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Alferon N Injection (Interferon Alfa-N3) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Alferon N Injection® is indicated for the intralesional treatment of refractory or recurring external condylomata acuminata.

DOSAGE AND ADMINISTRATION

The recommended dose of Alferon N Injection® for the treatment of condylomata acuminata is 0.05 ml (250,000 IU) per wart. Alferon N Injection® should be administered twice weekly for up to 8 weeks. The maximum recommended dose per treatment session is 0.5 ml (2.5 million IU). Alferon N Injection® [Interferon alfa-n3 (human leukocyte derived)] should be injected into the base of each wart, preferably using a 30 gauge needle. For large warts, Alferon N Injection® may be injected at several points around the periphery of the wart, using a total dose of 0.05 ml per wart.

The minimum effective dose of Alferon N Injection® for the treatment of condylomata acuminata has not been established. Moderate to severe adverse experiences may require modification of the dosage regimen or, in some cases, termination of therapy with Alferon N Injection®.

Genital warts usually begin to disappear after several weeks of treatment with Alferon N Injection®. Treatment should continue for a maximum of 8 weeks. In clinical trials with Alferon N Injection®, many patients who had partial resolution of warts during treatment experienced further resolution of their warts after cessation of treatment. Of the patients who had complete resolution of warts due to treatment, half the patients had complete resolution of warts by the end of the treatment and half had complete resolution of warts during the 3 months after cessation of treatment. Thus, it is recommended that no further therapy (Alferon N Injection® or conventional therapy) be administered for 3 months after the initial 8-week course of treatment unless the warts enlarge or new warts appear. Studies to determine the safety and efficacy of a second course of treatment with Alferon N Injection® have not been conducted.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

HOW SUPPLIED

Injectable Solution: Each vial contains 1 ml of Alferon N Injection®. Each ml of Alferon N Injection® contains 5 million IU of Interferon alfa-n3, 3.3 mg of phenol, and 1 mg of Albumin (Human) in a pH 7.4 phosphate-buffered saline solution (8.0 mg/ml sodium chloride, 1.74 mg/ml sodium phosphate dibasic, 0.20 mg/ml potassium phosphate monobasic, and 0.20 mg/ml potassium chloride). One vial per box. (NDC 54746-001-01).

STORAGE

Alferon N Injection® [Interferon alfa-n3 (human leukocyte derived)] should be stored at 2° to 8°C (36° to 46°F). Do not freeze. Do not shake.

Rx Only

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