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Revolade

Eltrombopag

Prescribing Information

(Please refer to full SmPC before prescribing)  

Revolade® (eltrombopag) 25mg and 50mg film-coated tablets. Each tablet contains eltrombopag olamine equivalent to 25mg and 50mg eltrombopag respectively.   

Indication:

  • Treatment of adult chronic immune (idiopathic) thrombocytopenic purpura (ITP) splenectomised patients who are refractory to other treatments. 
  • Eltrombopag may be used as a second line treatment for adult non-splenectomised patients where surgery is contraindicated. 

Dosage and administration

  • Treated by physician experienced in treatment of haematological diseases. 
  • Dosing must be is individualised based on patient’s platelet counts, aiming to keep platelet count above level of haemorrhagic risk (≥50,000/µl).
  • Recommended starting dose is 50mg once daily or, for patients of East Asian ancestry, a reduced dose of 25mg once daily. 
  • After initiation, dose should be adjusted to achieve and maintain a platelet count >50,000/µl as necessary. 
  • Wait for at least 2 weeks to see effect of dose adjustment on patient’s platelet response prior to considering another dose adjustment. 
  • Dose is not to exceed 75 mg/day. 
  • Clinical haematology and liver tests should be monitored regularly.
  • FBCs should be assessed weekly until a stable platelet count (at least 4 weeks) is achieved and monthly thereafter. 
  • Food interaction: Dairy products, antacids, calcium-containing products and mineral supplements containing polyvalent cations should be avoided for at least 4 hours before or after taking eltrombopag.   
  • Hepatic Impairment: Should not be used in ITP patients with hepatic impairment (Child-Pugh score ≥ 5) unless the expected benefit outweighs the identified risk of portal venous thrombosis. If  the use of eltrombopag  is deemed necessary in this patient group the starting dose must be 25 mg once daily. After initiating the dose of eltrombopag wait 3 weeks before increasing the dose. 
  • Paediatric Population: Not recommended for use in children and adolescents below age 18 due to insufficient data on safety and efficacy.

Contraindications:

  • Hypersensitivity to eltrombopag or to any of the excipients. 

Special Warnings and Precautions for use:

Hepatic effects:

  • Can cause abnormal liver function. 
  • Clinical studies show mostly mild (Grade 1-2), reversible increase in serum alanine aminotransferase (ALT), aspartate aminotransferase (AST) and bilirubin. 
  • Serum ALT, AST and bilirubin should be measured prior to eltrombopag initiation, every 2 weeks during dose adjustment and monthly on a stable dose. 
  • Abnormal serum liver tests should be repeated within 3-5 days and patients monitored until abnormalities resolve, stabilise, or return to baseline levels.
  • Use a lower starting dose of eltrombopag and monitor closely when administering eltrombopag to patients with hepatic impairment.

Thrombotic/thromboembolic complications: 

  • Caution should be used for patients with known risk factors for thromboembolism. 
  • Dose should be reduced or discontinued if platelet count exceeds target levels. 
  • Risk of throboembolic events (TEEs) has been found to be increased in patients with chronic liver disease treated with 75mg/day for 2 weeks in preparation for invasive procedures. 

Bleeding following discontinuation of eltrombopag: 

  • On discontinuation of eltrombopag platelet counts return to baseline levels within 2 weeks, increasing the risk of bleeding. 
  • This risk is increased if discontinued in the presence of anticoagulants or anti-platelet agents. 
  • If discontinued, patients should restart therapy according to current treatment guidelines. 

Bone marrow reticulin formation and risk of bone marrow fibrosis: 

  • Increased risk.

Progression of existing Myelodysplastic Syndromes (MDS):

  • Progression of existing Myelodysplastic Syndromes (MDS): there is a concern that thrombopoietin receptor agonists (TPO-RAs) may stimulate existing haematopoietic malignancies such as MDS.
  • In clinical studies with a TPO-RA in patients with MDS, cases of transient increases in blast cell counts were observed and cases of MDS disease progression to acute myeloid leukaemia were reported.
  • Diagnosis of ITP should be confirmed by exclusion of other clinical entities presenting with thrombocytopenia, in particular MDS.

Cataracts:

  • Routine monitoring recommended. 

Loss of response:

  • Search for causative factors. 

Interaction with other medicinal products and other forms of interaction:

  • Effects of eltrombopag on other medicinal products: Boceprevir – monitor for HCV suppression;
  • Rosuvastatin and other HMG-CoA reductase inhibitors: interactions expected
  • OATP1B1 and BCRP substrates: co-administer with caution
  • Cytochrome P450 substrates: no clinically significant interactions.
  • Effects of other medicinal products on eltrombopag: polyvalent cations must be administered at least 4 hours apart to avoid reduction in eltrombopag absorption; 
  • Lopinavir/ritonavir: co-administer with caution.
  • Medicinal products for treatment of ITP: platelet counts should be monitored when co-administered with other ITP treatments. 

Pregnancy:

  • Not recommended during pregnancy and in women of childbearing potential not using contraception. 

Effects on ability to drive and use machines:

  • No studies conducted. 

Undesirable effects:

Very common:

  • Headache.

Common:

  • Insomnia
  • Paraesthesia
  • Cataract
  • Dry eye
  • Nausea
  • Diarrhoea
  • Constipation
  • Abdominal pain upper
  • Hepatobiliary disorders
  • Rash
  • Pruritus
  • Alopecia
  • Arthralgia
  • Myalgia
  • Muscle spasm
  • Bone pain
  • Fatigue
  • Oedema peripheral

Other serious side effects include:

  • Bleeding after stopping treatment
  • High platelet counts
  • Risk of blood clots (uncommon)
  • Liver (common, see above)
  • Bone marrow problems (rare)

Risk of thromboembolic events (TEEs) are increased in patients with chronic liver disease. 

Overdose: 

  • Platelet counts may increase excessively resulting in thrombotic/thromboembolic complications. 
  • Oral administration of chelates limits absorption. 

Basic NHS Cost:

  • 50mg x 28 tablet pack £1540. 
  • 25mg x 28 tablet pack £770. 

Marketing Authorisation (MA) no.

EU/1/10/612/002, 005. 

MA holder:

GlaxoSmithKline Trading Services Limited, Currabinny, Carrigaline, County Cork, Ireland. 

Legal Category:

POM

Date of Preparation:

UK/ELT/0019b/12(4) Date of Preparation: June 2014

For the UK, further information is available from Customer Contact Centre, GlaxoSmithKline, Stockley Park West, Uxbridge, Middlesex UB11 1BT; customercontact@gsk.com; Freephone: 0800 221 441. For Ireland, please contact 1800 244 255.

Adverse events should be reported. For the UK, reporting forms and information can be found at www.mhra.gov.uk/yellowcard. For Ireland, adverse events should be reported directly to the IMB Pharmacovigilance Section, Irish Medicines Board, Kevin O'Malley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2, Tel: +353 1 6764971. Adverse events should also be reported to GlaxoSmithKline on 0800 221 441 in the UK or 1800 244 255 in Ireland.
Revolade is a trade mark of the GlaxoSmithKline group of companies.

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Z.A: Last updated June 2014: UK/ELT/0013/13(1)

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