Zavedos capsules 5 mg – patient leaflet, side effects, dosage

1. What Zavedos is and what it is used for

• Zavedos contains an active ingredient called idarubicin hydrochloride, which belongs to a group of medicines called anthracyclines. Zavedos interferes with ways in which the cells of your body grow and increase in number and is used in the treatment of cancers (chemotherapy).
• Zavedos is used for the treatment of acute non-lymphoblastic leukaemia (ANLL) also referred to as acute myelogenous leukaemia (AML), or advanced breast cancer.

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 take Zavedos

Do not take Zavedos if:

• You have ever had an allergic (hypersensitivity) reaction to idarubicin or any of the other ingredients of this medicine (listed in section 6) or other anthracyclines.
• You have an infection which is not under control.
• Your liver or kidneys are not working properly.
• You have had previous or current history of bone marrow depression caused by previous therapy.
• You have had a previous or current history of heart disease.
• You have had a previous or current history of abnormal heart rhythms.
• You have previously been treated with high doses of idarubicin hydrochloride and/ or other anthracyclines or anthracenediones.
• You are breast-feeding.

Warnings and precautions

Talk to your doctor or pharmacist before taking Zavedos:

• If you suffer from bone marrow depression caused by previous therapy.
• If you have suffered from heart trouble in the past or are presently receiving treatment for this.
• If you have had a previous or current history of stomach problems (e.g. ulcer) or any problem with your bowels.
• 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 Zavedos for up to 7 months after you have stopped taking trastuzumab. If Zavedos is used before this time, then your heart function should be carefully monitored.

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, breast-feeding and fertility” section). If you desire to have children after Zavedos treatment, talk to you doctor about your options. Your doctor will assess your health and discuss the risk and benefits of your treatment carefully before prescribing Zavedos capsules to you.

Zavedos might not be a suitable treatment for you, or a reduced dose might have to be used. Zavedos might not be a suitable treatment for infants or children as they are more at risk of heart trouble.

Other medicines and Zavedos

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines:

• If you are given medicines or were previously given medicines such as anthracyclines or anthracenediones that have a similar action to Zavedos. They can make the effects of Zavedos stronger.
• If you are using Zavedos with medicines like calcium channel blockers or chemotherapies that have cardiac toxicity.
• If you are receiving radiotherapy.
• If you are taking oral drugs that prevent blood clots as it will require close monitoring.
• If you are taking a medicine called Cyclosporin A.

You should not take live or live-attenuated vaccines (e.g. yellow fever) because of the risk of serious infection after treatment with chemotherapy.

Zavedos with food and drink

Zavedos capsules may be taken with a light meal.

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 taking this medicine.

Pregnancy

Avoid becoming pregnant while you or your partner is being treated with Zavedos.

Zavedos may harm an unborn baby, so it is important to tell your doctor if you think you are pregnant. Contraception in women of childbearing potential

You should always use effective birth control (contraception) whilst receiving Zavedos and for at least 6.5 months after the last dose. Talk to your doctor about birth control methods that are right for you and your partner. Contraception in men

Men should always use effective contraception whilst receiving Zavedos and for at least 3.5 months after the last dose. Breast-feeding

Do not breast-feed whilst receiving Zavedos and for at least 14 days after the last dose, as some of the medicine may get into your milk and possibly harm your child.

Fertility

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

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Special care should be taken if it is essential that you drive or operate machinery while undergoing treatment especially if you are lacking strength or are in a debilitated condition.

3. How to take Zavedos

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Zavedos capsules are taken by mouth.

• Your doctor will prescribe the required amount (the dose). The dose is decided by taking into account your condition being treated, your height and weight.
• From your height and weight the doctor will work out your body surface area (in square metres); this is necessary because the dose is usually calculated as ‘…milligrams per square metre’ (mg/m²).
• The dose will be given daily for three days (or on one day only for breast cancer).
• However, your doctor may alter the dose and number of days depending on your condition and any other treatment you may receive.
• The capsules should be swallowed whole with some water and should not be sucked, bitten or chewed. Regular checks by your doctor during Zavedos treatment

During treatment your doctor will be making regular checks of:

• Your blood, to check for low blood cell counts that may need treatment.
• Your heart function, as Zavedos can have effects upon this.
• Your liver - again using blood tests - to check that Zavedos is not affecting the way it functions in a harmful way.
• Blood uric acid levels - Zavedos 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.

You will find more information on some of these effects in Section 4.

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If you take more Zavedos than you should

The single-dose packaging is designed to minimise the risk of overdose.

