Bi Eligard cp (bicalutamide & leuprorelin acetate) Drug / Medicine Information

Bi Eligard cp (bicalutamide & leuprorelin acetate) Drug / Medicine Information

bicalutamide & leuprorelin acetate

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Bi ELIGARD cp. 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
Bi ELIGARD cp 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.

What Bi ELIGARD cp is used for

Bi ELIGARD cp combination therapy is the brand name for packs containing ELIGARD (leuprorelin
acetate) 7.5 mg or 22.5 mg subcutaneous injection plus MPL-BICALUTAMIDE 50 mg tablets.

Bi ELIGARD cp is used to reduce the symptoms of advanced cancer of the prostate gland.

Bicalutamide tablets can also be used to treat disease flare associated with previous
leuprorelin therapy.

Bi ELIGARD cp is a combination pack consisting of an anti-androgen (MPL-BICALUTAMIDE)
medicine and a Luteinising Hormone Releasing Hormone (LHRH) agonist (ELIGARD).

Androgens such as testosterone are natural male sex hormones. In some types of prostate
cancer, androgens may help the cancer cells to grow.

LHRH agonists reduce the level of testosterone in men.

Bi ELIGARD cp interferes with some of the actions of these hormones.

Bi ELIGARD cp should only be taken by men.

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

Your doctor may have prescribed it for another reason.

This medicine is not addictive.

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

Before you are given Bi ELIGARD cp

When you must not be given it

You must not be given Bi ELIGARD cp if you have an allergy to:

any medicine containing bicalutamide or leuprorelin

any of the ingredients listed at the end of this leaflet

any other anti-androgen medicines

any other LHRH agonists.

Some of the 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

rash, itching or hives on the skin.

Do not use Bi ELIGARD cp following surgical removal of your testes, as in that case
Bi ELIGARD cp does not lead to further decrease in serum testosterone levels.

You must not be given this medicine if you are pregnant or plan to become pregnant
or are breastfeeding.

This medicine has not been studied in women.

If used during pregnancy, it may affect the developing baby.

This medicine must not be given to children.

Safety and effectiveness has not been established in children.

Do not use Bi ELIGARD cp if you are taking cisapride or the antihistamines, terfenadine
and astemizole.

You must not be given this medicine after the expiry date printed on the pack or if
the packaging is torn or shows signs of tampering.

If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should be given this medicine, talk to your doctor.

Before you are given it

Tell your doctor if you have allergies to any other medicines, foods, preservatives
or dyes.

Tell your doctor if you have nerve problems caused by bone lesions in the spine, problems
passing urine or blood in your urine.

These conditions may get worse for a short time after treatment is started. Your doctor
may prescribe another medicine when you first receive Bi ELIGARD cp to reduce the
likelihood of this occurring.

Tell your doctor if you have or have had any of the following medical conditions:

liver problems

diabetes

cardiovascular disease, heart problems or blood vessel conditions, including heart
rhythm problems (arrhythmia), or are being treated with medicines for these conditions.
The risk of you having further heart rhythm problems may increase with Bi ELIGARD
cp

osteoporosis

history of epilepsy, fits or seizures

tumour in your pituitary gland.

Talk to your doctor about the effects Bi ELIGARD cp may have on fertility.

This medicine may impair fertility in men.

If you have not told your doctor about any of the above, tell him/her before you start
treatment with Bi ELIGARD cp.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any
that you get without a prescription from your pharmacy, supermarket or health food
shop.

Bi ELIGARD cp may interfere with some medicines used to treat heart rhythm problems,
such as:

quinidine

disopyramide

amiodarone

sotalol.

Bi ELIGARD cp may increase the risk of heart rhythm problems when used with other
medicines which also have the same risk, such as:

methadone (used for pain relief and part of drug addiction detoxification)

moxifloxacin (an antibiotic)

antipsychotics used for serious mental illness.

Some medicines may interfere with Bi ELIGARD cp and these include:

medicines used to prevent blood clots, especially warfarin as Bi ELIGARD cp may reduce
their effectiveness which may lead to bleeding and you therefore may need more monitoring

midazolam

cyclosporin

medicines used to treat high cholesterol

calcium channel blockers

carbamazepine

antiviral medicines for HIV infection.

Your doctor and pharmacist have more information on medicines to be careful with or
avoid while taking this medicine.

