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Infergen (Interferon Alfacon-1) - Indications and Dosage

 
 



INDICATIONS AND USAGE

INFERGEN is indicated for the treatment of chronic HCV infection in patients 18 years of age or older with compensated liver disease who have anti-HCV serum antibodies and/or the presence of HCV RNA. Other causes of hepatitis, such as viral hepatitis B or autoimmune hepatitis, should be ruled out prior to initiation of therapy with INFERGEN. In some patients with chronic HCV infection, INFERGEN normalizes serum ALT, reduces serum HCV RNA concentrations to undetectable quantities (< 100 copies/mL), and improves liver histology.

DOSAGE AND ADMINISTRATION

The recommended dose of INFERGEN for treatment of chronic HCV infection is 9 mcg TIW administered SC as a single injection for 24 weeks. At least 48 hours should elapse between doses of INFERGEN. (See illustrated MEDICATION GUIDE for instructions.)

Patients who tolerated previous interferon therapy and did not respond or relapsed following its discontinuation may be subsequently treated with 15 mcg of INFERGEN TIW administered SC as a single injection for up to 48 weeks. (See illustrated MEDICATION GUIDE for instructions.)

There are significant differences in specific activities among interferons. Healthcare providers should be aware that changes in interferon brand may require adjustments of dosage and/or change in route of administration. Patients should be warned not to change brands of interferon without medical consultation. Patients should also be instructed by their physician not to reduce the dosage of INFERGEN prior to medical consultation.

Dose Reduction

For patients who experience a severe adverse reaction on INFERGEN, dosage should be withheld temporarily. If the adverse reaction does not become tolerable, therapy should be discontinued. Dose reduction to 7.5 mcg may be necessary following an intolerable adverse event. In the pivotal study, 11% of patients (26/231) who initially received INFERGEN at a dose of 9 mcg (0.3 mL) were dose-reduced to 7.5 mcg (0.25 mL).

If adverse reactions continue to occur at the reduced dosage, the physician may discontinue treatment or reduce dosage further. However, decreased efficacy may result from continued treatment at dosages below 7.5 mcg.

During subsequent treatment for 48 weeks with 15 mcg of INFERGEN, up to 36% of patients required dose reductions in 3 mcg increments.

Administration of INFERGEN

If home use is determined to be desirable by the physician, instructions on appropriate use should be given by a healthcare professional. After administration of INFERGEN, it is essential to follow the procedure for proper disposal of syringes and needles. See the MEDICATION GUIDE for detailed instructions.

Storage

Just prior to injection, INFERGEN may be allowed to reach room temperature.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration; if particulates or discoloration are observed, the container should not be used.

HOW SUPPLIED

Use only 1 dose per vial; do not re-enter the vial. Discard unused portions. Do not save unused drug for later administration.

Single-dose, preservative-free vials containing 9 mcg (0.3 mL) of Interferon alfacon-1 are available in dispensing packs of 6 vials (NDC 0187-2007-06).

Single-dose, preservative-free vials containing 15 mcg (0.5 mL) of Interferon alfacon-1 are available in dispensing packs of 6 vials (NDC 0187-2006-05).

INFERGEN should be stored in the refrigerator at 2° to 8°C (36° to 46°F). Do not freeze. Avoid vigorous shaking and exposure to direct sunlight.

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