Feronsure (Interferon alfa – 2a, recombinant) is a sterile protein product for use by injection. Feronsure manufactured by recombinant DNA technology that (employs a genetically engineered Escherichia coli bacterium containing DNA that codes for the human protein). Interferon alfa – 2a, recombinant is a highly purified protein containing 165 amino acids, and it has an approximate molecular weight of 19,200 daltons.
Feronsure is supplied in sterile, white, lyophilized powder. The reconstituted preparation with 1 ml solvent (containing 0.9% benzyl alcohol) results in a clear, colorless solution.
Feronsure is supplied as an injectable solution in vials and prefilled syringes. Solution for injection is sterile, clear, and colorless.
Administration route: SC or IM injection.
Feronsure is indicated for the treatment of:
- Hairy cell leukaemia.
- AIDS patients with progressive, asymptomatic Kaposi's sarcoma who have a CD4 count > 250/mm3.
- Chronic phase Philadelphia-chromosome positive chronic myelogenous leukaemia.
- Cutaneous T-cell lymphoma.
- Adult patients with histologically proven chronic hepatitis B who have markers for viral replication,i.e., those who are positive for HBV DNA or HBeAg.
- Adult patients with histologically proven chronic hepatitis C who are positive for HCV antibodies or HCV RNA and have elevated serum alanine aminotransferase (ALT) without liver decompensation.
- The efficacy of interferon alfa-2a in the treatment of hepatitis C is enhanced when combined with ribavirin.
- Feronsure should be given alone mainly in case of intolerance or contraindication to ribavirin.
- Follicular non-Hodgkin's lymphoma.
- Advanced renal cell carcinoma.
- Patients with AJCC stage II malignant melanoma (Breslow tumour thickness > 1.5 mm, no lymph node involvement or cutaneous spread) who are free of disease after surgery.
- A history of hypersensitivity to recombinant interferon alfa-2a or to any of the excipients.
- Patients with severe pre-existing cardiac disease or with any history of cardiac illness. No direct cardiotoxic effect has been demonstrated, but it is likely that acute, self-limiting toxicities (i.e., fever, chills) frequently associated with administration of Feronsure may exacerbate pre-existing cardiac conditions.
- Severe renal, hepatic or myeloid dysfunction.
- Uncontrolled seizure disorders and/or compromised central nervous system function.
- Chronic hepatitis with advanced, decompensated hepatic disease.
- Chronic hepatitis who have been recently treated with immunosuppressive agents.
Storage: Store in the refrigerator at 2°C - 8°C. Do not freeze. Keep away from light.
The solution for injection should be inspected visually for particulates and discoloration before administration.
Shelf Life: 24 months from manufacturing date
Reconstituted solution is stable for 30 days at temperatures of 2°C - 8°C
Packing Units:
Box of 01 vial of lyophilized powder and 1 vial solvent (1 mL)
Box of 01, 05 vial(s) of solution for injection (1 mL)
Box of 01, 06, 12 prefilled syringe(s) of solution for injection (0.5 mL)
