Takhzyro

Takhzyro is given as an injection under the skin, preferably in the abdomen (belly), thighs or upper arms. The recommended starting dose of Takhzyro is 300 mg every 2 weeks. If the patient remains free of attacks with the two-weekly dose, the doctor can reduce the frequency to once every 4 weeks.

The doctor may decide that patients or their caregivers can inject the medicine themselves after they have been properly trained.

Takhzyro can only be obtained with a prescription and should be started under supervision of a doctor experienced in managing hereditary angioedema.

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

Patients with hereditary angioedema have high levels of a substance called ‘bradykinin’, which causes blood vessels to widen and leak fluid into the surrounding tissue leading to the swelling attacks seen in angioedema.

The active substance in Takhzyro, lanadelumab, works by attaching to and blocking an enzyme in the blood called 'kallikrein', which has several functions, including increasing levels of bradykinin. By blocking the actions of kallikrein, lanadelumab helps to prevent the swelling and related symptoms of angioedema.

Takhzyro was found to be effective in reducing the number of angioedema attacks in a main study in 126 adults and children above 12 years of age with hereditary angioedema.

Patients experienced on average 0.3 attacks per month when given Takhzyro injections every 2 weeks and 0.5 attacks when given injections every 4 weeks. This compared with 2 attacks per month for patients on placebo (a dummy treatment).

The most common side effects with Takhzyro (which may affect more than 1 patient in 10) are reactions at the site of injection including erythema (redness), bruising and pain.

For the full list of side effects and restrictions with Takhzyro, see the package leaflet.

Takhzyro is effective in preventing angioedema attacks and the fact that it only needs to be given every 2 or 4 weeks was considered an advantage over existing treatments. Overall, the safety profile was considered acceptable.

The European Medicines Agency therefore decided that Takhzyro’s benefits are greater than its risks and it can be authorised for use in the EU.

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

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

Takhzyro received a marketing authorisation valid throughout the EU on 22 November 2018.