Skip to Content


View full screen / Print PDF » Download PDF ⇩

PDF Transcript

Doxorubicin RD
DO 051 COO Farmitalia to Pfizer

Pfizer logo
Doxorubicin 10 mg, 20 mg, 50 mg and 150 mg Rapid Dissolution (RD)
Read all of this leaflet carefully before you start using this medicine
 Keep this leaflet. You may need to read it again.
 If you have any further questions, please ask your doctor or pharmacist.
 This medicine has been prescribed for you personally and you should not pass it on to
 others. It may harm them, even if their symptoms are the same as yours.
 If any of the side effects gets serious, or if you notice any side effects not listed in this
 leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Doxorubicin is and what it is used for
2. Before you are given Doxorubicin
3. How Doxorubicin is given to you
4. Possible side effects
5. How to store Doxorubicin
6. Further information
1. What Doxorubicin is and what it is used for

Doxorubicin is a freeze dried powder for injection that contains doxorubicin
hydrochloride. It belongs to a group of medicines called cytotoxics used for
chemotherapy. This medicine causes cells such as cancer cells that are actively growing,
to slow or stop their growth and increases the likelihood that they die. Doxorubicin
treatment helps to selectively kill the cancer tissue rather than normal, healthy tissue. It
can be used in both adults and children.

Doxorubicin 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

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

Doxorubicin 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 also be used after other
treatments to try and prevent such cells from growing again.

2. Before you are given Doxorubicin
Do not use Doxorubicin if you have:
 an allergy (hypersensitivity) to Doxorubicin, other similar medicines called
anthracyclines or anthracenediones or any of the other ingredients of the injection (a list
of ingredients can be found in Section 6).
 low blood cell counts, as it can lower them further.
 previously been treated with doxorubicin or similar chemotherapy drugs like
Pharmorubicin, idarubicin, epirubicin or danuorubicin as previous treatment with these
August 2012

Page 1 of 12

Doxorubicin RD
DO 051 COO Farmitalia to Pfizer

similar medicines can increase the risk of side effects with this medicine.
suffered from severe heart trouble in the past, or are presently receiving treatment for
severe liver problems
a urine infection or inflammation of the bladder.

Take special care with Doxorubicin:
Your doctor will assess your health carefully before prescribing this medicine. Make sure
your doctor knows before you start taking Doxorubicin:
 if you have had or if you are due to have any vaccinations.
Other Anticancer Medicines
Problems are more likely if you have been given other anticancer medicines, especially at
high doses, just before or at the same time as doxorubicin. If you have recently been treated
with another anticancer medicine you will be given time to recover from effects of the
anticancer drug before you begin treatment with this medicine. Your doctor will want to
monitor you care fully during and after treatment (See Section 3 ‘How Doxorubicin is given
to you’ for more information).
Taking other medicines:
Please tell your doctor or pharmacist if you have recently taken any other medicines,
even those not prescribed, particularly any of the following:
 Ciclosporin: which can make the effects of Doxorubicin stronger
 Calcium channel blocker: medicines for your heart.
 Sorafenib used to treat inoperable liver cancer and advanced kidney cancer.
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.
You should stop breast-feeding before starting treatment with this medicine as some of the
drug may get into your breast milk and possibly harm your child.
Ask your doctor or pharmacist for advice before taking any medicine while breast-feeding.
Driving and using machinery
There are no special precautions, and you can drive or operate machinery as long as you feel
fully recovered following your hospital treatment.
Important information about some of the ingredients of Doxorubicin
This medicine contains methyl hydroxybenzoate. This may cause allergic reactions (possibly
delayed) and exceptionally, bronchospasm.
3. How Doxorubicin is given to you
If you are prescribed Doxorubicin 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 nurse through a drip (infusion)
August 2012

