VI.B.2 Elements for a public summary

Transcription

1 VI.B.2 Elements for a public summary VI.B.2.1 Overview of disease epidemiology Fexofenadine hydrochloride is a non-sedating H 1 -antihistamine. [Fexofenadine] 180mg filmcoated tablets are indicated for symptomatic relief of chronic idiopathic urticaria. Studies aiming to assess the exact number of people having chronic urticaria in the general population are still missing. It has been estimated that this disease affects about 0.1% of the general population but the real number of people having chronic urticaria possibly exceeds this amount. Chronic urticaria occurs predominantly in adults; women are more commonly affected than men and the disease frequently shows a familiar pattern. Results of two studies on number of people having chronic urticaria on 2010 among adults in Spain (population-based study) and in a general German population (questionnaire survey) reveals the same result 8.7% and 8,8% respectively. The 70.3% referred to female cases, showing a sensitivity of the female population to the disease. VI.B.2.2 Summary of treatment benefits Many studies have been performed to prove efficacy of fexofenadine in the treatment of chronic idiopathic urticaria. The drug appeared effective in the treatment of its indicated conditions in comparison to the placebo but also to other drugs used for the treatment of chronic idiopathic urticaria, such as levocetirizine. Patients tolerated fexofenadine well. In addition, fexofenadine acts faster than other drugs, such as levocetirizine for example, and no major side effects have been occurred. In addition, studies using higher doses of fexofenamide than 180mg (e.g 360mg) have been run. Side effects noticed in these studies are headache and sedation such as for the 120mg administration VI.B.2.3 Unknowns relating to treatment benefits The treatment benefits remain unknown for children under 12 years. VI.B.2.4 Summary of safety concerns Important identified risks Important identified risks Risk What is known Preventability Safety concern in lay language (medical term) Brief summary in lay language Whether risk can be minimised or mitigated, and how film coated tablets should not be administered in case of allergy (hypersensitivity) to fexofenadine hydrochloride or In rare symptoms of anaphylactic reactions (for example swelling or difficulty breathing) or serious skin reactions occur. Risk can be minimized or mitigated by discontinuation of the treatment and immediate medical advice. Revision Date: Page 38 REG Version 2.0 Approved Page 38 of 72

2 any of the other ingredients of the product (Hypersensitivity to the active substance or to any of the excipients) Taking fexofenadine IVAX 180 mg film coated tablets may lead to a fast or irregular heartbeat. Thus, special care should be given when there is a history or ongoing heart disease (Use in patients with a history or ongoing cardiovascular disease) Patients with a history of or ongoing cardiovascular disease should be warned that, antihistamines as drug class have been associated with the adverse events, tachycardia and palpitations. These adverse events are uncommon, meaning that appeared with a frequency from 1/ 1,000 to 1/100 Risk can be minimized or mitigated by therapy discontinuation and seeking of medical advice Important potential risks Risk Fexofenadine may interact with erythromycin, ketoconazole or lopinavir/ritonavir. (Increased exposure to Fexofenadine due to interactions with erythromycin, ketoconazole or single dose of lopinavir and ritonavir combination) Indigestion remedies containing aluminium and magnesium may affect the action of Fexofenadine by lowering the amount of drug absorbed. (Co-administration of Fexofenadine with antacids containing aluminum and magnesium hydroxide) film coated tablets should be What is known (Including reason why it is considered a potential risk) These medicines increase the Fexofenadine level in the blood, and so may increase any side effects been occurred. The physician should be aware of a potential need for concomitant administration of these drugs. Therefore, he might have to reduce the dose of Fexofenadine Co-administration of fexofenadine with indigestion remedies containing aluminum and magnesium hydroxide results on fexofenadine decreased bioavailability. Thus, if any such indigestion remedies are taken, it is recommended to leave about 2 hours between the time that the ingestion remedy is taken and Fexofenadine There is limited data regarding administration of Fexofenadine in elderly. Thus, drug should be used with Revision Date: Page 39 REG Version 2.0 Approved Page 39 of 72

3 administered carefully to the elderly (Use in elderly) film coated tablets should be administered carefully in patients with kidney problems (Use in patients with renal impairment) film coated tablets should be administered carefully in patients with liver problems caution in this category of patients This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Thus, drug should be administered with caution in these patients. Due to the limited data available, concerning administration of Fexofenadine in patients with liver problems, drug should be administered with caution in these patients (Use in patients with hepatic impairment) Revision Date: Page 40 REG Version 2.0 Approved Page 40 of 72

4 Important missing information Risk Use in children less than 12 years of age What is known The efficacy and safety of fexofenadine hydrochloride has not been studied in children under 12 years old. Therefore use of the product in children less than 12 years of age is not recommended Use during pregnancy Use during lactation There is no experience with the use of fexofenadine for pregnant women. Limited animal studies do not indicate direct or indirect harmful effects with respect to effects on pregnancy, embryonal/foetal development, parturition or postnatal development. In a reproduction toxicity trial with mice fexofenadine did not impair fertility, was not teratogenic and did not impair the pre- or postnatal development. However, Fexofenadine should be used during pregnancy only if strictly necessary. It is not known if fexofenadine is excreted in human milk. There are no adequate and well-controlled studies in women during lactation. Because many drugs are excreted in human milk, caution should be exercised when fexofenadine hydrochloride is administered to a nursing woman. VI.B.2.5 Summary of risk minimisation measures by safety concern Not applicable as no additional risk minimisations measures are related to fexofenadine VI.B.2.6 Planned post authorisation development plan Not applicable VI.B.2.7 Summary of changes to the risk management plan over time Version Date Safety concerns Change NA Initial version Hypersensitivity to the active substance or to any of the excipients Cardiac risks (in patients with a history or ongoing cardiovascular disease) Increased exposure to Fexofenadine due to Implementation of updated EU template Inclusion of risk management measures for [Fexofenadin] 180mg film-coated tablets Revision Date: Page 41 REG Version 2.0 Approved Page 41 of 72

5 interactions Fexofenadine use in children under 12 years Fexofenadine use in elderly Fexofenadine use in patients with renal or hepatic impairment Lack of experience with the use of fexofenadine in pregnant women Lack of experience with the use of fexofenadine in breastfeeding women Important identified risks Hypersensitivity to the active substance or to any of the excipients Use in patients with a history or ongoing cardiovascular disease Important potential risks Increased exposure to Fexofenadine due to interactions with erythromycin, ketoconazole or single dose of lopinavir and ritonavir combination Reduced bioavailability of Fexofenadine with antacids containing aluminum and magnesium hydroxide Use in elderly Use in patients with renal impairment Use in patients with hepatic impairment Missing information Day 40 RMS comment Implementation of assessor requests Revision Date: Page 42 REG Version 2.0 Approved Page 42 of 72

6 Use in children less than12 years of age Use during pregnancy Use during lactation Revision Date: Page 43 REG Version 2.0 Approved Page 43 of 72