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AstraZeneca

Avastin
bevacizumab

Package leaflet: Information for the user


Avastin 25 mg/ml concentrate for solution for infusion

bevacizumab


Read all of this leaflet carefully before you start using this medicine because it contains important information for you.


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, pharmacist or nurse.


  1. Possible side effects


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


    If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.


    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.


    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, chills and shivering, feeling sick (nausea) or being sick (vomiting).


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


    Severe side effects, which may be very common (affects more than 1 user in 10), include:

    • high blood pressure,

    • 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,

    • feeling weak and having no energy,

    • tiredness,

    • diarrhoea, nausea, vomiting and abdominal pain.


      Severe side effects, which may be common (affects 1 to 10 users in 100), include:

    • 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 by a blood clot,

    • blocking of the blood vessels of the lungs by a blood clot,

    • blocking of the veins of the legs by a blood clot,

    • heart failure,

    • problems with wound healing after surgery,

    • redness, peeling, tenderness, pain, or blistering on the fingers or feet,

    • decreased number of red cells in the blood,

    • lack of energy,

    • stomach and intestinal disorder,

    • muscle and joint pain, muscular weakness,

    • dry mouth in combination with thirst and/or reduced or darkened urine,

    • inflammation of the moist lining of mouth and gut, lungs and air passages, reproductive, and urinary tracts,

    • sores in the mouth and the tube from the mouth to the stomach, which may be painful and cause difficulty swallowing,

    • pain, including headache, back pain and pain in the pelvis and anal regions,

    • localised pus collection,

    • infection, and in particular infection in the blood or bladder,

    • reduced blood supply to the brain or stroke,

    • sleepiness,

    • 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,

    • infections of the skin or deeper layers under the skin,

    • fistula: abnormal tube-like connection between internal organs and skin or other tissues that are not normally connected, including connections between vagina and the gut in patients with cervical cancer.


      Severe side effects of unknown frequency (frequency cannot be estimated from the available data), include:

    • serious infections of the skin or deeper layers under the skin, especially if you had holes in the gut wall or problems with wound healing,

    • allergic reactions (the signs may include difficulty breathing, facial redness, rash, low blood pressure or high blood pressure, low oxygen in your blood, chest pain, or nausea/vomiting),

    • a negative effect on a woman’s ability to have children (see the paragraphs below the list of side effects for further recommendations),

    • a brain condition with symptoms including seizures (fits), headache, confusion, and changes in vision (Posterior Reversible Encephalopathy Syndrome or PRES),

    • symptoms that suggest changes in normal brain function (headaches, vision changes, confusion, or seizures), and high blood pressure,

    • an enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall (aneurysms

      and artery dissections),

    • clogging of a very small blood vessel(s) in the kidney,

    • abnormally high blood pressure in the blood vessels of the lungs which makes the right side of the heart work harder than normal,

    • a hole in the cartilage wall separating the nostrils of the nose,

    • a hole in the stomach or intestines,

    • an open sore or hole in the lining of the stomach or small intestine (the signs may include abdominal pain, feeling bloated, black tarry stools or blood in your stools (faeces) or blood in your vomit),

    • bleeding from the lower part of the large bowel,

    • lesions in the gums with an exposed jaw bone that does not heal and may be associated with pain and inflammation of the surrounding tissue (see the paragraphs below the list of side effects for further recommendations),

    • hole in the gall bladder (symptoms and signs may include abdominal pain, fever, and nausea/vomiting).

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


      Very common (affects more than 1 user in 10) side effects, which were not severe, include:

    • constipation,

    • loss of appetite,

    • fever,

    • problems with the eyes (including increased production of tears),

    • changes in speech,

    • change in the sense of taste,

    • runny nose,

    • dry skin, flaking and inflammation of the skin, change in skin colour,

    • loss of body weight,

    • nose bleeds.


      Common (affects 1 to 10 users in 100) side effects, which were not severe, include:

    • voice changes and hoarseness.


