This is an X-PIL, which is a text only patient information leaflet, designed for people with sight problems.
Table of Contents
Vectibix® 20 mg/ml concentrate for solution for infusion
panitumumab
1. What Vectibix is and what it is used for 2. What you need to know before you use Vectibix 3. How to use Vectibix 4. Possible side effects 5. How to store Vectibix 6. Contents of the pack and other information
Vectibix is used in the treatment of metastatic colorectal cancer (cancer of the bowel) for patients with wild-type KRAS tumours. Vectibix is used alone or in combination with other anticancer medicines.
Vectibix is for use in adults 18 years and over.
Vectibix contains the active substance panitumumab, which belongs to a group of medicines called monoclonal antibodies. Monoclonal antibodies are proteins, which specifically recognise and attach (bind) to other unique proteins in the body.
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.
Tell your doctor if you use contact lenses and/or have a history of eye problems such as severe dry eye, inflammation of the front part of the eye (cornea) or ulcers involving the front part of the eye.
Your doctor will check your blood levels of several substances such as magnesium, and other electrolyte levels such as calcium and potassium in your blood before you start Vectibix treatment. If these levels are too low, your doctor may prescribe you appropriate supplements.
Based on your age (older than 65 years) or general health, your doctor will discuss with you your ability to tolerate taking Vectibix with your chemotherapy treatment.
You may experience dermatologic toxicities (skin reactions), if these worsen or become intolerable please tell your doctor or nurse immediately. If you experience a severe skin reaction, your doctor may recommend an adjustment of the dose of Vectibix.
It is recommended that you limit sun exposure whilst receiving Vectibix 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 may ask you to use a moisturiser, sun screen (SPF > 15), topical steroid, and/or oral antibiotics which may help in the management of skin toxicities that can be associated with the use of Vectibix.
Your doctor will ask you to come in for tests to monitor hypomagnesaemia (low magnesium levels in the blood) and hypocalcaemia (low calcium levels in the blood) periodically during your treatment, and for up to 8 weeks after you have finished your treatment.
If you experience severe diarrhoea please tell your doctor or nurse since you may lose a lot of water from your body (become dehydrated) and this could damage your kidneys.
If you develop acute or worsening redness and pain in the eye, increased eye watering, blurred vision and/or sensitivity to light, please tell your doctor or nurse immediately as you may need urgent treatment (see Possible Side Effects below).
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Vectibix should not be used in combination with bevacizumab (another monoclonal antibody used in cancer of the bowel).
Vectibix 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. Vectibix 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 Vectibix and for 6 months after the last dose.
If you become pregnant during Vectibix treatment you are encouraged to enrol in a Pregnancy Surveillance programme. It is not recommended to breast-feed your baby during treatment with Vectibix and for 3 months after the last dose. If you are nursing during Vectibix treatment you are encouraged to enrol in a Lactation Surveillance programme. Local representative contact details are provided in section 6 of this leaflet.
Ask your doctor or pharmacist for advice before taking any medicine.
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.
This medicinal product contains 0.150 mmol sodium (which is 3.45 mg sodium) per ml of concentrate. To be taken into consideration by patients on a controlled sodium diet.
Vectibix will be administered in a healthcare facility under the supervision of a doctor experienced in the use of anti-cancer medicines.
Vectibix is administered intravenously (into a vein) with an infusion pump (a device that gives a slow injection).
The recommended dose of Vectibix 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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most serious side effects and main side effects for Vectibix are listed below:
Infusion reactions
During or following treatment you may experience an infusion reaction. These can be mild or moderate (likely to occur in approximately 4 out of 100 people who take Vectibix), or severe (likely to occur in less than 1 out of 100 people who take Vectibix). Symptoms may include headache, rashes, itching or hives, flushing, swelling (face, lips, mouth, around the eyes, and throat area), palpitations, fast pulse, sweating, nausea, vomiting, dizziness, difficulty breathing or swallowing, or a decrease in blood pressure that may be severe or life-threatening and very rarely, may lead to death. If you experience any of these symptoms, you should notify your doctor immediately. Your doctor may decide to reduce the rate of your infusion or discontinue your treatment with Vectibix.
Allergic reactions
Very rarely, serious allergic (hypersensitivity) reactions involving symptoms similar to an infusion reaction have occurred more than 24 hours after treatment and resulted in a fatal outcome. If you experience an allergic reaction to Vectibix, you should notify your doctor immediately. Your doctor may decide to reduce the rate of your infusion or discontinue your treatment with Vectibix.
Skin reactions
Skin-related reactions are likely to occur in approximately 90 out of 100 people who take Vectibix and are usually mild to moderate. The skin rash commonly resembles acne and often involves the face, upper chest and back, but can affect any area of the body. Some rashes have been associated with redness, itching and flaking of the skin which can become severe. In some cases, it may cause infected sores requiring medical and/or surgical treatment, or cause severe skin infections that in rare cases could be fatal. Prolonged exposure to the sun can make the rash worse. Also, dry skin, fissures (cracks in the skin) on the fingers or toes, fingernail bed or toenail bed infection (paronychia) or inflammation has been reported. Once treatment is withheld or discontinued, the skin reactions will generally resolve. Your doctor may decide to treat the rash, adjust the dose or discontinue your treatment with Vectibix.
Other side effects include:
Very common side effects (seen in more than 1 in 10 people who take Vectibix)
Common side effects (seen in more than 1, but less than 10 in 100 people taking Vectibix)
Uncommon side effects (seen in less than 1 in 100, but more than 1 in 1000 people taking Vectibix)
Rare side effects (seen in less than 1 in 1000, but more than 1 in 10,000 people taking Vectibix)
Frequency unknown:
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Vectibix will be stored in the healthcare facility where it is used.
Keep out of the sight and reach of children.
Store in a refrigerator (2°C – 8°C).
Do not freeze.
Store in the original carton in order to protect from light.
Do not use Vectibix after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
Vectibix is a colourless liquid that may contain visible particles and is supplied in a vial. Each pack contains one vial of either 5 ml, 10 ml or 20 ml of concentrate.
Not all pack sizes may be marketed.
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
This leaflet was last approved in February 2012.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/
This medicine has been given “conditional approval”.
This means that there is more evidence to come about this medicine.
The European Medicines Agency (EMA) will review new information on the medicine every year and this leaflet will be updated as necessary.
Link to this document from your website:http://www.medicines.ie/medicine/13339/XPIL/Vectibix/