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The Belgian Next Generation Sequencing Guidelines for Haematological and Solid Tumours

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The Belgian Next Generation Sequencing Guidelines for Haematological and Solid Tumours Name: Revolade 12,5/25/50/75 mg film-coated tablets and 25 mg powder for oral suspension. Composition: Each film-coated tablet contains eltrombopag olamine equivalent to 12,5/25/50/75 PRACTICE GUIDELINES mg eltrombopag. Each sachet contains eltrombopag olamine equivalent to 25 mg of eltrombopag. For the full list of excipients, see section 6.1 of the full leaflet. Pharmaceutical form: Film-coat- Ex-factory price 56 ed tablet: 12.5 mg : Round, biconvex, white film-coated tablet (approximately 7.9 mm in diameter) debossed with ‘GS MZ1’ and ‘12.5’ on one side. 25 mg : Round, biconvex, white film-coated Revolade 25 mg: 28 film-coated tablets 922,36 € tablet (approximately 10.3 mm in diameter) debossed with ‘GS NX3’ and ‘25’ on one side. 50 mg: Round, biconvex, brown film-coated tablet (approximately 10.3 mm in diameter) debossed with ‘GS UFU’ and ‘50’ on one side. 75 mg: Round, biconvex, pink film-coated tablet (approximately 10.3 mm in diameter) debossed with ‘GS FFS’ and ‘75’ on one side. Powder for oral suspension: Revolade 50 mg: 28 film-coated tablets 1.844,71 € Reddish-brown to yellow powder. Therapeutic indications: Revolade is indicated for chronic immune (idiopathic) thrombocytopenic purpura (ITP) patients aged 1 year and above who are refrac- tory to other treatments (e.g. corticosteroids, immunoglobulins) (see full leaflet). Revolade is indicated in adult patients with chronic hepatitis C virus (HCV) infection for the treatment of thrombocytopenia, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon-based therapy (see full leaflet). Revolade is indicated in adult patients with acquired severe aplastic anaemia (SAA) who were either refractory to prior immunosuppressive therapy or heavily pretreated and are unsuitable for haematopoietic stem cell transplantation (see full leaflet). Posology: Eltrombopag treatment should be initiated and remain under the supervision of a physician who is experienced in the treatment of haematological diseases or the management of chronic hepatitis C and its complications. Eltrombopag dosing The Belgian next generation sequencing requirements must be individualised based on the patient’s platelet counts. The objective of treatment with eltrombopag should not be to normalise platelet counts. The powder for oral suspension may lead to higher eltrombopag exposure than the tablet formulation (see section 5.2). When switching between the tablet and powder for oral suspension formulations, platelet counts should be monitored weekly for 2 weeks. Chronic immune (idiopathic) thrombocytopenia: The lowest dose of eltrombopag to achieve and maintain a platelet count ≥ 50,000/µl should be used. Dose adjustments are based upon the platelet count response. Eltrombopag must not be used to normalise platelet counts. In clinical studies, platelet counts generally increased within 1 to 2 weeks after starting eltrombopag and decreased within 1 to 2 weeks after discontinuation. Adults and paediatric population aged 6 to 17 years: The recommended starting dose of eltrombopag is 50 mg once daily. For patients of East Asian ancestry (such as Chinese, Japanese, Taiwanese, Korean or Thai), eltrombopag should be initiated at a reduced dose of 25 mg once daily (see full guidelines for haematological and leaflet). Paediatric population aged 1 to 5 years: The recommended starting dose of eltrombopag is 25 mg once daily. Monitoring, dose adjustment and discontinuation: see full leaflet. Chronic hepatitis C (HCV) associated thrombocytopenia: When eltrombopag is given in combination with antivirals reference should be made to the full summary of product characteristics of the respective coadministered medicinal products for comprehensive details of relevant safety information or contraindications. In clinical studies, platelet counts generally began to increase within 1 week of starting eltrombopag. The aim of treatment with eltrombopag should be to achieve the minimum level of platelet counts needed to initiate antiviral therapy, in adherence to clinical practice recommendations. During antiviral therapy, the aim of treatment should be to keep platelet counts at a level that prevents the risk of bleeding complications, normally around 50,000-75,000/µl. Platelet counts > 75,000/µl should be avoided. The lowest dose of eltrombopag needed to achieve the targets should be used. Dose adjustments are based upon the platelet count response. Initial dose solid tumours regimen: Eltrombopag should be initiated at a dose of 25 mg once daily. No dosage adjustment is necessary for HCV patients of East Asian ancestry or patients with mild hepatic impairment (see full