Page 2 of 12

Doxorubicin RD
DO 051 COO Farmitalia to Pfizer

into a vein. Your doctor will decide what dose to give and the number of days treatment you
will receive depending on your condition. You will be monitored regularly both during and
after your treatment.
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.
Doxorubicin made into a solution 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 Doxorubicin 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 Doxorubicin 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: Doxorubicin 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 Doxorubicin
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.
4. Possible side effects
Like all medicines Doxorubicin can have side effects.
Please contact your doctor or nurse immediately if you notice any of the following side
 Feeling dizzy, feverish, short of breath with a tight chest or throat or have an itchy rash.
This type of allergic reaction can be very serious.
 Anaemia (a low red blood cell count) that can leave you feeling tired and lethargic.
 White blood cell counts (which fight infection) can also drop, increasing the chance of
infections and a raised temperature or fever.
 Platelets (these are cells that help the blood to clot) can be affected which could make you
bruise or bleed more easily, or bleed more than usual if you hurt yourself. It is important
to seek medical advice if this happens.
 Doxorubicin may also cause decreased activity in your bone marrow. Your doctor should
test your blood cell count during treatment.
August 2012

Page 3 of 12

Doxorubicin RD
DO 051 COO Farmitalia to Pfizer

Other side effects that may occur are as follows:
 Reddening of your 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.
 Irritation of the bladder, damage to the bladder wall (called necrosis).
 You may notice your heart beating abnormally erratically, with an increase in pulse rate.
In some cases, you may notice heart problems several months or years after medication
has been completed.
 Heart failure which can be associated with the symptoms of shortness of breath and
swelling of the ankles.
 Inflammation of veins, blockage of a blood vessel by a clot (thromboembolism), hot
 Raised levels of liver enzymes (as detected by a blood test) can determine if the medicine
is having an abnormal effect on your liver.
 In women, Doxorubicin may cause infertility during the time the drug is taken. Women
may also find that their periods stop, but their periods should return to normal after
medication is stopped. In some cases early menopause can occur.
 In men, Doxorubicin may cause a decrease in sperm count, but this may return to normal
after medication is stopped. Both men and women taking Doxorubicin should use
effective contraceptive methods.
 Conjunctivitis (usually causing red watery eyes), excess tear production, and inflamed
 Lack of appetite, dehydration, and increased uric acid in your urine.
 Abnormal ECG (this is an electrical trace of your heart) results.
 Hair loss is common and may be quite severe. Beard growth may stop in men. Hair
normally re-grows when your treatment course ends.
 Sunlight may cause excessive irritation to your skin. Skin rashes, redness, hives,
numbness and tingling in the palms and feet may also occur whilst being treated with
Doxorubicin. Skin and nails may also appear darker than usual. Redness and swelling
may develop at site of injection.
 Soreness or ulcers in the mouth, which may not appear until 3-10 days after treatment,
heartburn, feeling sick (nausea) being sick (vomiting) irritation or bleeding in the
intestines or diarrhoea. If vomiting is very bad, other medicines called anti-emetics can be
given to help you.
If you get any of the above side effects, or notice any other unusual side effects not
listed in this leaflet, tell your doctor at once.
5. How to store Doxorubicin

The unopened vials should be stored in the original container until ready for use.
Keep out of the reach and sight of children.
This medicine should not be used after the expiry date printed on the box and on the vial.
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.

6. Further Information
What Doxorubicin contains
The active substance is doxorubicin hydrochloride. The other ingredients are lactose
August 2012

Page 4 of 12

Doxorubicin RD
DO 051 COO Farmitalia to Pfizer

monohydrate and methyl hydroxybenzoate.
What Doxorubicin looks like and contents of the pack
Doxorubicin is a freeze-dried powder in single glass vials containing 10mg, 20mg 50mg or
150mg of the active ingredient, doxorubicin hydrochloride.
Marketing Authorisation Holder:
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom.
Actavis Italy S.p.A, 10 Viale Pasteur, 20014 Nerviano (MI), Italy.
Company Contact address:
If you have any comments on the way this leaflet is written, please contact Medical
Information at Pfizer Limited in Walton Oaks, Tadworth, Surrey.
Tel :01304 616161.
This leaflet was last revised in August 2012
Ref: DO 8_0

