What Vectibix is used for and how to use it
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Vectibix – Consumer Medicine Information

Manufacture: Amgen
Country: United States
Condition: Metastatic Breast Cancer (Breast Cancer, Metastatic)
Class: EGFR inhibitors, Immunologic agents
Form: Liquid solution, Intravenous (IV)
Ingredients: medicines, panitumumab, sodium chloride, sodium acetate trihydrate, glacial acetic acid, water for injections

Vectibix 100mg/5ml concentrate for solution for infusion vials When used in advanced colorectal cancer

Vectibix (Vektibix) is a medicine which is used in advanced colorectal cancer. Vectibix contains panitumumab. It is supplied by AMGEN Ltd.

Your medicine

Vectibix is used to treat certain types of colorectal cancer in cases where other treatments have not been effective. Vectibix may be used alone or with other medicines to treat cancer.

Your medical team will discuss with you the options for treating your cancer. They will take into account factors such as the type of cancer, where it is, which stage it is at and whether you have had treatment before. The results of blood tests and other investigations will also be considered.

How well you feel and how you are likely to cope with treatment is also important.

Your cancer treatment will usually consist of a treatment session with Vectibix once every two weeks. This cycle may be repeated many times as part of your cancer treatment.

Vectibix works by blocking some of the effects of a chemical called epidermal growth factor (EGF) in the body. Some types of colorectal cancers need EGF to grow. Blocking some of the effects of EGF can help stop these cancers from growing or reduce their size.

As well as damaging cancer cells in the body. Vectibix also affects healthy cells and treatment with Vectibix may cause damage to your skin or lungs. Your medical team will tell you about symptoms you should look out for and may arrange for you to have tests to monitor these effects.

Other information about Vectibix:

  • you should protect your skin from sunlight if you develop a skin reaction while you are being treated with Vectibix. Sunlight may worsen skin problems which have been caused by Vectibix. To protect your skin from sunlight you should use a high protection sun screen and wear clothing that covers you as much as possible

Vectibix is usually given to you by a healthcare professional. The person responsible for giving you your medicine will make sure that you get the right dose.

If you feel that the medicine is making you unwell or you do not think it is working, then talk to your prescriber or someone involved in your medical care.

When to take your medicine

The person with responsibility for giving you your medicine will make sure that you have your medicine at the prescribed times.

How to take your medicine

This medicine will be given to you as an injection. If you have any concerns about this medicine or how this will be given to you, talk to someone who is involved in your medical care.

Taking too much of your medicine

Having extra doses of some medicines can be harmful. In some cases even one extra dose can cause you problems.

In the case of Vectibix, the person who is responsible for giving you your medicine will make sure that you are given the correct dose.

Stopping your medicine

The person in charge of your care will make the decision about when you should stop this medicine. If you experience any problems while having this medicine, talk to someone who is involved in your medical care.

Looking after your medicine

As Vectibix will be given to you as an injection, it will usually be stored by the medical team.

Whether this medicine is suitable for you

Vectibix is not suitable for everyone and some people should never use it. Other people should only use it with special care. It is important that the person prescribing this medicine knows your full medical history.

Your prescriber may only prescribe this medicine with special care or may not prescribe it at all if you:

  • are allergic or sensitive to or have had a reaction to any of the ingredients in the medicine
  • are on a diet which must be low in sodium from all sources, including medicines
  • have, have had or have risk factors for eye or eyesight problems such as dry eye, inflammation or ulceration of the front part of the eye
  • have liver problems
  • have kidney problems
  • have or have had lung problems

Furthermore the prescriber may only prescribe this medicine with special care or may not prescribe it at all for a child.

As part of the process of assessing suitability to take this medicine a prescriber may also arrange tests:

  • to determine whether or not the medicine is suitable and whether it must be prescribed with extra care
  • to check that this medicine is having the desired effect
  • to check that this medicine is not having any undesired effects

Over time it is possible that Vectibix can become unsuitable for some people, or they may become unsuitable for it. If at any time it appears that Vectibix has become unsuitable, it is important that the prescriber is contacted immediately.

Side effects

A medicine is only made available to the public if the clinical trials have shown that the benefits of taking the medicine outweigh the risks.