leaflet). Monitoring, dose adjustment and discontinuation: see full leaflet. Severe aplastic anaemia: Initial dose regimen: Eltrombopag should be initiated at a dose of 50 mg once daily. For patients of East Asian ancestry, eltrombopag should be initiated at a reduced dose of 25 mg once daily (see section 5.2). The treatment should not be initiated when the patients have existing cytogenetic abnormalities of chromosome 7. Monitoring, dose adjustment and discontinuation: see full leaflet. Special populations: Renal impairment, Hepatic impairment, Elderly, East Asian patients, Paediatric population: see full leaflet. Contraindications: Hypersensitivity to eltrombopag or to any of the excipients, listed in sec- tion 6.1. Undesirable effects: Summa- A. Hébrant, Ir, PhD1, G. Froyen, PhD2, B. Maes, MD, PhD2, R. Salgado, MD3, M. Le Mercier, PhD4, N. D’Haene, MD, ry of the safety profile: see full leaflet. List of adverse reactions: The adverse reactions in the adult ITP studies (N=550), paediatric ITP studies PhD4, S. De Keersmaecker, PhD5, K. Claes, PhD6, J. Van der Meulen, PhD6, P. Aftimos, MD7, J. Van Houdt, PhD8, (N=107), the HCV studies (N=955), the SAA studies (N=43) and post-marketing reports are listed below by MedDRA system organ class and by frequency. K. Cuppens, MD9, K. Vanneste, PhD5, E. Dequeker, PhD8, S. Van Dooren, PhD10, J. Van Huysse, MD11, F. Nollet, PhD12, Very common (≥ 1/10); Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100); Rare (≥ 1/10,000 to < 1/1,000); Very rare (< 1/10,000); Not S. van Laere, PhD13, B. Denys, MD12, V. Ghislain14, C. Van Campenhout, PhD14, M. Van den Bulcke, PhD1 known (cannot be estimated from the available data). ITP study population: Infections and infestations: Very com- mon: Nasopharyngitis♦, upper respirato- ry tract infection♦. Common: Rhinitis♦. Uncommon: Pharyngitis, Urinary tract infection, Influenza, Oral herpes, Pneu- monia, Sinusitis, Tonsillitis, Respiratory tract infection, Gingivitis, Skin infection. Neoplasms benign, malignant and un- specified (incl cysts and polyps): Un- common: Rectosigmoid cancer. Blood SUMMARY and lymphatic system disorders:Un- common: Anaemia, Anisocytosis, Eo- sinophilia, Haemolytic anaemia, Leuko- cytosis, Myelocytosis, Thrombocytope- Targeted next generation sequencing is a complex procedure including the ‘wet bench’ and ‘dry bench’ nia, Haemoglobin increased, Band neu- trophil count increased, Haemoglobin decreased, Myelocyte present, Platelet count increased, White blood cell count parts. Both parts are composed of many steps for which optimal assay conditions and settings must be decreased. Immune system disor- ders:Uncommon: Hypersensitivity. Me- tabolism and nutrition disorders: Un- common: Anorexia, Hypokalaemia, De- determined. creased appetite, Gout, Hypocalcae- mia, Blood uric acid increased. Psychi- atric disorders: Uncommon: Sleep disorder, Depression, Apathy, Mood The aim of these guidelines is to provide generic, platform independent, recommendations for targeted next altered, Tearfulness. Nervous system disorders: Common: Paraesthesia. Un- common: Hypoaesthesia, Somnolence, NEW REIMBURSEMENT in 3 indications Migraine, Tremor, Balance disorder, generation sequencing tests to detect acquired somatic mutations in DNA, in (haemato)-oncology that are Dysaesthesia, Hemiparesis, Migraine with aura, Neuropathy peripheral, Pe- ripheral sensory neuropathy, Speech disorder, Toxic neuropathy, Vascular complementary to the ISO 15189 norm (medical laboratories) in order to: headache. Eye disorders: Common: ST Dry eye. Uncommon: Vision blurred, Lenticular opacities, Astigmatism, Cat- as of 1 FEBRUARY 2017 aract cortical, Eye pain, Lacrimation in- 1) facilitate the implementation of the required quality metrics for the detection of somatic variants by next creased, Retinal haemorrhage, Retinal pigment epitheliopathy, Visual acuity re- duced, Visual impairment, Visual acuity 1 tests abnormal, Blepharitis and Kerato- generation sequencing in oncology and haemato-oncology in the Belgian laboratories, conjunctivitis sicca. Ear and labyrinth and now via eHealth disorders: Uncommon: Ear pain, Vertigo. Cardiac disorders: Uncommon: Tachy- cardia, Acute myocardial infarction, Car- 2) harmonise test validation and verification, diovascular disorder, Cyanosis, Sinus tachycardia, Electrocardiogram QT pro- longed. Vascular disorders: Uncommon: Deep vein thrombosis, Embolism, Hot 3) harmonise clinical interpretation and reporting of variants and, flush, Thrombophlebitis superficial, Flushing, Haematoma. Respiratory, tho- racic and mediastinal disorders: Com- mon: Cough♦, Oropharyngeal pain♦, 4) assure and maintain optimal test performance by establishing procedures and modalities for internal qua- Rhinorrhoea♦. Uncommon: Pulmonary embolism, Pulmonary infarction, Nasal discomfort, Oropharyngeal blistering, Oropharyngeal
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