ZADAXIN thymosin alpha 1 (thymalfasin) is indicated as a monotherapy or combination therapy with interferon for the treatment of chronic hepatitis B. Pooled analysis of 3 randomized controlled trials comprising 223 patients was performed. Thymosin alpha 1 was administered twice weekly for 6 months. Follow-up assessments were performed at 12 months after completion of treatment (see table below).

^*Response rate is defined as the percentage of subjects who were HBV DNA and HBeAg negative at 12-months follow up.

In multiple studies, ZADAXIN was shown to have a delayed therapeutic response 12 months or longer after completion of therapy. A transient increase in ALT to more than twice baseline value (flare) can occur during ZADAXIN therapy. When ALT flare occurs, ZADAXIN should generally be continued unless signs and symptoms of liver failure are observed.

ZADAXIN thymosin alpha 1 (thymalfasin) is indicated as a combination therapy with interferon for the treatment of chronic hepatitis C. Pooled analysis of 2 randomized controlled trials and 1 historical controlled trial comprising 121 ZADAXIN plus interferon, or interferon treated patients, was performed. Thymosin alpha 1 was administered at least twice weekly for 6 to 12 months and interferon was administered up to three times weekly for 6 to 12 months. Follow-up assessments were performed upon completion of treatment and at 6 months after completion of treatment (see table below).

^*Intent-to-treat analysis.

^**ALT Response Rate is defined as the percentage of subjects who were ALT negative at end of treatment. Virologic Response Rate is defined as the percentage of subjects who were HCV RNA negative at end of treatment.

^***ALT Response Rate is defined as the percentage of subjects who were ALT negative at end of 6 months follow up. Virologic Response Rate is defined as the percentage of subjects who were HCV RNA negative at end of 6 months follow up. US Phase 3 sustained response includes patients treated for 6 and relapsers retreated for a total of 12 months.

⁺ P=0.0096

⁺⁺ P=0.10

Pooled intent-to-treat analysis demonstrated sustained biochemical (ALT) response, defined as normal ALT 6 to 12 months after completion of treatment, observed in 22.4% of patients treated with combination therapy compared to 9.3% with interferon alone.

ZADAXIN thymosin alpha 1 (thymalfasin) is indicated as an adjuvant (immune response enhancer) for influenza vaccination in immunocompromised patients. Thymosin alpha 1 is indicated as an adjuvant for influenza vaccine in elderly patients and as an adjuvant for both influenza and hepatitis B vaccines in chronic hemodialysis patients who failed to achieve adequate antibody titers from previous immunization (see table below).

^*The treated groups were treated with thymosin

alpha 1 in addition to the vaccine. The Placebo or control groups received the vaccination without thymosin alpha 1.

^**Response Rate is defined as in each study by percentage of subjects who developed sufficiently high antibody levels.

^***900 ug/m² is approximately equal to 1.6 mg.

ZADAXIN is intended for subcutaneous injection and should not be given intravenously. It should be reconstituted with 1.0 ml of the diluent provided, which consists of 1.0 ml Sterile Water for Injection, immediately prior to use. At the discretion of the physician, the patient may be taught to self-administer the medication.

The recommended dose of ZADAXIN for chronic hepatitis B when used as a monotherapy or in combination with interferon (at the labeled dose and schedule for interferon) is 1.6 mg (900 ug/m²) administered subcutaneously twice a week for 6 to 12 months. Patients weighing less than 40 kg should receive a ZADAXIN dose of 40 ug/kg.

The recommended dose of ZADAXIN for chronic hepatitis C when used in combination with interferon (at the labeled dose and schedule for interferon) is 1.6 mg (900 ug/m²) administered subcutaneously twice a week for 12 months. Patients weighing less than 40 kg should receive a ZADAXIN dose of 40 ug/kg.

The recommended dose of ZADAXIN when used as an enhancement to viral vaccines is 900 ug/m² (1.6 mg) administered subcutaneously twice a week with doses separated by 3 or 4 days and the first dose given coincident with the vaccine. Therapy should be continued for 4 weeks (a total of 8 doses) after a single dose vaccine immunization regimen. For a multidose vaccine immunization regimen, therapy should continue twice a week between vaccinations and for 3 weeks (a total of 5-6 doses) after the last vaccination.

