Introduction

Hydrocortisone (trade name: Alkindi) has been approved in Germany since May 2018 for the treatment of adrenal insufficiency specifically in newborn babies, children and teenagers.

The adrenal glands produce various hormones, including cortisol. This hormone influences many metabolic processes in the body. For instance, it regulates the conversion of energy in the body’s cells, and also affects blood sugar levels, the immune system and bone metabolism. Sometimes the adrenal glands don’t work as well as they normally should. Known as adrenal insufficiency, this condition can lead to low blood sugar levels, nausea, exhaustion and pain in the muscles, joints and bones. If this hormone deficiency isn’t treated, it can become life-threatening.

The drug hydrocortisone is used to replace the hormone cortisol, with the aim of preventing these symptoms and effects of the cortisol deficiency.

Application

Alkindi is available in the form of granule-filled capsules at doses of 0.5 to 5 mg.

The capsule is opened and the granules are emptied out directly onto the child’s tongue, or sprinkled on a spoonful of soft food. Once the granules have been taken, the child should immediately have a drink to make sure that the granules are all swallowed down.

The dose is adjusted individually in order to replace the hormones that are missing.

Other treatments

The hormone medication hydrocortisone has long been a well-established drug. So far, newborn babies, children and teenagers (up to the age of 18) have been given medications that haven’t been specifically approved for them.

Assessment

In 2018, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into whether Alkindi has any advantages or disadvantages for newborn babies, children and teenagers who have an adrenal insufficiency when compared with other hydrocortisone drugs.

But the manufacturer did not provide any suitable data with which to do the assessment.

More information

This information summarizes the main results of a review produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The review was commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of the review and the hearings received, the G-BA passed a resolution on the added benefit of hydrocortisone (Alkindi).