August 2012

Page 5 of 12

Doxorubicin RD
DO 051 COO Farmitalia to Pfizer

Pfizer Logo
Doxorubicin Rapid Dissolution 10 mg, 20 mg, 50 mg & 150 mg
Powder for Injection
doxorubicin hydrochloride
Refer to Summary of Product Characteristics before prescribing.
Powder for injection containing 10 mg, 20 mg, 50 mg and 150 mg doxorubicin
hydrochloride. Also contains methyl hydroxybenzoate and lactose monohydrate.
Doxorubicin is used in the treatment of a range of neoplastic diseases including acute
leukaemia, lymphoma, paediatric malignancies and adult solid tumours, in particular, breast
and lung carcinomas.
Dosage and administration
Routes of administration
Intravenous and intra-arterial injection, and intravesical instillation. Doxorubicin cannot be
used as an antibacterial agent.
Intravenous Administration
Reconstituted solution is given via tubing of a freely-running intravenous infusion, over 3–10
minutes. Commonly used solutions are sodium chloride injection, dextrose injection 5% or
sodium chloride and dextrose injection. Direct push injection not recommended due to risk
of extravasation, even in the presence of adequate blood return upon needle aspiration.
Total doxorubicin dose per cycle may differ according to the treatment regimen (e.g. given
as a single agent or in combination therapy) and according to the indication. The dosage is
usually calculated on the basis of body surface area.

As a single agent the recommended standard starting dose per cycle in adults is 60-75 mg/m
of body surface area.
The total starting dose per cycle may be given as a single dose, divided over 3 successive
days or in divided doses given on days 1 and 8. Under conditions of normal recovery from
drug-induced toxicity (particularly bone marrow depression and stomatitis), each treatment
cycle could be repeated every 3-4 weeks. If used in combination with other anti-tumour
agents with overlapping toxicity the doxorubicin dose may need to be reduced to 30-60
mg/m every three weeks.
If dosage is calculated using body weight 1.2-2.4 mg/kg should be given as a single dose
every three weeks.
Giving doxorubicin as a single dose every three weeks greatly reduces mucositis. However
dividing the dose over three successive days (0.4-0.8 mg/kg or 20-25 mg/m on each day)
gives greater effectiveness even though at the cost of high toxicity.
August 2012

Page 6 of 12

Doxorubicin RD
DO 051 COO Farmitalia to Pfizer

Administration as a weekly regimen has been shown to be as effective as a 3-weekly
regimen. The recommended dosage is 20 mg/m weekly, although objective responses have
been seen at 6-12 mg/m . Weekly administration leads to a reduction in cardiotoxicity.
Dosage may need to be reduced for patients who have had prior treatment with other
cytotoxic agents. Dosage may also need to be reduced in children, obese patients and the
Lower starting doses or longer intervals between cycles may need to be considered for
heavily pre-treated patients, or patients with neoplastic bone marrow infiltration.
Hepatic dysfunction
If hepatic function is impaired doxorubicin should be reduced as follows:
Serum bilirubin levels

Recommended dose

1.2-3.0 mg/100 ml
> 3.0 mg/100 ml

50% normal dose
25% normal dose

Do not administer to patients with severe hepatic impairment (see Contra-indications).
Intra-arterial Administration
Intra-arterial injection has been used to produce intense local activity while keeping the total
dose low and to reduce general toxicity. This technique is potentially extremely hazardous
and can lead to widespread necrosis of the perfuse tissue unless due precautions are taken.
Drug doses administered and dosing intervals utilized for intra-arterial perfusion vary.
Intra-arterial injection should only be attempted by those fully conversant with this
Intravesical Administration
Doxorubicin is used by intravesical administration for the treatment of transitional cell
carcinoma, papillary bladder tumours and carcinoma-in-situ. Do not use this route for the
treatment of invasive tumours which have penetrated the bladder wall. Doxorubicin can be
instilled (30-50 mg in 25-50 mL of saline solution) into the bladder at intervals after
transurethral resection of a tumour in order to reduce the probability of recurrence. In cases
of local toxicity (chemical cystitis) dose should be instilled in 50-100 mL of saline solution.
Patients may continue to receive instillations in weekly to monthly intervals.
The concentration of doxorubicin in the bladder should be 50 mg per 50 mL. To avoid undue
dilution with urine patients must not to drink fluid in the 12 hours prior to instillation to limit
urine production to approximately 50 mL per hour. The patient should be rotated a quarter
turn every 15 minutes while the drug is in situ.
Exposure to the drug solution for one hour is generally adequate and the patient should be
instructed to void at the end of this time.
Contra-indications, Special Warnings & Precautions for Use:
Hypersensitivity to doxorubicin, any other component of the product, other anthracyclines or
Intravenous (IV) use
• persistent myelosuppression
August 2012

