pronounced (a-vas-tin)

contains the active ingredient bevacizumab(rch)

Consumer Medicine Information

This leaflet answers some common questions about Avastin infusion.

It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking Avastin against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

Avastin is used to treat;

brain tumours resistant to previous treatments

metastatic (spreading) cancer of the large bowel (i.e. in the colon or rectum), breast or cervix in combination with chemotherapy agents

lung cancer and cancer of the ovaries and fallopian tubes (which can extend to the lining of surrounding organs such as stomach, liver) in combination with chemotherapy agents

kidney cancer (renal cell cancer) in combination with interferon therapy (Roferon-A^®).

Avastin contains the active ingredient bevacizumab.

Avastin belongs to a group of medicines known as anti-neoplastic (or anti-cancer) agents. There are many different classes of anti-neoplastic agents. Avastin belongs to a class known as anti-angiogenic agents.

Anti-angiogenic agents inhibit angiogenesis (the process of forming new blood vessels in your body).

Avastin selectively binds to vascular endothelial growth factor (VEGF), a protein found on the cells that line blood vessels. Tumours produce high levels of VEGF, which stimulates blood vessels to grow, thereby providing the tumour with nutrients and oxygen.

When Avastin blocks VEGF it disrupts the blood supply to the tumour, stopping or slowing down its growth.

There are many different types of medicines used to treat brain tumours and metastatic cancer of the large bowel, breast, lung, kidney and cervix.

Your doctor may have prescribed Avastin for another purpose.

Ask your doctor if you have any questions about why Avastin has been prescribed for you.

Avastin is not addictive.

This medicine is available only with a doctor’s prescription.

Do not use Avastin if:

1.you have had an allergic reaction to Avastin or any ingredients listed at the end of this leaflet

Symptoms of an allergic reaction may include shortness of breath; wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body or rash, itching or hives on the skin

2.you have had an allergic reaction to any proteins that are of Chinese hamster origin or to other recombinant human or humanised antibodies

3.the package is torn or shows signs of tampering

4.the expiry date (EXP) printed on the pack has passed.

If you take this medicine after the expiry date has passed, it may not work as well.

If you are not sure if you should be given Avastin, talk to your doctor.

Do not give Avastin to children and adolescents.

Safety and effectiveness in children and adolescents have not been established.

Tell your doctor if:

1.you are pregnant or plan to become pregnant

Do not use Avastin if you are pregnant. Avastin may cause damage to your unborn baby.

You should use contraception during treatment with Avastin and for at least 6 months after your last dose. If you become pregnant while you are being treated with Avastin, immediately inform your doctor.

Your doctor will advise you about using contraception during treatment with Avastin.

2.you plan to start a family in the future

Avastin may interfere with your ability to become pregnant. Your doctor will advise you of your options prior to starting treatment.

3.you are breast-feeding or plan to breast-feed

You should not breast-feed while being treated with Avastin and for at least 6 months after the last dose. Avastin may interfere with the growth and development of your baby.

4.you have any other health problems, especially the following:

inflammation of the bowel (symptoms may include fever, vomiting, diarrhoea and stomach pain) or stomach ulcers,

hypertension (high blood pressure) – it is important to follow all your doctor’s instructions to control your blood pressure

history of blood clots or stroke, or you are taking medicine to prevent blood clots (e.g. warfarin)

you or anyone in your family suffer from bleeding problems

heart disease

history of diabetes

5.you have had major surgery within the last 28 days or have a wound that has not healed properly

Avastin can cause an increased risk of post-operative bleeding or problems with wound healing.

6.you have had a blocked lung artery (pulmonary embolism)

Avastin may increase the risk of recurrence

7.you have ever received anthracyclines (e.g. doxorubicin), a specific type of chemotherapy used to treat some cancers, or have had radiotherapy to your chest Avastin can increase the risk of developing a weak heart.

8.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 immediately.

