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Daliresp (roflumilast) – Conditions or restrictions regarding supply and use - R03DX07

Updated on site: 06-Oct-2017

Medication nameDaliresp
ATC CodeR03DX07
Substanceroflumilast
ManufacturerAstraZeneca AB

A.MANUFACTURER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer responsible for batch release

Takeda GmbH

Production Site Oranienburg

Lehnitzstrasse 70-98

D-16515 Oranienburg

Germany

B.CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Medicinal product subject to medical prescription.

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION

Periodic Safety Update Reports

The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT

Risk Management Plan (RMP)

The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.

An updated RMP should be submitted

At the request of the European Medicines Agency;

Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.

If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.

Additional risk minimisation measures

The Marketing Authorisation Holder shall agree the content and format of the updated educational material with the national competent authority.

The Marketing Authorisation Holder (MAH) should ensure that all Healthcare Professionals who are expected to prescribe Daliresp are provided with an updated Educational pack.

The educational pack should contain the following:

Summary of Product Characteristics and Patient Information Leaflet for Daliresp

Educational material for the physician.

Copies of the patient card to be given to patients or caregivers before they receive Daliresp

The educational material for the prescriber should include information on the following key elements:

The specific indication approved.

The fact that Daliresp is not indicated for the treatment of COPD patients outside of the approved indication, nor for use in patients with asthma or alpha-1 antitrypsin deficiency.

The need to inform patients about the risks of Daliresp and the precautions for safe use including:

The risk of weight decrease in underweight patients and the need to monitor the body weight at each visit and to stop the treatment in the event of an unexplained and clinically concerning weight decrease. Patients should be advised to weigh themselves at regular intervals and record the weight in the patient card.

The risk of psychiatric disorders such as insomnia, anxiety, depression in patients receiving Daliresp and the potential risk of suicide. Rare instances of suicidal ideation and behaviour, including completed suicide, have been observed in patients with and without a history of depression, usually in the first weeks of treatment. Physicians should carefully assess the benefit risk balance of this treatment in patients with existing psychiatric symptoms or with history of depression. Daliresp is not recommended in patients with a history of depression associated with suicidal ideation or behaviour. If patients suffer from new or worsening psychiatric symptoms, or suicidal ideation or suicidal attempt, it is recommended to discontinue treatment with Daliresp.

Patients and caregivers should be requested to report any changes in the patient`s behaviour or mood or suicidal ideation.

The potential risk of malignant tumours and the lack of experience in patients with past history of cancer. Daliresp should not be initiated or should be stopped in patients with cancers (except basal cell carcinoma).

That increased exposure might occur in certain populations and increase the risk of persistent

intolerability:

oSpecial populations who have increased PDE4 inhibition such as black non smoking females;

oPatients concomitantly treated with CYP1A2/2C19/3A4 inhibitors (such as fluvoxamine and cimetidine) or CYP1A2/3A4 inhibitors (such as enoxacin).

The potential risk of infections: Daliresp should not be initiated, or treatment should be stopped, in patients with severe acute infectious diseases. The limited experience in patients with latent infections such as tuberculosis, viral hepatitis or herpes infections.

The lack of experience in patients with HIV infection or active hepatitis, with severe immunological diseases (e.g. multiple sclerosis, lupus erythematosus, multifocal leukoencephalopathy) or treated with immunosuppressive therapy (other than short-term systemic corticosteroids) and that Daliresp should not be initiated or should be stopped in these patients.

The potential cardiac risk: Daliresp has not been studied in patients in congestive heart failure (NYHA grade 3 and 4); hence, it is not recommended in this population.

The limited or missing information in patients with liver impairment. Daliresp is contraindicated in patients with moderate or severe liver impairment (Child-Pugh B or C). Clinical data are considered insufficient to recommend dose adjustment and caution should be observed in patients with mild liver impairment (Child-Pugh A).

The lack of clinical data to support the combination with theophylline and that such combination is not recommended.

Patient Card

The patient card should contain the following key elements:

That they should tell their doctor if they have a history of any of the following conditions

cancer

insomnia, anxiety, depression, suicidal ideation or behaviour

multiple sclerosis or SLE

infection with tuberculosis, herpes, hepatitis, HIV

That patients or their caregivers should tell their doctor if the patient develops symptoms indicative of:

insomnia, anxiety, depression, changes in behaviour or mood, suicidal ideation or behaviour

severe infection

That patients should tell their doctor if they are taking any other medicines.

That Daliresp may cause weight loss and patients should weigh themselves regularly and record their weight on the patient card.

The patient card should include an area where patients can record their weight and the date they weighed themselves and they should be asked to bring the patient card with them at each visit.

 

Obligation to conduct post-authorisation measures

 

The MAH shall complete, within the stated timeframe, the below measures:

 

 

 

 

 

Description

Due date

 

ANX 2.1 - The MAH commits to conduct a long-term comparative

Interim Study

 

observational safety study. This study should be appropriate to compare

Reports - with each

 

the incidences of all-cause mortality, major cardiovascular events, new

PSUR

 

diagnosis of cancer, all-cause hospitalisation, hospitalisation related to

 

 

respiratory disease, suicide or hospitalisation for suicide attempt, and new

Final study report

 

diagnosis of depression, tuberculosis or viral hepatitis B or C in

by 31/03/2021

 

roflumilast treated COPD patients compared with COPD patients not

 

 

treated with roflumilast.

 

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