Skip to Content

UK Edition. Click here for US version.

PHARMORUBICIN SOLUTION FOR INJECTION 2MG/ML

Active substance(s): EPIRUBICIN HYDROCHLORIDE / EPIRUBICIN HYDROCHLORIDE / EPIRUBICIN HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

A GUIDE FOR HOSPITAL STAFF
Pharmorubicin® 2mg/ml Solution for Injection
Solution for Injection or Infusion
epirubicin hydrochloride
Pfizer Logo
IMPORTANT: Refer to Summary of Product Characteristics before prescribing.
Presentation:
Sterile, red, mobile solution containing 10 mg, 20 mg, 50 mg and 200 mg of epirubicin
hydrochloride as a 2 mg/ml solution in 0.9% sodium chloride solution.
Uses:
Pharmorubicin has produced responses in a wide range of neoplastic conditions including breast,
ovarian, gastric, lung and colorectal carcinomas, malignant lymphomas, leukaemias and multiple
myeloma.
Intravesical administration of epirubicin has been found to be beneficial in the treatment of
superficial bladder cancer, carcinoma-in-situ and the prophylaxis of recurrences after
transurethral resection.
Dosage and administration:
Intravenous administration:
Pharmorubicin is not active when given orally and should not be injected intramuscularly or
intrathecally.
Pharmorubicin solution should be administered only under the supervision of a qualified physician
experienced in antiblastic and cytotoxic therapy. Treatment with high dose Pharmorubicin in
particular requires the availability of facilities for the care of possible clinical complications due to
profound myelosuppression.
It is advisable to give the drug via a freely-running i.v. saline infusion after checking that the
needle is well placed in the vein. This method minimises the risk of drug extravasation and
makes sure that the vein is flushed with saline after the administration of the drug. Extravasation
of Pharmorubicin from the vein during injection may give rise to severe tissue lesions, even
necrosis. Venous sclerosis may result from injection into small vessels or repeated injections into
the same vein.
Conventional doses:
When Pharmorubicin is used as a single agent, the recommended dosage in adults is 60-90 mg/m²
body area; the drug should be injected i.v. over 3-5 minutes and, depending on the patient’s
haematomedullary status, the dose should be repeated at 21-day intervals.
Dose modification (reduction) following signs of toxicity (specifically severe
neutropaenia/neutropaenic fever and thrombocytopaenia, which could persist on Day 21 after the
first dose) could be required or the following dose could be delayed, as in cases of liver
impairment.

PMA 12_0

Page 1 of 16

2016-0015185

High doses:
Pharmorubicin as a single agent for the treatment of lung cancer at high doses should be
administered according to the following regimens:
 small cell lung cancer (previously untreated): 120 mg/m² day 1, every 3 weeks.
 non-small cell lung cancer (squamous, large cell, and adenocarcinoma previously
untreated): 135 mg/m² day 1 or 45mg/m² days 1, 2, 3, every 3 weeks.
 breast cancer: in the adjuvant treatment of early breast cancer patients with positive
lymph nodes, intravenous doses of epirubicin ranging from 100 mg/m² (as a single dose
on day 1) to 120 mg/m² (in two divided doses on days 1 and 8) every 3-4 weeks, in
combination with intravenous cyclophosphamide and 5-fluorouracil and oral tamoxifen,
are recommended.
The drug should be given as an i.v. bolus over 3-5 minutes or as an infusion up to 30 minutes.
Lower doses (60-75 mg/m² for conventional treatment and 105-120 mg/m² for high dose
schedules) are recommended for patients whose bone marrow function has already been impaired
by previous chemotherapy or radiotherapy, by age, or neoplastic bone marrow infiltration. The
total dosage per cycle may be divided over 2-3 successive days.
When the drug is used in combination with other antitumour agents, the doses need to be
adequately reduced. Since the major route of elimination of Pharmorubicin is the hepatobiliary
system, the dosage should be reduced in patients with impaired liver function, in order to avoid an
increase in overall toxicity. Moderate liver impairment (bilirubin: 1.4-3 mg/100 ml) requires a
50% reduction of dose, while severe impairment (bilirubin 3 mg/100 ml) necessitates a dose
reduction of 75%.
Moderate renal impairment does not appear to require a dose reduction in view of the limited
amount of Pharmorubicin excreted by this route.
Intravesical administration:
Pharmorubicin may be given by intravesical administration for the treatment of superficial
bladder cancer and carcinoma-in-situ. It should not be used in this way for the treatment of
invasive tumours which have penetrated the bladder wall where systemic therapy or surgery is
more appropriate. Epirubicin has also been successfully used intravesically as a prophylactic
agent after transurethral resection of superficial bladder tumours in order to prevent recurrences.
While many regimens have been used, the following may be helpful as a guide: for therapy, 8 x
weekly instillations of 50 mg/50 ml (diluted with saline or distilled sterile water). In the case of
local toxicity (chemical cystitis), a dose reduction to 30 mg/50 ml is advised. For carcinoma-insitu, depending on the individual tolerability of the patient, the dose may be increased up to 80
mg/50 ml. For prophylaxis, 4 x weekly administrations of 50 mg/50 ml followed by 11 x monthly
instillations at the same dosage, is the schedule most commonly used.
The solution should be retained intravesically for 1 hour. To avoid undue dilution with urine, the
patient should be instructed not to drink any fluid in the 12 hours prior to instillation. During
instillation, the patient should be rotated occasionally and should be instructed to void at the end
of the instillation time.
Contraindications:

