Doxorubicin solution for injection 2 mg / ml – patient leaflet, side effects, dosage

1. What Doxorubicin is and what it is used for

• This medicine contains doxorubicin hydrochloride, which 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 treated.
• It has been found to be particularly 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 and leukaemia.
• You must talk to a doctor if you do not feel better or if you feel worse.

2. What you need to know before you are given Doxorubicin

Do not use Doxorubicin if you have:

• If you have an allergy (hypersensitivity) to doxorubicin, other similar medicines called anthracyclines or anthracenediones or any of the other ingredients of this medicine (listed in section 6).
• If you have low blood cell counts, as it can lower them further.
• If you have previously been treated with doxorubicin or similar chemotherapy drugs like pharmorubicin, idarubicin, epirubicin or danuorubicin as previous treatment with these similar medicines can increase the risk of side effects with this medicine.
• If you have suffered from severe heart trouble in the past, or are presently receiving treatment for this.
• If you have severe liver problems.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before being given 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 or have ever had heart disease, either before or during radiotherapy
• If you have had or are due to have live or live-attenuated vaccinations.
• Both men and women must use two effective contraception methods (e.g. including a condom) during and for a period after their treatment with doxorubicin.
• If you want to have children after treatment with doxorubicin, you should talk to your doctor about genetic counselling and options to preserve fertility before starting the treatment.
• If you are currently taking or have recently taken Trastuzumab (a medicine used in the treatment of certain cancers). Trastuzumab can remain in the body for up to 7 months. As trastuzumab may affect the heart, you should not use doxorubicin for up to 7 months after you have stopped taking trastuzumab. If doxorubicin is used before this time, then your heart function should be carefully monitored.

Doxorubicin may also cause the following:

• Decreased blood cells and bone marrow function
• Abnormal cell growth and infertility
• Blood found in the urine
• Severely impaired liver function
• Damage to body tissue including that of the heart, skin, liver and the thin layer which lines the body cavities and passages
• Clotting blockages in blood flow
• High levels of uric acid in the blood

Refer to section 4 for further information.

Other Anti-cancer Medicines

Problems are more likely to occur if you have been given other anticancer medicines especially at high doses just before or at the same time as doxorubicin. You will be given time to recover from the effects of the anticancer drug before you begin treatment with this medicine. Your doctor will want to monitor you carefully during and after treatment (see section 3 for more information).

Other medicines and Doxorubicin

Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription, particularly any of the following:

• Some medicines effect the concentration and clinical effect of doxorubicin. (e.g. verapamil, phenobarbital, phenytoin, St. John’s Wort). Please tell your doctor or pharmacist if you are taking any of these medicines.
• Cyclosporine: which can make the effects of doxorubicin stronger and may result in prolonged decrease in bone marrow and blood cells (coma and seizures have also been described with concomitant administration of cyclosporine and doxorubicin).
• Calcium Channel Blockers: medicines for your heart.
• Sorafenib: used to treat inoperable liver cancer and advanced kidney cancer.

• Paclitaxel: which can make the effects of doxorubicin stronger

  Pregnancy, breast-feeding and fertility

  If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before being given this medicine because it may cause birth defects. If you are a woman, you should not get pregnant during treatment with doxorubicin and for at least 7 months after treatment.

  If you are a man, you should take adequate precautions to ensure that your partner does not become pregnant during your treatment with doxorubicin and for at least 4 months after treatment.

  If you are sexually active, you are advised to use effective birth control to prevent pregnancy during treatment, whether you are male or female.

  Contraception (to prevent pregnancy) in women of childbearing potential

  You should always use two effective birth control methods (e.g. include a condom) whilst receiving doxorubicin and for at least 7 months after the last dose. Talk to your doctor about birth control methods that are right for you and your partner.

  Contraception in men (to prevent getting a woman pregnant)

  Men should always use two effective contraception methods (e.g. include a condom) whilst receiving doxorubicin and for at least 4 months after the last dose. Talk to your doctor about birth control methods that are right for you and your partner.

  Breast-feeding

  Do not breast-feed during treatment with doxorubicin as some of the drug may get into your breast milk and possibly harm your child. Additionally, women should not breast-feed for at least 10 days after last dose. Fertility

  Both men and women should discuss with their doctor and seek advice on fertility preservation before treatment. In women, doxorubicin may cause infertility during the period when receiving treatment with the medicine. Men being treated with doxorubicin are advised to seek advice on preserving their sperm (cryo-conservation) before starting treatment because of the possibility of irreversible infertility in men due to therapy with doxorubicin. Driving and using machines

  There are no special precautions and you can drive and operate machinery as long as you feel fully recovered following your hospital treatment.

  Doxorubicin contains sodium

  Doxorubicin 10 mg/5 ml, 20 mg/10 ml, 50 mg/25 ml and 200 mg/100 ml contain 17.7 mg, 35.4 mg, 88.5 mg and 354 mg sodium (main component of cooking/table salt) in each vial. This is equivalent to 0.9%, 1.77%, 4.43% and 17.7% of the recommended maximum daily dietary intake of sodium for an adult, respectively.

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 be given to you by a doctor or 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. 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. While one course of treatment may sometimes be enough, more often your doctor will advise further courses in either one, 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 your treatment with Doxorubicin solution

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, your doctor will 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, this medicine can have side effects although not everybody gets them. Please contact your doctor or nurse immediately if you notice any of the following side effects:

• 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 (fever).
• Platelets (these are 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. Your doctor should test your blood cell count during treatment.
• Doxorubicin may also cause decreased activity in your bone marrow.

