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Roferon-A

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Roferon-A

Indications
Dosage
How Supplied

INDICATIONS

Roferon-A (interferon alfa-2a, recombinant) is indicated for the treatment of chronic hepatitis C and hairy cell leukemia 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).

For Patients With Chronic Hepatitis C

Roferon-A (interferon alfa-2a, recombinant) is indicated for use in patients with chronic hepatitis C diagnosed by HCV antibody and/or a history of exposure to hepatitis C who have compensated liver disease and are 18 years of age or older. A liver biopsy and a serum test for the presence of antibody to HCV should be performed to establish the diagnosis of chronic hepatitis C. Other causes of hepatitis, including hepatitis B, should be excluded prior to therapy with Roferon-A (interferon alfa-2a, recombinant) .

DOSAGE AND ADMINISTRATION

Roferon-A (interferon alfa-2a, recombinant) recommended dosing regimens are different for each of the following indications as described below.

Note: Parenteral drug products should be inspected visually for particulate matter and discoloration before administration, whenever solution and container permit.

Roferon-A (interferon alfa-2a, recombinant) is administered subcutaneously.

Chronic Hepatitis C

The recommended dosage of Roferon-A (interferon alfa-2a, recombinant) for the treatment of chronic hepatitis C is 3 MIU three times a week (tiw) administered subcutaneously for 12 months (48 to 52 weeks). As an alternative, patients may be treated with an induction dose of 6 MIU tiw for the first 3 months (12 weeks) followed by 3 MIU tiw for 9 months (36 weeks). Normalization of serum ALT generally occurs within a few weeks after initiation of treatment in responders. Approximately 90% of patients who respond to Roferon-A (interferon alfa-2a, recombinant) do so within the first 3 months of treatment; however, patients responding to Roferon-A (interferon alfa-2a, recombinant) with a reduction in ALT should complete 12 months of treatment. Patients who have no response to Roferon-A (interferon alfa-2a, recombinant) within the first 3 months of therapy are not likely to respond with continued treatment; treatment discontinuation should be considered in these patients.

Patients who tolerate and partially or completely respond to therapy with Roferon-A (interferon alfa-2a, recombinant) but relapse following its discontinuation may be re-treated. Re-treatment with either 3 MIU tiw or with 6 MIU tiw for 6 to 12 months may be considered. Please see ADVERSE REACTIONS regarding the increased frequency of adverse reactions associated with treatment with higher doses.

Temporary dose reduction by 50% is recommended in patients who do not tolerate the prescribed dose. If adverse events resolve, treatment with the original prescribed dose can be re-initiated. In patients who cannot tolerate the reduced dose, cessation of therapy, at least temporarily, is recommended.

Chronic Myelogenous Leukemia

For patients with Ph-positive CML in chronic phase: Prior to initiation of therapy, a diagnosis of Philadelphia chromosome positive CML in chronic phase by the appropriate peripheral blood, bone marrow and other diagnostic testing should be made. Monitoring of hematologic parameters should be done regularly (e.g., monthly). Since significant cytogenetic changes are not readily apparent until after hematologic response has occurred, and usually not until several months of therapy have elapsed, cytogenetic monitoring may be performed at less frequent intervals. Achievement of complete cytogenetic response has been observed up to 2 years following the start of Roferon-A (interferon alfa-2a, recombinant) treatment.

The recommended initial dose of Roferon-A (interferon alfa-2a, recombinant) is 9 MIU daily administered as a subcutaneous injection. Based on clinical experience3, short-term tolerance may be improved by gradually increasing the dose of Roferon-A (interferon alfa-2a, recombinant) over the first week of administration from 3 MIU daily for 3 days to 6 MIU daily for 3 days to the target dose of 9 MIU daily for the duration of the treatment period.

The optimal dose and duration of therapy have not yet been determined. Even though the median time to achieve a complete hematologic response was 5 months in study MI400, hematologic responses have been observed up to 18 months after treatment start. Treatment should be continued until disease progression. If severe side effects occur, a treatment interruption or a reduction in either the dose or the frequency of injections may be necessary to achieve the individual maximally tolerated dose (see PRECAUTIONS).

Limited data are available on the use of Roferon-A (interferon alfa-2a, recombinant) in children with CML. In one report of 15 children with Ph-positive, adult-type CML doses between 2.5 to 5 MIU/m²/day given intramuscularly were tolerated8. In another study, severe adverse effects including deaths were noted in children with previously untreated, Ph-negative, juvenile CML, who received interferon doses of 30 MIU/m²/day12.

Hairy Cell Leukemia

Prior to initiation of therapy, tests should be performed to quantitate peripheral blood hemoglobin, platelets, granulocytes and hairy cells and bone marrow hairy cells. These parameters should be monitored periodically (e.g., monthly) during treatment to determine whether response to treatment has occurred. If a patient does not respond within 6 months, treatment should be discontinued. If a response to treatment does occur, treatment should be continued until no further improvement is observed and these laboratory parameters have been stable for about 3 months. Patients with hairy cell leukemia have been treated for up to 24 consecutive months. The optimal duration of treatment for this disease has not been determined.

The induction dose of Roferon-A (interferon alfa-2a, recombinant) is 3 MIU daily for 16 to 24 weeks, administered as a subcutaneous injection. The recommended maintenance dose is 3 MIU, tiw. Dose reduction by one-half or withholding of individual doses may be needed when severe adverse reactions occur. The use of doses higher than 3 MIU is not recommended in hairy cell leukemia.

HOW SUPPLIED

Single Use Prefilled Syringes

(for subcutaneous administration)

3 million IU Roferon-A (interferon alfa-2a, recombinant) per syringe — Each 0.5 mL contains 3 MIU of Interferon alfa-2a, recombinant, 3.605 mg sodium chloride, 0.1 mg polysorbate 80, 5 mg benzyl alcohol as a preservative and 0.385 mg ammonium acetate. Boxes of 1 (NDC 0004-2015-09); Boxes of 6 (NDC 0004-2015-07).

6 million IU Roferon-A (interferon alfa-2a, recombinant) per syringe — Each 0.5 mL contains 6 MIU of Interferon alfa-2a, recombinant, 3.605 mg sodium chloride, 0.1 mg polysorbate 80, 5 mg benzyl alcohol as a preservative and 0.385 mg ammonium acetate. Boxes of 1 (NDC 0004-2016-09); Boxes of 6 (NDC 0004-2016-07).

9 million IU Roferon-A (interferon alfa-2a, recombinant) per syringe — Each 0.5 mL contains 9 MIU of Interferon alfa-2a, recombinant, 3.605 mg sodium chloride, 0.1 mg polysorbate 80, 5 mg benzyl alcohol as a preservative and 0.385 mg ammonium acetate. Boxes of 1 (NDC 0004-2017-09); Boxes of 6 (NDC 0004-2017-07).

Storage

The prefilled syringe should be stored in the refrigerator at 36° to 46°F (2° to 8°C). Do not freeze or shake. Protect Roferon-A (interferon alfa-2a, recombinant) from light during storage.

REFERENCES

12. Maybee D, et al. Proc Annu Meet Am Soc Clin Oncol. 1992; 11:A950.

Revised: January 2008. Hoffmann-La Roche Inc., 340 Kingsland Street, Nutley, New Jersey. NJ 07110-1199. FDA revision date: 8/29/2006

Last reviewed on RxList: 11/25/2008
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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