Roferon

Interferon alfacon-1 (Inferax ), interferon alfa-2b (IntronA ), and interferon alfa-2a (Roferon -A) are applied in the treatment of chronic hepatitis B and C and some malignancies, especially hairy cell leukemia. IFN-a proteins induce the expression of antiviral, antiproliferative and immunomodulatory genes. [Pg.411]

Interferon alfa-2a (Roferon A), interferon alfa-2b (Intron-A), and interferon alfacon-1 (Infergen) are approved for chronic hepatitis C. However, they are not prescribed alone because only 12% to 16% of patients achieve a sustained virologic response (SVR). Adding ribavirin, a synthetic guanosine analogue that inhibits viral polymerase, increases the SVR rate to 35% to 45%. [Pg.356]

Roferon-A Interferon a-2a Hoffman-La Roche Hairy cell leukemia, AIDS-related Kaposi s sarcoma, myelogenous leukemia, hepatitis C,... [Pg.695]

Roferon (interferon a-2a) Solution or lyophile for IV injection Stable for 1 month at 2-8°C after reconstitution Each mL contains 3, 6, 36 million IU protein with 9 mg NaCl, 5 mg HAS, and 3 mg phenol... [Pg.709]

Interferon alfa-2a Interferon alfa-2b 18 million IU 18 million IU 209.58 218.04 Roferon-A Intron-A ... [Pg.185]

Roferon A (rhIFN-a-2a) Hoffman-La-Roche Hairy cell leukaemia... [Pg.224]

Roferon IFN alfa-2a Stemgen (stem cell factor) Hoffman-La Roche Amgen... [Pg.147]

Interferon alpha (Roferon-A) Lamivudine (Epivir, Epivir-HBV)... [Pg.412]

Brand Name(s) Roferon-A (alfa-2a), Intron-A (alfa-2b)... [Pg.631]

Injection 3 million units, 6 million units, 9 million units, 36 million units (Roferon-A). [Pg.632]

B. Indications and use Roferon-A is indicated for the treatment of chronic hepatitis C, hairy-cell leukemia, and AIDS-related Kaposi s sarcoma in patients 18 years of age or older. In addition it is indicated for chronic phase, Philadelphia chromosome (Ph) positive chronic myelogenous leukemia (CML) patients who are minimally pretreated (within 1 year of diagnosis). [Pg.190]

Dosage form Roferon-A is available as single-use injectable solutions, single-use prefilled syringes, and multidose injectable solutions. [Pg.190]

Route of administration Roferon-A can be administered intramuscularly or subcutaneously. The route of administration for the prefilled syringe is subcutaneous only. [Pg.190]

Recommended dosage and monitoring requirements The recommended dose of Roferon-A for chronic hepatitis C is 3 million international units (MIU) three times a week for 12 months. The recommended dose for CML is 9 MIU daily optimal duration of therapy has not been determined. The recommended dose for hairy cell leukemia is 3 MIU daily for 16 to 24 weeks. The recommended dose for AIDS-related Kaposi s sarcoma is 36 MIU daily for 10 to 12 weeks. There are five types of interferon alfa currently available in the United States interferon alfa-2a, peginterferon alfa-2a, interferon alfa-2b, interferon alfacon-1, and interferon alfa n3. Doses are not consistent for these preparations. [Pg.190]

Pharmacokinetics A mean elimination half-life of approximately 5 hours has been reported after intravenous doses of Roferon-A. Pharmacokinetic parameters are similar in healthy subjects and cancer patients after intramuscular doses. Dose-proportionate increases in serum levels occur with doses up to 198 MIU. The bioavailability of interferon alfa-2a after intramuscular administration is 80% to 83%, and its volume of distribution is 0.223 to 0.748 liter/kg. The total body clearance of interferon alfa-2a has been reported to range from 2.14 to 3.62ml/min per kg. [Pg.191]

E. Therapeutic response According to the product label, studies have shown that Rofewn-A can normalize serum transaminases, improve Uver histology, and reduce viral load in patients with chronic hepatitis C virus (HCV) infection. Other studies have shown that Roferon-A can produce clinically meaningful tumor regression or disease stabilization in patients with hairy-cell leukemia or in patients with AIDS-related Kaposi s sarcoma. In Ph-positive CML, Roferon-A supplemented with intermittent chemotherapy has been shown to prolong overall survival and to delay disease progression compared to patients treated with chemotherapy alone. In addition Roferon-A has been shown to produce sustained complete cytogenetic responses in a small subset of patients with CML in chronic phase. [Pg.191]

F. Role in therapy According to Micromedex, Roferon-A is recommended as the drug of choice in renal carcinoma and the chronic phase of chronic myelogenous leukemia. The role of Gleevec (Ima-tinib) in CML is yet to be determined, but it may replace the use of interferon alfa-2a. Roferon-A is an alternative (for unrespon-sive/intolerant patients) to current regimens of choice in hairy-cell leukemia, multiple myeloma, metastatic melanoma, and AIDS-related Kaposi s sarcoma. Other alpha interferons appear to have similar efficacy and can be used in lieu of Roferon-A in some instances. In particular, interferon alfa-2b (Intron) can be considered to have the same role as interferon alfa-2a in chronic hepatitis C, Kaposi s sarcoma, and hairy-cell leukemia. [Pg.191]

G. Other applications Roferon-A has also been used in renal cell carcinoma, multiple myeloma, metastatic melanoma, and primary resected cutaneous melanoma. [Pg.191]

Interferons and cytokines Interferon alfa-2a Roferon-A Sterile solution, SDV and prefilled syringes containing 3, 6,9,36MIU IV, SC... [Pg.461]

Parenteral 100 mg lyophilized powder for IV injection Interferon alfa-2a (Roferon)... [Pg.1206]

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