PMA 12_0

Page 2 of 16

2016-0015185

Hypersensitivity to epirubicin or any other component of the product, other anthracyclines or
anthracenediones.


Lactation

Intravenous use:
 persistent myelosuppression
 severe hepatic impairment
 severe myocardial insufficiency
 recent myocardial infarction
 severe arrhythmias
 previous treatments with maximum cumulative doses of epirubicin and/or other
anthracyclines and anthracenediones (see section 4.4)
 patients with acute systemic infections
 unstable angina pectoris
 myocardiopathy
Intravesical use:
 urinary tract infections
 inflammation of the bladder
 haematuria
 invasive tumours penetrating the bladder
 catheterisation problems
Warnings & Precautions
(refer to the SPC, section 4.4 - special warnings & precautions for use, for further information)
General
Epirubicin should be administered only under the supervision of qualified physicians experienced
in the use of cytotoxic therapy.
Patients should recover from acute toxicities (such as stomatitis, neutropenia, thrombocytopenia,
and generalized infections) of prior cytotoxic treatment before beginning treatment with
epirubicin.
While treatment with high doses of epirubicin (e.g., ≥ 90 mg/m2 every 3 to 4 weeks) causes
adverse events generally similar to those seen at standard doses (< 90 mg/m2 every 3 to 4 weeks),
the severity of the neutropenia and stomatitis/mucositis may be increased. Treatment with high
doses of epirubicin does require special attention for possible clinical complications due to
profound myelosuppression.
Cardiac function - Cardiotoxicity is a risk of anthracycline treatment that may be manifested by
early (i.e., acute) or late (i.e., delayed) events.
The risk of developing CHF increases rapidly with increasing total cumulative doses of epirubicin
in excess of 900 mg/m2; this cumulative dose should only be exceeded with extreme caution (see
section 5.1 - pharmacodynamic properties, clinical studies).
Cardiac function should be assessed before patients undergo treatment with epirubicin and must
be monitored throughout therapy to minimize the risk of incurring severe cardiac impairment.

