Elodyst 50 mg Solution

ELODYST contains the active substance decitabine. Decitabine is an anti-cancer medicine, used to treat patients with acute myeloid leukaemia (AML). This is a type of cancer that affects your blood cells. You will use ELODYST when you are first diagnosed with AML. It is used in adults for 65 years and older. ELODYST works by stopping cancer cells from growing. It also kills cancer cells.

ELODYST should not be administered to you:

• if you are hypersensitive (allergic) to decitabine or to any of the other ingredients of ELODYST (listed in section 6).
• if you are breastfeeding your baby (see Pregnancy, breastfeeding and fertility).

Warnings and precautions

Before you start your treatment with ELODYST, you will have blood tests to check that you have enough blood cells and sufficient liver and kidney functions to receive ELODYST. Tell your doctor or health care provider before being given the ELODYST:

• If you have low number of platelets, red blood cells or white blood cells,
• If you have an infection.
• If you have a liver disease.
• If you have a serious kidney disorder
• If you have a heart disease

If any of the above applies to you (or you are not sure), tell to your doctor or healthcare provider immediately before you are given ELODYST.

Children and adolescents

ELODYST is not for use in children or adolescents.

Other medicines and ELODYST

Always tell your health care provider if you are taking any other medicine. (This includes complementary or traditional medicines). This is because ELODYST can affect the way how other medicines work or some medicines can affect the way ELODYST works.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before receiving ELODYST.

You will not be expected to give yourself ELODYST. It will be given to you by a person who is qualified to do so. The solution is given into a vein (as an infusion).

Your doctor will work out your dose of ELODYST. This depends on your height and weight (body surface area).

5 - Day Treatment Regimen

ELODYST is given by intravenous infusion over 1 hour, repeated daily for 5 days. This is one treatment cycle. There is a gap between treatment cycles of about 4 weeks. Before each treatment cycle you will have a blood test to see if you are well enough for treatment. You will usually receive at least 4 treatment cycles. Your doctor may change or delay your dose and change the total number of cycles, depending on how you respond to the treatment.

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

If you missed a dose of ELODYST Since health care provider will administer ELODYST, it is unlikely that the dose will be missed.

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

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

• ‘swelling of your hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing’,
• ‘rash or itching’,
• ‘fainting’

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to ELODYST. 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:

Frequent:

• Chest pain or shortness of breath (with or without fever of cough) these may be signs of an infection of the lung called pneumonia
• Urinary tract infection
• Other infection in any part of the body, caused by bacteria, virus or fungi
• Decrease in the number of red blood cells (anaemia) – feeling tired or looking pale
• Decrease in the number of white blood cells (neutropenia, leucopaenia) – you might get a fever and are more likely to get infections
• Decrease in the number of blood platelets – which results in increased risk of bleeding or bruising
• Lack of white blood cells associated with fever and infection
• Bleeding, including blood in the stools – this may be a sign of bleeding in the stomach or gut
• Bleeding inside your head. Symptoms of this may be difficulty with moving, speaking or understanding or seeing; sudden severe headache, seizure, numbness or weakness in any part of the body
• Difficulty breathing, swelling of the lips. Itching or rash. This may be due to an allergic (hypersensitivity) reaction
• Nose bleeds
• Inflammation of the mucous membrane of the mouth (stomatitis)

Less frequent:

• Red, raised painful skin rash that appears mostly on the arms, face and neck and fever. These may be signs of acute febrile neutrophilic dermatosis or “Sweet’s Syndrome”

Frequency unknown:

• High level of sugar in the blood
• Heart muscle disease
• Abnormal liver function
• High levels of bilirubin in the blood
• Mouth or tongue ulcers
• Sore or runny nose, sore sinuses
• Interstitial lung disease (an umbrella term used for a large group of diseases that cause scarring (fibrosis) of the lungs
• Enterocolitis (an inflammation that occurs in a person’s digestive tract

These are all serious side effects. You may need urgent medical attention. Tell your doctor as soon as possible if you notice any of the following:

Frequent:

• Headache
• Loose or watery stools (diarrhoea)
• Feeling sick (nausea)
• Being sick (vomiting)
• feeling of tension or fullness in the nose, cheeks and behind your eyes, sometimes with a throbbing ache.Sometimes may also get fever, stuffy nose and loss of the sense of smell (sinusitis)
• Septic shock (a life-threatening condition that happens when your blood pressure drops to a dangerously low level after an infection)
• Sepsis (the body’s overwhelming and life-threatening response to infection that can lead to tissue damage, organ failure and 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 or pharmacist. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za. or to the Holder of certificate of registration through the mail: [email protected]. By reporting side effects, you can help provide more information on the safety of ELODYST.

• Store at or below 25 °C. Do not freeze the reconstituted solution.
• Store all medicines out of reach of children.
• Protect from light and moisture.
• Keep the vial in the outer carton until required for use.
• After reconstitution, the concentrate must be further diluted within 15 minutes using cold infusion fluids. This prepared diluted solution can be stored refrigerated at 2°C - 8°C for up to a maximum of 4 hours, followed by up to 1 hour at room temperature before administration.
• Do not store in a bathroom.
• Do not use after the expiry date stated on the label / carton / vial.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).
• For single use only. Discard any unused contents.