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Public Assessment Report for Paediatric Studies Submitted in Accordance with Article 45 of Regulation (EC) No1901/2006, As Amended

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Public Assessment Report for Paediatric Studies Submitted in Accordance with Article 45 of Regulation (EC) No1901/2006, As Amended Public Assessment Report for paediatric studies submitted in accordance with Article 45 of Regulation (EC) No1901/2006, as amended Uniphyllin / Uniphyllin continus / Theophyllin Krugmann / Theophyllin Theodel / Theophylline Bruneau / Solosin / Solosin Retard / Solosin Retard Mite / Solosin Tropfen Theospirex retard Theo-dur Euphylong / Euphylong retard / Euphyllin / Euphyllin long / Euphyllin CR / Euphyllin CR N / Euphyllina / Euphyllina Rilcon / Respicur / Respicur retard Theostat / Theoplus (Theophylline) DK/W/0021/pdWS/001 Rapporteur: Denmark Finalisation procedure (day 120): August 9, 2013 Date of finalisation of PAR January 16, 2014 Theophylline DK/W/0021/pdWS/001 Page 1/117 TABLE OF CONTENTS I. Executive Summary ....................................................................................................... 4 RecommendatioN ...................................................................................................................... 5 II. INTRODUCTION ............................................................................................................. 5 III. SCIENTIFIC DISCUSSION .............................................................................................. 7 III.1 MAH I (mundipharma) ................................................................................................................. 7 III.2 Information on the pharmaceutical formulation. ................................................................. 7 III.3 Non-clinical aspects ................................................................................................................... 7 III.4 Clinical aspects ............................................................................................................................ 7 I. MAH 2 Sanofi-Aventis .................................................................................................. 46 I.1 Information on the pharmaceutical formulation used in the clinical study(ies) ....... 46 I.2 Non-clinical aspects ................................................................................................................. 46 I.3 Clinical aspects .......................................................................................................................... 46 II. MAH 3 Gebro pharma .................................................................................................. 73 II.1 Information on the pharmaceutical formulation used in the clinical study(ies) ....... 73 II.2 Non-clinical aspects ................................................................................................................. 74 II.3 Clinical aspects .......................................................................................................................... 74 III. MAH 4 biophausia/astrazeneca ................................................................................... 80 III.1 Information on the pharmaceutical formulation used in the clinical study(ies) ....... 80 III.2 Non-clinical aspects ................................................................................................................. 80 III.3 Clinical aspects .......................................................................................................................... 81 IV. MAH 5 Nycomed ........................................................................................................... 95 IV.1 Information on the pharmaceutical formulation used in the clinical study(ies) ....... 95 IV.2 Non-clinical aspects ................................................................................................................. 95 IV.3 Clinical aspects .......................................................................................................................... 95 V. MAH 6 Pierre Fabre .................................................................................................... 111 V.1 Information on the pharmaceutical formulation .............................................................. 111 V.2 Non-clinical aspects ............................................................................................................... 112 V.3 Clinical aspects ........................................................................................................................ 112 VI. MEMBER STATES Overall Conclusion AND RECOMMENDATION ......................... 116 VII. List of Medicinal products and marketing authorisation holders involved ........... 