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

9.you are 65 years of age or older

Avastin can increase the risk of blood clots which can lead to strokes or heart attacks in patients older than 65 years of age compared with younger patients. Avastin can also increase the risk of fatigue, hair loss, reduce the number of white cells in the blood and cells which help blood clot, inflammation of the mouth or throat, high blood pressure and a feeling of numbness or tingling in the hands or feet in patients older than 65 years of age compared with younger patients.

10.you are allergic to any other medicines, foods, dyes or preservatives

If you have not told your doctor about any of the above, tell them before you start taking Avastin.

Tell your doctor if you are taking any other medicines, including any that you have bought from a pharmacy, supermarket or health food shop.

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

Tell your doctor if you have recently received, or are receiving, a bisphosphonate (for example medicines containing ibandronate sodium, zoledronic acid or disodium pamidronate).

Some medicines may interfere with Avastin.

Some medicines may be affected by Avastin, or may affect how well it works. You may need to use different amounts of your medicine, or you may need to take different medicines. Your doctor will advise you.

Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking Avastin.

Ask your doctor or pharmacist if you are not sure about this list of medicines.

Avastin solution is prepared by a health care professional.

Avastin is given by infusion into a vein (intravenous infusion) by a health care professional.

The first infusion is usually given over 90 minutes. If it is well tolerated the second infusion may be given over 60 minutes. Later infusions may be given over 30 minutes.

Your dose depends on your body weight and the type of cancer to be treated. Avastin can be given either once every 2 weeks or once every 3 weeks. Your doctor will prescribe a dose of Avastin that is right for you.

If you have been given too much Avastin you may develop a severe migraine. If this happens tell your health care professional immediately.

The number of infusions you will receive depends on how you are responding to treatment. Your doctor will discuss this with you.

Your doctor will decide when you should be given your next dose of Avastin.

Tell all doctors, dentists and pharmacists who are treating you that you are being treated with Avastin.

Tell your doctor immediately if you become pregnant during treatment with Avastin, or plan to start a family in the near future.

Tell your doctor immediately if you are breast-feeding while being treated with Avastin.

Tell your doctor if you are planning to have surgery or you have a wound that is not healing properly.

Tell your doctor if you need to undergo an invasive dental treatment or dental surgery, in particular when you are also receiving or have received a bisphosphonate (for example medicines containing ibandronate sodium, zoledronic acid or disodium pamidronate)

Tell your doctor if you feel Avastin is not helping your condition.

Be sure to keep all of your appointments with your doctor so that your progress can be checked.

Do not take any other medicines whether they require a prescription or not without first telling your doctor or consulting a pharmacist.

Be careful driving or operating machinery until you know how Avastin affects you.

Avastin has not been shown to impair your ability to drive or operate machinery.

Tell your doctor or pharmacist as soon as possible if you do not feel well while being treated with Avastin.

Avastin helps most people with brain tumours and cancer of the large bowel (i.e. colon or rectum), breast, lung, kidney, ovary/fallopian tube (which can extend to the lining of surrounding organs such as stomach, liver) and cervix but it may have unwanted side effects in some people.

All medicines can have some unwanted side effects. Sometimes they are serious, but most of the time they are not. Your doctor has weighed the risks of you being treated with Avastin against the benefits they expect it will have for you.

Because Avastin is used with other medicines that treat cancer (including chemotherapy), it may be difficult for your doctor to tell whether the side effects are due to Avastin or due to other medicines.

Avastin may exacerbate some chemotherapy side effects when used in combination with chemotherapy agents including hair loss, nail disorders, pain, redness and/or swelling of your hands and/or soles of your feet, and a feeling of numbness or tingling in the hands or feet.

Do not be alarmed by this list of possible side effects.

You may not experience any of them.

