Fact Sheet - VECTIBIX

Authorization with Conditions of VECTIBIXTM
20 mg/ml concentrate for solution for infusion (panitumumab)

FACT SHEET

What is VECTIBIXTM (panitumumab)?

The active substance in VECTIBIXTM is panitumumab (20 mg/ml). The other ingredients of VECTIBIXTM are sodium chloride, sodium acetate trihydrate, acetic acid (glacial) and water for injections. VECTIBIXTM is a colourless liquid that may contain visible particles and is supplied in a vial.

VECTIBIXTM contains the active substance panitumumab, which belongs to a group of medicines called monoclonal antibodies. Monoclonal antibodies are proteins, which specifically recognize and attach (bind) to other unique proteins in the body.

VECTIBIXTM is a concentrate for solution for infusion. Each vial contains 20 mg/mL of panitumumab. Before VECTIBIXTM is given it is mixed with 100mL of 9mg/mL (0.9%) sodium chloride solution. The prepared solution will be infused into a vein over a 60 minute period.

Health Canada has authorized VECTIBIXTM with conditions, under the Notice of Compliance with Conditions Policy. This authorization reflects the promising nature of the clinical evidence, which must be verified and/or extended with further studies. Products authorized under Health Canada's NOC/c Policy, have demonstrated promising benefit, are of high quality and possess an acceptable safety profile based on a benefit/risk assessment.

What is metastatic colorectal carcinoma?

Colorectal cancer is a disease in which malignant (cancer) cells form in the tissues of the colon (the longest part of the large intestine) or rectum (the last several inches of the large intestine). Metastatic colorectal cancer (mCRC) is cancer that has spread from the colon or rectum to other parts of the body such as the liver, lungs, or bones.

What other treatments have been used to treat mCRC?

Chemotherapy is a cancer treatment that uses drugs to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. The 3 most commonly used chemotherapy drugs for mCRC include a fluoropyrimidine, oxaliplatin, and irinotecan. In many cases, combinations of a fluoropyrimidine and either oxaliplatin or irinotecan are administered.

What is VECTIBIXTM (panitumumab) used for?

VECTIBIXTM is used as a monotherapy in the treatment of metastatic colorectal carcinoma (cancer of the bowel) with non-mutated or "wild type" KRAS after failure of chemotherapy (medicines used to treat cancer) treatment.

How does VECTIBIXTM work?

VECTIBIXTM (panitumumab) recognises and binds specifically to a protein known as epidermal growth factor receptor (EGFR), which is found on the surface of some cancer cells. When growth factors (other body proteins) attach to the EGFR, the cancer cell is stimulated to grow and divide. Panitumumab binds onto the EGFR and prevents the cancer cell from receiving the messages it needs for growth and division.

KRAS plays an important role in cell growth regulation and oncogenesis. Anti-EGFR therapies work by blocking the activation of EGFR, thereby inhibiting downstream events that lead to malignant signaling. However, in patients with tumors harboring a mutated or activated KRAS, the KRAS protein is always turned "on" regardless of whether EGFR has been activated or therapeutically inhibited. Thus, in patients with mutated KRAS, signaling continues despite anti-EGFR therapy. Mutant KRAS is detected in approximately 40 percent of CRC tumors.

What do patients need to know about using VECTIBIXTM?

Do not use VECTIBIXTM if you are allergic (hypersensitive) to panitumumab or any of the other ingredients of VECTIBIXTM.

Before starting treatment with VECTIBIXTM, please tell your doctor or nurse if you have previously had or have evidence of interstitial pneumonitis (swelling of the lungs causing coughing and difficulty breathing) or pulmonary fibrosis (scarring and thickening in the lungs with shortness of breath).

This medicinal product contains 0.150 mmol sodium (which is 3.45 mg sodium) per ml of concentrate. This is to be taken into consideration by patients on a controlled sodium diet.

During treatment with VECTIBIXTM you may experience dermatologic toxicities (skin reactions), if these worsen or become intolerable please tell your doctor or nurse immediately.

It is recommended that you limit sun exposure while receiving treatment with VECTIBIXTM and if you are experiencing skin reactions as sunlight can worsen these. Wear sunscreen and a hat if you are going to be exposed to sunlight.

Your doctor will ask you to come in for tests every 2 weeks to monitor potential hypomagnesemia (low magnesium levels in the blood) and hypocalcemia (low calcium levels in the blood) during your treatment, and 8 weeks after you have finished your treatment.

VECTIBIXTM has not been tested in pregnant women. It is important to tell your doctor if you are pregnant; think you may be pregnant; or plan to get pregnant. VECTIBIXTM could affect your ability to stay pregnant. If you are a woman of child bearing potential, you should use suitable methods of contraception during treatment with VECTIBIXTM and for 6 months after the last dose. VECTIBIXTM has the potential to cause embryo-lethal or abortifacient (causes abortion) effects and fetal harm when administered to pregnant women. Do not breast-feed your baby during treatment with VECTIBIXTM and for 3 months after the last dose.

Ask your doctor or pharmacist for advice before taking any medicine. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

No studies on the effects on the ability to drive and use machines have been performed. You should speak with your doctor before driving or using machines, as some side effects may impair your ability to do so safely.

What are the side effects and how serious are they?

Like all medicines, VECTIBIXTM can cause side effects, although not everybody gets them.

The very common side effects (seen in more than 1 in 10 people who take VECTIBIXTM) were: pruritis (itching); erythema (redness of skin); rash; skin exfoliation (flaking skin); dry skin; skin fissures (cracks in the skin); paronychia (infection of a nail bed); diarrhea; fatigue (extreme tiredness); nausea and vomiting; cough; dyspnea (breathing difficulties).

The common side effects (seen in more than 1, but less than 10 in 100 people taking VECTIBIXTM) were: infusion type reactions (which may include signs and symptoms such as chills; and/or pyrexia (fever or high temperature); hypomagnesemia (low magnesium levels in the blood); hypocalcemia (low calcium levels in the blood); and hypokalemia (low potassium levels in the blood); dehydration; headache; conjunctivitis (eye inflammation); growth of eyelashes and increased lacrimation (flow of tears); ocular hyperemia (redness of the eye); dry eye; eye pruritus (itchy eyes); stomatitis (mouth ulcers and cold sores); mucosal inflammation (inflammation of the mouth); dry mouth; onycholysis (loosening of the nails); hypertrichosis (excess hair growth); alopecia (hair loss); nasal dryness.

If any of the side effects gets serious, or if you notice any side effects not listed in this Fact Sheet, please tell your doctor.

How is VECTIBIXTM taken?

VECTIBIXTM will be administered in a healthcare facility under the supervision of a doctor experienced in the use of anti-cancer medicines.

VECTIBIXTM is administered intravenously (into a vein) with an infusion pump (a device that gives a slow injection).

The recommended dose of VECTIBIXTM is 6 mg/kg (milligrams per kilogram of body weight) given once every two weeks. The treatment will usually be given over a period of approximately 60 minutes.

Where can I learn more about VECTIBIXTM?

Should you have any questions or require further information regarding the use of VECTIBIXTM, please contact Amgen Medical Information at 1-866-502-6436

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