Page 7 of 12

Doxorubicin RD
DO 051 COO Farmitalia to Pfizer

• severe hepatic impairment
• severe myocardial insufficiency
• recent myocardial infarction
• severe arrhythmias
• previous treatment with maximum cumulative doses of doxorubicin, daunorubicin,
epirubicin, idarubicin and/or other anthracyclines and anthracenediones (see section Special
Warnings and Precautions for use).
Intravesical use
• urinary infections
• inflammation of the bladder
Special Warnings
Doxorubicin should be administered only under the supervision of physicians experienced in
the use of cytotoxic therapy.
Patients should recover from acute toxicities of prior cytotoxic treatment (such as stomatitis,
neutropenia, thrombocytopenia, and generalized infections) before beginning treatment. The
systemic clearance of doxorubicin is reduced in obese patients (i.e. >130% ideal body
Precautions for use:
Cardiac function - cardiotoxicity is a risk of anthracycline treatment that may be manifested
by early (i.e. acute) or late (i.e. delayed) events. Refer to SPC for additional information.
Haematologic Toxicity
Doxorubicin may produce myelosuppression. Haematologic profiles should be assessed
before and during each cycle of therapy with doxorubicin, including differential WBC
counts. A dose-dependent, reversible leucopenia and/or granulocytopenia (neutropenia) is the
predominant manifestation of doxorubicin haematologic toxicity and is the most common
acute dose-limiting toxicity. Leucopenia and neutropenia generally reach the nadir between
days 10 and 14 after drug administration; the WBC/neutrophil counts return to normal values
in most cases by day 21. Thrombocytopenia and anaemia may also occur. Clinical
consequences of severe myelosuppression include fever, infections, sepsis/septicaemia,
septic shock, haemorrhage, tissue hypoxia or death.
Secondary Leukaemia
Secondary leukaemia, with or without a preleukaemic phase, has been reported in patients
treated with anthracyclines. Secondary leukaemia is more common when such drugs are
given in combination with DNA-damaging antineoplastic agents, when patients have been
heavily pretreated with cytotoxic drugs or when doses of the anthracyclines have been
escalated. These leukaemias can have a 1 to 3 year latency period.
Carcinogenesis, Mutagenesis and Impairment of Fertility
Doxorubicin was genotoxic and mutagenic in in vitro or in vivo tests. In women doxorubicin
may cause infertility during the time of drug administration. Doxorubicin may cause
amenorrhoea. Ovulation and menstruation appear to return after termination of therapy,
although premature menopause can occur.
Doxorubicin is mutagenic and can induce chromosomal damage in human spermatozoa.
Oligospermia or azoospermia may be permanent. Sperm counts have been reported to return
to normospermic levels in some instances and may occur several years after end of therapy.
Men undergoing doxorubicin treatment should use effective contraception.
August 2012

