Revolade 25 mg/50 mg Film-Coated Tablets

REVOLADE contains eltrombopag, which belongs to a group of medicines called thrombopoietin receptor agonists. It is used to help increase the number of platelets in your blood.

What REVOLADE is used for

REVOLADE is a medicine that may help to increase the number of platelets, a type of blood cell that helps to reduce or prevent bleeding. It is used to treat a bleeding disorder known as immune (primary) thrombocytopenia (ITP) in patients aged 1 year and above who have already taken other medicines (corticosteroids or immunoglobulins), which have not worked. REVOLADE may also be used to treat adult patients with low blood counts caused by severe aplastic anaemia (SAA). SAA is a disease in which the bone marrow is damaged, causing a deficiency of the red blood cells (anaemia), white blood cells (leukopenia) and platelets (thrombocytopenia).

Do not take REVOLADE if you:

• are allergic (hypersensitive) to eltrombopag olamine, or any of the excipients of REVOLADE
• are pregnant or plan to become pregnant
• are breastfeeding.

Warnings and precautions

Talk to your doctor before taking REVOLADE:

• if you have liver problems. People who have low platelet counts as well as advanced chronic (long-term) liver disease are more at risk of side effects, including life-threatening liver damage and blood clots. If your doctor considers that the benefits of taking REVOLADE outweigh the risks, you will be closely monitored during treatment
• If you have a history of thrombosis (formation of a clot inside a blood vessel, obstructing the flow of blood), or you know that thrombosis has occurred in your family: You may be at higher risk of blood clots:
• as you get older
• if you have had to stay in bed for a long time
• if you have cancer
• if you are taking the contraceptive birth control pill or hormone replacement therapy
• if you have recently had surgery or sustained a physical injury
• if you are very overweight (obese)
• if you are a smoker
• if you have advanced chronic liver disease
• If any of these apply to you, tell your doctor before starting treatment. You should not take REVOLADE unless your doctor considers that the expected benefits outweigh the risk of blood clots.

If you have cataracts (the lens of the eye getting cloudy)

have problems with your bone marrow

have bleeding after you stop treatment

have kidney disease. Liver problems: REVOLADE may damage your liver and cause serious, even life-threatening, illness. You must have blood tests to check your liver before you start taking REVOLADE and during treatment. Your doctor will order these blood tests. In some cases REVOLADE treatment may need to be stopped.

Bleeding after you stop treatment: When you stop taking REVOLADE, your blood platelet count will drop back down to what it was before you started taking REVOLADE. These effects are most likely to happen within 4 weeks after you stop taking REVOLADE. The lower platelet counts may increase your risk of bleeding. Your doctor will check your platelet counts for at least 4 weeks after you stop taking REVOLADE.

Problems with your bone marrow: People with the disease for which you are being treated may have problems with their bone marrow. REVOLADE could make this problem worse. Signs of bone marrow changes may show up as abnormal results in your blood tests. Your doctor may also carry out tests to directly check your bone marrow during treatment with REVOLADE.

Always take REVOLADE exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

REVOLADE should be taken at least 2 hours before or at least 4 hours after taking antacids, dairy products or other mineral supplements such as aluminium, calcium, iron, magnesium, selenium and zinc. One way to avoid issues with these products would be to take them in the morning and REVOLADE in the evening.

How much to take

For ITP

Adults and children (6 to 17 years) – the usual starting dose for ITP is one 50 mg REVOLADE tablet a day. If you are of East/Southeast-Asian origin you need to start at a lower dose of 25 mg. Children (1 to 5 years) — the usual starting dose for ITP is one 25 mg tablet of REVOLADE a day.

For SAA

Adults – the usual starting dose for SAA is one 50 mg tablet of REVOLADE a day. If you are of East/Southeast-Asian origin you need to start at a lower dose of 25 mg. Based on your response to REVOLADE your doctor will adapt the dose and may recommend that your daily dose of REVOLADE be increased or decreased. Please expect that at the beginning of therapy your platelet count and other routine blood parameters will need to be monitored frequently. Your doctor will also carry out blood tests to check your liver function before and during treatment with REVOLADE.

