20 mg/ml Concentrate for infusion solution , solution.
panitumumab
What Vectibix is and what it is used for
Vectibix is used to treat metastatic colorectal cancer (cancer of the colon) in adult patients with a particular type of tumor called “tumors with wild-type RAS “. Vectibix is used alone or in combination with other cancer medicines.
Vectibix contains the active substance panitumumab, which belongs to a group of medicines called monoclonal antibodies. Monoclonal antibodies are proteins that specifically recognize and attach to (bind to) other unique proteins in the body.
Panitumumab recognizes and binds specifically to a protein called epidermal growth factor receptor (EGFR ), which is found on the surface of some cancer cells. When growth factors (other body proteins) bind to EGFR, the cancer cell is stimulated to grow and divide. Panitumumab binds to EGFR and thus prevents the cancer cell from receiving the information it needs to grow and divide.
What you need to know before using Vectibix
Do not use Vectibix
- if you are allergic to panitumumab or any of the other ingredients of this medicine (listed in section 6).
- if you have previously had or had interstitial pneumonitis (swelling of the lungs leading to coughing and difficulty breathing) or pulmonary fibrosis (scarring and thickening of the lungs with shortness of breath).
- in combination with oxaliplatin-based chemotherapy (medicine to treat cancer), if your RAS test shows that you have a tumor with mutated RAS or if your RAS mutation status is not known. Consult your doctor if you are unsure of your RAS mutation status.
Warnings and precautions
You may develop skin reactions or severe swelling and tissue damage. If these symptoms worsen or become unbearable, tell the doctor or nurse immediately. If you get a serious skin reaction, your doctor may recommend that the dose of Vectibix be changed. If you develop a serious infection or fever due to skin reactions, your doctor may decide to stop treatment with Vectibix.
You should limit your exposure to the sun while being treated with Vectibix and if you experience skin reactions, as sunlight may worsen these. Use sunscreen and protective headgear if you are going to be in the sun. Your doctor may tell you to use a moisturizing cream, sunscreen (sun protection factor (SPF) > 15), topical ( external ) steroid cream (cortisone cream), and/or oral antibiotics to manage skin reactions that may occur when using Vectibix.
Before you start treatment with Vectibix, the doctor will check the level of various substances in the blood, e.g. magnesium, calcium, and potassium. The doctor will also check the level of magnesium and calcium in the blood regularly during the treatment and for up to 8 weeks after the end of the treatment. If these levels are too low, the doctor can prescribe appropriate supplements.
Tell your doctor or nurse if you have severe diarrhea, as you may lose a lot of fluid from your body (be dehydrated) and this may damage your kidneys.
Tell the doctor if you wear contact lenses and/or if you have had eye problems in the past, e.g. very dry eyes, inflammation of the cornea (front part of the eye), or corneal ulcers.
If you develop acute or worsening eye redness and pain, increased tearing, blurred vision, and/or sensitivity to light, tell your doctor or nurse immediately as you may need immediate treatment (see “Possible side effects” below).
Depending on your age (over 65 years) or general health, your doctor will talk to you about your ability to tolerate Vectibix together with your chemotherapy.
Other medicines and Vectibix
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This also applies to over-the-counter medicines and herbal remedies.
Vectibix should not be used in combination with bevacizumab (another monoclonal antibody used in the treatment of bowel cancer) or with a chemotherapy combination called ‘IFL’.
Pregnancy, breastfeeding, and fertility
Vectibix has not been tested on pregnant women. It is important that you tell your doctor if you are pregnant, think you are pregnant, or plan to become pregnant. Vectibix can affect the unborn baby or your ability to maintain a pregnancy.
If you are a woman of childbearing age, you must use effective contraceptive methods while you are receiving treatment with Vectibix and for 2 months after the last dose.
It is not recommended that you breastfeed during treatment with Vectibix and 2 months after the last dose. It is important to tell the doctor if you plan to breastfeed.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving ability and use of machinery
Talk to your doctor before driving or using machines as some side effects may affect your ability to do so safely.
Vectibix contains sodium
This medicine contains 3.45 mg of sodium (the main ingredient in common/table salt) per ml. This corresponds to 0.17% of the maximum recommended daily intake of sodium for adults.
How to use Vectibix
The recommended dose of Vectibix is 6 mg/kg (milligrams per kilogram of body weight) once every two weeks. The treatment generally takes about 60 minutes.
Vectibix is administered in a ward under the supervision of a doctor experienced in treatment with cancer drugs.
Vectibix is administered intravenously (into a vein) using an infusion pump (an instrument that gives a slow injection ).
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most serious side effects and the main side effects with Vectibix are described below:
Infusion reactions
During or after treatment, you may experience an infusion reaction. Such reactions may be mild or moderate (likely to affect about 5 in 100 people who use Vectibix), or serious (likely to affect 1 in 100 people who use Vectibix). Symptoms may include headache, rash, itching or hives, hot flushes, swelling (face, lips, mouth, around the eyes and throat), fast and irregular heartbeat, fast pulse, sweating, nausea, vomiting, dizziness, difficulty breathing or swallowing, or a drop in blood pressure that can be serious or life-threatening and, in very rare cases, lead to death. If you experience any of these symptoms, talk to your doctor immediately. The doctor may decide to reduce the infusion rate or stop treatment with Vectibix.
