Medication Discontinuation Alert

November 29, 2007

ISSUE:	Roche announces market discontinuation of Roferon-A (interferon alfa-2a) for market reasons
MEDICATION:	Roferon-A® (interferon alfa-2a), 3, 6 and 9 Million IU prefilled syringes

The FDA Drug Shortages website posted a notice about the market discontinuation of Roche’s Roferon-A injection on 11/29/2007. An excerpt from Roche’s "Dear Healthcare Professional" Letter dated October 1, 2007 stated as follows:
"[The] production of ROFERON-A(Interferon alfa-2a, recombinant) has been discontinued for the United States market and sale of ROFERON-A will be discontinued when existing supply for the U.S. is depleted, which is estimated to be early to mid-2008. This action is not being taken due to the safety or efficacy profile of the product, but rather for decisions related to the lifecycle of this product.

Discontinuation Schedule
The distribution of ROFERON-A prefilled syringes will be discontinued as follows:
3 MIU strength: It is expected that the Roche inventory of 3 MIU prefilled syringes will be exhausted between early to mid-October 2007. After this time, the product will no longer be available from Roche; however, you will still be able to obtain product through your servicing wholesaler or retail pharmacy until their supply runs out.
6 and 9 MIU strength: The last date of distribution from Roche for the 6 and 9 MIU prefilled syringes is December 31, 2007. After this time, the product will no longer be available from Roche; however, you will still be able to obtain product through your servicing wholesaler or retail pharmacy until their supply runs out.

In anticipation of this delisting, we have verified the existence of alternative treatments and their current use for the same indications and diagnoses as ROFERON-A. ROFERON-A is indicated for the treatment of chronic hepatitis C, AIDS-related Kaposi's Sarcoma, and hairy-cell leukemia. Additionally, it is indicated for chronic phase, Philadelphia chromosome (Ph) positive chronic myelogenous leukemia (CML) patients who are minimally pretreated (within 1 year of diagnosis).

Alternative Therapies
Chronic hepatitis C: The management of patients with chronic hepatitis C still focuses on the administration of interferon alfa; however, the current standard of care, as promulgated by the American Gastroenterological Association, is pegylated interferon in combination with oral ribavirin. These recommended therapies will not be impacted by the delisting of ROFERON-A.
AIDS-related Kaposi's sarcoma: AIDS-related Kaposi's Sarcoma is typically managed with one or more of the following treatment modalities: surgery, cryotherapy, chemotherapy, radiation therapy, and biological therapy. Biological treatment involves interferon administration, and between 25% and 50% of selected patients improve on high-dose therapy. When this intervention is indicated, alternative formulations of interferon alfa-2a to ROFERON-A are available for patient management.
Hairy-cell leukemia: Current treatment for hairy cell leukemia requires the administration of chemotherapy. The drugs most frequently used are cladribine and pentostatin. Up to 80% of patients respond to these drugs, and the responses usually last for more than 5 years in a large majority of patients. More recently it has been reported that the use of rituximab after cladribine in patients who have not shown a complete response may induce a complete response. Because go few people develop this disease it is not known if this secondary response will translate into long-term control of the disease.
Chronic myelogenous leukemia: in the case of chronic myelogenous leukemia (CML) chemotherapies such as busulfan or hydroxyurea in combination with cytarabine and immune therapy, with or without bone marrow transplant, have been traditionally used for treatment. At the present time, imatinib mesylate is the preferred treatment because a complete hematological remission is achieved in almost every patient.

If you have any questions or require additional information concerning ROFERON-A, please contact the Roche Pharmaceuticals Service Center at (800) 526-6367."