PMA 12_0

Page 3 of 16

2016-0015185

Given the risk of cardiomyopathy, a cumulative dose of 900 mg/m2 epirubicin should be
exceeded only with extreme caution.
Heart failure (New York Heart Association [NYHA] class II-IV) has been observed in patients
receiving trastuzumab therapy alone or in combination with anthracyclines such as epirubicin.
This may be moderate to severe and has been associated with death.
Trastuzumab and anthracyclines such as epirubicin should not be used currently in combination
except in a well-controlled clinical trial setting with cardiac monitoring. Patients who have
previously received anthracyclines are also at risk of cardiotoxicity with trastuzumab treatment,
although the risk is lower than with concurrent use of traztuzumab and anthracyclines.
Because the reported half-life of trastuzumab is approximately 28-38 days, trastuzumab may
persist in the circulation for up to 27 weeks after stopping trastuzumab treatment. Patients who
receive anthracyclines such as epirubicin after stopping trastuzumab may possibly be at increased
risk of cardiotoxicity. If possible, physicians should avoid anthracycline-based therapy for up to
27 weeks after stopping trastuzumab. If anthracyclines such as epirubicin are used, the patient’s
cardiac function should be monitored carefully (see Interactions).
If symptomatic cardiac failure develops during trastuzumab therapy after epirubicin therapy, it
should be treated with the standard medications for this purpose.
(Please refer to the SPC, section 4.4 - special warnings & precautions for use, for further
information)
Haematologic toxicity - As with other cytotoxic agents, epirubicin may produce
myelosuppression. Haematologic profiles should be assessed before and during each cycle of
therapy with epirubicin, including differential white blood cell (WBC) counts.
Secondary leukaemia - Secondary leukaemia, with or without a preleukaemic phase, has been
reported in patients treated with anthracyclines, including epirubicin.
Gastrointestinal - Epirubicin is emetigenic. Mucositis/stomatitis generally appears early after
drug administration and, if severe, may progress over a few days to mucosal ulcerations.
Liver function - The major route of elimination of epirubicin is the hepatobiliary system. Serum
total bilirubin and AST levels should be evaluated before and during treatment with epirubicin.
Lower doses of epirubicin are recommended in patients with elevated bilirubin or AST levels.
Renal function - Serum creatinine should be assessed before and during therapy.
Dosage adjustment is necessary in patients with serum creatinine >5 mg/dL.
Effects at site of injection - Phlebosclerosis may result from an injection into a small vessel or
from repeated injections into the same vein. Following the recommended administration
procedures may minimize the risk of phlebitis/thrombophlebitis at the injection site (see section
4.2).
Extravasation - Extravasation of epirubicin during intravenous injection may produce local pain,
severe tissue lesions (vesication, severe cellulitis) and necrosis. The adverse effect of
extravastation of anthracyclines may be prevented or reduced by immediate use of a specific
treatment e.g. dexrazoxane (please refer to relevant labels for use). The patient’s pain may be
relieved by cooling down the area and keeping it cool, using hyaluronic acid and DMSO. If
PMA 12_0

Page 4 of 16

2016-0015185

extravasation occurs the patient should be monitored closely during the subsequent period of
time, as tissue necrosis at the extravasation site may occur after several weeks from the
extravasation episode.
Other - As with other cytotoxic agents, thrombophlebitis and thromboembolic phenomena,
including pulmonary embolism (in some cases fatal), have been coincidentally reported with the
use of epirubicin.
Tumour-lysis syndrome - Epirubicin may induce hyperuricemia because of the extensive purine
catabolism that accompanies rapid drug-induced lysis of neoplastic cells (tumour-lysis
syndrome).
Immunosuppressant effects/increased susceptibility to infections - Administration of live or
live-attenuated vaccines in patients immunocompromised by chemotherapeutic agents including
epirubicin, may result in serious or fatal infections (see section 4.5). Vaccination with a live
vaccine should be avoided in patients receiving epirubicin. Killed or inactivated vaccines may be
administered; however, the response to such vaccines may be diminished.
Reproductive system - Epirubicin can cause genotoxicity. Men and women treated with
epirubicin should adopt appropriate contraceptives.
Intravesical administration of epirubicin may produce symptoms of chemical cystitis (such as
dysuria, polyuria, nocturia, stranguria, haematuria, bladder discomfort, necrosis of the bladder
wall) and bladder constriction.
Intra-arterial administration of epirubicin (transcatheter arterial embolization for the localized or
regional therapies of primary hepatocellular carcinoma or liver metastases) may produce (in
addition to systemic toxicity qualitatively similar to that observed following intravenous
administration of epirubicin) localized or regional events which include gastro-duodenal ulcers
(probably due to reflux of the drugs into the gastric artery) and narrowing of bile ducts due to
drug-induced sclerosing cholangitis. This route of administration can lead to widespread necrosis
of the perfused tissue.
For additional warnings and precautions for other routes of administration refer to the SPC
section 4.4 – special warnings & precautions for use.
Interactions:
Epirubicin is mainly used in combination with other cytotoxic drugs. Additive toxicity may
occur especially with regard to bone marrow/haematologic and gastro-intestinal effects (see
section 4.4). The use of epirubicin in combination chemotherapy with other potentially
cardiotoxic drugs, as well as the concomitant use of other cardioactive compounds (e.g., calcium
channel blockers), requires monitoring of cardiac function throughout treatment.
Epirubicin is extensively metabolized by the liver. Changes in hepatic function induced by
concomitant therapies may affect epirubicin metabolism, pharmacokinetics, therapeutic efficacy
and/or toxicity (see section 4.4).
Anthracyclines including epirubicin should not be administered in combination with other
cardiotoxic agents unless the patient’s cardiac function is closely monitored.
PMA 12_0

