Doxorubicin 10 mg/5 ml Solution

Doxorubicin is one of a group of medicines known as anthracyclines. Doxorubicin works by killing tumour and blood cancer cells. DOXORUBICIN FRESENIUS is used in the treatment of various cancers to slow or stop the growth of cancer cells. A combination of different types of cancer medicines will often be used to achieve better results and minimise side effects. Your doctor will be able to explain how DOXORUBICIN FRESENIUS might help in your particular condition.

Do not use DOXORUBICIN FRESENIUS • if you are hypersensitive (allergic) to doxorubicin hydrochloride, or any of the other ingredients of DOXORUBICIN FRESENIUS (listed in section 6) • if you are allergic to any other anthracycline • if you have been told your blood is thin (your bone marrow is not working well) • if your liver is not working well • if you suffer from heart disease • if you had a recent heart attack • serious abnormality of the heartbeat (dysrhythmia) • if you have previously been treated with doxorubicin or similar chemotherapy medicines like, idarubicin, epirubicin or daunorubicin, as previous treatment with these similar medicines can increase the risk of side effects with DOXORUBICIN FRESENIUS

Warnings and precautions

DOXORUBICIN FRESENIUS will only be used in specialised departments of oncology (cancer) and will be administered under the supervision of doctor experienced in cancer chemotherapy. Tell your doctor or healthcare provider before being given the injection: • if you suffer from liver disease • if you suffer from mouth ulcers • if you have secondary acute myelogenous leukaemia (AML), a type of cancer of the blood cells

Site of administration: Avoid any contact with your skin and mucous membranes. Tell your doctor as soon as you experience stinging or redness at the site of injection. The infusion will immediately be stopped and restarted in another vein. Skin reactions due to previous cancer therapy may recur with administration of DOXORUBICIN FRESENIUS. DOXORUBICIN FRESENIUS irritates the skin and thrombophlebitis (inflammation of the vein with formation of a clot) and streaking of the skin over the vein used for infusion may occur and it should not be confused with extravasation (stinging or burning at injection site).

Cardiac risk with administration of DOXORUBICIN FRESENIUS:

Your doctor will monitor your heart function carefully during the treatment because: DOXORUBICIN FRESENIUS may damage the heart muscle and may lead to heart failure after a certain cumulative dose (adding up of single doses). The risk for heart muscle damage is higher if you have previously received medicines that may damage the heart or radiotherapy of the upper body. If you are on this treatment, you will undergo frequent ECG monitoring and if your doctor finds any abnormalities, he/she will discontinue treatment or do further evaluation tests.

Myelosuppression with the administration of DOXORUBICIN FRESENIUS:

You may suffer from myelosuppression (a reduction in bone marrow activity that leads to a lower concentration of platelets, red blood cells and white blood cells). This may make you more prone to infections or bleeding. Your doctor will conduct blood tests regularly to monitor your blood cells.

Other safety information DOXORUBICIN FRESENIUS may enhance the toxicity of other anticancer therapies. Your doctor will ensure that the necessary tests are done to monitor these effects. The levels of uric acid (showing that cancer cells are destroyed) in your blood may be high during treatment. Your doctor will tell you if you need to take any medicine to control this. Existing infections should be treated before DOXORUBICIN FRESENIUS therapy is started. DOXORUBICIN FRESENIUS is generally not recommended in combination with live, attenuated vaccines. Contact with persons recently vaccinated against polio should be avoided.

You may experience changes in your menstrual cycle and your ability to conceive may be affected. DOXORUBICIN FRESENIUS may give a red colour to your urine, which should not be mistaken for blood. This is a normal effect of the medicine that does not pose any health hazards.

You will not be expected to give yourself DOXORUBICIN FRESENIUS. It will be given to you by a person who is qualified to do so. DOXORUBICIN FRESENIUS can only be given under supervision by a doctor with experience in cancer treatment. Your doctor will calculate your dosage according to your body surface area, your condition and the cancer to be treated. DOXORUBICIN FRESENIUS will be administered intravenously (injected into a vein). The dose will be repeated at intervals determined by your doctor. Your doctor will tell you how long your treatment with DOXORUBICIN FRESENIUS will last. If you have the impression that the effect of DOXORUBICIN FRESENIUS is too strong or too weak, tell your doctor.

