KENILWORTH, N.J., July 9 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP) today announced that Schering-Plough K.K., the company's country operation in Japan, has received marketing approval for ASMANEX TWISTHALER (mometasone furoate dry powder inhaler) for the treatment of bronchial asthma in adults.(1)
"We are pleased to announce the approval of the ASMANEX TWISTHALER in Japan," said Thomas P. Koestler, Ph.D., executive vice president and president, Schering-Plough Research Institute. "ASMANEX was discovered and developed by Schering-Plough Research Institute and offers physicians and patients in Japan an effective inhaled corticosteroid to treat bronchial asthma in an innovative dry powder inhaler device," Koestler added. "Schering-Plough K.K. has received eight total new chemical entity approvals in Japan during the past two years, underscoring Schering-Plough's commitment to improving health and well being for patients in Japan."
Important Information about ASMANEX in the United States
Clinical studies with ASMANEX have shown improvement in lung function, decreased use of rescue medication, and improvement in daytime symptoms in patients 12 and older.
ASMANEX is approved for the maintenance treatment of asthma in patients 4 years of age and older. ASMANEX will not relieve sudden asthma symptoms and is not for children less than 4 years of age.
In the U.S., it is available in two dose strengths, 110 mcg for children between 4 and 11 years old, and 220 mcg for patients 12 and older.
Important Safety Information
ASMANEX is not a rescue inhaler and should not be used to treat sudden asthma symptoms. Use a rescue inhaler to relieve sudden asthma symptoms.
ASMANEX should not be used to treat acute asthma episodes (including status asthmaticus) where extra measures are required.
ASMANEX is not for patients who have a hypersensitivity (including allergic reactions) to mometasone or any of the ingredients in ASMANEX. There have been cases of hypersensitivity, allergic reactions, facial swelling, hives, and throat tightness reported.
Patients who use inhaled steroid medicines for asthma may develop a fungal infection of the mouth and throat. Rinse your mouth after using ASMANEX.
It is possible that hypercorticism (an excess level of steroids in your body) or adrenal insufficiency (your adrenal gland cannot produce enough steroids) may appear in a small number of patients, particularly when ASMANEX is administered at higher than recommended doses over prolonged periods of time. If such effects occur, consult your health care provider as the dosage of ASMANEX should be reduced slowly.
If you or your child took steroids by mouth and are having them decreased or are being switched to ASMANEX, you should be followed closely by your health care provider and the oral steroids should be reduced slowly. Deaths due to adrenal insufficiency have occurred during and after switching from oral steroids to inhaled steroids. Tell your health care provider right away about any symptoms such as feeling tired or exhausted, weakness, nausea, vomiting, or symptoms of low blood pressure (such as dizziness or faintness). If you or your child is under stress, such as with surgery, after surgery, or trauma, you may need steroids by mouth again.
Avoid coming in contact with measles, chicken pox virus, tuberculosis, or any other infections before or while using ASMANEX. Contact your health care provider immediately if you or your child have been exposed.
Patients who use inhaled steroids, including ASMANEX, for a long time may have an increased risk of decreased bone mass, which can affect bone strength. Patients who are at increased risk of decreased bone mass should be monitored.
Inhaled steroids, including ASMANEX, may cause a reduction in growth velocity when administered to pediatric patients. The long-term effect on final adult height is unknown. Health care providers should closely follow the growth of children and adolescents taking corticosteroids by any route, and reduce each patient's dose to the lowest dose that effectively controls his/her symptoms.
ASMANEX may increase the risk of some eye problems such as cataracts, glaucoma, and increased intraocular pressure. Patients with a change in vision or a history of eye problems should be monitored by their health care provider.
Use ASMANEX as directed by your health care provider, since its ability to work in your lungs depends on regular use. Maximum benefit may take 1 to 2 weeks or longer. If your asthma symptoms do not improve, or get worse, contact your health care provider.
The most common side effects with ASMANEX in patients 4-11 years old include fever, allergic rhinitis, abdominal pain, vomiting, urinary tract infection, and bruise.
The most common side effects with ASMANEX in patients 12 years of age and older include headache, allergic rhinitis, sore throat, and upper respiratory infection.(2)
Additional important product information is available at: http://www.spfiles.com/piasmanex.pdf
About Schering-Plough Corporation
Schering-Plough is an innovation-driven, science-centered global health care company. Through its own biopharmaceutical research and collaborations with partners, Schering-Plough creates therapies that help save and improve lives around the world. The company applies its research-and-development platform to human prescription and consumer products as well as to animal health products. Schering-Plough's vision is to "Earn Trust, Every Day" with the doctors, patients, customers and other stakeholders served by its colleagues around the world. The company is based in Kenilworth, N.J., and its Web site is www.schering-plough.com.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release includes certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to potential market for ASMANEX. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering-Plough's forward-looking statements, including market forces, economic factors, product availability, patent and other intellectual property protection, current and future branded, generic or over-the-counter competition, the regulatory process, and any developments following regulatory approval, among other uncertainties. For further details about these and other factors that may impact the forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including Part II, Item 1A "Risk Factors" in the Company's first quarter 2009 10-Q, filed May 1, 2009.
1. ASMANEX (R) Package Insert. Schering-Plough K.K.
2. ASMANEX (R) U.S. Package Insert. Schering Corporation.
SOURCE Schering-Plough Corporation