What is it and how is it used?

Avastin contains the active substance bevacizumab, which is a humanised monoclonal antibody. Monoclonal antibodies are proteins which specifically recognise and bind to other unique proteins in the body. Bevacizumab binds selectively to a protein called human vascular endothelial growth factor (VEGF), which is found on the lining of blood and lymph vessels in the body. VEGF causes blood vessels to grow within tumours, these blood vessels provide the tumour with nutrients and oxygen. Once bevacizumab is bound to VEGF, it stops VEGF working properly. This has the effect of preventing tumour growth by blocking the growth of the blood vessels providing the nutrients and oxygen to the tumour.

Avastin is a medicine used for the treatment of advanced cancer in the large bowel, i.e., in the colon or rectum. Avastin will be administered in combination with chemotherapy treatment containing a fluoropyrimidine medicine.

Avastin is also used for the treatment of metastatic breast cancer. When used for patients with breast cancer, it will be administered with a chemotherapy drug called paclitaxel.

Avastin is also used for the treatment of advanced non-small cell lung cancer. Avastin will be administered together with a chemotherapy regimen containing platinum.

Avastin is also used for treatment of advanced kidney cancer. When used for patients with kidney cancer, it will be administered with another type of medicine called interferon.

Table of Contents
What do you have to consider before using it?
How is it used?
What are possible side effects?
How should it be stored?
Further information

What do you have to consider before using it?

Do not use Avastinif:

  • you are allergic (hypersensitive) to bevacizumab or to any of the other ingredients of Avastin.
  • you are allergic (hypersensitive) to Chinese hamster ovary (CHO) cell products or to other recombinant human or humanised antibodies.
  • you are pregnant.
Take special care with Avastin:

  • if you have conditions causing inflammation inside the abdomen (e.g. diverticulitis, stomach ulcers, colitis associated with chemotherapy), as it is possible that Avastin may increase the risk of developing holes in the gut wall.
  • - if you are going to have an operation, if you have had major surgery within the last 28 days or if you still have an unhealed wound following surgery, you should not receive this medicine as Avastin can increase the risk of bleeding or increase the risk of problems with wound healing after surgery.
  • if you have high blood pressure which is not well controlled with blood pressure medicines as Avastin can increase the incidence of high blood pressure. Your doctor should make sure that your blood pressure is under control before starting Avastin treatment.
  • if you have high blood pressure, as you may have a higher risk of having protein in your urine.
  • if you are over 65 years old and also have had blood clots in your arteries (a type of blood vessel) in the past, as these factors can increase the risk of further blood clots in the arteries.
  • if you or your family tend to suffer from bleeding problems or you are taking medicines to thin the blood for the treatment of blood clots.
  • if you have been coughing or spitting blood or had any bleeding in your lungs.
  • if you have ever received anthracyclines (for example doxorubicin, a specific type of chemotherapy used to treat some cancers) or had radiotherapy to your chest, or if you have heart disease as Avastin can increase the risk of developing a weak heart.
  • if you have headache, vision changes, confusion or seizure with or without high blood pressure, you should contact your doctor. This could be a rare neurological side effect named reversible posterior leukoencephalopathy syndrome.

Please consult your doctor, even if these statements were applicable to you at any time in the past.

Before you are given Avastin or while you are being treated with Avastin:

  • if you have or have had pain in the mouth, teeth and/or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loosening of a tooth tell your doctor and dentist immediately .
  • if you need to undergo an invasive dental treatment or dental surgery , tell your dentist that you are being treated with Avastin, in particular when you are also receiving or have received an iv bisphosphonate.

You may be advised to have a dental check-up before you start treatment with Avastin.

Using other medicines

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

Please tell your doctor if you have recently received, or are receiving, radiotherapy.

Pregnancy and breast feeding

You must not use this medicine if you are pregnant. Avastin may cause damage to your unborn baby as it may stop the formation of new blood vessels. Your doctor should advise you about using contraception during treatment with Avastin and for at least 6 months after the last dose of Avastin.

Tell your doctor straightaway if you are pregnant, become pregnant during treatment with this medicine, or plan to become pregnant in the near future.

You must not breast-feed your baby during treatment with Avastin and for at least 6 months after the last dose of Avastin, as this medicine may interfere with the growth and development of your baby.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Avastin has not been shown to impair your ability to drive or to use any tools or machines.

How is it used?

Dosage and frequency of administration

The dose of Avastin needed depends on your body weight and the kind of cancer to be treated. The recommended dose is 5 mg, 7.5 mg, 10 mg or 15 mg per kilogram of your body weight. Your doctor will prescribe a dose of Avastin that is right for you. You will be treated with Avastin once every 2 or 3 weeks. The number of infusions that you receive will depend on how you are responding to treatment; you should continue to receive this medicine until Avastin fails to stop your tumour growing. Your doctor will discuss this with you.

