Expansion of Indication: Anti-Influenza Drug Oseltamivir Phosphate (Product Name: Tamiflu(reg) Capsule 75)

Main Category: Infectious Diseases / Bacteria / Viruses
Also Included In: Flu / Cold / SARS
Article Date: 13 Jul 2004 - 14:00 PDT


Chugai Pharmaceutical Co., Ltd. ("Chugai") [Head Office: Chuo-ku, Tokyo. President: Osamu Nagayama] announced that "prophylaxis of A or B-type influenza" was approved as a newly added indication for the anti-influenza drug oseltamivir phosphate [product name: Tamiflu(reg) Capsule 75 1)] on July 9, 2004.

When administering Tamiflu(reg) Capsule 75 for the "prophylaxis of A or B-type influenza", target person and administration method are regulated in detail as seen on the package insert, in the written warning for the "Administration and Dosage" and "Indication" sections.

Chugai believes that the fundamentals of influenza infection prophylaxis lie in yearly vaccine inoculations performed before each start of the influenza season, and that this cannot be replaced by prophylactic administrations of Tamiflu(reg) Capsule 75.

For those family members and other cohabitants of influenza patients exposing the influenza virus, the risk of infection becomes clearly higher. The reduction of infection risk under this type of condition is the clinical significance of the prophylactic administration of Tamiflu(reg) Capsule 75.

For those at or over the age of 65 or those considered "high risk patients 2)" at or over the age of 13 who cohabit with patients displaying influenza symptoms, this approval for additional indication will make possible the once a day, 75mg oral administration of Tamiflu(reg) Capsule 75 within 2 days of contact with influenza patients, for a period of 7 to 10 days.

In regards to "prophylaxis of A or B-type influenza" as an approved additional indication, prophylactic administration is not targeted for "anyone, anytime", and is only intended for use within a short period after contact with influenza patients. It is Chugai's intent to make earnest efforts in thoroughly providing information so that these points are clearly understood by health care professionals. In addition, when used for "prophylaxis of A or B-type influenza," Tamiflu(reg) Capsule 75 will not be reimbursed by the national health insurance.

Chugai places infectious diseases therapy as one of its key areas of focus. It is our belief that this expansion of indication for Tamiflu(reg) Capsule 75 will allow us to make an additional contribution to the further development of infectious diseases therapies.

1) The prophylactic administration of "Tamiflu(reg) Dry Syrup 3%" is not approved.

2) "High risk patients": Patients suffering from chronic respiratory diseases ["COPD" (chronic obstructive pulmonary disease), bronchial asthma, chronic bronchitis, pulmonary tuberculosis, etc.], chronic cardiac diseases (cardiac failure, valvular disease, myocardial infarction, etc.), metabolic diseases (diabetes, etc.), and renal dysfunctions.

Chugai Pharma

• Additional
• References
• Citations