Innovair/Innovair NEXThaler Adverse Reactions

Innovair: As Innovair contains beclometasone dipropionate and formoterol fumarate dihydrate, the type and severity of adverse reactions associated with each of the compounds may be expected. There is no incidence of additional adverse events following concurrent administration of the 2 compounds.
Undesirable effects which have been associated with beclometasone dipropionate and formoterol administered as a fixed combination (Innovair) and as single agents are given as follows, listed by system organ class. Frequencies are defined as: Very common (1/10), common (1/100 and <1/10), uncommon (1/1000 and <1/100), rare (1/10,000 and <1/1000) and very rare (1/10,000).
Common and uncommon adverse drug reactions were derived from clinical trial data. The incidence on placebo was not taken into account.
Infections and Infestations: Common: Pharyngitis. Uncommon: Influenza, oral fungal infection, pharyngeal and oesophageal candidiasis, vaginal candidiasis, gastroenteritis, sinusitis.
Blood and Lymphatic System Disorders: Uncommon: Granulocytopenia. Very Rare: Thrombocytopenia.
Immune System Disorders: Uncommon: Allergic dermatitis. Very Rare: Hypersensitivity reactions, including erythema, lips, face, eye and pharyngeal oedema.
Endocrine Disorders: Very Rare: Adrenal suppression.
Metabolism and Nutrition Disorders: Uncommon: Hypokalaemia, hyperglycaemia.
Psychiatric Disorders: Uncommon: Restlessness. Very Rare: Abnormal behaviour, sleep disorder, hallucination.
Nervous System Disorders: Common: Headache. Uncommon: Tremor, dizziness.
Eye Disorders: Very Rare: Glaucoma, cataract.
Ear and Labyrinth Disorders: Uncommon: Otosalpingitis.
Cardiac Disorders: Uncommon: Palpitations, prolonged ECG QT corrected interval, ECG change, tachycardia, tachyarrhythmia. Rare: Ventricular extrasystoles, angina pectoris. Very Rare: Atrial fibrillation.
Vascular Disorders: Uncommon: Hyperaemia, flushing.
Respiratory, Thoracic and Mediastinal Disorders: Common: Dysphonia. Uncommon: Rhinitis, cough, productive cough, throat irritation, asthmatic crisis. Rare: Paradoxical bronchospasm. Very Rare: Dyspnoea, exacerbation of asthma.
Gastrointestinal Disorders: Uncommon: Diarrhoea, dry mouth, dyspepsia, dysphagia, burning sensation of the lips, nausea, dysgeusia.
Skin and Subcutaneous Tissue Disorders: Uncommon: Pruritus, rash, hyperhidrosis. Rare: Urticaria, angioneurotic oedema.
Musculoskeletal, Connective Tissue and Bone Disorders: Uncommon: Muscle spasms, myalgia. Very Rare: Growth retardation in children and adolescents.
Renal and Urinary Disorders: Rare: Nephritis.
General Disorders and Administration Site Conditions: Very Rare: Peripheral oedema.
Investigations: Uncommon: Increased C-reactive protein, platelet count, free fatty acids, blood insulin, blood ketone body. Rare: Increased or decreased blood pressure. Very Rare: Decreased bone density.
As with other inhalation therapy, paradoxical bronchospasm may occur (see Precautions).
Among the observed adverse reactions those typically associated with formoterol are: Hypokalaemia, headache, tremor, palpitations, cough, muscle spasms and prolongation of QTc interval.
Adverse reactions typically associated with the administration of beclometasone dipropionate are: Oral fungal infections and candidiasis, dysphonia, throat irritation. Dysphonia and candidiasis may be relieved by gargling or rinsing the mouth with water or brushing the teeth after using Innovair. Symptomatic candidiasis can be treated with topical antifungal therapy while continuing the treatment with Innovair.
Systemic effects of inhaled corticosteroids (eg, beclometasone dipropionate) may occur particularly when administered at high doses prescribed for prolonged periods, these may include adrenal suppression, decrease in bone mineral density, growth retardation in children and adolescents, cataract and glaucoma.
Hypersensitivity reactions including rash, urticaria pruritus, erythema and oedema of the eyes, face, lips and throat may also occur.
Innovair NEXThaler: The most common adverse reaction is tremor. In a 12-week clinical trial with Innovair Nexthaler, tremor was seen only with the highest dose regimen (2 inhalations bid), appeared most frequently at the beginning of treatment and was mild in intensity. No patient was withdrawn from the trial as a result of tremor.
Clinical Trials Experience in asthma patients: The safety of Innovair Nexthaler was assessed in active- and placebo-controlled clinical trials in which 719 patients aged 12 and older with asthma of varying severity were exposed to the drug. The incidence of adverse reactions in the table as follows relates to asthmatic patients aged 12 years and older and is based upon the safety findings of two pivotal clinical trials where Innovair Nexthaler was administered at the doses recommended in this SmPC for a period of 8-12 weeks. No psychiatric disorders were observed in the clinical trials with Innovair Nexthaler but they are included in the table as a potential class-effect of inhaled corticosteroids.
Undesirable effects which have been associated with beclometasone dipropionate and formoterol administered as a fixed combination (Innovair Nexthaler) are given as follows, listed by system organ class. Frequencies are defined as: 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) and very rare (<1/10,000), not known (cannot be estimated from the available data). (See table.)


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Among the observed adverse reactions those typically associated with formoterol are: tremor, headache, tachycardia, sinus bradycardia, angina pectoris, myocardial ischaemia, QT prolongation.
Among the observed adverse reactions those typically associated with beclometasone dipropionate are: nasopharyngitis, oral candidiasis, dysphonia, throat irritation, irritability, cortisol free urine decreased, blood cortisol decreased, blood glucose increased.
Additional adverse reactions not observed in the clinical experience with Innovair Nexthaler but typically associated with the inhaled administration of beclometasone dipropionate are other oral fungal infections and pneumonia. Taste disturbances have occasionally been reported during inhaled corticosteroid therapy.
See Precautions for measures to minimize the occurrence of oral fungal infections, oral candidiasis and dysphonia.
Systemic effects of inhaled corticosteroids (e.g. beclometasone dipropionate) may occur particularly when administered at high doses prescribed for prolonged periods, these may include Cushing's Syndrome, Cushingoid features, adrenal suppression, decrease in bone mineral density, growth retardation in children and adolescents, cataract and glaucoma (see also Precautions).
Additional adverse reactions not observed in the clinical experience with therapeutic doses of Innovair Nexthaler but typically associated with the administration of beta₂-agonist such as formoterol are palpitations, atrial fibrillation, ventricular extrasystoles, tachyarrhythmia, potentially serious hypokalaemia and increase/decrease of blood pressure. Insomnia, dizziness, restlessness, and anxiety have occasionally been reported during inhaled formoterol therapy. Formoterol may also induce muscle cramps, myalgia.
Hypersensitivity reactions including rashes, urticaria, pruritus and erythema and oedema of the eye, face, lips and throat (angioedema) have been reported.
As with other inhalation therapy paradoxical bronchospasm may occur with an immediate increase in wheezing, cough and shortness of breath after dosing (see also Precautions).
Paediatric population: There is no information on the safety of Innovair Nexthaler in children up to 11 years of age, and only limited information in adolescents 12 - 17 years of age. In a 12 weeks randomised clinical trial in adults and adolescents, 162 adolescents aged 12 - 17 years with moderate to severe asthma received Innovair Nexthaler or the corresponding pressurised inhalation solution formulation, 1 or 2 inhalations bid; the frequency, type and severity of adverse drug reactions were not different in adolescents compared to adults.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.