What is Nymusa?
Nymusa is a solution for infusion (drip into a vein) that contains the active substance caffeine citrate (20 mg / ml). The solution can also be taken orally.
What is Nymusa used for?
Nymusa is used in the treatment of primary apnea in premature infants. In the infant, apnea is the cessation of breathing for more than 20 seconds; by "primary" is meant the fact that it has no apparent cause. The medicine can only be obtained with a prescription.
Because the number of premature babies with primary apnea is low, the disease is considered 'rare' and Nymusa was designated an 'orphan medicine' (a medicine used in rare diseases) on 17 February 2003.
How is Nymusa used?
Treatment with Nymusa should only be started under the supervision of a doctor who has experience in the treatment of infants in need of intensive care. Treatment with the drug should only be conducted in a neonatal intensive care unit appropriately equipped for monitoring the baby.
Treatment starts at a dose of 20 mg per kilogram of body weight, to be administered at once by slow infusion lasting 30 minutes. After 24 hours it is possible to start the daily administration of a maintenance dose of 5 mg per kg of body weight, by slow infusion lasting 10 minutes or by mouth through a nasogastric tube (a tube that is inserted into the nose and reaches the stomach). .
If necessary, the doctor can monitor the blood level of caffeine in the baby, possibly correcting the dose. Your doctor will stop Nymusa treatment after five to seven consecutive days have elapsed without apnea.
How does Nymusa work?
In premature babies, apnea is due to an incomplete development of the brain centers responsible for breathing. The active ingredient contained in Nymusa, caffeine citrate, is a stimulant of the nervous system. Caffeine citrate is an "antagonist" of adenosine, a substance which blocks the activity of certain parts of the brain including that which controls breathing. In the case of apnea, caffeine citrate acts by blocking the receptors to which adenosine normally binds, thus reducing the effect of adenosine and stimulating the brain to reactivate breathing.
How has Nymusa been studied?
As caffeine citrate has been used for a long time in premature babies, the company presented data from the scientific literature. In a published study involving 85 premature babies with multiple apnea episodes, caffeine citrate was compared with placebo (a dummy treatment). The main measure of effectiveness was based on reducing the daily number of apnea episodes to at least half over the course of ten days.
A large published study compared caffeine citrate with a placebo in the treatment of 2006 premature babies with apnea. The study looked at how long the children survived and whether or not they had neurological handicaps after 18 months.
In a published review of five studies, caffeine and theophylline (another stimulant) were compared with placebo in 192 premature babies with apnea. The main measure of effectiveness was the number of patients without "therapeutic failure", understood as the failure to halve the apneic episodes, or the need to resort to assisted breathing or the death of the child.
What benefit has Nymusa shown during the studies?
Caffeine citrate was more effective than placebo in the treatment of apnea in premature infants. In 6 out of 10 days, caffeine citrate was more effective than placebo in reducing the number of apneic episodes by at least half. number of infants treated with caffeine citrate and who spent at least eight days without apneic episodes, 22% of infants treated with caffeine citrate compared to no infants treated with placebo.
In a large published study, 46% of infants treated with placebo (431 out of 932) died or reported neurological handicaps, compared with 40% of infants treated with caffeine citrate (377 out of 937).
In the review of the five studies, there were fewer treatment failures in children treated with caffeine or theophylline than in those treated with placebo.
What is the risk associated with Nymusa?
The most common side effects associated with caffeine citrate (i.e. seen in 1 to 10 out of 100 patients) are phlebitis (inflammation of a vein) at the infusion site and inflammation of the infusion site. For the full list of side effects reported with caffeine citrate, see the package leaflet.
Nymusa should not be used in babies who may be hypersensitive (allergic) to caffeine citrate or any of the other ingredients.
Why has Nymusa been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Nymusa's benefits are greater than its risks in the treatment of primary apnea in preterm infants, and recommended that Nymusa be given a marketing authorization.
What measures are being taken to ensure the safe use of Nymusa?
The company that produces Nymusa has undertaken to prepare, in agreement with the Member States, a card to be posted in the intensive care units where the drug will be used; this sheet will contain information on how to administer Nymusa, the dosages, the need to monitor the levels of caffeine in the plasma and the undesirable effects that may occur during the
treatment.
Other information about Nymusa:
On 02 July 2009, the European Commission granted Chiesi Farmaceutical SpA a "marketing authorization" for Nymusa, valid throughout the European Union.
For the summary of the opinion of the Committee for Orphan Medicinal Products for Nymusa, click here.
For the full version of Nymusa's EPAR, click here.
Last update of this summary: 05-2009.
The information on Nymusa - caffeine citrate published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
