Adriamycin

Main information

  • Trade name:
  • Adriamycin 2 mg/mL Solution for injection
  • Dosage:
  • 2 mg/mL
  • Pharmaceutical form:
  • Solution for injection
  • Units in package:
  • Vial, glass, 5 mL
  • Class:
  • Prescription
  • Prescription type:
  • Prescription
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • Olon SpA

Documents

Localization

  • Available in:
  • Adriamycin 2 mg/mL Solution for injection
    New Zealand
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Doxorubicin has produced significant therapeutic responses in a number of solid tumours and haematologic malignancies, and is commonly used in the treatment of the following tumours:· carcinoma of the breast · carcinoma of the lung · carcinoma of the ovary · transitional bladder cell cancer · neuroblastoma · Wilms' tumour · soft tissue sarcomas · osteosarcoma · acute lymphocytic - lymphoblastic leukaemia · acute myelogenous leukaemia · non-Hodgkin's lymphoma · Hodgkin's disease Doxorubicin has also shown antitumour activity in the following adult and paediatric malignancies:· carcinoma of the thyroid · carcinoma of the endometrium · carcinoma of the head and neck · carcinoma of the stomach · primary hepatocellular carcinoma · non-seminomatous carcinoma of the testis · carcinoma of the prostate · Ewing's sarcoma · rhabdomyosarcoma · multiple myeloma · chronic leukaemias

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 2203
  • Authorization date:
  • 02-08-1990
  • Last update:
  • 27-09-2017

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

ADRIAMYCIN

INJECTION

ADRIAMYCIN

®

INJECTION

Doxorubicin hydrochloride

Consumer Medicine Information

What is in this leaflet

Please read this leaflet carefully

before treatment with

ADRIAMYCIN.

This leaflet answers some common

questions about this medicine.

It does not contain all the available

information.

It does not take the place of talking to

your doctor.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you taking

ADRIAMYCIN against the benefits

expected for you.

If you have any concerns about

taking this medicine, ask your

doctor or pharmacist.

Please keep this leaflet.

You may need to read it again.

What ADRIAMYCIN is

used for

ADRIAMYCIN is used to treat many

types of cancer. ADRIAMYCIN

works by stopping cancer cells from

growing and multiplying. It contains

the active ingredient doxorubicin

hydrochloride.

Ask your doctor if you have any

questions about why

ADRIAMYCIN has been

prescribed for you.

ADRIAMYCIN is to be given only

under the strict supervision of your

doctor.

ADRIAMYCIN is not addictive.

Before you are given it

When you must not be given

ADRIAMYCIN

Do not have ADRIAMYCIN if you

are allergic to ADRIAMYCIN or

have had an allergic reaction to

any other cancer medication e.g.

daunorubicin, epirubicin,

mitozantrone.

Symptoms of an allergic reaction to

ADRIAMYCIN 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

light-headedness or back pain.

Do not have ADRIAMYCIN if:

you have bone marrow

suppression (reduced number of

red or white blood cells or

platelets) caused by previous

treatment with other cancer

medicines or radiation therapy,

symptoms include tiredness,

mouth ulcers or bleeding or

bruising more easily than usual

you have a generalised infection

you have an irregular heart rate,

poor blood flow to the heart or

had a heart attack

you have severe liver problems

you have previously received

treatment with the maximum dose

of medicines such as doxorubicin

(ADRIAMYCIN), daunorubicin,

epirubicin, idarubicin,

mitozantrone or mitomycin C

you are pregnant or likely to

become pregnant, as it may harm

your developing baby

you are breastfeeding, as it passes

into breast milk and may affect

your child.

Do not have the infusion into the

bladder if you have:

a tumour of the bladder wall

a urinary infection

bladder inflammation

a catheter in the bladder

blood in your urine.

Before you start

ADRIAMYCIN

Tell your doctor if you have any

heart or liver problems.

You will be given a blood test and

your heart will be monitored before

you start treatment with

ADRIAMYCIN.

Taking other medicines

Tell your doctor if you are taking

any other medicines, including

those you buy without a

prescription from a pharmacy,

supermarket or health food store.

Some medicines and ADRIAMYCIN

may interfere with each other. These

include:

other cancer medicines, such as

cyclophosphamide, paclitaxel,

6-mercaptopurine, sorafenib

ADRIAMYCIN

INJECTION

some medicines used to prevent

blood clots, such as heparin

propranolol and other medicines

for your heart.

inactivated vaccines

verapamil used for high blood

pressure, angina or irregular heart

beat

phenobarbitone and phenytoin

used to treat epilepsy

St. John's Wort, a herbal

supplement, used for mild anxiety

and low mood

cyclosporin used in transplant

patients to prevent organ rejection

These medicines may be affected by

ADRIAMYCIN, or may affect how

well it works. You may need

different amounts of your medicine,

or you may need to take different

medicines. Your doctor will advise

you.