How Bi ELIGARD cp is given

Follow all directions given to you by your doctor or pharmacist carefully.

They may differ from the information contained in this leaflet.

How much is given

An ELIGARD injection will be injected underneath the skin every month for the 7.5
mg strength, or once every 3 months for the 22.5 mg strength.

One 50 mg tablet of MPL-BICALUTAMIDE is then taken each day for one or three months,
as considered appropriate by your doctor.

How it is given

The injection should only be given to you by a doctor or nurse. It will be administered
once a month or once every three months.

The content of the two syringes in the ELIGARD kit (one containing the active ingredient
and the other containing the delivery system) will be mixed together, then injected
underneath the skin. The site of the injection should be varied from time to time.

The tablets should be taken at about the same time each day.

Swallow your tablet whole with a full glass of water.

It does not matter if you take the tablets before, with or after food.

How long it is given for

Continue treatment with your medicine for as long as your doctor tells you.

This medicine helps to control your condition, but does not cure it. It is important
that you continue to receive your medicine even if you feel well.

If you forget to take it

If you have missed your injection, contact your doctor or pharmacist to find out what
to do.

If you miss taking a tablet, take it as soon as you remember, as long as it is 12
hours before the next dose is due.

If it is less than 12 hours to the next dose, do not take the dose you have missed.

Do not take a double dose to make up for the dose that you missed.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to take your medicine, ask your pharmacist for some
hints.

If you take too much (overdose)

Immediately telephone your doctor or pharmacist or the Poisons Information Centre
(telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital.
Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

While you are being given Bi ELIGARD cp

Things you must do

If your condition worsens, tell your doctor.

If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are being given Bi ELIGARD cp.

Tell any other doctors, dentists, and pharmacists who treat you that you are being
given this medicine.

If you are about to have any blood tests, tell your doctor that you are taking this
medicine.

It may interfere with the results of some tests.

Keep all of your doctor’s appointments so that your progress can be checked.

Your doctor may do some blood and other tests from time to time to make sure the medicine
is working.

Things you must not do

Do not give your medicine to anyone else, even if they have the same condition as
you.

Do not stop treatment with your medicine without checking with your doctor.

Things to be careful of

Be careful driving or operating machinery until you know how Bi ELIGARD cp affects
you.

This medicine may cause fatigue, dizziness and visual disturbances in some people.
If you have any of these symptoms, do not drive, operate machinery or do anything
else that could be dangerous.

Side effects

Tell your doctor, nurse or pharmacist as soon as possible if you do not feel well
while you are being given BI ELIGARD cp.

This medicine helps most people with advanced prostate cancer, but it may have unwanted
side effects in a few people. All medicines can have side effects. Sometimes they
are serious, most of the time they are not. You may need medical attention if you
get some of the side effects.

Do not be alarmed by the following lists of side effects. You may not experience any
of them.

Ask your doctor, nurse or pharmacist to answer any questions you may have.

Tell your doctor, nurse or pharmacist if you notice any of the following and they
worry you:

hot flushes or sweating

breast tenderness or changes in breast size

itching or dry skin, rashes

increased hairiness or hair loss

stomach pain or indigestion

nausea or vomiting

diarrhoea or constipation

flatulence (wind)

dry mouth

loss of appetite or weight changes

depression

unusual tiredness or weakness

dizziness or light-headedness

changes in blood pressure

difficulty sleeping

headache

pelvic pain

painful joints

chills

tingling in fingers or toes

decrease in your sexual drive

inability to get or maintain an erection

trouble passing urine or experience lower back pain

your testicles getting smaller.

Bi ELIGARD cp may also cause a period of low fertility or infertility whilst you are
taking it and for a period afterwards. However, you may not be infertile and as Bi
ELIGARD cp may affect your sperm, effective contraception must be used by you and/or
your partner while you are taking Bi ELIGARD cp and for at least 130 days after you
have stopped taking Bi ELIGARD cp.

Tell your doctor, nurse or pharmacist immediately if you notice any of the following:

frequent urination

shortness of breath and dizziness when exercising and looking pale (anaemia)

excessive thirst with weight loss, and passing large amounts of urine.

The above list includes serious side effects that may require medical attention.