Method and route of administration

Avastin is a concentrate for solution for infusion. Depending on the dose prescribed for you, some or all of the contents of the Avastin vial will be diluted with sodium chloride solution before use. A doctor or nurse will give you this diluted Avastin solution by intravenous infusion. The first infusion will be given to you over 90 minutes. If this is well-tolerated the second infusion may be given over 60 minutes. Later infusions may be given to you over 30 minutes.

The administration of Avastin should be temporarily discontinued

  • if you develop severe high blood pressure requiring treatment with blood pressure medicines,
  • if you have problems with wound healing following surgery,
  • if you undergo surgery.
The administration of Avastin should be permanently discontinued if you develop

  • severe high blood pressure which cannot be controlled by blood pressure medicines; or a sudden severe rise in blood pressure,
  • presence of protein in your urine accompanied by swelling of your body,
  • a hole in your gut wall,
  • an abnormal tube-like connection or passage between the windpipe and the gullet, or between internal organs and skin or other tissues that are not normally connected, and are judged by your doctor to be severe,
  • a blood clot in your arteries,
  • a blood clot in the veins of your lungs,
  • any severe bleeding.
If too much Avastin is given

  • you may develop a severe migraine. If this happens you should talk to your doctor or pharmacist immediately.
If a dose of Avastin is missed

  • your doctor will decide when you should be given your next dose of Avastin. You should discuss this with your doctor.

If you stop treatment with Avastin

Stopping your treatment with Avastin may stop the effect on tumour growth. Do not stop treatment with Avastin unless you have discussed this with your doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

What are possible side effects?

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

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

The side effects listed below were seen when Avastin was given together with chemotherapy. This does not necessarily mean that these side effects were strictly caused by Avastin.

These side effects may occur with certain frequencies, which are defined as follows:

  • very common: affects more than 1 user in 10
  • common: affects 1 to 10 users in 100
  • uncommon: affects 1 to 10 users in 1,000
  • rare: affects 1 to 10 users in 10,000
  • very rare: affects less than 1 user in 10,000
  • not known: frequency cannot be estimated from the available data.

Allergic reactions
If you have an allergic reaction, tell your doctor or a member of the medical staff straight away. The signs may include: difficulty in breathing or chest pain. You could also experience redness or flushing of the skin or a rash, increased muscle tension, feeling sick (nausea) or being sick (vomiting).

You should seek help immediately if you suffer from any of the below mentioned side effects.

The common side effects are:

  • perforation of the gut,
  • bleeding, including bleeding in the lungs in patients with non-small cell lung cancer,
  • blocking of the arteries by a blood clot,
  • blocking of the veins in the lungs by a blood clot.

The severe side effects, which may be very common, include:

  • high blood pressure,
  • problems with wound healing after surgery,
  • feeling of numbness or tingling in hands or feet,
  • decreased number of cells in the blood, including white cells that help to fight against infections (this may be accompanied by fever), and cells that help the blood to clot,
  • lack of energy or tiredness,
  • diarrhoea, nausea and vomiting.

The severe side effects, which may be common, include:

  • allergic reactions,
  • decreased number of red cells in the blood,
  • bleeding associated with the tumour,
  • lack of energy,
  • abdominal pain,
  • muscle pain,
  • dry mouth in combination with thirst and/or reduced or darkened urine,
  • inflammation of the lining of the mouth,
  • pain, including headache,
  • blood clots in the veins of the legs or difficulties in getting the blood to clot,
  • localised pus collection,
  • infection, and in particular infection in the blood or bladder,
  • reduced blood supply to the brain or stroke,
  • blood clots in the arteries, which can lead to a stroke and a heart attack,
  • falling asleep or fainting,
  • problems with the heart with breathing difficulties,
  • nose bleed,
  • increase in heart rate (pulse),
  • blockage in the gut or bowel,
  • abnormal urine test (protein in the urine),
  • shortness of breath or low levels of oxygen in the blood.

The severe side effects, which may be rare, include:

  • seizures (fits),
  • headache,
  • confusion,
  • changes in vision,
  • an abnormal tube-like connection between the windpipe and the passage to the stomach (gullet).
You should seek help as soon as possible if you suffer from any of the below mentioned side effects

The very common side effects, which were not severe, include:

  • high blood pressure,
  • pain, including joint pain,
  • lack of energy,
  • constipation, bleeding from the lower part of the large bowel, inflammation of the mouth,
  • loss of appetite,
  • protein in the urine,
  • nose bleed,
  • fever,
  • headache,
  • problems with the eyes (including increased production of tears).

