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 concentrations, reduces serum HCV RNA concentrations to undetectable quantities (< 100 copies/mL), and improves liver histology.

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. Health care 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 with 15 mcg of Infergen, 33% 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 health care professional. After administration of Infergen, it is essential to follow the procedure for proper disposal of syringes and needles. See "Information For Patients" leaflet for detailed instructions provided separately.

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.

Use only one dose per vial; do not re-enter the vial. Dis-card 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 six vials (NDC 64116-039-06).

Single-dose, preservative-free vials containing 15 mcg (0.5 mL) of Interferon alfacon-1 are available in dispensing packs of 6 vials (NDC 64116-031-06).

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

REFERENCES

1. Alton K, Stabinsky Y, Richards R, et al. Production, characterization and biological effects of recombinant DNA derived human IFN-alpha and IFN-gamma analogs. In: De Maeyer E, Schellekens H, eds. The Biology of the Interferon System 1983. Elsevier Science Publishers: Amsterdam. 1983;119-128.

2. Blatt LM, Davis J, Klein SB, Taylor MW. The biologic activity and molecular characterization of a novel synthetic interferon-alpha species, consensus interferon. J Interferon Cytokine Res. 1996;16:489-499.

3. Fish EN, Banerjee K, Levine HL, Stebbing N. Antiherpetic effects of a human alpha interferon analog IFN-alfa Con₁, in hamsters. Antimicrob Agents Chemother. 1986;30:52-56.

4. Trown PW, Willis RJ, Kamm JJ. The preclinical development of Roferon®-A. Cancer. 1986;57:1648-1656.

5. Tong MJ, Reddy KR, Lee WM, et al. Treatment of chronic hepatitis C with consensus interferon: a multicenter, randomized, controlled trial. Hepatology . 1997;26:747-754.

6. Knodell RG, Ishak KG, Black WC, et al. Formulation and application of a numerical scoring system for assessing histological activity in asymptomatic chronic active hepatitis. Hepatology . 1981;1:431-435.

7. Heathcote E, Keeffe E, Lee S, et al. Retreatment of chronic hepatitis C with consensus interferon. Hepatology . 1997;27:1136-1143.

8. Vial T, Descotes J. Clinical toxicity of interferons. Drug Safety . 1994;10:115-150.

9. Horsmans Y, Brenard R, Geubel AP. Short report: interferon-(alpha) decreases 14 C-aminopyrine breath test values in patients with chronic hepatitis C. Aliment Pharmacol Ther. 1994;8:353-355.

This product and its use are covered by the following US Patent Nos.: 4,695,623; 5,372,808; 5,541,293; 5,980,884.

INTERMUNE®
InterMune, Inc.
Brisbane, CA 94005
U.S. License No. 1626
©2003 InterMune, Inc.

All rights reserved.
FDA Approval November 2002 (B101)

Revised February 2003
LB-2007.2
3265701

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