Allergic reactions
In very rare cases, serious allergic reactions ( hypersensitivity reactions ), with symptoms similar to those of an infusion reaction (see “Infusion reactions”), have occurred more than 24 hours after treatment and have resulted in death. Seek immediate medical attention if you experience symptoms of an allergic reaction to Vectibix, including difficulty breathing, tightness in the chest, feeling of choking, dizziness, or fainting.
Skin reactions
Skin reactions are likely to affect about 94 out of 100 people who use Vectibix. They are usually mild or moderate. The rash generally resembles acne and often affects the face, upper chest, and back, but can appear anywhere on the body. Some rashes are red, itchy, and scaly and can become serious. In some cases, they can cause infected wounds that require drug treatment and/or surgery, and they can also cause severe skin reactions that are rarely fatal. In rare cases, patients may experience blisters on the skin, mouth, eyes, and genitals. This may indicate a serious skin reaction called “Stevens-Johnson syndrome”. Blisters on the skin can also indicate a serious skin reaction called “toxic epidermal necrolysis”. If you get blisters, contact a doctor immediately. Prolonged exposure to sunlight can worsen the rash. Dry skin, skin cracks on fingers and toes, and infection or inflammation of the nail bed on fingers or toes ( paronychia ) have also been reported. Skin reactions generally reverse when treatment is temporarily interrupted or discontinued. The doctor can decide to treat the rash, adjust the dose or stop the treatment with Vectibix.
Other side effects are:
Very common: may affect more than 1 in 10 users
- the low number of red blood cells ( anemia ), low potassium in the blood ( hypokalemia ), low magnesium in the blood ( hypomagnesemia )
- eye inflammation ( conjunctivitis )
- localized or widespread rash that may be bumpy (with or without spots), itchy, red, or scaly
- hair loss ( alopecia ), mouth sores and mouth ulcers ( stomatitis ), inflammation of the mouth (mucositis)
- diarrhea, nausea, vomiting, abdominal pain, constipation, decreased appetite, weight loss
- extreme tiredness (fatigue), fever or elevated temperature ( pyrexia ), weakness ( asthenia ), accumulation of fluid in the arms and legs (peripheral edema)
- back pain
- difficulty sleeping (insomnia)
- cough, dyspnoea (difficulty breathing).
Common side effects: may affect up to 1 in 10 users
- the low number of white blood cells ( leukopenia ), low calcium in the blood ( hypocalcemia ), low phosphate in the blood ( hypophosphatemia ), high glucose in the blood ( hyperglycemia )
- eyelash growth, increased lacrimation, eye redness ( ocular hyperemia ), dry eyes, itchy eyes (ocular pruritus), eye irritation, eyelid inflammation ( blepharitis )
- skin wounds, scabs, excessive hair growth (hypertrichosis), redness and swelling of the palms of the hands and soles of the feet (hand-foot syndrome), excessive sweating ( hyperhidrosis ), skin reaction ( dermatitis )
- infection that spreads under the skin ( cellulitis ), inflammation of hair follicles ( folliculitis ), localized infection, a rash with blisters (pustular rash), urinary tract infection
- nail problems, brittle nails (onycholysis)
- dehydration _ _
- dry mouth, indigestion ( dyspepsia ), rectal bleeding, lip inflammation (cheilitis), heartburn ( gastroesophageal reflux )
- chest pain, pain, chills, pain in arms and legs, immune reaction (hypersensitivity), fast heartbeat ( tachycardia )
- blood clots in the lungs (pulmonary embolism), with symptoms such as sudden shortness of breath or chest pain, nosebleeds ( epistaxis ), blood clots in blood vessels (deep vein thrombosis ), high blood pressure ( hypertension ), hot flashes
- headache, dizziness, and anxiety.
Uncommon: may affect up to 1 in 100 users
- bluish discoloration of the skin and mucous membranes (cyanosis)
- cell death in the skin (skin necrosis)
- severe skin reaction with blisters on the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome)
- severe skin reaction with blisters on the skin ( toxic epidermal necrolysis )
- a serious condition with ulcers in the cornea (front part of the eye) that requires immediate treatment (ulcerative keratitis )
- inflammation of the cornea (front part of the eye) ( keratitis )
- eyelid irritation, chapped lips and/or dry lips, eye infection, eyelid infection, dry nose, loosening of nails ( onycholysis ), ingrown nails, excessive hair growth ( hirsutism )
- inflammation of the lungs (interstitial lung disease).
How Vectibix should be stored
Vectibix must be stored in the ward where it is used.
Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2°C–8°C).
Do not freeze.
Store in the original packaging. Light sensitive.
Use before the expiry date which is stated on the label and carton after EXP. The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- Each ml of concentrate contains 20 mg of panitumumab. Each vial contains either 100 mg panitumumab in 5 ml or 400 mg panitumumab in 20 ml.
- The active substance is panitumumab 20 mg/ml. Other ingredients are sodium chloride, sodium acetate trihydrate, acetic acid (concentrated), and water for injections. See section 2, “Vectibix contains sodium”.
Appearance and package sizes of the medicine
Vectibix is a colorless liquid that may contain visible particles and is supplied in a glass vial. Each pack contains one vial.
Amgen Europe BV
Minervum 7061
4817 ZK Breda
Netherlands