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film-coated tablets
Eltrombopag olamine
Consumer Medicine Information
Disclaimer
This information answers some common questions about REVOLADE.
It does not contain all the available information. It does not take the place of talking to your doctor or
pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking REVOLADE against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
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 idiopathic thrombocytopenic purpura (ITP). ITP is the condition of having a low platelet count (thrombocytopenia).
ITP patients may suffer from an increased risk of bleeding.
Symptoms/signs patients with ITP may notice are petechiae (pinpoint sized flat round red spots under the
skin), purpura (bruising), nosebleeds, bleeding gums and not being able to control bleeding if cuts or injuries occur.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed it for another reason.
Before you take REVOLADE
You must not take REVOLADE:
• if you are allergic (hypersensitive) to eltrombopag olamine or to any other ingredients of REVOLADE (listed at the end of this information piece).
Check with your doctor if you think this may apply to you.
Tell your doctor if you:
• have liver problems. You may need a lower dose of REVOLADE
• have risk factors for thrombosis (formation of a clot inside a blood vessel, obstructing the flow of blood), or you know that thrombosis occurs frequently in your family
• have a history of cataracts (problems with sight)
• are pregnant or plan to become pregnant
• are breast feeding.
Taking other medicines
There are certain groups of medicines, including prescription and non-prescription medicines and vitamins that interact with REVOLADE that you should not take at the same time or that require a dose adjustment while receiving a course of REVOLADE.
These medications include some products within the following groups:
• antacid medicines to treat stomach ulcers or heartburn
• certain drugs used to lower cholesterol (statins)
• minerals such as aluminium, calcium, iron, magnesium, selenium and zinc which may be found in mineral supplements and complementary medicines.
Your doctor will review the medicines you are currently taking to make sure you are not taking something that cannot be taken with the REVOLADE. If you require any of these medications and a suitable substitute is not available, please discuss this with your doctor.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Taking REVOLADE with food and drink
REVOLADE is affected by calcium intake. REVOLADE may be taken with food low in calcium such as:
• fruits such as pineapple, raisins and strawberries
• lean ham, chicken or beef
• unfortified fruit juice, soy milk and grain. (Unfortified means no added calcium, magnesium or iron).
Please discuss this matter with your doctor; they will be able to advise on the most suitable meals to be eaten while you are taking REVOLADE.
Don't take REVOLADE during the 4 hours before or after you take:
• antacid medication to treat indigestion
• mineral supplements, such as aluminium, calcium, iron, magnesium, selenium or zinc
• dairy products.
If you do, the medicine will not be properly absorbed into your body.
One way to avoid issues with these products would be to take them in the morning and REVOLADE in the
evening. Ask your doctor or pharmacist for advice if you are unsure.
Pregnancy and breast-feeding
You should avoid becoming pregnant while taking REVOLADE because the effect of REVOLADE on pregnancy is not known. You should use a reliable method of contraception (a way to prevent you from becoming pregnant).
If you become pregnant during treatment, tell your doctor.
Breast feeding is not recommended while you are taking REVOLADE. It is not known whether REVOLADE
passes into breast milk.
Ask your doctor or pharmacist for advice before taking any medicine if you are unsure.
Cataracts
In animal studies it was found that REVOLADE caused the development of cataracts (a clouding of the lens in the eye). In trials in humans however, no increased risk in the incidence of cataracts has been seen so far. Your doctor may recommend that you are checked for cataracts as part of any routine eye examination.
How to take REVOLADE
Always take REVOLADE exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
How much to take and when to take it
REVOLADE should be taken at least 4 hours before or at least 4 hours after antacids, dairy products or some mineral supplements such as iron, calcium, magnesium, aluminium, selenium and zinc.
One way to avoid issues with these products would be to take them in the morning and REVOLADE in the
evening.
The usual dose is one 50 mg REVOLADE tablet a day. 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.
East Asian patients (Chinese, Japanese, Taiwanese and Korean) may need to start at a lower dose.
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 it
Swallow REVOLADE with a glass of water.