Once a medicine has been licensed, information on the medicine's effects, both intended and unintended, is continuously recorded and updated.

Some side effects may be serious while others may only be a mild inconvenience.

Everyone's reaction to a medicine is different. It is difficult to predict which side effects you will have from taking a particular medicine, or whether you will have any side effects at all. The important thing is to tell your prescriber or pharmacist if you are having problems with your medicine.

Very common: More than 1 in 10 people who have Vectibix

  • acne or acne like rash
  • back pain
  • blood problems
  • breathing difficulties seek immediate medical advice if you experience breathing difficulties
  • broken or cracked skin
  • constipation
  • cough
  • diarrhoea if you have diarrhoea and are dehydrated, this may lead to kidney problems. Seek immediate medical advice if you have diarrhoea
  • difficulty sleeping
  • dry skin
  • eye or eyesight problems such as inflammation or ulceration of the outer surface of the eye seek immediate medical advice if you develop increased tear production, light sensitivity, blurred vision, inflammation, pain or redness of the eye
  • fever
  • hair loss
  • inflammation of the mouth
  • inflammation of the mucous membranes
  • itching
  • loss of appetite
  • metabolic problems
  • nail problems
  • nausea
  • oedema of the extremities
  • redness of the skin
  • skin exfoliation
  • skin lesions
  • skin rash or rashes
  • stomach pain
  • tiredness
  • vomiting
  • weakness
  • weight loss

Common: More than 1 in 100 people who have Vectibix

  • abnormal laboratory test results
  • blood pressure changes
  • cellulitis seek immediate medical advice if you develop a skin infection
  • chest pain
  • deep vein thrombosis
  • dehydration if you are dehydrated and have diarrhoea, this may lead to kidney problems
  • dermatitis
  • dry eye
  • dry mouth
  • excessive growth of hair
  • faster heart rate
  • feeling anxious
  • feeling dizzy
  • flushing
  • gastro oesophageal reflux
  • hand foot syndrome
  • headaches
  • increased blood sugar levels
  • increased growth of the eyelashes
  • increased sweating
  • indigestion
  • inflammation of the eyelid
  • inflammation of the hair follicles
  • inflammation of the lip
  • infusion reactions some of these hypersensitivity reactions may be delayed and may be fatal. Seek immediate medical advice if you develop anaphylactic reactions or have symptoms such as breathing difficulties, bronchospasm, fever, chills or angioedema
  • irritation of the eye
  • itchy eye
  • localised infection
  • mouth ulcers
  • nose bleed
  • pain
  • painful extremities
  • pulmonary embolism
  • rectal bleeding
  • scab
  • skin ulcers
  • urinary tract infection

Uncommon: More than 1 in 1000 people who have Vectibix

  • chapped or dry lips
  • cyanosis
  • dryness in the nose
  • hair overgrowth
  • infection of the eye or eyelid
  • ingrown nail
  • irritation of the eyelid

Rare: More than 1 in 10,000 people who have Vectibix

  • skin necrosis
  • Stevens Johnson syndrome seek immediate medical advice if you have any unusual bad skin reaction while being treated with Vectibix
  • toxic epidermal necrolysis seek immediate medical advice if you have any unusual bad skin reaction while being treated with Vectibix

The frequency of these side effects is unknown

  • lung problems some of these lung problems may be fatal
  • serious skin reactions leading to abscess formation, skin infection, sepsis and death seek immediate medical advice if you have an unusually bad skin reaction, or if any skin reaction worsens or becomes intolerable while you are being treated with Vectibix. Sunlight may worsen skin problems which have been caused by Vectibix and you should try to minimize the time your skin is exposed to sunlight. You should protect your skin from sunlight while you are being treated with Vectibix by using a high protection sun screen and wear a hat before you go out in the sun
  • worsening of pulmonary symptoms

If you feel unwell or if you have concerns about a side effect, you will need to seek advice. If you feel very ill, get medical help straight away. Contact your prescriber, pharmacist, nurse or call 111.

Taking other medicines

If you are taking more than one medicine they may interact with each other. At times your prescriber may decide to use medicines that interact, in other cases this may not be appropriate.