The common side effects, which were not severe, include:

  • shortness of breath,
  • nose bleed,
  • runny nose,
  • dry skin, flaking and inflammation of the skin, change in skin colour,
  • change in the sense of taste,
  • voice changes, hoarseness.

Other less common side effects of any severity which have been reported are heart failure, bleeding from the lining of the mouth or vagina, abnormal tube-like connection between internal organs and skin or other tissues that are not normally connected and ulcers in the digestive system (the signs may include abdominal pain, feeling bloated, black tarry stools or blood in your stools (faeces) or blood in your vomit).

There have been very rare reports of patients developing a hole in the septum of the nose ? the structure, which separates the nostrils.

Some side effects are more common in elderly patients. These side effects include blood clot in the arteries which can lead to a stroke or a heart attack. In addition, elderly patients have a higher risk of a reduction in the number of white cells in the blood, and cells that help the blood clot. Other side effects reported with a higher frequency in elderly patients were diarrhoea, sickness, headache and fatigue.

Avastin may also cause changes in laboratory tests carried out by your doctor. These include a decreased number of white cells in the blood, in particular neutrophils (one type of white blood cell which helps protect against infections) in the blood; presence of protein in the urine; decreased blood potassium, sodium or phosphorous (a mineral); increased blood sugar; increased blood alkaline phosphatase (an enzyme); decreased haemoglobin (found in red blood cells, which carry oxygen), which may be severe.

Pain in the mouth, teeth and/or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loosening of a tooth. These could be signs and symptoms of bone damage in the jaw (osteonecrosis). Tell your doctor and dentist immediately if you experience any of them.

Outside of the approved use of Avastin for cancer treatment, the following side effects may occur when Avastin is injected directly into the eye (unapproved use):

  • Infection or inflammation of the eye globe,
  • Redness of the eye, small particles or spots in your vision (floaters), eye pain,
  • Seeing flashes of light with floaters, progressing to a loss of some of your vision,
  • Increased eye pressure,
  • Bleeding in the eye.

How should it be stored?

Keep out of the reach and sight of children.

Do not use after the expiry date which is stated on the outer carton and on the vial label after the abbreviation EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2°C?8°C).
Do not freeze.
Keep the vial in the outer carton in order to protect from light.

Infusion solutions should be used immediately after dilution. Do not use Avastin if you notice any particulate matter or discoloration prior to administration.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information

What Avastin contains

Each pack of Avastin concentrate for solution for infusion contains one vial. This vial contains either 4 ml or 16 ml of a slightly opaque, colourless to pale brown sterile liquid concentrate. The concentrate must be diluted before use to make a solution for intravenous infusion.

  • Each ml contains 25 mg of bevacizumab, corresponding to 1.4 to 16.5 mg/ml when diluted as recommended.
  • The other ingredients are trehalose dihydrate, sodium phosphate, polysorbate 20 and water for injections.

What Avastin looks like and contents of the pack

Avastin is a clear, colourless to pale brown liquid in a glass vial with a rubber stopper. Each vial contains 100 mg bevacizumab in 4 ml of solution or 400 mg bevacizumab in 16 ml of solution.

Marketing Authorisation Holder

Roche Registration Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom.

Manufacturer

Roche Pharma AG, Emil-Barell-Str. 1, 79639 Grenzach-Wyhlen, Germany.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

LuxembourgLuxemburg Voirsiehe BelgiqueBelgien BelgiëBelgiqueBelgien N.V. Roche S.A. TélTel 32 0 2 525 82 11

359 2 818 44 44 Magyarország Roche Magyarország Kft. Tel 36 - 23 446 800

Malta See United Kingdom eská republika Roche s. r. o. Tel 420 - 2 20382111

Danmark Roche as Tlf 45 - 36 39 99 99 Nederland Roche Nederland B.V. Tel 31 0 348 438050

Deutschland Roche Pharma AG Tel 49 0 7624 140 Norge Roche Norge AS Tlf 47 - 22 78 90 00

Eesti Roche Eesti OÜ Tel 372 - 6 177 380 Österreich Roche Austria GmbH Tel 43 0 1 27739

Roche Hellas A.E. 30 210 61 66 100 Polska Roche Polska Sp.z o.o. Tel 48 - 22 345 18 88

España Roche Farma S.A. Tel 34 - 91 324 81 00 Portugal Roche Farmacêutica Química, Lda Tel 351 - 21 425 70 00

France Roche Tél 33 0 1 46 40 50 00 România Roche România S.R.L. Tel 40 21 206 47 01

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Slovenská republika Roche Slovensko, s.r.o. Tel 421 - 2 52638201 Ísland Roche as co Icepharma hf Sími354 540 8000

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K .. . 357 - 22 76 62 76 Sverige Roche AB Tel 46 0 8 726 1200

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Lietuva

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Tel: +370 5 2546799

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