ADRIAMYCIN given at the same

time as radiation therapy may also

cause unwanted effects.

Your doctor has more information on

medicines to be careful with or avoid

while using ADRIAMYCIN.

How ADRIAMYCIN is

given

You should only be treated with

ADRIAMYCIN by a doctor who is

experienced in treating patients with

cancer. Treatment will normally take

place in a hospital because of the

need for hospital facilities and skilled

health care professionals.

You will be given a blood test and

your heart will be monitored before

you start treatment with

ADRIAMYCIN.

ADRIAMYCIN is given by slow

infusion into a vein or the bladder. If

it is infused into the bladder, you will

be asked not to urinate for one hour

while ADRIAMYCIN is given.

Tell your doctor or nurse

immediately if stinging, burning or

pain develops at the injection site.

Treatment is usually given once

every 3 weeks, or on three successive

days repeated every 4 weeks.

However, your doctor may give

ADRIAMYCIN more or less

frequently.

Your doctor will decide what dose

you will receive. This depends on

your condition and other factors,

such as your weight, liver function

and the effect on your bone marrow

of any previous treatment you may

have had with x-ray or chemotherapy

medicines.

Ask your doctor if you have any

questions about the dose of

ADRIAMYCIN and how it is

given.

If you are given too much

(overdose)

As ADRIAMYCIN is likely to be

given to you in hospital under the

supervision of a doctor, it is unlikely

that you will receive too much.

However, immediately tell your

doctor or telephone the Poisons

Information Centre (Phone

Australia 13 11 26 or New Zealand

0800 POISON or 0800 764 766) for

advice, or go to Accident and

Emergency at your nearest

hospital if you have side effects

after being given ADRIAMYCIN.

You may need urgent medical

attention.

Symptoms of overdose with

ADRIAMYCIN include the side

effects below in the 'Side Effects'

section, but they might be more

severe.

While you are given it

Things you must do

If you are about to be started on

any new medicine, tell your doctor,

dentist or pharmacist that you are

having or have had treatment with

ADRIAMYCIN.

Keep all appointments with your

doctor and always discuss with

your doctor any problems during

or after treatment with

ADRIAMYCIN.

It is also important to inform your

doctor if you have any infection or

fever before, during or after

treatment with ADRIAMYCIN, as

it will lower your ability to fight

infection.

Tell your doctor or nurse

immediately if stinging, burning or

pain develops at the injection site.

ADRIAMYCIN is known to be very

powerful at lowering the number of

white blood cells and platelets in

your blood. This means that you

have an increased chance of getting

an infection or bleeding.

Take the following precautions to

reduce your risk of infection or

bleeding:

Avoid people who have

infections. Check with your

doctor immediately if you think

you may be getting an infection,

or if you get a fever, chills,

cough, hoarse throat, lower back

or side pain or find it painful or

difficult to urinate

Be careful when using a

toothbrush, toothpick or dental

floss. Your doctor, dentist, nurse

or pharmacist may recommend

other ways to clean your teeth

and gums. Check with your

doctor before having any dental

work

Be careful not to cut yourself

when you are using sharp objects

such as a razor or nail cutters

Avoid contact sports or other

situations where you may bruise

or get injured.

Avoid vaccination with certain

vaccines. Your doctor or

pharmacist will tell you what

vaccines to avoid.

Your doctor will monitor the effects

of ADRIAMYCIN on your blood,

ADRIAMYCIN

INJECTION

liver and heart regularly by giving

you tests.

Men and women should use a

reliable method of contraception

(birth control).

If you become pregnant while on

treatment with ADRIAMYCIN,

consult your doctor.

Things to be careful of

Special care should be taken if it is

necessary that you drive or operate

machinery while undergoing

treatment with ADRIAMYCIN,

especially if you are in a weakened

condition.

Side effects

Tell your doctor as soon as possible

if you do not feel well during or

after treatment with

ADRIAMYCIN.

All medicines 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.

Tell your doctor, nurse or

pharmacist if you notice any of the

following and they worry you:

nausea and vomiting. This may

be expected 3-6 hours after

ADRIAMYCIN is given and may

last for several hours

diarrhoea, dehydration, flushing

of the face, abdominal pain

loss of appetite may be expected

for 24 hours following each

treatment with ADRIAMYCIN.