The decision to use medicines that interact depends on your specific circumstances. Your prescriber may decide to use medicines that interact, if it is believed that the benefits of taking the medicines together outweigh the risks. In such cases, it may be necessary to alter your dose or monitor you more closely.

Tell your prescriber the names of all the medicines that you are taking so that they can consider all possible interactions. This includes all the medicines which have been prescribed by your GP, hospital doctor, dentist, nurse, health visitor, midwife or pharmacist. You must also tell your prescriber about medicines which you have bought over the counter without prescriptions.

The following medicines may interact with Vectibix:

  • 5 fluorouracil
  • leucovorin
  • irinotecan
  • bevacizumab

The following types of medicine may interact with Vectibix:

  • cytotoxics
  • oxaliplatin containing chemotherapy

If you are taking Vectibix and one of the above medicines or types of medicines, make sure your prescriber knows about it.

Complementary preparations and vitamins

Medicines can interact with complementary preparations and vitamins. In general, there is not much information available about interactions between medicines and complementary preparations or vitamins.

If you are planning to take or are already taking any complementary preparations and vitamins you should ask your prescriber whether there are any known interactions with Vectibix.

Your prescriber can advise whether it is appropriate for you to take combinations that are known to interact. They can also discuss with you the possible effect that the complementary preparations and vitamins may have on your condition.

If you experience any unusual effects while taking this medicine in combination with complementary preparations and vitamins, you should tell your prescriber.

Driving and operating machinery

When taking any medicine you should be aware that it might interfere with your ability to drive or operate machinery safely.

In the case of Vectibix:

  • this medicine could affect your ability to drive or operate machinery
  • You should see how this medicine affects you before you judge whether you are safe to drive or operate machinery. If you are in any doubt about whether you should drive or operate machinery, talk to your prescriber.

    Diet

    Medicines can interact with certain foods. In some cases, this may be harmful and your prescriber may advise you to avoid certain foods.

    In the case of Vectibix:

    • this medicine may contain a large amount of sodium. This may be relevant to you if you are on a diet which must be low in sodium from all sources. Your prescriber will give you more information on this if this is relevant to you

    For more advice speak to your prescriber, dietitian or pharmacist.

    Alcohol

    Alcohol can interact with certain medicines.

    In the case of Vectibix:

    • there are no known interactions between alcohol and Vectibix

    Family planning and pregnancy

    Most medicines, in some way, can affect the development of a baby in the womb. The effect on the baby differs between medicines and also depends on the stage of pregnancy that you have reached when you take the medicine.

    In the case of Vectibix:

    • you must not have Vectibix during pregnancy. If you could become pregnant, you must use effective contraception or abstain from penetrative sex while you are having Vectibix and for at least two months after stopping treatment
    • this medicine may decrease female fertility

    This medicine is not suitable during pregnancy. It is very important that you seek urgent medical advice if you become pregnant or think you have become pregnant while taking this medicine.

    If you are planning to become pregnant, you should discuss your personal circumstances with your doctor so that together you can make a decision about what treatment you may need during your pregnancy.

    Breast feeding

    Certain medicines can pass into breast milk and may reach your baby through breast feeding.

    In the case of Vectibix:

    • you must not breast feed while you are having Vectibix and for at least two months after you have had the last dose of Vectibix

    Before you have your baby you should discuss breast feeding with your doctor or midwife. They will help you decide what is best for you and your baby based on the benefits and risks associated with this medicine. If you wish to breast­feed you should discuss with your prescriber whether there are any other medicines you could take which would also allow you to breast feed. You should not stop this medicine without taking advice from your doctor.

    Ingredients of your medicine

    Medicines contain active ingredients. They may also contain other, additional ingredients that help ensure the stability, safety and effectiveness of the medicine. Some may be used to prolong the life of the medicine.

    Vectibix contains:

    • panitumumab
    • sodium chloride
    • sodium acetate trihydrate
    • glacial acetic acid
    • water for injections

    If you are not able to take any of the ingredients in your medicine, talk to your prescriber or pharmacist to see if they can suggest an alternative medicine. If you have reacted badly to Vectibix before, do not have Vectibix. Talk to your prescriber, pharmacist or nurse as soon as possible.