Daunoblastin 20 mg Injection

DAUNOBLASTIN belongs to a group of anti-cancer medicines known as cytotoxic anthracycline antibiotics. It is used for chemotherapy either alone or in combination with other anti-cancer medicines to treat leukaemia (cancer of the blood and bone marrow). It works by preventing the growth of cancer cells and eventually destroying them.

DAUNOBLASTIN should not be administered to you:

• if you are hypersensitive (allergic) to daunorubicin hydrochloride, other medicines from the same group (anthracyclines or anthracenediones) or any of the other ingredients of DAUNOBLASTIN (listed in section 6)
• if you have long-term, reduced bone marrow function (blood cell production)
• if you have a low blood count following previous chemotherapy or radiotherapy
• if you have heart disease or heart problems, have recently had a heart attack, experienced chest pain or have a severe form of irregular heartbeat (dysrhythmia)
• if you have previously received the total permissible dose of DAUNOBLASTIN or any other medicine from the same group
• if you have severe infections
• if you have severe liver or kidney problems
• if you are pregnant or breastfeeding
• if you have mouth ulcers

Warnings and precautions

Tell your doctor if you have or have had heart disease or have high blood pressure. The elderly, children and infants are at the greatest risk of heart failure when being treated with DAUNOBLASTIN. The doctor will carefully monitor your heart function before, during and after treatment in order to detect signs of damage as early as possible and to start appropriate treatment in a timely manner.

Tell your doctor if you have liver problems or kidney problems. You should not be given this medicine if you have severe liver or kidney problems. Your doctor may need to monitor your liver or kidney function and adjust the DAUNOBLASTIN dose if necessary.

Tell your doctor if you are having or have had radiotherapy or if you are having or have had treatment with other anti-cancer medicines.

Do not share medicines prescribed for you with any other person. You will not be expected to give yourself DAUNOBLASTIN. It will be given to you by a person who is qualified to do so.

DAUNOBLASTIN is given as a slow intravenous (into a vein) infusion drip. Your doctor will decide what dose, how often and how long you will receive Daunoblastin. This depends on your condition and other factors, such as your weight and height, age, blood tests, how well your liver is working and whether or not other medicines are being given to you at the same time.

If you have the impression that the effect of DAUNOBLASTIN is too strong or too weak, tell your doctor, nurse or health care provider.

If you receive more DAUNOBLASTIN than you should Since a health care provider will administer DAUNOBLASTIN, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

If you forget to use DAUNOBLASTIN Since a health care provider will administer DAUNOBLASTIN, it is unlikely that the dose will be missed.

DAUNOBLASTIN can have side effects. Not all side effects reported for DAUNOBLASTIN are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving DAUNOBLASTIN, please consult your health care provider for advice.

If any of the following happens, stop receiving DAUNOBLASTIN and tell your doctor immediately or go to the casualty department at your nearest hospital:

• difficulty in breathing or any swelling - these are signs of an allergic reaction
• infections, fever, severe chills, sore throat, mouth ulcers - this can be caused by reduced white blood cells
• sores in mouth and on lips, heartburn, or difficulty swallowing
• unusual bruising or bleeding - this may be caused by reduced platelets in your blood
• heart problems (shortness of breath, blue or purple lips or skin, swollen ankles, feet or stomach are signs of heart problems)
• burning, stinging, hotness, redness or pain where the injection is being given
• abdominal pain
• swelling, redness or tenderness in the vein
• itchy rash or skin reaction

These are all very serious side effects. If you have them, you may have had a serious reaction to DAUNOBLASTIN. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

Frequent side effects

• infection in the blood/blood poisoning
• reduced blood cell production (bone marrow failure)
• low blood cell and platelet counts which may cause tiredness, fever or increased risk of bleeding
• nausea
• vomiting
• diarrhoea
• pain when swallowing (due to inflammation of the food pipe)
• inflammation and ulceration of the mucous membranes lining the digestive tract
• inflammation of the mouth and lips
• mouth ulcers
• stomach pain
• temporary hair loss (after your treatment finishes your hair should grow back)
• general pain
• increased blood bilirubin, aspartate aminotransferase and blood alkaline phosphatase (shown in blood tests)
• abnormal ECG (heart monitor results)
• irregular heartbeat
• increase or decrease of heart rate

Less frequent side effects

• cancer of the white blood cells (acute myeloid leukaemia)
• heart attack

Side effects with unknown frequency

• septic shock ( an infection in your blood that can cause changes in how you feel and how your organs work). Symptoms of septic shock may include feeling dizzy, cold, clammy and pale skin, chills, difficulty breathing, feeling confused.
• dehydration
• high levels of uric acid in the blood (symptoms of which may be pain and swelling of the joints)
• reduced blood flow to the heart resulting in chest pain (angina pectoris), thickening/hardening of the heart muscle, inflammation in and around the heart, abnormal/irregular heart rhythm
• flushing of the face (hot and red)
• shock ( symptoms of shock may include weakness, fast heart rate, fast breathing, sweating, anxiety and increased thirst)
• thickening of the vein if frequently used for the site of injection
• lack of oxygen to bodily tissues
• colitis (inflammation of the colon and rectum)
• inflammation of the skin (contact dermatitis)
• sunburn type rash at the site of radiation treatment
• discolouration of skin and nails
• itchy bumps on your skin
• red coloured urine (lasts 1 - 2 days after treatment)
• absence of menstruation in women
• low sperm count in men
• death

If you notice any 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 “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of DAUNOBLASTIN.

Store all medicines out of reach of children.

Freeze - dried product Store at or below 25 °C and protect from light.

Reconstituted solution Stable for 24 hours when stored at room temperature (or below 25 °C). Stable for 48 hours when refrigerated (2 °C - 8 °C).