Zavedos 5 mg/10 mg Solution

ZAVEDOS is used in the treatment of a type of leukaemia (blood cancer) in adults called acute non-lymphocytic leukaemia (ANLL), or acute myeloblastic leukaemia (AML). ZAVEDOS is used in combination with cytarabine for first remission induction-line treatment in children previously untreated with AML.

ZAVEDOS should not be administered to you:

• if you are hypersensitive (allergic) to idarubicin or any other ingredients of ZAVEDOS (listed in section 6)
• if you have an allergy to other similar medicines for cancer, e.g. daunorubicin, doxorubicin, epirubicin, mitozantrone
• if you have severe liver problems, including bilirubin levels exceeding 5 mg/dL (85,5 μmol/L)
• if you have severe kidney problems
• if you have severe heart problems including heart failure, abnormal heartbeat or have had a recent heart attack
• if you have decreased bone marrow activity resulting in a reduced number of red or white blood cells or platelets
• if you have previously received the full course of treatment with the maximum dose of ZAVEDOS or other similar medicines, e.g. daunorubicin, doxorubicin, epirubicin, mitozantrone
• if you have an infection which is not under control
• if you have a history of decreased bone marrow activity caused by previous therapy or radiotherapy
• if you have been given a live attenuated vaccine and the yellow fever vaccine
• if you are pregnant, trying to become pregnant or you are breastfeeding your baby (see Pregnancy and breastfeeding)

Warnings and precautions

Special care should be taken with ZAVEDOS:

• if you are still recovering from serious side effects from a previous chemotherapy treatment
• if you have a heart disease, as ZAVEDOS can have an effect on your heart function
• if you have liver disease or kidney disease
• if you have any previous or current history of stomach problems (e.g. ulcers)
• if you have recently had a vaccination

Your doctor will monitor your heart during your therapy and will take regular blood tests to measure your levels of white and red blood cells and your platelets and the enzymes produced by your liver. This will make sure your blood, liver and kidneys are functioning properly.

ZAVEDOS may affect male fertility. Talk to your doctor about fertility preservation before starting treatment. Both men and women should use effective contraception (see “Pregnancy, breastfeeding and fertility” section).

If you desire to have children after ZAVEDOS treatment, talk to your doctor about your options.

Other medicines and ZAVEDOS

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.)

ZAVEDOS sometimes affects the action of other medicines and sometimes ZAVEDOS is affected by other medicines. Make sure your doctor knows:

• if you are taking or have recently been given other medicines for cancer
• if you are taking medicines for heart problems, including calcium channel blockers, used to treat high blood pressure and angina
• if you are taking any medicines that affect the way your liver or kidneys work, e.g. some antibiotics
• if you are receiving or have received radiotherapy

Do not share medicines prescribed for you with any other person. ZAVEDOS is an anticancer medicine.

You will not be expected to give yourself ZAVEDOS. The injection will be given to you by a person who is qualified to do so. Your doctor will determine the dosage that is suitable for you. Your doctor will tell you how long your treatment with ZAVEDOS will last.

If you have the impression that the effect of ZAVEDOS is too strong or too weak for you, tell your doctor or pharmacist.

If you receive more ZAVEDOS than you should Since a healthcare provider will administer this medicine, he/she will control the dosage. However, in the unlikely event of overdosage your doctor will manage the overdosage.

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

If any of the following happens, tell your doctor immediately:

• allergic reaction (swelling of the face, lips and tongue or other parts of the body, shortness of breath, wheezing or trouble breathing)
• skin rash, itching, redness of the skin, hives
• signs of an infection such as fever, chills, cough, hoarse throat or mouth ulcers (which may be signs of leukopenia/low white blood cells)
• bleeding or bruising more easily than normal (signs of thrombocytopenia/low platelets)
• signs of anaemia (low red blood cells) such as tiredness, dizziness, looking pale
• shock
• signs of sepsis or blood poisoning such as high fever, chills, headache, confusion and rapid breathing
• chest pain, abnormal heartbeat, fast heartbeat
• swelling and redness along a vein which is extremely tender when touched, clotting in a vein
• vomiting blood or bleeding from the back passage, black sticky bowel motions (stools) or bloody diarrhoea

The above list includes very serious side effects that may require urgent medical attention.

Frequent side effects:

• headache
• stomach pain or burning sensation
• nausea, vomiting, diarrhoea, loss of appetite
• loss of hair
• red coloured urine for 1 - 2 days after treatment
• fever
• abnormal liver function tests

Less frequent side effects:

• other cancers of the blood
• dehydration
• high levels of uric acid in the blood
• inflammation of the heart muscle or of the tissue surrounding the heart
• hot flushes
• mouth ulcers, redness and irritation of the throat and mouth
• skin changes including darkening of the skin and nails
• abnormal ECG (heart test)

Other side effects:

• decreased bone marrow activity
• high blood sugar
• difficulty swallowing
• tiredness

The side effects experienced by both adults and children are similar except that children are more prone to experiencing problems with their heart when receiving ZAVEDOS treatment.

If any of the side effects are troublesome, or 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 or pharmacist. 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 ZAVEDOS.

Store all medicines out of reach of children. ZAVEDOS would be stored at a healthcare facility.

ZAVEDOS Powder for solution for injection Store at or below 25 °C. Protect from light.

Reconstituted solution for injection Should not be stored for longer than 24 hours at room temperature at or below 25 °C, or 48 hours in a refrigerator at 2 °C - 8 °C.

ZAVEDOS RTU Solution for injection RTU solution in vial Store in a refrigerator at 2 °C - 8 °C and protect from light. RTU solution in 0,9 % sodium chloride infusion ZAVEDOS RTU Solution for injection is intended for single use only and any unused portion should be discarded. However, to avoid the risk of microbial contamination, it is recommended that the solution be used as soon as possible after adding it to the 0,9 % sodium chloride infusion bag. Any remaining injection will be disposed of correctly by the nurse or doctor at the hospital.