Page 8 of 12

Doxorubicin RD
DO 051 COO Farmitalia to Pfizer

Liver function
The major route of elimination is the hepatobiliary system. Serum total bilirubin should be
evaluated before and during treatment with doxorubicin. Patients with elevated bilirubin may
experience slower clearance of the drug, with an increase in overall toxicity, so lower doses
are recommended. Patients with severe hepatic impairment should not receive doxorubicin.
Doxorubicin may potentiate the toxicity of other anticancer therapies. Cyclophosphamideinduced haemorrhagic cystitis and enhanced hepatotoxicity of 6-mercaptopurine have been
reported. Radiation-induced toxicities (myocardium, mucosae, skin and liver) have also been
As with other cytotoxic agents thrombophlebitis and thromboembolic phenomena, including
pulmonary embolism (in some cases fatal) have been reported.
Doxorubicin may induce hyperuricaemia as a consequence of tumour-lysis syndrome. Blood
uric acid levels, potassium, calcium phosphate and creatinine should be evaluated after initial
treatment. Hydration, urine alkalinization, and prophylaxis with allopurinol may minimize
potential complications of tumour lysis syndrome.
Intravesical Administration
Administration by the intravesical route may produce symptoms of chemical cystitis and
bladder constrictions. Special attention is required for catherization problems (e.g. uretheral
obstruction due to massive intravesical tumours).
Intra-arterial administration of doxorubicin (transcatheter arterial embolization) may be
employed for localized or regional therapy of primary hepatocellularcarcinoma or liver
metastases. Intra-arterial administration may, in addition to systemic toxicity similar to that
observed following IV administration, gastro-duodenal ulcers and narrowing of bile ducts.
Intravesical administration can lead to widespread necrosis of the perfused tissue.
Adverse reactions
Neoplasms Benign and Malignant (including cysts and polyps): secondary acute myeloid
leukaemia, with or without a pre-leukaemic phase, has been reported rarely in patients
concurrently treated with DNA-damaging antineoplastic agents. Such cases could have a
short (1-3 year) latency period. Acute lymphocytic leukaemia and acute myelogenous
Blood and Lymphatic System: haematological monitoring should be undertaken because of
the possibility of bone-marrow depression which may become evident around ten days from
the time of administration. Doxorubicin bone marrow/haematological toxicity may cause
fever, infections, sepsis/septicaemia, septic shock, haemorrhages, tissue hypoxia or death.
Leucopenia, neutropenia, anaemia and thrombocytopenia.
Immune System: anaphylaxis
Metabolism and Nutrition Disorders: anorexia, dehydration and hyperuricaemia.
Eye Disorders: Conjunctivitis / keratitis and lacrimation
Cardiac: cardiotoxicity may be manifested in tachycardia including supraventricular
tachycardia and ECG changes. Routine ECG monitoring is recommended and caution should
be exercised in patients with impaired cardiac function. Severe cardiac failure may occur
suddenly without premonitory ECG changes. Tachyarrhythmias, atrio-ventricular and bundle
branch block, asymptomatic reduction in left ventricular ejection fraction and congestive
August 2012

Page 9 of 12

Doxorubicin RD
DO 051 COO Farmitalia to Pfizer

heart failure.
Vascular: phlebitis, thrombophlebitis, thromboembolism, hot flushes and shock.
Gastrointestinal: nausea, vomiting and mucositis/stomatitis, hyperpigmentation of oral
mucosa, oesophagitis, abdominal pain, gastric erosions, gastrointestinal tract bleeding,
diarrhoea and colitis.
Hepatobiliary: transaminase level changes.
Skin and Subcutaneous Tissue: alopecia, skin rashes/itch, local toxicity, skin changes, skin
and nail hyperpigmentation, photosensitivity, hypersensitivity to irradiated skin (‘radiation
recall reaction’), urticaria, acral erythema and plantar-palmar dysaesthesia.
Renal and Urological: may impart a red colour to urine. Following intravesical
administration, side-effects include symptoms of bladder irritation, haematuria,
haemorrhagic cystitis and necrosis of the bladder wall.
Reproductive System and Breast: amenorrhoea, oligospermia and azoospermia.
General Disorders and Administration Site: thrombophlebitis, stinging or burning sensation
at the site of administration and extravasation. Fever, malaise, asthenia and chills.
Investigations: ECG abnormalities.
High dose cyclosporin increases the serum levels and myelotoxicity of doxorubicin.
Doxorubicin is mainly used in combination with other cytotoxic drugs. Additive toxicity may
occur especially with regard to bone marrow/haematologic and gastrointestinal effects. The
use of doxorubicin 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. Changes in hepatic
function induced by concomitant therapies may affect doxorubicin metabolism,
pharmacokinetics, therapeutic efficacy and/or toxic.
Paclitaxel can cause increased plasma-concentrations of doxorubicin and/or its metabolites
when given prior to doxorubicin. Certain data indicate that a smaller increase is observed
when doxorubicin is administered prior to paclitaxel.
In a clinical study, an increase in doxorubicin AUC of 21% was observed when given with
sorafenib 400 mg twice daily. The clinical significance of this finding is unknown.
Pregnancy and Lactation
Doxorubicin has harmful pharmacological effects on pregnancy and/or the foetus/newborn
child. Due to embryotoxic potential doxorubicin should not be used during pregnancy unless
clearly necessary. If a woman receives doxorubicin during pregnancy, or becomes pregnant
whilst taking the drug, she should be warned of the potential hazard to the foetus. Women of
childbearing potential must use effective contraception during treatment. Women should not
breast-feed while undergoing treatment with doxorubicin.
Single doses of 250mg and 500mg have proved fatal. Such doses may cause acute
myocardial degeneration within 24 hours and severe myelosupression (mainly leucopenia
and thrombocytopenia), the effects of which are greatest between 10 and 15 days after
administration. Supportive treatment should utilise measures as blood transfusions and
August 2012