117 Theophylline DK/W/0021/pdWS/001 Page 2/117 ADMINISTRATIVE INFORMATION Invented name of the medicinal See section VI product(s): INN (or common name) of the active Theophylline substance(s): MAH (s): See section VI Pharmaco-therapeutic group R03DA04 (ATC Code): Pharmaceutical form(s) and Capsules 100 mg, 200 mg, 250 mg, 300 mg, 400 mg strength(s): Sustained release capsules 100 mg, 125 mg, 200 mg, 250 mg, 300 mg, 375 mg, 400 mg, 500 mg Tablets 250 mg Coated tablets 250 mg Film-coated tablets 150 mg, 300 mg Prolonged-release tablets 100 mg, 135 mg, 200 mg, 250 mg, 270 mg, 300 mg. 400 mg, 600 mg Oral drops, solution 104 mg/ml Concentrate for solution for infusion 41.6 mg/ml Solution for injection 200 mg, 240 mg Theophylline DK/W/0021/pdWS/001 Page 3/117 I. EXECUTIVE SUMMARY SmPC and PL changes are proposed in sections 4.1, 4.2, 4.3, 4.4 and 5.2. Summary of outcome No change Change New study data: <section(s) xxxx, xxxx> New safety information: <section(s) xxxx, xxxx> Paediatric information clarified: section 4.2 New indication: <section(s) xxxx, xxxx> SmPC: Section 4.1 Therapeutic indications Theophylline should not be used as first drug of choice in the treatment of asthma in children. Section 4.2 Posology and method of administration Children below 6 months: <Product name> should not be used in children below 6 months of age. Solid dosage forms only: Children below 6 years: <Product name> should not be used in children below 6 years of age. Other dosage forms are available that are more suitable for children aged less than 6 years. Section 4.3 Contraindications Children under 6 months of age. 4.4 Special warnings: In case of insufficient effect of the recommended dose and in case of adverse events, theophylline plasma concentration should be monitored. Acute febrile illness Fever decreases the clearance of theophylline. It may be necessary to decrease the dose to avoid intoxication. 5.2 Pharmacokinetic properties Effective plasma concentrations: 5-12 μg/ml (do not exceed 20 μg/ml). Theophylline is mainly excreted by the kidneys. Theophylline DK/W/0021/pdWS/001 Page 4/117 RECOMMENDATION1 The outcome of the assessment of this article 45 submission regarding theophylline including the MAHs answers to the questions raised by the rapporteur (DK) and 3 CMSs (UK, NL, DE) is to recommend a harmonization process of the SmPCs with regard to paediatric dosing. We recommend implementing a therapeutic interval of 5-12 µg/ml, with a note, that plasma concentration up to 20 µg/ml can be necessary to achieve efficacy in some cases. The product should not be administered to children below 6 months and the solid forms not to children below 6 years of age. The maintenance dose should be given in mg and plasma concentrations should be measured in case of insufficient effect of the recommended dose and in case of adverse events. Finally it should be implemented that fever may decrease the clearance of theophylline why it may be necessary to decrease the dose to avoid intoxication. Finally it should be added that theophylline is not first drug of choice in the treatment of asthma in children. Recommendation Type IB variation to be requested from the MAH by October 8, 2013. II. INTRODUCTION Theophylline is a methylxanthine, similar in structure to caffeine. Theophylline is a bronchodilator and has modest anti-inflammatory properties. Theophylline is indicated for treatment of bronchial asthma and chronic obstructive pulmonary disease and prevention of asthma attacks. The mechanism of action is not fully established. Its use for acute symptoms of asthma has been described since 1936 (68). Theophylline is only efficient after systemic administration, mostly as sustained-release preparations, but can also be administered intravenously. Studies with aminophylline are included; aminophylline is a stable mixture of theophylline and ethylenediamine with greater solubility in water. The use of theophylline is limited in children, in line with international and national clinical guidelines for asthma prevention and management (GINA 2010). The pharmacokinetics, efficacy and safety of theophylline, also in children, are well-studied. Theophylline is rapidly and completely absorbed, and the bioavailability is close to 100 % when orally administered. Theophylline is extensively metabolised in the liver by CYP1A2, 2E1 and 3A4. Caffeine and 3-methylxanthine are active metabolites. The elimination half life is known to be considerably variable and ranges from 2 to 16 hours. Especially metabolism, but also volume of distribution is different in the various stages of childhood. In accordance with Article 45 of the Regulation (EC) No 1901/2006, as amended on medicinal products for paediatric use, six MAHs have submitted relevant paediatric data concerning theophylline for assessment. MAH 1 Mundipharma MAH 2 Sanofi-Aventis MAH 3 Gebro MAH 4 Biophausia MAH 5 Nycomed 1 The recommendation from section V can be copied in this section. Theophylline DK/W/0021/pdWS/001 Page 5/117 MAH 6 Pierre Fabre The MAHs have submitted 78
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