ZADAXIN is supplied in single use vials containing 1.6 mg of lyophilized thymosin alpha 1 per vial. Each carton contains two vials of ZADAXIN. Each carton also contains two ampoules of diluent for ZADAXIN, each containing 1.0 ml of Sterile Water for Injection, which are to be used for reconstituting the ZADAXIN.

Store ZADAXIN between 2^o and 8^o C (36^o to 46^o F). Reconstituted ZADAXIN should be used immediately.

ZADAXIN^™ thymosin alpha 1 (thymalfasin) for injection is manufactured for SciClone Pharmaceuticals International Ltd., Hong Kong, by I.S.F. S.p.A., Rome, Italy. For further information, contact SciClone Pharmaceuticals International Ltd. in Hong Kong at +852-2-510-0118, Singapore +65-6273-3144, or in San Mateo, California, USA at +650-358-3456.

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Thymosin: An innovative approach to the treatment of chronic hepatitis B, in Combination therapies. Biological Response Modifiers in the Treatment of Cancer and Infectious Diseases, A.L. Goldstein and E. Garaci, Editors. Plenum Publishing Corp: New York. p. 149-156.

2. Mutchnick, M.G., et al. (1995)

Thymosin alpha 1 treatment of chronic hepatitis B: a multicenter, randomized, placebo-controlled double blind study. Gastroenterology 108(4): p. A1127.

3. Lee, S.-D., D.-S. Chen, and Y.-F. Liaw (1997) Multicenter Study of Thymosin Alpha 1 in the Treatment of Chronic Hepatitis B. Data on file.

4. Chien, R.-N., Liaw Y.-F., Chen, T.-C., Yeh, C.-T., and I.-S. Sheen (1998) Efficacy of Thymosin a 1 in Patients with Chronic Hepatitis B: A Randomized, Controlled Trial. Hepatology 27 (5) May 1998: p.1383-1387.

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Combination Therapy with Thymosin alpha 1 and Interferon for the Treatment of Chronic Hepatitis C Infection: A Randomized, Placebo-Controlled Double-Blind Trial, Hepatology 27 (4): p.1128-1135.

7. Rasi, G., et al. (1996) Combination thymosin a1 and lymphoblastoid interferon treatment in chronic hepatitis C, Gut 39: p. 679-683.

8. Moscarella, S., et al. (1997) Treatment with interferon-alpha and thymosin alpha 1 of naive patients affected by chronic hepatitis C, in 4th International meeting on Hepatitis C Virus and Related Viruses. Kyoto, Japan.

9. Sherman, K.E., et al. (1997) Pooled analysis of interferon + thymosin alpha-1 efficacy for the treatment of chronic hepatitis C. Second International Conference on Therapies for Viral Hepatitis, Kona, Big Island, Hawaii, December 15-19: abstract #P50.

10. Gravenstein, S., et al. (1986) Anti-influenza antibody response: augmentation in elderly "non-responders" by thymosin alpha 1. Gerontologist 26: p. 150A.

11. Gravenstein, S., et al. (1989) Augmentation of influenza antibody response in elderly men by thymosin alpha one. A double-blind Placebo-controlled clinical study. Journal of the American Geriatric Society 37: p. 1-8.

12. McConnell, L. (1990) Influenza vaccine and adjuvant thymosin alpha 1. A double-blind Placebo-controlled trial. Data on file.

13. Shen, S.Y., et al. (1990) Age-dependent enhancement of influenza vaccine responses by thymosin in chronic hemodialysis patients, in Biomedical Advances in Aging, A.L. Goldstein, Editor. Plenum Press: New York. p. 523-530.

14. Shen, S., et al. Augmentation of specific antibody response to hepatitis vaccine with thymosin alpha 1 in chronic hemodialysis patients. University of Maryland. Data on file.

15. Shen, S., et al. (1987) Effects of thymosin alpha 1 (TA1) on peripheral T-cell and Heptavax-B vaccination (V) in previously non-responsive hemodialysis (HD) patients (PTS). Hepatology 7(5): p. 1120.

16. Ruggenini, A.M. Clinical experimentation for evaluation of the effect of thymosin alpha-1 in hepatitis B vaccination of unresponsive dialysis patients. Data on file.

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