If you take more REVOLADE than you should (overdose)
Immediately telephone your doctor or the Poisons Information Centre (In Australia call 13 11 26. In New Zealand call 0800 POISON or 0800764 766) for advice, or go to Accident and Emergency at the
nearest hospital, if you think that you or anyone else may have taken too much REVOLADE. Do this
even if there are no signs of discomfort or poisoning. If you are not sure what to do, contact your doctor or pharmacist.
If you forget to take REVOLADE
Do not take a double dose to make upfor a forgotten dose.
Once you have started taking REVOLADE
Do not stop taking REVOLADE before talking to your doctor or pharmacist.
After you have stopped taking REVOLADE, your bleeding symptoms may come back. Tell your doctor or pharmacist if you have any bleeding in the 4 weeks after you stop taking REVOLADE.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
What are the possible side-effects
Like all medicines, REVOLADE can cause side effects, although not everybody gets them.
The following side effects have been reported to be associated with treatment with REVOLADE.
Very common side effects
These may affect more than 1 in 10 people treated with REVOLADE.
• Nausea and diarrhoea
Common side effects
These may affect up to 1 in 10 people treated with REVOLADE.
• Increase of liver enzymes called aspartate and alanine transaminases,
• Dry mouth
• Vomiting
• Alopecia (unusual hair loss or thinning)
• Rash
• Back pain
• Musculoskeletal chest pain, musculoskeletal pain (pain that affects muscles and tendons along with bones)
• Myalgia (aching muscles)
• Pharyngitis (sore throat and discomfort when swallowing)
• Urinary tract infection (infection in the system that produces urine).
Tell your doctor immediately if you get any of these symptoms. These symptoms may persist after you stop
taking REVOLADE.
You may have problems with your bone marrow
People with the disease for which you are being treated may have problems with their bone marrow.
Medicines like REVOLADE could make this problem worse. Your doctor may also carry out tests to check your bone marrow during treatment with 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, but blood clots can occur with normal or even low platelet counts.
If you have cirrhosis of the liver you are at risk of a blood clot in a blood vessel that feeds your liver (portal vein thrombosis). You may have severe complications from some forms of blood clots, such as clots that travel to the lungs or that cause heart attacks or strokes.
Your doctor will check your blood platelet counts, and change your dose or stop REVOLADE if your platelet counts get too high.
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.
If any of the side effects listed in this leaflet get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Tell your doctor or pharmacist if you have any bleeding in the 4 weeks after you stop taking REVOLADE.
Storage
Do not store above 30°C.
Keep out of the reach and sight of children.
Do not use REVOLADE after the expiry date which is stated on the carton.
Disposal
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
Product description
What REVOLADE looks like
REVOLADE is presented in packs of 28 tablets.
25 mg tablets
REVOLADE film-coated tablets are round, biconvex, white, debossed with 'GS NX3' and '25' on one side.
50 mg tablets
REVOLADE film-coated tablets are round, biconvex, brown, debossed with 'GS UFU' and '50' on one side.
Ingredients
REVOLADE contains the active ingredient eltrombopag olamine.
REVOLADE also contains hypromellose, macrogol 400, magnesium stearate, mannitol, cellulose - microcrystalline, povidone, sodium starch glycollate, titanium dioxide (E171).
25 mg
The 25 mg tablet also contains polysorbate 80.
50 mg
The 50 mg tablet also contains iron oxide red CI77491 (E172) and iron oxide yellow CI77492 (E172).
Supplier
Your REVOLADE is supplied by:
GlaxoSmithKline Australia Ltd
Level 4, 436 Johnston St,
Abbotsford, Victoria, 3067
AUSTRALIA.
or
GlaxoSmithKline NZ Ltd
Auckland, NEW ZEALAND
Where to go for further information
Pharmaceutical companies are not in a position to give people an individual diagnosis or medical advice.
Your doctor or pharmacist is the best person to give you the individual advice you need.
In Australia: For more information on REVOLADE please go to www.gsk.com.au/revolade or your doctor or pharmacist.
In New Zealand: For more information on REVOLADE please go to www.medsafe.govt.nz or your doctor or pharmacist.
This information was prepared on 14 September 2011.
The information provided applies only to REVOLADE.
REVOLADE is a registered trade mark of the GlaxoSmithKline Group of Companies.
25 mg tablets AUST R 158419
50 mg tablets AUST R 158356
© 2011 GlaxoSmithKline Australia
Version 5.0
Eltrombopag olamine
Consumer Medicine Information
Disclaimer
This information answers some common questions about REVOLADE.