If any of the following happen, tell your doctor or nurse immediately or go to Accident
and Emergency at your nearest hospital:

signs of an allergic reaction, such as shortness of breath, wheezing or difficulty
breathing, swelling of the face, lips, tongue or other parts of the body, rash, itching
or hives on the skin

yellowing of the skin or eyes and dark coloured urine

serious breathlessness, or sudden worsening of breathlessness possibly with a cough
or fever

chest pain.

The above list includes very serious side effects. You may need urgent medical attention
or hospitalisation.

Tell your doctor, nurse or pharmacist if you notice anything that is making you feel
unwell.

Other side effects not listed above may also occur in some people.

Some of these side can only be found when your doctor does tests from time to time
to check your progress.

Because Bi ELIGARD cp lowers the amount of sex hormones in your body your sex drive
will probably be reduced.

It is also unlikely that you can father a child while using Bi ELIGARD cp, but you
must use your normal contraceptive method to make sure.

After being given Bi ELIGARD cp

Storage

Bi ELIGARD cp will be stored in the refrigerator (below 8°C) in the pharmacy.

Once Bi ELIGARD cp is dispensed to you, keep it in a place where the temperature stays
below 25°C.

It may be stored in this manner for a period of up to 8 weeks prior to administration.

Keep this medicine in the original pack until it is time to use it.

If you take it out of the pack, it may not keep well.

Keep MPL-BICALUTAMIDE tablets in the blister foil until it is time to take them.

Do not store it or any other medicine in the bathroom or near a sink. Do not leave
it on a window sill or in the car.

Heat and dampness can destroy some medicines.

Keep it where children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.

Disposal

If your doctor tells you to stop taking this medicine or the expiry date has passed,
ask your pharmacist what to do with any medicine that is left over.

Product description

What it looks like

Bi ELIGARD cp is available in three different combinations:

1 x ELIGARD 7.5 mg pack + 28 (1 month) tablets MPL-BICALUTAMIDE 50 mg

1 x ELIGARD 22.5 mg pack + 28 (1 month) tablets MPL-BICALUTAMIDE 50 mg

1 x ELIGARD 22.5 mg pack + 84 (1 month) tablets MPL-BICALUTAMIDE 50 mg

ELIGARD is available in a single use kit, containing a cardboard frame and two removable
sealed plastic trays. The tray containing syringe A contains a syringe filled with
the delivery system, known as the Atrigel® Delivery System, plus a long white replacement plunger rod and a desiccant pack (to
absorb moisture). The tray containing syringe B contains a syringe filled with a powder
which is the active ingredient, plus a needle and a desiccant pack (to absorb moisture).

Once the contents of syringe A and syringe B have been mixed together (prior to injection),
the colour of the resulting liquid will be:

light tan to tan for ELIGARD
1 month

colourless to pale yellow for ELIGARD 3 month, ELIGARD.

The mixed solution may appear slightly grey due to tiny air bubbles. This is acceptable
and not representative of product quality.

The tablets are packaged in a blister strip and are white to off-white, round, film-coated,
biconvex tablet, engraved with ‘BC 50’ on one face and plain on the other.

The tablets are packed in blister foils of 28 tablets.

Ingredients

ELIGARD contains leuprorelin acetate as the active ingredient. The Atrigel® delivery system consists of a biodegradable polymer, dissolved in a solvent (N-methyl-2-pyrrolidone).
Each presentation of ELIGARD contains a different mixture and volume of the polymer.

Each tablet contains 50 mg of bicalutamide as the active ingredient, plus:

lactose monohydrate

sodium starch glycollate type A

povidone

magnesium stearate

Opadry Complete film coating system White Y-1-7000 (PI 1475).

Bi ELIGARD cp does not contain added sucrose, gluten, tartrazine or any other azo
dyes.

Supplier

Bi ELIGARD cp is supplied in Australia by:

Mundipharma Pty Limited

ABN 87 081 322 509

88 Phillip Street

SYDNEY NSW 2000

® ELIGARD and ATRIGEL are registered trademarks of Tolmar Therapeutics, Inc. used
under licence.

This leaflet was prepared in December 2018.

Bi ELIGARD cp 7.5 mg/50 mg tablets (pack of 28) AUST R 237653

Bi ELIGARD cp 22.5 mg/50 mg tablets (pack of 28) AUST R 238311

Bi ELIGARD cp 22.5 mg/50 mg tablets (pack of 84) AUST R 237652

RA-0254

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