Esbriet 267 mg hard capsules

ATC Code
L04AX05
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About this drug

Admission country
Manufacturer InterMune UK Ltd.
Narcotic drug No
Psychotropic No
Anatomical group Antineoplastische und immunmodulierende mittel
Therapeutic group Immunsuppressiva
Pharmacological group Immunsuppressiva
Chemical group Andere immunsuppressiva
Substance Pirfenidon

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All to know

Author

InterMune UK Ltd.

What is it?

Esbriet is a medicine that contains the active substance pirfenidone. It is available as blue and gold capsules (267 mg).

What is it used for?

Esbriet is used to treat adults with mild to moderate idiopathic pulmonary fibrosis (IPF). IPF is a long-term disease in which hard fibrous tissue continuously forms in the lungs, causing persistent cough, frequent lung infections and severe shortness of breath. ?Idiopathic? means that the cause of the disease is unknown.

Because the number of patients with IPF is low, the disease is considered ?rare?, and Esbriet was designated an ?orphan medicine? (a medicine used in rare diseases) on 16 November 2004.

The medicine can only be obtained with a prescription.

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How is it used?

Treatment with Esbriet should be started and supervised by a doctor experienced in the diagnosis and treatment of IPF. Patients receiving Esbriet should have their liver function checked before and regularly during treatment.

Esbriet is taken three times a day at mealtimes. The dose of Esbriet is increased steadily, starting with one capsule per meal in the first week, two capsules per meal in the second week and three capsules per meal from the third week onwards. The capsules should be swallowed whole with water.

Patients who experience side effects such as stomach problems, light-sensitive skin reactions or significant changes in the levels of liver enzymes may need to have their dose reduced at least temporarily..

How does it work?

The mechanism of action of pirfenidone, the active substance in Esbriet, is not fully understood, but it has been shown to reduce the production of fibroblasts and other substances involved in the formation of hard fibrous tissue during the body?s tissue repair process, thereby slowing down the progression of the disease in IPF patients.

How has it been studied?

The effects of Esbriet were first tested in experimental models before being studied in humans.

Esbriet was compared with placebo (a dummy treatment) in two main studies involving a total of 779 IPF patients. The first study also compared two different doses of Esbriet. In IPF patients, lung function worsens over time. In both studies, the main measure of effectiveness was therefore the change in the functioning of the patients? lungs after 72 weeks of treatment, measured by their ?forced vital capacity? (FVC). FVC is the maximum amount of air the patient can breathe out forcefully after taking in a deep breath, which decreases as the condition gets worse.

What benefits has it shown during the studies?

In the first study, the patients taking Esbriet had a smaller reduction in FVC after 72 weeks than the patients taking placebo. The first study also found Esbriet to be most effective at the higher dose. The higher dose results from the first study, combined with the results of the second study (which involved the same higher dose), showed that the average reduction in FVC was 8.5% for patients taking Esbriet compared with 11% for patients taking placebo.

What is the risk associated?

The most commonly reported side effects during clinical study experience with Esbriet were nausea (feeling sick), rash, fatigue, diarrhoea, dyspepsia (heartburn), and photosensitivity reaction (skin reactions due to light sensitivity). For the full list of all side effects reported with Esbriet, see the package leaflet. Esbriet may also lead to raised levels of liver enzymes.

Esbriet should not be used in people who may be hypersensitive (allergic) to pirfenidone or any of the other ingredients. It must not be taken by patients already taking fluvoxamine (a medicine used to treat depression and obsessive compulsive disorder) or patients with severe liver or kidney problems.

Why has it been approved?

The CHMP noted that Esbriet had a modest effect on slowing down the progression of the disease, as measured by FVC, without serious risks for patients. It also noted the lack of effective alternative treatments. It therefore decided that Esbriet?s benefits are greater than its risks and recommended that it be given marketing authorisation.

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