Intestinal bleeding can occur with high doses of Zavedos. This may need to be observed for patients treated with oral idarubicin. However if you take more Zavedos than you should, then seek medical attention.

If you forget to take Zavedos

If you forget to take Zavedos take it as soon as you can. Take your next dose at the right time. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor immediately if you experience any of the following symptoms after taking this medicine. Although they are very rare the symptoms can be severe.

• You may have allergic reactions such as feel dizzy, feverish, short of breath with a tight chest, with or without an itchy rash.
• You have an inflammation of the pericardium (the fibrous sac surrounding the heart), inflammation of the heart muscle, a disease of the electrical system of the heart.
• A condition in which a blood clot that has formed inside a blood vessel or inside the heart, redness of the skin, typically over the cheeks or neck.
• Stomach ulcer (abdominal pain or burning sensation).
• Hand foot syndrome (tingling, redness, flaking, swelling or small sores on the palms of the hands or soles of the feet).
• Anaemia (low red cells) that can leave you feeling tired and lethargic.
• Leukopenia (low white cells) leading to increased chance of infections with symptoms of raised temperature or fever and chills (like flu).
• Thrombocytopenia (low platelets, these help the blood to clot). You may bruise more easily or bleed more than usual if you hurt yourself.
• Tumour lysis syndrome (severe infections can occur after treatment with idarubicin alone or in combination with other medicines, and may be fatal).

Very common (may affect more than 1 in 10 people)

• Infections.
• Decrease in number of red blood cells, reduced numbers of white blood cells, abnormally low amount of platelets.
• A lack or loss of appetite for food.
• Feeling sick or being sick, the painful inflammation and ulceration of the mucous membranes lining the digestive tract, diarrhoea, stomach ache.
• Hair loss.
• Red colouration of urine.
• Fever (rise in temperature).
• Headache.
• Chills.

Common (may affect up to 1 in 10 people)

• Increase or decrease in heart rate, irregular heart beat/pulse, heart failure, heart attack.
• Inflammation of the vein, swelling (inflammation) of a vein caused by a blood clot.
• Bleeding from the intestines, bellyache.
• Liver enzyme elevation.
• Rash, itch.
• Haemorrhages.
• Increased sensitivity of irradiated skin ‘radiation recall reaction’.

Uncommon side effects (may affect up to 1 in 100 people)

• Blood infection, bacteria in the blood.
• Cancers of blood such as secondary leukaemia or unfavourable leukaemia (acute myeloid leukaemia (AML) or myelodysplastic syndrome (MDS)).
• Painful joints due to increased uric acid levels in your blood (gouty arthritis).
• ECG changes.
• Shock.
• Inflammation of the oesophagus, inflammation of the colon.
• Darkening of the skin and nails.
• Excessive loss of body fluid.
• Spreading of bacterial infection below the skin surface and tissue damage.
• Heart attack.
• Hives.

Rare side effects (may affect up to 1 in 1,000 people)

• Stroke

Very Rare side effects (may affect up to 1 in 10,000 people)

• Serious allergic reaction.
• Inflammation of the pericardium (the fibrous sac surrounding the heart), defect in the heart’s electrical system.
• Minor ulceration of the gastric mucosa.
• Hand foot syndrome.
• Inflammation of covering of the heart and heart muscle.

Not known (frequency cannot be estimated from the available data

• Change in certain chemicals in the blood.
• Abnormally low levels of all blood cells produced by the bone marrow.

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 directly 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 Zavedos

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date, which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Store in a dry place.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Zavedos contains

The active substance is idarubicin hydrochloride.

The other ingredients are microcrystalline cellulose and glyceryl palmito-stearate.

Capsule shell: red iron oxide (E172), titanium dioxide (E171) and gelatin.

Printing ink: shellac, propylene glycol, black iron oxide (E172), strong ammonia solution and potassium hydroxide. What Zavedos looks like and the contents of the pack

Zavedos are capsules containing 5 mg or 10 mg of the active substance idarubicin hydrochloride and are packaged singly in amber glass bottles.

5 mg capsules: Opaque, red cap and red body

10 mg capsules: Opaque, red cap and white body

The capsules are packed in amber glass bottles.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK.

Manufacturer:

Corden Pharma Latina S.p.A

Via Murillo, 7

04013 Sermoneta,

Latina, Italy

Company Contact address:

If you have any comments on the way this leaflet is written, please contact Medical Information at Pfizer Ltd., Walton Oaks, Tadworth, Surrey, UK. Telephone: 01304 616161.

This leaflet was last revised in 11/2021.

Ref: ZD 17_0 2020-0013093A

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