Ofev

Ofev can only be obtained with a prescription, and treatment should be started by a doctor experienced in the diagnosis and treatment of the diseases it is used for.

Ofev is available as capsules (100 and 150 mg). The recommended dose is 150 mg taken twice a day with food, approximately 12 hours apart. In patients who do not tolerate this dose, the dose should be reduced to 100 mg twice a day or treatment should be interrupted.

For more information about using Ofev, see the package leaflet or contact your doctor or pharmacist.

The active substance in Ofev, nintedanib, blocks the activity of some enzymes known as tyrosine kinases. These enzymes are present in certain receptors (such as VEGF, FGF and PDGF receptors) in cells in the lungs, where they activate several processes involved in the generation of fibrous tissue. By blocking these enzymes, nintedanib helps to reduce the formation of fibrous tissue in the lungs, thereby helping to prevent the symptoms of the disease from getting worse.

Ofev has been compared with placebo (a dummy treatment) in four main studies involving a total of 1,066 patients with IPF, 580 patients with systemic sclerosis associated interstitial lung disease and 663 patients with progressive fibrosing interstitial lung disease. In all studies, the main measure of effectiveness was the decline in the functioning of the patients’ lungs over the course of 1 year 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 and this decreases as the condition gets worse.

In 2 studies in patients with IPF, patients taking Ofev had a smaller decline in FVC than patients taking placebo, meaning that Ofev slowed down the worsening of the condition. The average FVC of patients before treatment was between 2600 and 2700 millilitre (ml). In the first study, the average decrease in FVC over 1 year was 115 ml in patients taking Ofev compared with a decrease of 240 ml in patients taking placebo. In the second study, the average decrease was 114 ml for Ofev compared with 207 ml for placebo. A further analysis of the results of the 2 main studies, which took into account that some patients stopped treatment, confirmed the benefits of Ofev over placebo, although the difference in FVC between the two was less pronounced.

In the study in patients with systemic sclerosis associated interstitial lung disease, the average decrease in FVC was 52 ml for Ofev compared with 93 ml for placebo. The average FVC of patients before treatment was around 2500 ml.

In the study in patients with progressive fibrosing interstitial lung disease, the average decrease in FVC was 81 ml for Ofev compared with 188 ml for placebo. The average FVC of patients before treatment was around 2330 ml.

The most common side effects with Ofev (which may affect more than 1 in 10 people) are diarrhoea, nausea (feeling sick), vomiting, abdominal pain (belly ache), decreased appetite and raised levels of liver enzymes in the blood (a sign of liver problems). Weight loss (which may affect up to 1 in 10 people) is also common. For the full list of side effects reported with Ofev, see the package leaflet.

Ofev must not be used in patients who are hypersensitive (allergic) to nintedanib, peanut or soya, or any of the other ingredients. Ofev must also not be used in pregnant women.

The European Medicines Agency decided that Ofev’s benefits are greater than its risks and it can be authorised for use in the EU. The Agency considered that Ofev is effective at slowing down the worsening of lung function in patients with IPF, systemic sclerosis associated interstitial lung disease and other chronic fibrosing interstitial lung diseases which are progressive. Regarding safety, the side effects associated with Ofev were considered manageable with dose interruptions or reductions.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ofev have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Ofev are continuously monitored. Side effects reported with Ofev are carefully evaluated and any necessary action taken to protect patients.

Ofev received a marketing authorisation valid throughout the EU on 14 January 2015.