resulting in dehydration. The most serious adverse events observed were pulmonary fibrosis, severe dermatologic toxicity complicated by infectious sequelae and septic death, infusion reactions, abdominal pain, hypomagnesemia, nausea, vomiting, and constipation.
