If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  Pulmozyme Approved For Kids With Cystic Fibrosis SOUTH SAN FRANCISCO, CA -- March 2, 1998 -- The United States Food and Drug Administration has approved a change in the labelling of Genentech, Inc.’s Pulmozyme(R) (dornase alfa) Inhalation Solution, an aerosol treatment for cystic fibrosis (CF), which includes the safety and alternative administration of Pulmozyme in patients under the age of five. Pulmozyme had been previously approved by the FDA for use in CF patients five years or older. However, because of the limited experience with the administration of Pulmozyme to patients younger than five years of age, its use should be considered only for those patients in whom there is a potential for benefit in pulmonary function or for reducing risk of respiratory tract infection. The safety of 2.5 mg of Pulmozyme Inhalation Solution over two weeks of administration was evaluated in 98 patients with cystic fibrosis ages three months to 10 years. Young patients in the trial who were unable to utilise a nebulizer mouthpiece used the Pari Baby(TM) -- a reusable nebulizer which is equipped with a tight-fitting facemask. Adverse events in the under five patient population were similar to those seen in older patients with mild to moderate disease (FVC greater than or equal to 40 percent), including voice alteration, pharyngitis, laryngitis, rash, chest pain and conjunctivitis. However, cough, including moderate to severe cough, rhinitis and rash were reported more frequently in these very young CF patients compared to older children (five to less than or equal to 10 years of age). CF is an inherited disorder that affects about 25,000 Americans, 3,000 Canadians and 9,000 Europeans. Currently, there are approximately 3,000 patients under five in the U.S. that have CF. A faulty gene in CF patients leads to the production of thick viscous secretions that can cause persistent bacterial infection and congestion. As white blood cells attempt to destroy bacteria, they release DNA, which further thickens the secretions. These thick secretions also encourage and prolong respiratory tract infections that damage lung tissue and ultimately lead to death. Today, the average life span of patients with CF is 31 years compared to 14 years in 1969. In December 1993, Pulmozyme Inhalation Solution received approval by the FDA for the management of mild to moderate CF in patients over the age of five in conjunction with standard therapies to reduce the incidence of respiratory tract infections requiring parenteral antibiotics and to improve pulmonary function. In December 1996, the indication for Pulmozyme was expanded to include patients with advanced disease. More information on: Pulmozyme, Genentech, Inc.
|