How to take REVOLADE tablets

Swallow the tablet whole, with some water.

When to take REVOLADE

Make sure that – in the 2 hours before you take REVOLADE and the 4 hours after you take REVOLADE you don’t consume any of the following:

• dairy foods such as cheese, butter, yoghurt or ice cream
• milk or milk shakes, drinks containing milk, yoghurt or cream
• antacids, a type of medicine for indigestion and heartburn
• some mineral and vitamin supplements including iron, calcium, magnesium, aluminium, selenium and zinc

If you do, the medicine will not be properly absorbed into your body.

If you take more REVOLADE than you should: In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. If possible show them the pack, or this leaflet. You will be monitored for any signs or symptoms of side-effects and given appropriate treatment immediately.

If you forget to take REVOLADE: Do not take a double dose to make up for a forgotten dose on a given day; simply resume your dosing with the next scheduled dose the following day. If you have any further questions on the use of REVOLADE, ask your doctor or pharmacist.

Once you have started using REVOLADE: Do not stop taking REVOLADE until your doctor advises you to do so. If your doctor advises you to stop treatment with REVOLADE, your platelet count will then be checked each week for four weeks. If you have any problems/questions regarding the use of REVOLADE, please consult with your doctor.

REVOLADE can cause side-effects. Not all side-effects reported for REVOLADE are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking this medicine, please consult your doctor, pharmacist or other health care provider for advice.

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

• swelling of the hands, feet, ankles, face, lips, 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 REVOLADE. You may need urgent medical attention or hospitalisation.

REVOLADE may cause serious side-effects: Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Liver problems: REVOLADE may damage your liver and cause serious, even life-threatening, illness. Tell your doctor right away if you have any of these signs and symptoms of liver problems:
• yellowing of the skin or the whites of the eyes (jaundice)
• unusual darkening of the urine
• unusual tiredness
• right upper stomach area pain.
• Bleeding after you stop treatment: When you stop taking REVOLADE, your blood platelet count will drop back down to what it was before you started taking REVOLADE. Tell your doctor or pharmacist if you have any bruising or bleeding after you stop taking REVOLADE.
• High platelet counts and higher chance for blood clots: You have a higher chance of getting a blood clot if your platelet count is too high during treatment with REVOLADE. Tell your doctor right away if you have signs and symptoms of a blood clot in the leg, such as swelling or pain/tenderness of one leg.

These are all serious side-effects. You may need urgent medical attention. The following side-effects have been reported to be associated with treatment with REVOLADE in adult patients with ITP.

Frequent side effects

• common cold
• feeling sick (nausea)
• diarrhoea
• cough
• infection in the nose, sinuses, throat and upper airways, common cold (upper respiratory tract infection)
• muscle pain, muscle spasm, muscle weakness
• back pain
• bone pain
• heavy menstrual period
• sore throat and discomfort when swallowing
• eye problems including abnormal eye test, dry eye, eye pain and blurred vision
• vomiting
• flu (influenza)
• cold sore
• pneumonia
• irritation and inflammation (swelling) of the sinuses
• inflammation (swelling) and infection of the tonsils, infection of the lungs, sinuses, nose and throat, bladder
• inflammation of the gum tissue
• loss of appetite
• feeling of tingling, prickling or numbness, commonly called “pins and needles”
• feeling drowsy
• ear pain
• pain, swelling and tenderness in one of your legs (usually the calf) with warm skin in the affected area (signs of a blood clot in a deep vein)
• localised swelling filled with blood from a break in a blood vessel (haematoma)
• mouth problems including dry mouth, sore mouth, sensitive tongue, bleeding gums, mouth ulcers
• runny nose
• toothache
• stomach pain and tenderness
• liver problems
• skin changes including excessive sweating, itching bumpy rash, red spots, changes in appearance of the skin
• hair loss
• foamy, frothy or bubbly-looking urine (signs of protein in urine)
• generally feeling unwell, have a high temperature, feeling hot
• chest pain
• problems sleeping, depression
• migraine
• decreased vision
• spinning sensation (vertigo)
• digestive wind/gas

Store all medicines out of reach of children.

Store at or below 30 °C. Do not remove blisters from the carton until required for use. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).