Page 10 of 12

Doxorubicin RD
DO 051 COO Farmitalia to Pfizer

reverse barrier nursing.
Acute overdose with doxorubicin will result in gastrointestinal toxic effects (mainly
mucositis) which generally appears early after administration.
Delayed cardiac failure may occur up to six months after the overdosage.
Pharmaceutical Precautions
Instructions for Use/Handling
As vial contents are under a negative pressure to minimise aerosol formation during
reconstitution particular care should be taken when needle is inserted. Avoid inhalation of any
aerosol produced during reconstitution.
The following protective recommendations are given due to the toxic nature of this substance:
• Personnel should be trained in good technique for reconstitution and handling.
• Pregnant staff should be excluded from working with this drug.
• Personnel handling doxorubicin should wear protective clothing: goggles, gowns and
disposable gloves and masks.
• A designated area should be defined for reconstitution (preferably under a laminar flow
system). The work surface should be protected by disposable plastic-backed absorbent paper.
• All items used for reconstitution, administration or cleaning, including gloves, should be
placed in high-risk waste-disposal bags for high temperature incineration.
• Always wash hands after removing gloves.
• In case of skin contact, thoroughly wash the affected area with soap and water or sodium
bicarbonate solution. However, do not graze the skin by using a scrubbing brush.
• In case of contact with the eye(s), hold back the eyelid(s) and flush the affected eye(s) with
copious amounts of water for at least 15 minutes. Then seek medical evaluation by a
• Spillage or leakage should be treated with dilute sodium hypochlorite (1% available chlorine)
solution, preferably soaking overnight and then water. All cleaning materials should be
disposed of as indicated previously.
Intravenous administration
The vial contents must be reconstituted before use with water for injections or normal saline.
For reconstitution the contents of the 10mg vial may be dissolved in 5mL Water for injections
or Sodium Chloride Injection and those of the 20mg vial in 10mL of the same solvents; 50mg
vial in 25mL of the same solvents and 150mg vial in 75mL of the same solvents.
After adding the diluent, the vial contents will dissolve with gentle shaking, without
inversion, within 30 seconds. The approximate displacement value of the contents of a 50mg
vial, after 25mL of solvent has been added is 0.15mL.
The reconstituted solution contains 0.02% methylhydroxybenzoate. This is not a preservative
solution. Discard any unused solution.
Intravesical administration
Doxorubicin should be instilled using a catheter and retained intravesically for 1-2 hours.
During instillation, the patient should be rotated to ensure that the vesical mucosa of the pelvis
receives the most extensive contact with the solution. To avoid undue solution with urine, the
patients should be instructed not to drink any fluid in the 12 hours prior to instillation. The
patient should be instructed to void at the end of the instillation.
August 2012

Page 11 of 12

Doxorubicin RD
DO 051 COO Farmitalia to Pfizer

Doxorubicin Rapid Dissolution should not be mixed with heparin as a precipitate may form
and it is not recommended that Doxorubicin Rapid Dissolution be mixed with other drugs.
Prolonged contact with any solution of an alkaline pH should be avoided as it will result in
hydrolysis of the drug.
Doxorubicin should not be mixed with fluorouracil (eg, in the same IV infusion bag or at the
Y-site of an IV infusion line) since it has been reported that these drugs are incompatible to
the extent that a precipitate might form. If concomitant therapy with doxorubicin and
fluorouracil is required, it is recommended that the IV line be flushed between the
administration of these drugs.
Shelf Life
48 months
Shelf life after dilution or reconstitution according to directions:
Once reconstituted, the solution should be used straight away. If not it may be stored for up
to 24 hours.
Package Quantities
10, 20, 50 and 150 mg glass vials with white or grey rubber stopper, aluminium seal and
snap cap.
PL 00057/1463
This leaflet was prepared in August 2012
Further information is available to the medical and allied professions from:
Medical Information, Pfizer Limited, Walton Oaks, Dorking Road, Tadworth, Surrey KT20
Tel: 01737 616161

August 2012

Page 12 of 12

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.