Datrenal 2,5 mg/5 mg/7,5 mg/10 mg/15 mg/20 mg/25 mg

DATRENAL belongs to a group of medicines called immunomodulatory medicines, which can modify or regulate the functioning of the immune system.

• DATRENAL in combination with dexamethasone is used to treat adult patients who have been diagnosed with multiple myeloma. Multiple myeloma is a type of blood cancer that affects the white blood cells that produce antibodies.
• DATRENAL is also used to treat adult patients who have been diagnosed with myelodysplastic syndromes. Patients with myelodysplastic syndromes have an abnormality of their bone marrow, which means they don’t make enough healthy blood cells.

Your doctor will have enrolled you in the KEY ASSIST RISK MANAGEMENT PROGRAM to ensure that DATRENAL is used safely. Do not take DATRENAL:

• if you are allergic (hypersensitive) to lenalidomide or any of the other ingredients of DATRENAL listed in the following Section: ‘What DATRENAL contains. If you think you may be allergic, ask your doctor for advice.
• if you are pregnant or think you may be pregnant or are planning to become pregnant, as DATRENAL is harmful to an unborn child.
• if you are able to become pregnant, unless you follow all the necessary measures to prevent you from becoming pregnant. If you are able to become pregnant, your doctor will record with each prescription that the necessary measures have been taken and will provide you with this confirmation. If any of these apply to you, tell your doctor before you take DATRENAL.

Warnings and precautions

Take special care/ Special care should be taken with DATRENAL:

For women taking DATRENAL

Before starting the treatment, you should ask your doctor if you are able to become pregnant, even if you think this is unlikely. If you are able to become pregnant:

• you will have pregnancy tests under the supervision of your doctor (before treatment, every 4 weeks during treatment, and 4 weeks after the treatment has finished) except in the case of confirmed tubal sterilisation.
• and you must use two effective methods of contraception for 4 weeks before starting treatment, during treatment including dose interruptions and until 4 weeks after stopping treatment. Your doctor will advise you on appropriate methods of contraception.

For men taking DATRENAL

DATRENAL passes into human semen. If your female partner is pregnant or able to become pregnant, and she doesn’t use effective methods of contraception, you must use condoms during treatment including dose interruptions and for 4 weeks after the end of treatment (even if you have undergone vasectomy). Male patients taking DATRENAL should not donate sperm or semen during treatment including dose interruptions and for 4 weeks following the end of treatment.

All patients

Before starting the treatment you should tell your doctor if you had blood clots in the past. During the treatment with DATRENAL you have an increased risk of developing blood clots in the veins and arteries. If you have Myelodysplastic syndromes, which are a group of disorders caused by blood cells that are poorly formed or don't work properly, you may be more likely to get a more advanced condition called acute myeloid leukaemia (AML). In addition, it is not known how DATRENAL affects the chances of you getting AML. Your doctor may therefore do tests to check for signs which may better predict the likelihood of you getting AML during your treatment with DATRENAL.

Before and during the treatment with DATRENAL you will have regular blood tests as DATRENAL may cause a fall in the blood cells that help fight infection and help the blood to clot. Your doctor may ask you to have a blood test:

• before treatment
• every week for the first 8 weeks of treatment
• at least every month after that.

Your doctor may adjust your dose of DATRENAL or stop your treatment based on the results of your blood tests and on your general condition. Before you start treatment you should tell your doctor if you have kidney disease. Your doctor may adjust your dose of DATRENAL based on this information.

Do not share medicines prescribed for you with any other person. Always take DATRENAL exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.

DATRENAL is taken alone or in combination with dexamethasone. Always take DATRENAL alone or DATRENAL and dexamethasone in combination exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. You should refer to the package leaflet for dexamethasone for further information on its use and effects.

The usual dose for Myelodysplastic Syndromes is: 10 mg given orally once a day on days 1-21 of repeating 28-day treatment cycles. The usual dose for Multiple Myeloma is: 25 mg/day orally on Days 1-21 of repeated 28-day cycles for multiple myeloma. The recommended dose of dexamethasone is 40 mg/day on Days 1-4, 9-12, and 17-20 of each 28-day cycle for the first 4 cycles of therapy and then 40 mg/day orally on Days 1-4 every 28 days. Your doctor will prescribe the correct dose for your condition. Your doctor may adjust your dose of DATRENAL or stop your treatment based on the results of your blood tests and on your general condition.