It does not contain all the available information. It does not take the place of talking to your doctor or
pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking REVOLADE against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
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 idiopathic thrombocytopenic purpura (ITP). ITP is the condition of having a low platelet count (thrombocytopenia).
ITP patients may suffer from an increased risk of bleeding.
Symptoms/signs patients with ITP may notice are petechiae (pinpoint sized flat round red spots under the
skin), purpura (bruising), nosebleeds, bleeding gums and not being able to control bleeding if cuts or injuries occur.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed it for another reason.
Before you take REVOLADE
You must not take REVOLADE:
• if you are allergic (hypersensitive) to eltrombopag olamine or to any other ingredients of REVOLADE (listed at the end of this information piece).
Check with your doctor if you think this may apply to you.
Tell your doctor if you:
• have liver problems. You may need a lower dose of REVOLADE
• have risk factors for thrombosis (formation of a clot inside a blood vessel, obstructing the flow of blood), or you know that thrombosis occurs frequently in your family
• have a history of cataracts (problems with sight)
• are pregnant or plan to become pregnant
• are breast feeding.
Taking other medicines
There are certain groups of medicines, including prescription and non-prescription medicines and vitamins that interact with REVOLADE that you should not take at the same time or that require a dose adjustment while receiving a course of REVOLADE.
These medications include some products within the following groups:
• antacid medicines to treat stomach ulcers or heartburn
• certain drugs used to lower cholesterol (statins)
• minerals such as aluminium, calcium, iron, magnesium, selenium and zinc which may be found in mineral supplements and complementary medicines.
Your doctor will review the medicines you are currently taking to make sure you are not taking something that cannot be taken with the REVOLADE. If you require any of these medications and a suitable substitute is not available, please discuss this with your doctor.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Taking REVOLADE with food and drink
REVOLADE is affected by calcium intake. REVOLADE may be taken with food low in calcium such as:
• fruits such as pineapple, raisins and strawberries
• lean ham, chicken or beef
• unfortified fruit juice, soy milk and grain. (Unfortified means no added calcium, magnesium or iron).
Please discuss this matter with your doctor; they will be able to advise on the most suitable meals to be eaten while you are taking REVOLADE.
Don't take REVOLADE during the 4 hours before or after you take:
• antacid medication to treat indigestion
• mineral supplements, such as aluminium, calcium, iron, magnesium, selenium or zinc
• dairy products.
If you do, the medicine will not be properly absorbed into your body.
One way to avoid issues with these products would be to take them in the morning and REVOLADE in the
evening. Ask your doctor or pharmacist for advice if you are unsure.
Pregnancy and breast-feeding
You should avoid becoming pregnant while taking REVOLADE because the effect of REVOLADE on pregnancy is not known. You should use a reliable method of contraception (a way to prevent you from becoming pregnant).
If you become pregnant during treatment, tell your doctor.
Breast feeding is not recommended while you are taking REVOLADE. It is not known whether REVOLADE
passes into breast milk.
Ask your doctor or pharmacist for advice before taking any medicine if you are unsure.
Cataracts
In animal studies it was found that REVOLADE caused the development of cataracts (a clouding of the lens in the eye). In trials in humans however, no increased risk in the incidence of cataracts has been seen so far. Your doctor may recommend that you are checked for cataracts as part of any routine eye examination.
How to take REVOLADE
Always take REVOLADE exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
How much to take and when to take it
REVOLADE should be taken at least 4 hours before or at least 4 hours after antacids, dairy products or some mineral supplements such as iron, calcium, magnesium, aluminium, selenium and zinc.
One way to avoid issues with these products would be to take them in the morning and REVOLADE in the
evening.
The usual dose is one 50 mg REVOLADE tablet a day. 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.
East Asian patients (Chinese, Japanese, Taiwanese and Korean) may need to start at a lower dose.
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 it
Swallow REVOLADE with a glass of water.
If you take more REVOLADE than you should (overdose)
Immediately telephone your doctor or the Poisons Information Centre (In Australia call 13 11 26. In New Zealand call 0800 POISON or 0800764 766) for advice, or go to Accident and Emergency at the
nearest hospital, if you think that you or anyone else may have taken too much REVOLADE. Do this
even if there are no signs of discomfort or poisoning. If you are not sure what to do, contact your doctor or pharmacist.