Page 5 of 16

2016-0015185

Vaccination with a live vaccine should be avoided in patients receiving epirubicin. Killed or
inactivated vaccines may be administered; however, the response to such vaccines may be
diminished.
Cimetidine increased the AUC of epirubicin by 50% and should be discontinued during treatment
with epirubicin.
When given prior to epirubicin, paclitaxel can cause increased plasma concentrations of
unchanged epirubicin and its metabolites, the latter being, however, neither toxic nor active.
Increase of myelosuppression may occur in patients receiving combination therapy of
anthracycline and dexrazoxane.
Refer to the SPC, section 4.5 – interaction with other medicinal products and other forms of
interaction, for further information.
Adverse reactions:
The undesirable effects in the table below have been observed and reported during treatment with
epirubicin with the following frequencies: very common (≥1/10); common (≥1/100 to <1/10);
uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known
(cannot be estimated from the available data).
More than 10% of treated patients can expect to develop undesirable effects. The most common
undesirable effects are myelosuppression, gastrointestinal side effects, anorexia, alopecia,
infection.
System organ class
Frequency
Undesirable effects
Infections and infestations

Common

Infection

Not known

Septic shock, sepsis, pneumonia

Neoplasms benign,
malignant and unspecified
(incl cysts and polyps)

Rare

Acute lymphocytic leukaemia,
acute myelogenous leukaemia

Blood and the lymphatic
system disorders

Very
common

Myelosuppression (leucopenia,
granucytopenia and neutropenia,
anaemia and febrile neutropenia)

Uncommon

Thrombocytopenia

Not known

Haemorrhage and tissue hypoxia as
result of myelosoppression.

Immune system disorders

Rare

Anaphylaxis

Metabolism and nutrition
disorders

Common

Anorexia, dehydration

Rare

Hyperuricaemia (see section 4.4 )

Nervous system disorders

Rare

Dizziness

Eye disorders

Not known

Conjunctivitis, keratitis

Cardiac disorders

Rare

Congestive heart failure (dyspnoea,
oedema, hepatomegaly, ascites,
pulmonary oedema, pleural

PMA 12_0

Page 6 of 16

2016-0015185

effusions, gallop rhythm),
cardiotoxicity (e.g. ECG
abnormalities, arrhythmias,
cardiomyopathy), ventricular
tachycardia, bradycardia, AV block,
bundle-branch block
Vascular disorders

Common

Hot flashes, hot flushes

Uncommon

Phlebitis, thrombophlebitis

Not known

Shock, thromboembolism,
including pulmonary emboli

Gastrointestinal disorders

Common

Mucositis, esophagitis, stomatitis,
vomiting, diarrhoea, nausea

Skin and subcutaneous
tissue disorders

Very
common

Alopecia

Rare

Very
common

Urticaria
Local toxicity, rash, itch, skin
changes, erythema, flushes, skin
and nail hyperpigmentation,
photosensitivity, hypersensitivity to
irradiated skin (radiation-recall
reaction)
Red colouration of urine for 1 to 2
days after administration