Tell your doctor if you notice any of the following and they worry you:

high blood pressure

body pain

muscle and joint pain

lack of energy or tiredness

diarrhoea; constipation or rectal bleeding

inflammation of the mouth

sore mouth; mouth ulcers; cold sores

loss of appetite

shortness of breath

nose bleed; runny or blocked nose

dry skin; rash; flaking, swelling or redness of the skin or change in skin colour

pain, redness and/or swelling of your hands and/or the soles of your feet that has affected your normal activities (hand-foot syndrome)

numbness or weakness of the arms and legs

change in sense of taste

blurred vision or other problems with the eye (including increased production of tears)

dizziness

fever; chills; shivering or headache

signs of infection such as swelling, redness and increased temperature, fever, chills, sore throat or mouth ulcers

bleeding or bruising more easily than normal

changes in your voice or hoarseness

difficulty speaking

loss of body weight

abdominal, pelvic, anal or back pain

These are the more common side effects of Avastin. Mostly these are mild.

Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you notice any of the following:

stomach cramps or pains

severe or bloody diarrhoea

bleeding from stomach or intestines which may look like coffee grounds or black sticky bowel motions (stools)

nausea and vomiting; including vomiting blood or material that looks like coffee grounds

coughing or spitting blood

pain, redness, swelling and warmth over a vein which may suggest deep vein thrombosis (blood clots in the veins of legs)

severe body pain including headaches

loss of control of your bladder or bowels; passage of wind or bowel motions through the vagina

severe bleeding

problems with your wounds healing after surgery

confusion

seizures (fits)

feeling of numbness or tingling in hands or feet

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

abscesses (pus-filled sores)

falling asleep or fainting

problems with the heart with breathing difficulties

chest pain

increase in heart rate (pulse)

shortness of breath

These are serious side effects. You may need urgent medical attention. Serious side effects are rare.

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

Some side effects are more common in elderly patients. These include blood clots 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, which can lead to infections and bleeding or bruising more easily than normal. Other side effects reported with a higher frequency in elderly patients were diarrhoea, nausea or sickness, headache, hair loss, inflammation of the mouth and throat, a feeling of numbness or tingling in the hands or feet and fatigue.

There have been reports of abnormal tube-like connections (fistulae) between internal organs and skin or other tissues that are not normally connected. You may have an increased risk of fistulae forming between the vagina and any part of the gastro-intestinal system if you are being treated with Avastin for cancer of the cervix.

There have been very rare reports of patients developing a hole in the septum of the nose, the structure that separates the nostrils. Symptoms may include nose bleeds, nasal congestion or infection, or whistling sounds when breathing.

Avastin is not approved for use in the eye. The following side effects may also occur if Avastin is injected directly into the eye:

infection (some cases leading to blindness)

eye pain, redness of the eye

small particles or spots in your vision (floaters)

seeing bright flashes of light with floaters, progressing to a loss of sight

bleeding in the eye

cataracts, leading to surgery of the eye lens

serious side effects affecting other organs, which can be severe or life-threatening and lead to hospitalisation, e.g. stroke.

This is not a complete list of all possible side effects. Others may occur in some people and there may be some side effects not yet known.

Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list.

Ask your doctor or pharmacist if you don’t understand anything in this list.

Avastin will be stored in the pharmacy or on the hospital ward in a refrigerator at a temperature between 2 to 8°C.

Avastin is for single use only.

The vials should be used once only and any remaining contents should be discarded.

Avastin is available as 100 mg and 400 mg single-dose vials.

Avastin is a clear to slightly opaque, colourless to pale brown solution.

Active ingredient

Bevacizumab

Inactive ingredients

trehalose dihydrate

sodium phosphate – monobasic monohydrate

sodium phosphate – dibasic

polysorbate 20

water for injections

Avastin is distributed by:

Roche Products Pty Limited

ABN 70 000 132 865

Level 8, 30 – 34 Hickson Road

Sydney NSW 2000

AUSTRALIA

Medical enquiries: 1800 233 950

 

Please check with your pharmacist for the latest Consumer Medicine Information.

 

Australian Registration Numbers

100 mg/4 mL AUST R 99755

400 mg/16 mL AUST R 99757

 

This leaflet was prepared on 24 November 2017.