If you receive more DOXORUBICIN FRESENIUS than you should: Since a healthcare provider will administer DOXORUBICIN FRESENIUS, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage. The symptoms of overdosage will be an extension of the side effects. Please tell your doctor if you experience a worsening of any of the side effects. If you forget to use DOXORUBICIN FRESENIUS Since a healthcare provider will administer DOXORUBICIN FRESENIUS, it is unlikely that the dose will be missed.

DOXORUBICIN FRESENIUS can have side effects. Not all side effects reported for DOXORUBICIN FRESENIUS are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving DOXORUBICIN FRESENIUS, please consult your healthcare provider for advice. If any of the following happens, stop using DOXORUBICIN FRESENIUS and tell your doctor immediately or go to the casualty department at your nearest hospital: • Swelling of the hands, feet, face, lips or throat, which may cause difficulty breathing, • rash or itching, hives, red swollen skin.

These are all serious side effects. If you have them, you may have a serious reaction to DOXORUBICIN FRESENIUS. You may need urgent medical attention or hospitalisation. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following: • fever (high temperature), chills, shivering and fast heartbeat (sepsis, blood poisoning) • anaemia (a low red blood cell count) that can leave you feeling tired and lethargic • low blood platelet count that could make you bleed or bruise more easily • low white blood cell counts (these cells fight infection), increasing the chance of infections and raised temperature (fever) • decreased activity in your bone marrow, affecting your immunity against infections. Your doctor should test your blood cell count during treatment • abnormal increase in or irregular heart rate (cardiomyopathy, dysrhythmias) • shortness of breath, swollen legs (congestive heart failure) • intestinal perforation (blood in the stool, severe abdominal pain, nausea and vomiting blood) • acute renal failure (decreased urine output, swelling of legs, fatigue) • pain and swelling at the injection site.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following: Frequent side effects: • anorexia • nausea • vomiting • swollen or sore mouth • diarrhoea • loss of hair • facial flushing Less frequent side effects • dehydration (loss of water, feeling thirsty) • headache • eye infection • excessive secretion of tears • low blood pressure • inflammation in vein (phlebitis) • inflammation of the food pipe (painful swallowing) • abdominal pain • ulcers in the intestines and mouth • excessive pigmentation of skin and nails • detached nails • urine might appear red in colour • gout (high uric acid) • absence of menstruation • reduced sperm volume • enlarged breasts • feeling unwell • weakness • shivering • dizziness Frequency unknown: • thromboembolism (clot formed in a blood vessel) • excessive pigmentation of oral mucosa - feeling of intense heat (hot flushes) • inflammation of the large intestine (colitis) • liver disorders (yellowing of skin and eyes, increase in liver enzyme blood test results) • tissue hypoxia (low oxygen in your tissues) (your skin may feel cold and if severe take on a bluish colour • plantar-palmar dysaesthesia (hand-to-foot syndrome is a distinctive and relatively frequent skin toxic reaction) • photosensitivity • no sperm formation • asthenia (loss or lack of bodily strength; weakness; debility) • thrombophlebitis (vein inflammation under the skin) • a stinging or burning sensation at the administration site in relation to extravasation. Extravasation can lead to local death of calls of the tissue which may require surgical measures. If you notice any of side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects If you get side effects, talk to your doctor, pharmacist or nurse . You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of DOXORUBICIN FRESENIUS. Patients are asked to report any suspected adverse drug reactions to their healthcare provider or Holder of the Certificate of Registration at the following email address: [email protected] and to the relevant medicine’s regulatory authority in the country where the product is marketed.

Store all medicines out of reach of children. Store at or below 2 - 8 °C. Do not freeze. Keep vial in carton to protect from light. Store in upright position.