Reproductive system and
breast disorders

Rare

Amenorrhoea, azoospermia

General disorders and
administration site
conditions

Common

Infusion site erythema

Rare

Malaise, asthenia, fever, chills

Investigations

Rare

Changes in transaminase levels
Asymptomatic drops in left
ventricular ejection fraction
Chemical cystitis, sometimes
haemorrhagic, has been observed
following intravesical
administration (see section 4.4)

Not known

Renal and urinary disorders

Not known
Injury, poisoning and
procedural complications

Common

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare
professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard.
Impairment of fertility
Epirubicin could induce chromosomal damage in human spermatozoa.
Epirubicin may cause amenorrhoea or premature menopause in premenopausal women.
Pregnancy
PMA 12_0

Page 7 of 16

2016-0015185

Experimental data, however, suggest that epirubicin may harm the foetus.
If epirubicin is used during pregnancy or if the patient becomes pregnant while taking this drug,
the patient should be apprised of the potential hazard to the foetus.
There are no studies in pregnant women. Epirubicin should be used during pregnancy only if the
potential benefit justifies the potential risk to the foetus.
Lactation
It is not known whether epirubicin is excreted in human milk. Because many drugs, including
other anthracyclines, are excreted in human milk and because of the potential for serious adverse
reactions in nursing infants from epirubicin, mothers should discontinue nursing prior to taking
this drug.
Refer to SPC section 4.6 - pregnancy and lactation, for further information.
Effects on ability to drive and use machines
There have been no reports of particular adverse events relating to effects on ability to drive and
to use machines.
Overdosage:
Acute overdosage with epirubicin will result in severe myelosuppression (mainly leucopoenia and
thrombocytopenia), gastrointestinal toxic effects (mainly mucositis) and acute cardiac
complications. Latent cardiac failure has been observed with anthracyclines several months to
years after completion of treatment (see section 4.4). Patients must be carefully monitored. If
signs of cardiac failure occur, patients should be treated according to conventional guidelines.
Treatment:
Symptomatic Epirubicin cannot be removed by dialysis.
Pharmaceutical precautions:
The following protective recommendations are given due to the toxic nature of this substance:
 Personnel should be trained in good technique for handling.
 Pregnant staff should be excluded from working with this drug.
 Personnel handling Pharmorubicin Solution should wear protective clothing: goggles, gowns,
and disposable gloves and masks.
 All items used for administration or cleaning, including gloves, should be placed in high-risk
waste-disposal bags for high-temperature incineration.
Spillage or leakage should be treated with dilute sodium hypochlorite (1% available chlorine)
solution, preferably by soaking, and then water. All cleaning materials should be disposed of as
indicated previously. Accidental contact with the skin or eyes should be treated immediately by
copious lavage with water, or soap and water, or sodium bicarbonate solution; medical attention
should be sought.
Discard any unused solution.
Incompatibilities

PMA 12_0

Page 8 of 16

2016-0015185

Prolonged contact with any solution of an alkaline pH should be avoided as it will result in
hydrolysis of the drug. Pharmorubicin should not be mixed with heparin due to chemical
incompatibility which may lead to precipitation when the drugs are in certain proportions.
Pharmorubicin can be used in combination with other antitumour agents, but it is not recommended
that it be mixed with other drugs.
Shelf life
Glass vials – three years from time of manufacture.
Polypropylene Cytosafe® vials – three years from time of manufacture.
Storage

The vials should be stored at between 2C - 8C (in the refrigerator).
Keep the container in outer carton.
Shelf life after first opening the container
From a microbiological point of view, the product should be used immediately after first
penetration of the rubber stopper. If not used immediately, in use storage times and conditions are
the responsibility of the user.
Vials are for single use only and any unused portion must be discarded after use.
Package quantities:
10 mg, 20 mg, 50 mg and 200 mg vials for intravenous or intravesicular use.

POM
PL 0057/1023
This leaflet was prepared in 03/2016
Further information is available to the medical and allied professions on request from:
Medical Information at Pfizer Limited, Walton Oaks, Tadworth, Surrey, KT20 7NS, UK.
Tel: 01304 616161.