      Patients older than 65 years have an increased risk of experiencing the following side effects :

    • blood clot in the arteries which can lead to a stroke or a heart attack,

    • reduction in the number of white cells in the blood, and cells that help the blood clot,

    • diarrhoea,

    • sickness,

    • headache,

    • fatigue,

    • high blood pressure.


      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); increased serum creatinine (a protein measured by a blood test to see how well your kidneys are working); 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.


      Pre-menopausal women (women who have a menstrual cycle) may notice that their periods become irregular or are missed and may experience impaired fertility. If you are considering having children you should discuss this with your doctor before your treatment starts.


      Avastin has been developed and made to treat cancer by injecting it into the bloodstream. It has not been developed or made for injection into the eye. It is therefore not authorised to be used in this way. When Avastin is injected directly into the eye (unapproved use), the following side effects may occur:


    • 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.

      Reporting of side effects

      image

      If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting

      system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.


  2. How to store Avastin


    Keep this medicine out of the sight and reach of children.


    Do not use this medicine 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. If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless the infusion solutions have been prepared in a sterile environment. When dilution has taken place in a sterile environment, Avastin is stable for 30 days at 2°C to 8°C plus an additional 48 hours at 2°C to 30°C.

    Do not use Avastin if you notice any particulate matter or discolouration prior to administration. 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.


  3. Contents of the pack and other information What Avastin contains


What Avastin looks like and contents of the pack

Avastin is a concentrate for solution for infusion. The concentrate 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. Each pack of Avastin contains one vial.


Marketing Authorisation Holder

Roche Registration GmbH Emil-Barell-Strasse 1

79639 Grenzach-Wyhlen Germany

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.


België/Belgique/Belgien

N.V. Roche S.A.

Tél/Tel: +32 (0) 2 525 82 11

Lietuva

UAB “Roche Lietuva” Tel: +370 5 2546799


България

Рош България ЕООД Тел: +359 2 818 44 44

Luxembourg/Luxemburg

(Voir/siehe Belgique/Belgien)


Česká republika

Roche s. r. o.

Tel: +420 - 2 20382111

Magyarország

Roche (Magyarország) Kft. Tel: +36 1 279 4500


Danmark

Roche a/s

Tlf: +45 - 36 39 99 99

Malta

(See Ireland)


Deutschland

Roche Pharma AG Tel: +49 (0) 7624 140

Nederland

Roche Nederland B.V. Tel: +31 (0) 348 438050


Eesti

Roche Eesti OÜ

Tel: + 372 - 6 177 380

Norge

Roche Norge AS

Tlf: +47 - 22 78 90 00


Ελλάδα

Roche (Hellas) A.E.

Τηλ: +30 210 61 66 100

Österreich

Roche Austria GmbH Tel: +43 (0) 1 27739


España

Roche Farma S.A.

Tel: +34 - 91 324 81 00

Polska

Roche Polska Sp.z o.o. Tel: +48 - 22 345 18 88


France

Roche

Tél: +33 (0) 1 47 61 40 00

Portugal

Roche Farmacêutica Química, Lda Tel: +351 - 21 425 70 00


Hrvatska

Roche d.o.o.

Tel: + 385 1 47 22 333

România

Roche România S.R.L. Tel: +40 21 206 47 01


Ireland

Roche Products (Ireland) Ltd. Tel: +353 (0) 1 469 0700

Slovenija

Roche farmacevtska družba d.o.o. Tel: +386 - 1 360 26 00

Ísland

Roche a/s

c/o Icepharma hf Sími:+354 540 8000

Slovenská republika Roche Slovensko, s.r.o. Tel: +421 - 2 52638201


Italia

Roche S.p.A.

Tel: +39 - 039 2471

Suomi/Finland

Roche Oy

Puh/Tel: +358 (0) 10 554 500


Kύπρος

Γ.Α.Σταμάτης & Σια Λτδ. Τηλ: +357 - 22 76 62 76

Sverige

Roche AB

Tel: +46 (0) 8 726 1200


Latvija

Roche Latvija SIA Tel: +371 - 6 7039831

United Kingdom (Northern Ireland)

Roche Products (Ireland) Ltd. Tel: +44 (0) 1707 366000


This leaflet was last revised in

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