Other side effects that may occur are as follows:

Very common: may affect more than 1 in 10 people

• Infection
• Lack of appetite.
• Inflammation in the mouth, diarrhoea, feeling sick (nausea) being sick (vomiting).
• Reddening, swelling, numbness, pain and tingling in the palms and feet may also occur whilst being treated with doxorubicin.
• Hair loss is common and may be quite severe. Beard growth may stop in men. Hair normally re-grows when your treatment course ends.
• Fever, feeling weak, chills.
• Abnormal ECG (this is an electrical trace of your heart) results.
• Raised levels of liver enzymes (as detected by a blood test) can determine if the medicine is having an abnormal effect on your liver.
• Weight increased in patients with early breast cancer.

Common: may affect up to 1 in 10 people

• Blood poisoning.
• You may notice your heart beating abnormally quickly, with an increase in pulse rate. In some cases, you may notice heart problems several months or years after medication has been completed. TECHNICAL LEAFLET

Doxorubicin 2 mg/ml

Solution for Injection

doxorubicin hydrochloride

Package leaflet: Information for the patient

Doxorubicin 2 mg/ml

Solution for Injection

Continued overleaf... Continued overleaf...

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• Conjunctivitis (usually causing red watery eyes), excess tear production.
• Heart failure which can be associated with the symptoms of shortness of breath and swelling of the ankles.
• Increased heart rate, inflammation of the throat and gullet, stomach pain, skin rashes, redness, hives, nails and skin may appear darker than usual.
• Redness and swelling may develop at site of injection.

Uncommon: may affect up to 1 in 100 people

• Embolism (a blockage in the bloodstream).

Not known: (frequency cannot be estimated from the available data)

• Dehydration, increased uric acid in your urine, inflamed cornea, watery eyes, general discomfort.
• Increased heart rate, chest pain which could indicate heart problems, shock (low blood pressure and circulation), internal bleeding.
• Inflammation of veins, blockage of a blood vessel by a clot (thromboembolism), hot flushes.
• Irritation or bleeding in the intestines, inflammation of the lining of the stomach, heartburn, soreness or ulcers in the mouth, which may not appear until 3-10 days after treatment, discoloration inside the mouth.
• Increased sensitivity of the skin to the sunlight
• Inflammation reaction, which could occur soon after treatment or years later, itchy skin and other skin disorders.
• 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. Let your doctor know if you get these symptoms.

• 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 an absence or 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.

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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Doxorubicin

• The unopened vials should be stored in the original container in a fridge until ready for use.
• 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 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.

6. Contents of the pack and other information

What Doxorubicin contains

The active substance is doxorubicin hydrochloride. The other ingredients are sodium chloride, water for injections and hydrochloric acid.

What Doxorubicin looks like and contents of the pack

Doxorubicin solution for injection is a red liquid in single glass vials containing 2 mg/ml of the active ingredient, doxorubicin hydrochloride.

Marketing Authorisation Holder

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Manufacturer:

Pfizer Service Company BV

Hermeslaan 11

1932 Zaventem

Belgium

Company Contact Address:

For further information on your medicine please contact Medical Information at Pfizer Limited, Walton Oaks, Tadworth, Surrey, KT20 7NS, UK.

Tel: 01304 616161

This leaflet was last revised in 10/2025

Ref: DO 19_4

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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

Fertility, pregnancy and lactation

Doxorubicin should not be used during pregnancy unless clearly necessary. It is reported to have harmful pharmacological effects on pregnancy and/or the foetus/newborn child. This product should not normally be administered to patients who are pregnant or to mothers who are breast-feeding.

Women of Childbearing Potential/Contraception in Males and Females

Women of childbearing potential should be advised to avoid becoming pregnant during treatment and to use two effective contraceptive methods (e.g. including a barrier method) during treatment and for at least 7 months after last dose. Men with female partners of childbearing potential should be advised to use two effective contraceptive methods (e.g. including a barrier method) during treatment with doxorubicin and for at least 4 months after last dose.

Breast-feeding

Doxorubicin is secreted into breast milk. Because of the potential for serious reactions in nursing infants from doxorubicin, women should not breastfeed while undergoing treatment with doxorubicin and for at least 10 days after last dose. Fertility

Both men and women should seek advice on fertility preservation before treatment.

Overdose

Very high single doses of doxorubicin may be expected to cause acute myocardial degeneration within 24 hours and severe myelosuppression within 10-15 days. Treatment should aim to support the patient during this period and should utilise such measures as blood transfusion and reverse barrier nursing.

Delayed cardiac failure has been seen with the anthracyclines up to 6 months after the overdose, if signs of cardiac failure arise, they should be treated along conventional lines.

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 doxorubicin 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.
• Always wash hands after removing gloves.

Incompatibilities

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 heparin due to chemical incompatibility which may lead to precipitation when the drugs are in certain proportions.

Doxorubicin can be used in combination with other antitumour agents, but it is not recommended that it be mixed with other drugs.

Doxorubicin should not be mixed with fluorouracil (e.g., 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

2 years.

Storage

The vials should be stored at between 2° - 8° C (in the refrigerator).

Package Quantities

10 mg, 20 mg, 50 mg and 200 mg vials. Not all pack sizes may be marketed.

POM

PL 00057/0970

Ref: DO 19_3

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

GUJ-DRUGS/G/28/1267