PMA 12_0

Page 9 of 16

2016-0015185

Patient leaflet: Information for the user
Pharmorubicin® 2 mg/ml Solution for Injection or Infusion
Epirubicin hydrochloride
Read all of this leaflet carefully before you start using this medicine because it contains
important information for you.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, please ask your doctor, pharmacist or nurse.
 This medicine has been prescribed for you only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same as yours.
 If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1.
What Pharmorubicin is and what it is used for
2.
What you need to know before you usePharmorubicin
3.
How to use Pharmorubicin
4.
Possible side effects
5.
How to store Pharmorubicin
6.
Contents of the pack and other information
1.

What Pharmorubicin is and what it is used for


Pharmorubicin is an injection that contains epirubicin hydrochloride. It belongs to a
group of medicines called cytotoxics used for chemotherapy. Pharmorubicin causes cells
that are actively growing, such as cancer cells, to slow or stop their growth and increases
the likelihood that they die. This medicine helps to selectively kill the cancer tissue rather
than normal, healthy tissue.



Pharmorubicin is used to treat a variety of cancers, either alone or in combination with
other drugs. The way in which it is used depends upon the type of cancer that is being
treated.



It has been found to be particularly useful in the treatment of cancers of the breast,
ovaries, stomach, bowel and lung. In addition, this medicine can be given to treat cancers
of the blood forming tissues such as malignant lymphomas, leukaemias and multiple
myeloma.



Pharmorubicin can also be put directly into the bladder through a tube. This is sometimes
used to treat abnormal cells or cancers of the bladder wall. It can be used after other
treatments to try and prevent such cells from growing again.

You must talk to a doctor if you do not feel better or if you feel worse.

PMA 12_0

Page 10 of 16

2016-0015185

2.

What you need to know before you use Pharmorubicin

Do not use Pharmorubicin:














if you are allergic to epirubicin or any of the other ingredients of this medicine (listed in
section 6) or similar chemotherapy drugs (anthracyclines or anthracenediones)
if you have infections affecting multiple organs
If you have urine infection
if you have inflammation of the bladder
if you have invasive tumours penetrating the bladder
if you have catheterisation problems (your doctor has problems inserting a catheter (tube)
into your bladder)
if you have presence of blood in urine
if you have decreased ability to produce blood cells leading to low blood cell counts, as it
can lower them further
if you have previously been treated with Pharmorubicin or similar chemotherapy drugs,
as previous treatment with these medicines can increase the risk of side effects
if you have suffered from recent heart attack, poor functioning of the heart muscle, severe
irregular heartbeat pattern, sudden pain in the chest, non-inflammatory disease of the
heart muscle or any other severe heart trouble in the past, or are presently receiving
treatment for this
if you have severe liver disease
if you are pregnant or breast-feeding

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Pharmorubicin:
 if your liver or kidneys are not working properly
 if you have had or you are due to have any vaccination
 if you are currently suffering from acute toxicities such as
o acute inflammation of the mouth
o low white blood cell count
o low platelet count or
o infections in general
This will help your doctor decide if this medicine is suitable for you.
Other medicines and Pharmorubicin:
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, even those obtained without a prescription, particularly the following:
 Cimetidine (a drug usually used to treat stomach ulcers and heartburn). Cimetidine can
make the effects of Pharmorubicin stronger
 Calcium channel blockers (medicines for the heart)
 Quinine (antimalaria drug)
 Antibiotics such as sulphonamide and chloramphenicol
 Antiretroviral (drugs used to treat infection by HIV)
 Diphenylhydantoin (a drug used to treat epilepsy)
 Painkillers such as amidopyrine derivate
 Trastuzumab therapy for treatment of cancer Your doctor should avoid using
pharmorubicin for up to 27 weeks after stopping trastuzumab when possible. If
PMA 12_0

