What Malignant Hyperthermia Association Says About Ryanodex
Article ID: 622644
Released: 2-Sep-2014 10:00 AM EDT
Source Newsroom: Malignant Hyperthermia Association of the United States (MHAUS)
Newswise — The discovery and subsequent introduction of dantrolene in 1979 was a major breakthrough in the treatment of malignant hyperthermia (MH) that is responsible for saving hundreds, if not thousands, of lives. However, one of the major challenges in the successful treatment of MH is the need for rapid mixing, suspension, and administration of dantrolene during a crisis.
Ryanodex® (Eagle Pharmaceuticals) is a new FDA approved preparation of dantrolene that significantly speeds dantrolene preparation and administration. With Ryanodex, 250 mg of dantrolene can be suspended in 5 ml of sterile water for injection in less than 30 seconds and administered in less than one minute. Thus, an initial treatment dose of dantrolene of 2.5mg/kg for an 80 kg patient requires only 4 ml (200 mg) of Ryanodex.
Although efficacy of Ryanodex in treating MH in an established pig model has been demonstrated,1 the preparation has not yet been used to treat MH in humans. Now that FDA approval for the treatment of MH by Ryanodex has been granted, MHAUS recommends that The North American Malignant Hyperthermia Registry AMRA* Report be utilized to report Ryanodex use. This will permit independent evaluation of its safety and efficacy in the treatment of human MH.
* Adverse Metabolic or Muscular Reaction to Anesthesia
The North American Malignant Hyperthermia Registry of MHAUS has University of Pittsburgh IRB approval to receive AMRA reports. Submission of AMRA reports does not require patient consent because all data is gathered anonymously. AMRA reports may be downloaded from www.mhaus.org/registry. 1 Schutte, JK, Becker S, Burmester S, et al. Comparison of the therapeutic effectiveness of a dantrolene sodium solution and a novel nanocrystalline suspension of dantrolene sodium in malignant hyperthermia normal and susceptible pigs. Eur. J. Anesthesiol., 2011; 28(4):256-264 The foregoing is presented for informational purposes only. Each practitioner should use his/her best judgment in deciding which preparation of dantrolene to use in her/his practice.
About Malignant HyperthermiaMalignant Hyperthermia is an inherited genetic disorder found in an estimated 1 out of 2,000 people. MH crisis situations are triggered by commonly used general anesthetics and the paralyzing agent, succinylcholine, and results in a biochemical chain reaction response in the skeletal muscles of susceptible individuals. General signs of MH crisis include increased heart rate, greatly increased body metabolism, muscle rigidity, and/or fever that may exceed 110° F along with muscle breakdown. Without proper and prompt treatment, MH crisis mortality is extremely high, without immediate recognition and treatment with the antidote, dantrolene sodium.
About Malignant Hyperthermia Association of the United States (MHAUS) Established in 1981 when families who lost their children to Malignant Hyperthermia or were unable to find information about MH. Malignant Hyperthermia is a genetic disorder found in an estimated 1 out of every 2,000 people. Today MHAUS provides information and resources to medical and lay communities through conferences, educational materials, ID tags, 24-hour MH Hotline, MHAUS website, and with the help of MH Groups. The mission of the MHAUS is to promote optimum care and scientific understanding of MH and related disorders.