This may occasionally last for

several days

ADRIAMYCIN may colour your

urine red for 1-2 days after

treatment. This is no cause for

alarm

a burning sensation in the mouth,

throat, food pipe, rectum or

vagina may occur usually 5 to 10

days after treatment with

ADRIAMYCIN. This pain will

normally subside within 10 days

hair loss is expected 1 to 2 weeks

after beginning treatment with

ADRIAMYCIN. You may lose

all your hair, but after treatment is

stopped, your hair is expected to

grow back. Male patients may

notice lack of beard growth

during treatment

skin infections, blisters, itchy skin

bleeding or easy bruising

permanent darkening of areas on

the skin, nail beds, and the inside

of the mouth

discharge with itching of the eyes

and crusty eyelids, dry eyes

excess tears

redness or pins and needles on the

palms of your hands and soles of

your feet

drowsiness, unusual tiredness,

weakness, feeling unwell, hot

flushes, shock

painful swelling of joints (gout)

weight gain.

infertility in both men and women

Women may stop menstruating.

Regular menstruation usually

returns a few months after

treatment is stopped in

premenopausal women, although

premature menopause can occur.

Men may permanently experience

a low sperm count or remain

infertile. Sometimes male

fertility may return several years

after stopping ADRIAMYCIN

therapy.

Tell your doctor or nurse as soon

as possible if you notice any of the

following serious side effects:

swelling and redness of skin

along the vein in which

ADRIAMYCIN is injected

infections, fever, sweats, severe

chills, bruising more easily than

normal

fatigue, chest pain, palpitations,

shortness of breath or swelling in

the feet or legs due to fluid build-

up. ADRIAMYCIN may also

affect heart muscle and function.

Your doctor will monitor your

heart regularly before, during and

after treatment.

bleeding or ulceration of the

bowel

blood poisoning

kidney problems

blockage of a blood vessel caused

by a clot

leukaemia.

Other side effects not listed above

may occur in some patients.

If you are given ADRIAMYCIN

into the bladder, tell your doctor as

soon as possible if you develop the

following temporary side effects:

cystitis (pain in the bladder or

back, blood in urine)

difficulty passing urine or an

increased frequency of passing

urine.

Tell your doctor if you notice

anything that is making you feel

unwell.

Product description

What it looks like

ADRIAMYCIN injection is a clear

red solution. There is one vial in

each pack.

Ingredients

The active ingredient in

ADRIAMYCIN Injection is

doxorubicin hydrochloride. It also

contains sodium chloride and water

for injections.

ADRIAMYCIN does not contain

lactose, sucrose, gluten, tartrazine or

any other azo dyes.

Storage

This medicine will be stored in the

hospital pharmacy. Vials of

ADRIAMYCIN Injection should be

ADRIAMYCIN

INJECTION

kept in a refrigerator (2°C to 8°C).

Do not freeze.

Supplier

ADRIAMYCIN is supplied in

Australia by:

Pfizer Australia Pty Ltd

ABN 50 008 422 348

38-42 Wharf Road

West Ryde NSW 2114

Toll free number 1800 675 229

ADRIAMYCIN is supplied in New

Zealand by:

Pfizer New Zealand Ltd

PO Box 3998

Auckland

Toll Free Number: 0800 736 363

Australian Registration

Numbers

ADRIAMYCIN can be identified by

the Australian Register Number

which is found on the carton.

10 mg/5 mL: AUST R 15407 (not

currently supplied)

20 mg/10 mL: AUST R 47344 (not

currently supplied)

50 mg/25 mL: AUST R 47345

200mg/100mL: AUST R 47345

Date of preparation

This leaflet was revised in June 2014.

© Pfizer Australia Pty Ltd

Registered Trademark

28-11-2018

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EU/3/10/810 (Celgene Europe B.V.)

EU/3/10/810 (Celgene Europe B.V.)

EU/3/10/810 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3808 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/084/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3803 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/069/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/888 (Gilead Sciences Ireland UC)

EU/3/11/888 (Gilead Sciences Ireland UC)

EU/3/11/888 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3802 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/152/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/887 (Gilead Sciences Ireland UC)

EU/3/11/887 (Gilead Sciences Ireland UC)

EU/3/11/887 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3801 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/020/11/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/886 (Gilead Sciences Ireland UC)

EU/3/11/886 (Gilead Sciences Ireland UC)

EU/3/11/886 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3799 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/019/11/T/03

Europe -DG Health and Food Safety