You should swallow the DATRENAL capsules whole, preferably with water, once a day. Do not break, open or chew the capsules. The DATRENAL capsules can be taken either with or without food.

You should take DATRENAL at about the same time each day. Your doctor will tell you how long your treatment with DATRENAL will last. Do not stop any treatment unless your doctor tells you to do so. DATRENAL is taken in treatment cycles, each cycle lasting 28 days. You should continue the cycles of treatment until your doctor tells you to stop.

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

If you take more DATRENAL than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to take DATRENAL

If less than 12 hours has elapsed since missing a dose, you can take the dose. If more than 12 hours has elapsed since missing a dose at the normal time, you should not take the dose, but take the next dose at the normal time on the following day. Do not take a double dose to make up for forgotten individual doses.

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

DATRENAL may reduce the number of white blood cells that fight infection and also the blood cells which help the blood to clot (platelets). DATRENAL may also cause blood clots in the veins (thrombosis).

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

• Swelling around the eyes or face or tongue, (which may rarely be a serious allergic reaction)
• Rash which spreads with loss of skin
• Swelling in the ankles, wrists, arms and legs
• Any fever, chills, sore throat, cough, mouth ulcers or any other symptoms of infection;
• Any bleeding or bruising in the absence of injury;
• Any chest or leg pain;
• Wheezing, any shortness of breath, dry cough

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

It is important to note that patients with multiple myeloma may develop additional types of cancer, and it is possible that this risk may be increased with DATRENAL treatment, therefore your doctor should carefully evaluate the benefit and risk when you are prescribed DATRENAL.

Tell your doctor if you notice any of the following:

Frequent side effects:

• A fall in the number of white blood cells (the cells that fight infection), platelets (the cells that help the blood to clot, which may lead to bleeding disorders) and red blood cells (anaemia leading to tiredness and weakness)
• Constipation, diarrhoea, nausea, redness of skin, rashes, vomiting, muscle cramps, muscle aches, bone pain, joint pain, tiredness, generalised swelling including swelling of the limbs
• Fever and flu like symptoms including fever, muscle ache, headache, and chills
• Numbness, tingling or burning sensation to the skin, pains in hands or feet, dizziness, tremor
• taste disturbance
• Decreased appetite, low levels of potassium in the blood
• Leg pain (which could be a symptom of blood clots (thrombosis)), chest pain, shortness of breath (which may be a symptom of blood clots in the lungs)
• Infection of the lung and the upper respiratory tract, shortness of breath, nosebleed.
• Blurred vision
• Headache
• Chest pain
• Difficulty breathing
• Infections of all types
• Infection of the sinuses that surround the nose
• Bleeding from the gums, stomach, or bowels, bruising
• Increased blood pressure or a fall in blood pressure, slow, fast or irregular heart beat
• Skin eruptions, skin cracking, flaking

Less frequent side effects:

• Bleeding in the brain
• Circulatory problems
• Certain types of cancer of the skin
• Hypersensitivity or an allergic reaction (angioedema), a type of allergic reaction that may have symptoms such as hives, rashes, swelling of eyes, mouth or face, difficulty of breathing, or itching
• Tumour lysis syndrome - metabolic complications that can occur during treatment of cancer and sometimes even without treatment

Other side effects where the frequency is not known are sudden, or mild but worsening pain in the upper abdomen and/or back, which remains for a few days, possibly accompanied by nausea, vomiting, fever and a rapid pulse - these symptoms may be due to inflammation of the pancreas.

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. This includes any possible side effects not listed in this leaflet. You can also report side effects via https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of DATRENAL.

STORE ALL MEDICINES OUT OF REACH OF CHILDREN.

DATRENAL will be stored in the pharmacy.

Store at or below 25 °C. Keep the container in the outer carton in order to protect from light. Do not use after the expiry date stated on the vial and the carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).