Page 11 of 16

2016-0015185








pharmorubicin is used before this time, careful monitoring of cardiac function is
recommended
Vaccination with a live vaccine should be avoided in patients receiving epirubicin
Paclitaxel or docetaxel (drugs used to treat cancer). When paclitaxel is given prior to

epirubicin, it may increase concentration of epirubicin in blood. However when
paclitaxel and docetaxel are given together and given after epirubicin, they did not
affect concentration of epirubicin
Dexverapamil (used to treat some heart conditions)
Dexrazoxane (used to prevent chronic cumulative cardiotoxicity caused by epirubicin)
Interferon α2b (used to treat cancers)

Pregnancy, breast-feeding and fertility
Pregnancy
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor
for advice before being given this medicine. Avoid becoming pregnant while you or your partner
is being treated with this medicine. If you are sexually active, you are advised to use effective
birth control to prevent pregnancy during treatment, whether you are male or female. It may
cause birth defects, so it is important to tell your doctor if you think you are pregnant.
Breast feeding
You should stop breast feeding before starting treatment with this medicine as some of the drug
may get into your milk and possibly harm your child.
Fertility
Men: There is a risk of sterility due to therapy with epirubicin and male patients should consider
storage of sperm before treatment.
Women: Epirubicin may cause lack of menstrual cycles or premature menopause in
premenopausal women.
Driving and using machines
There are no special precautions, as long as you feel fully recovered following your hospital
treatment and you have discussed this with your doctor.
Pharmorubicin contains sodium
This medicinal product contains less than 1mmol sodium (23 mg) per dose, i.e. essentially
sodium free.
3.

How to use Pharmorubicin

If you are prescribed Pharmorubicin it will only be given to you by doctors or nurses experienced
in giving chemotherapy.
This medicine will normally be given to you by a doctor or a nurse through a drip (infusion) into
a vein. Your doctor will decide what dose to give and the number of days’ treatment you will
receive depending on your condition.

PMA 12_0

Page 12 of 16

2016-0015185

The dose is decided by taking into account the condition you have, your height and weight. From
your height and weight the doctor will work out your body surface area, and it is this that your
dose is calculated from.
Pharmorubicin can also be put directly into the bladder to treat bladder cancer, or to help prevent
it returning. The dose depends on the type of bladder cancer you have. When this medicine is
injected directly into the bladder, you will be instructed not to drink any fluid for 12 hours before
treatment to avoid dilution of the medicine with urine in your bladder.
While one course of treatment may sometimes be enough, more often your doctor will advise
further courses in three or four weeks’ time. It may take several courses before your illness is
under control and you feel better.
Regular checks by your doctor during Pharmorubicin treatment
During treatment your doctor will be making regular checks of your:





Blood - to check for low blood cell counts that may need treatment
Heart function - heart damage can occur when high doses of Pharmorubicin are given.
This may not be detected for several weeks, so regular tests may be required during this
period
Liver – using blood tests to check that this medicine is not affecting the way it functions
in a harmful way
Blood uric acid levels – Pharmorubicin may increase uric acid levels in the blood, which
might cause gout. Another medicine may be given if your uric acid levels are too high

If you receive high doses of Pharmorubicin
High doses can worsen side effects like sores in the mouth or may decrease the number of white
blood cells (which fight infection) and platelets (these help the blood to clot) in the blood. Should
this happen, you may need antibiotics or blood transfusions. Mouth ulcers can be treated to make
them less uncomfortable as they heal.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or
nurse.
4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Please contact your doctor or nurse immediately if you notice any of the following side
effects.
Although they are rare (may affect up to 1 in 1,000 people), these symptoms can be serious:
Sudden life-threatening allergic reaction. Symptoms include sudden signs of allergy
such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other
parts of the body, shortness of breath, wheezing or trouble breathing.



