Darbect 50 mg Solution

[PRODUCT NAME is an anti-cancer medicine. It contains the active substance ‘decitabine’. DARBECT is used to treat a type of cancer called ‘acute myeloid leukaemia’ (AML), a type of cancer that affects your blood cells. DARBECT works by stopping cancer cells from growing and it also kills cancer cells.

DARBECT should not be administered to you:

• if you are allergic to decitabine or any of the other ingredients of this medicine (listed in section 6).
• if you are breastfeeding.

Warnings and precautions

DARBECT may only be administered to you under the supervision of a medical practitioner, who specialised in oncology and has the facilities for regular monitoring, during and after therapy.

Special care with DARBECT should be taken:

• If you suffer from a condition of low platelets in your blood, low white or red blood cells
• If you suffer from lung problems
• If you suffer from liver or kidney disease
• If you suffer from heart problems

Other medicines and DARBECT:

Always tell your healthcare professional if you are taking any other medicine. (This includes all complementary or traditional medicines). Tell your doctor or pharmacist if you are currently using, have recently used or might use another medicines. DARBECT does not interfere with other medicines that you may be taking. However, some medicines may affect how DARBECT works, or DARBECT may affect how your other medicines work.

Pregnancy, breastfeeding and fertility

You should not be given DARBECT if you are pregnant as it may harm your baby. Tell your doctor immediately if you become pregnant during treatment with DARBECT.

Do not breastfeed if you are receiving DARBECT. This is because it is not known if DARBECT passes into the mother’s milk.

If you are male and receiving DARBECT you should not father a child and you should use effective contraception during treatment and for 2 months after treatment had stopped.

You should talk to your doctor if you wish to conserve your sperm before starting treatment.

If you are female and receiving DARBECT you should use effective contraception during treatment. It is unknown when it is safe for female patients to become pregnant after treatment has stopped.

Talk to your doctor if you wish to freeze your eggs before starting treatment.

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 healthcare professional for advice before being given DARBECT.

Driving and using machines

You may feel tired or weak after treatment with DARBECT. If this happens, do not drive or use any tools or machines.

You will not be expected to give yourself DARBECT. DARBECT will be administered to you under the direction of a doctor specialised in oncology (cancer treatment).

How much to receive:

• Your doctor will work out your dose of DARBECT. This depends on your height and weight (body surface area).
• The dose is 20 mg/m2 body surface area. You will receive DARBECT by intravenous infusion over 1 hour repeated daily for 5 consecutive days.
• This is called a ‘treatment cycle’
• The treatment cycle is repeated every 4 weeks. You will usually receive at least 4 treatment cycles.
• Your dose and number of cycles can change, depending on how you respond to treatment.

If you receive more DARBECT than you should:

Since a healthcare provider will administer [PROUCT NAME], he/she will control the dosage. However, in the event of overdosage, your doctor will manage any symptoms of the overdosage.

If you forget to use DARBECT:

Since a health care provider will administer DARBECT, it is unlikely that the dose will be missed.

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

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

• Fever: this may be a sign of an infection caused by low levels of white blood cells (neutropenia, febrile neutropenia, leukopenia)
• Low blood pressure, pale and cool arms and legs, chills, difficulty breathing and decreased urine output. You could be experiencing something called septic shock.
• Allergic reactions, causing breathing problems or closing of the throat
• Sudden fever and rash which consists of multiple tender red or bluish-red lesions or bumps (Sweets’ Syndrome). These are all very serious side effects. If you have them, you may have had a serious reaction to DARBECT. You may need urgent medical attention or hospitalisation.

The below side effects occur frequently:

• Pneumonia (chest pain or shortness of breath (with or without fever or cough)
• Urinary tract infection
• Viral, bacterial or fungal infections
• Septic shock, sepsis (an infection of the blood caused by bacteria – this could be due to a low level of white blood cells)
• Sinusitis
• Bleeding from gums or nose, blue or purple bruises on skin. This could be due to low platelets in your blood (thromobocytopenia).
• Low levels of iron in your blood characterised by excessive fatigue, dizziness, shortness of breath (anaemia)
• High blood sugar levels
• Headache
• Nose bleeds
• Diarrhoea
• Nausea
• Vomiting
• Mouth or tongue ulcers
• Liver problems
• Fever

The below side effects occur less frequently:

• Low red and white blood cells and platelets (pancytopenia). This will cause all of the symptoms associated with low red and white blood cells and low platelets mentioned above
• heart muscle disease
• red, raised painful patches on the skin, fever and an increase in white blood cells – these may be signs of ‘Acute Febrile Neutrophillic Dermatosis’ or ‘Sweet’s Syndrome’

The below side effects’ frequency is unknown:

• inflamed lungs (interstitial lung disease)
• inflamed gut (enterocolitis, colitis, caecitis), with symptoms of abdominal pain, bloating or diarrhoea. Enterocolitis may lead to septic complications and may be associated with a fatal outcome.

If you notice any side effects not mentioned in this leaflet, 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 Reaction 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 DARBECT.

Your doctor, nurse or pharmacist is responsible for storing DARBECT. Do not store above 25°C. Do not freeze. Protect from moisture. 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, before administration.

STORE ALL MEDICINES OUT OF REACH OF CHILDREN.

Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).