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FDA posts safety alerts, public health advisories, press releases and other notices from companies as a service to health professionals, consumers and other interested parties. Although FDA approves medical products, FDA does not endorse either the product or the company.
June 14, 2000
Dear Healthcare Professional:
InterMune Pharmaceuticals, Inc., would like to inform you of a change made to the ACTIMMUNE (Interferon gamma-1b) Injection labeling. InterMune, in agreement with FDA, has changed the expression of potency of the ACTIMMUNE drug product from units to International Units. This change does not affect the strength of the drug product. This change in labeling is based on direct calibration of the Interferon gamma reference standard to the WHO standard in the potency assay.
Carton and vial labels will now read "ACTIMMUNE (2 million IU)." This change also affects three sections of the package insert. The new package insert will read as follows:
Description
First paragraph, last sentence:
ACTIMMUNE is a highly purified sterile solution consisting of non-covalent dimers of two identical 16,465 dalton monomers; with a specific activity of 20 million International Units (IU)/mg (2x106 IU per 0.5 mL) which is equivalent to 30 million units/mg.
Second paragraph, last sentence:
Note that the above activity is expressed in International Units (1 million IU/50 mcg). This is equivqalent to what was previously expressed as units (l.5 million U/50 mcg).
Dosage and Administration
The recommended dosage of ACTIMMUNE...is 50 mcg/m2 (1 million IU) for patients whose body surface area is greater than 0.5 m2 ...Note that the above activity is expressed in International Units (1 million IU/50 mcg). This is equivalent to what was previously expressed as units (1.5 million U/50 mcg).
How Supplied
Each 0.5 mL of ACTIMMUNE contains 100 mcg (2 million IU)...
On February 10, 2000, FDA approve ACTIMMUNE (Interferon gamma -1b) Injection for delaying time to disease progression in patients with severe, malignant osteopetrosis. ACTIMMUNE is also indicated for reducing the freguency and severity of serious infection associated with Chronic Granulomatous Disease.
Please refer to the enclosed package insert for full prescribing information.
Sincerely,
Woodruff Emlen, M.D.
Vice President, Scientific and Medical Affairs
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