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.
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.
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.
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.
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).
Institute for Quality and Efficiency in Health Care (IQWiG). Hydrocortisone (adrenal insufficiency) – Benefit assessment according to §35a Social Code Book V. Dossier assessment; Commission A18-29. August 10, 2018. (IQWiG reports; Volume 656).
IQWiG health information is written with the aim of helping
people understand the advantages and disadvantages of the main treatment options and health
Because IQWiG is a German institute, some of the information provided here is specific to the German health care system. The suitability of any of the described options in an individual case can be determined by talking to a doctor. informedhealth.org can provide support for talks with doctors and other medical professionals, but cannot replace them. We do not offer individual consultations.
Our information is based on the results of good-quality studies. It is written by a team of health care professionals, scientists and editors, and reviewed by external experts. You can find a detailed description of how our health information is produced and updated in our methods.