Revolade (2012)
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
| Εκδότης | GlaxoSmithKline UK |
|---|---|
| Διεύθυνση | Stockley Park West, Uxbridge, Middlesex, UB11 1BT |
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Name of the medicinal product
Revolade 25 mg and 50 mg film-coated tablets.
Qualitative and quantitative composition
Each film-coated tablet contains eltrombopag olamine equivalent to 25 mg or 50 mg eltrombopag. Excipients: For the full list of excipients, see section 6.1.
Pharmaceutical form
Film-coated tablet. 25 mg: Round, biconvex, white film-coated tablet debossed with GS NX3 and 25 on one side. 50 mg: Round, biconvex, brown film-coated tablet debossed with GS UFU and 50 on one side. ...
Therapeutic indications
Revolade is indicated for adult chronic immune (idiopathic) thrombocytopenic purpura (ITP) splenectomised patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins). Revolade ...
Posology and method of administration
Eltrombopag treatment should remain under the supervision of a physician who is experienced in the treatment of haematological diseases. Eltrombopag dosing requirements must be individualised based on ...
Contraindications
Hypersensitivity to eltrombopag or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Risk of hepatotoxicity Eltrombopag administration can cause abnormal liver function. In clinical studies with eltrombopag, increases in serum alanine aminotransferase (ALT), aspartate aminotransferase ...
Interaction with other medicinal products and other forms of interaction
Effects of eltrombopag on other medicinal products HMG CoA reductase inhibitors In vitro studies demonstrated that eltrombopag is not a substrate for the organic anion transporter polypeptide, OATP1B1, ...
Fertility, pregnancy and lactation
Pregnancy There are no or limited amount of data from the use of eltrombopag in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
Undesirable effects
Based on an analysis of all chronic ITP patients receiving eltrombopag in 3 controlled and 2 uncontrolled clinical studies, the overall incidence of adverse events in subjects treated with eltrombopag ...
Overdose
In the event of overdose, platelet counts may increase excessively and result in thrombotic/thromboembolic complications. In case of an overdose, consider oral administration of a metal cation-containing ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antihemorrhagics ATC code: B02BX05 Mechanism of action TPO is the main cytokine involved in regulation of megakaryopoiesis and platelet production, and is the endogenous ligand ...
Pharmacokinetic properties
Pharmacokinetics The plasma eltrombopag concentration-time data collected in 88 subjects with ITP in Studies TRA100773A and TRA100773B were combined with data from 111 healthy adult subjects in a population ...
Preclinical safety data
Eltrombopag does not stimulate platelet production in mice, rats or dogs because of unique TPO receptor specificity. Therefore, data from these animals do not fully model potential adverse effects related ...
List of excipients
Tablet core (25 mg and 50 mg): Magnesium stearate Mannitol (E421) Microcrystalline cellulose Povidone (K30) Sodium starch glycolate Type A Tablet coating (25 mg): Hypromellose Macrogol 400 Polysorbate ...
Incompatibilities
Not applicable.
Shelf life
4 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
Aluminum blisters (PA/Alu/PVC/Alu) in a carton containing 14 or 28 film-coated tablets and multipacks containing 84 (3 packs of 28) film-coated tablets. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
Any unused product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
GlaxoSmithKline Trading Services Limited 6900 Cork Airport Business Park Kinsale Road Cork Ireland
Marketing authorization number(s)
25 mg (14 tablets): EU/1/10/612/001 25 mg (28 tablets): EU/1/10/612/002 25 mg (84 tablets): EU/1/10/612/003 50 mg (14 tablets): EU/1/10/612/004 50 mg (28 tablets): EU/1/10/612/005 50 mg (84 tablets): EU/1/10/612/006 ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 11 March 2010
Date of revision of the text
27 June 2012