If you forget to take REVOLADE
Do not take a double dose to make upfor a forgotten dose.
Once you have started taking REVOLADE
Do not stop taking REVOLADE before talking to your doctor or pharmacist.
After you have stopped taking REVOLADE, your bleeding symptoms may come back. Tell your doctor or pharmacist if you have any bleeding in the 4 weeks after you stop taking REVOLADE.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
What are the possible side-effects
Like all medicines, REVOLADE can cause side effects, although not everybody gets them.
The following side effects have been reported to be associated with treatment with REVOLADE.
Very common side effects
These may affect more than 1 in 10 people treated with REVOLADE.
• Nausea and diarrhoea
Common side effects
These may affect up to 1 in 10 people treated with REVOLADE.
• Increase of liver enzymes called aspartate and alanine transaminases,
• Dry mouth
• Vomiting
• Alopecia (unusual hair loss or thinning)
• Rash
• Back pain
• Musculoskeletal chest pain, musculoskeletal pain (pain that affects muscles and tendons along with bones)
• Myalgia (aching muscles)
• Pharyngitis (sore throat and discomfort when swallowing)
• Urinary tract infection (infection in the system that produces urine).
Tell your doctor immediately if you get any of these symptoms. These symptoms may persist after you stop
taking REVOLADE.
You may have problems with your bone marrow
People with the disease for which you are being treated may have problems with their bone marrow.
Medicines like REVOLADE could make this problem worse. Your doctor may also carry out tests to check your bone marrow during treatment with 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, but blood clots can occur with normal or even low platelet counts.
If you have cirrhosis of the liver you are at risk of a blood clot in a blood vessel that feeds your liver (portal vein thrombosis). You may have severe complications from some forms of blood clots, such as clots that travel to the lungs or that cause heart attacks or strokes.
Your doctor will check your blood platelet counts, and change your dose or stop REVOLADE if your platelet counts get too high.
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.
If any of the side effects listed in this leaflet get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Tell your doctor or pharmacist if you have any bleeding in the 4 weeks after you stop taking REVOLADE.
Storage
Do not store above 30°C.
Keep out of the reach and sight of children.
Do not use REVOLADE after the expiry date which is stated on the carton.
Disposal
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
Product description
What REVOLADE looks like
REVOLADE is presented in packs of 28 tablets.
25 mg tablets
REVOLADE film-coated tablets are round, biconvex, white, debossed with 'GS NX3' and '25' on one side.
50 mg tablets
REVOLADE film-coated tablets are round, biconvex, brown, debossed with 'GS UFU' and '50' on one side.
Ingredients
REVOLADE contains the active ingredient eltrombopag olamine.
REVOLADE also contains hypromellose, macrogol 400, magnesium stearate, mannitol, cellulose - microcrystalline, povidone, sodium starch glycollate, titanium dioxide (E171).
25 mg
The 25 mg tablet also contains polysorbate 80.
50 mg
The 50 mg tablet also contains iron oxide red CI77491 (E172) and iron oxide yellow CI77492 (E172).
Supplier
Your REVOLADE is supplied by:
GlaxoSmithKline Australia Ltd
Level 4, 436 Johnston St,
Abbotsford, Victoria, 3067
AUSTRALIA.
or
GlaxoSmithKline NZ Ltd
Auckland, NEW ZEALAND
Where to go for further information
Pharmaceutical companies are not in a position to give people an individual diagnosis or medical advice.
Your doctor or pharmacist is the best person to give you the individual advice you need.
In Australia: For more information on REVOLADE please go to www.gsk.com.au/revolade or your doctor or pharmacist.
In New Zealand: For more information on REVOLADE please go to www.medsafe.govt.nz or your doctor or pharmacist.
This information was prepared on 14 September 2011.
The information provided applies only to REVOLADE.
REVOLADE is a registered trade mark of the GlaxoSmithKline Group of Companies.
25 mg tablets AUST R 158419
50 mg tablets AUST R 158356
© 2011 GlaxoSmithKline Australia
Version 5.0
