Rescue medicinal products: Roflumilast is an anti-inflammatory substance indicated for maintenance treatment of severe COPD associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add on to bronchodilator treatment. It is not indicated as rescue medicinal product for the relief of acute bronchospasms.
Weight decrease: In 1-year studies (M2-124, M2-125), a decrease of body weight occurred more frequently in patients treated with Daxas compared to placebo-treated patients. After discontinuation of Daxas, the majority of patients had regained body weight after 3 months.
Body weight of underweight patients should be checked at each visit. Patients should be advised to check their body weight on a regular basis. In the event of an unexplained and clinically concerning weight decrease, the intake of Daxas should be stopped and body weight should be further followed-up.
Special clinical conditions: Due to lack of relevant experience, treatment with Daxas should not be initiated or existing treatment with Daxas should be stopped in patients with severe immunological diseases (e.g. HIV infection, multiple sclerosis, lupus erythematosus, progressive multifocal leukoencephalopathy), severe acute infectious diseases, cancers (except basal cell carcinoma), or patients being treated with immunosuppressive medicinal products (i.e.: methotrexate, azathioprine, infliximab, etanercept or oral corticosteroids to be taken long-term; except short-term systemic corticosteroids). Experience in patients with latent infections such as tuberculosis, viral hepatitis, herpes viral infection and herpes zoster is limited.
Patients with congestive heart failure (NYHA grades 3 and 4) have not been studied and therefore treatment of these patients is not recommended.
Psychiatric disorders: Daxas is associated with an increased risk of psychiatric disorders such as insomnia, anxiety, nervousness, depression. Rare instances of suicidal ideation and behavior, including completed suicide, have been observed in patients with or without history of depression, usually within first weeks of treatment. The risks and benefits of starting or continuing treatment with Daxas should be carefully assessed if patients report previous or existing psychiatric symptoms or if concomitant treatment with other medicinal products likely to cause psychiatric events is intended. Daxas is not recommended in patients with a history of depression associated with suicidal ideation or behavior.
Patients and caregivers should be instructed to notify their prescriber of any changes in behavior or mood and of any suicidal ideation. If patients suffered from new or worsening psychiatric symptoms, or suicidal ideation or suicidal attempt is identified, it is recommended to discontinue treatment with Daxas.
Persistent intolerability: While adverse reactions like diarrhea, nausea, abdominal pain and headache mainly occur within the first weeks of therapy and mostly resolve on continued treatment, Daxas treatment should be reassessed in case of persistent intolerability. This might be the case in special populations that may have higher exposure, such as in black, non-smoking females or in patients concomitantly treated with CYP1A2/2C19/3A4 inhibitors (such as fluvoxamine and cimetidine) or the CYP1A2/3A4 inhibitors enoxacin.
Theophylline: There are no clinical data to support the concomitant treatment with theophylline for maintenance therapy. Therefore, the concomitant treatment with theophylline is not recommended.
Lactose: Daxas tablets contain 199 mg lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Effect on Ability to Drive and Use Machines: Daxas has no influence on the ability to drive and use machines.