Whole-body inflammation caused by severe infection through blood (sepsis)
Severe infection leading to dangerously low blood pressure (septic shock)

PMA 12_0

Page 13 of 16

2016-0015185





Gasping for air, shortness of breath, swelling of abdomen, legs or ankles, fluid in lungs
(signs of congestive heart failure)
Insufficient tissue level of oxygen; low blood pressure, rapid heartbeat, confusion or loss
of consciousness may follow (shock)
Blood clots, including a clot in the lungs which causes chest pain and breathlessness

Very common: (may affect more than 1 in 10 people)
 White blood cell counts (which fight infection) can drop, which increases the chance of
infections and fever
 A low red blood cell count (anaemia) that can leave you feeling tired and lethargic
 Hair loss - may be quite severe. Beard growth may stop in men. Hair normally re-grows
when your treatment course ends
 Red discolouration of urine (which is normal and related to the colour of the medicine).
You should inform your doctor if it does not stop in a few days or you think there is
blood in your urine
Common: (may affect up to 1 in 10 people)
 Infections
 Loss of appetite
 Feeling thirsty (dehydration)
 Hot flushes
 Heartburn, nausea (feeling sick), vomiting (being sick) or diarrhoea.
 Inflammation of the gullet (esophagitis)
 Pain, redness, burning or stinging sensation at injection site
 Inflammation or irritation of the bladder, sometimes with bleeding. Frequent urination or
burning may occur after local administration the bladder wall.
 Painful inflammation and ulceration of the mucous membranes lining the digestive tract
(mucositis)
Uncommon: (may affect up to 1 in 100 people)
 Platelets (cells that help the blood to clot) can be affected which could make you bruise
or bleed more easily. It is important to seek medical advice if this happens
 Inflammation of veins at site of infusion, swelling, redness, leg pain, which can be
associated with blood clots
Rare: (may affect up to 1 in 1,000 people)
 When given in combination with other anti-cancer drugs, some patients have developed a
rare leukaemia (cancer of white blood cells) after completing treatment.
 Tiredness, weakness, fever and feeling cold
 Low sperm count
 Absence of menstruation.
 ECG abnormalities, irregular heartbeat, heart muscle disease, increase or decrease of
heart rate
 Changes in liver enzyme transaminase levels
 Increase uric acid levels in the blood which might cause gout
 A skin rash commonly known as hives (urticaria)
 Dizziness

PMA 12_0

Page 14 of 16

2016-0015185

Not known: (frequency cannot be estimated from the available data)
 Pneumonia
 Internal bleeding and lack of oxygen to tissues due to bone marrow suppression.
 Inflammation to the eye (conjunctivitis and keratitis)
 Discolouration of skin and nails
 Sensitive to light
 Rash, itch, skin changes
 Redness of the skin (erythema)
 Sensitive to skin treated with radiation
Reporting of side effects
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 Yellow Card
Scheme website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide
more information on the safety of this medicine.
5.

How to store Pharmorubicin
 The unopened vials should be stored in the original container until ready for use.



6.

Store at 2 to 8C (in a refrigerator).
Keep out of the sight and reach of children.
This medicine should not be used after the expiry date printed on the box and on the vial
label after EXP. The expiry date refers to the last day of that month. The pharmacist will
check this when your medicine is prepared for you. If the solution is cloudy after
preparation, the pharmacist will dispose of it safely.
Contents of the pack and other information

What Pharmorubicin contains
The active substance is epirubicin hydrochloride. The other ingredients are hydrochloric acid,
sodium chloride and water for injections.
What Pharmorubicin looks like and contents of the pack
Pharmorubicin is a red solution for injection or infusion containing 10 mg, 20 mg, 50 mg or 200
mg of epirubicin hydrochloride as a 2 mg/ml solution in single glass or plastic vials. Not all pack
sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:

Pfizer Limited
Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK

Manufacturer:

Pfizer Service Company BVBA,
10 Hoge Wei, 1930 Zaventem,
Belgium. (plastic vials)
Actavis Italy S.p.A 10 Viale Pasteur
20014 Nerviano (MI)
Italy. (glass vials)

PMA 12_0

Page 15 of 16

2016-0015185

Company contact address:
For further information please contact Medical Information at Pfizer Limited in Walton Oaks,
Tadworth, Surrey, KT20 7NS. Tel: 01304 616161.
This leaflet was last revised in 03/2016
Document Reference: United Kingdom PMA 12_0

PMA 12_0

Page 16 of 16

2016-0015185

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide