Indications : התוויות

4.1 Therapeutic indications
Intron A is indicated in adult patients for the treatment of:

Malignant melanoma
As adjuvant to surgical treatment in patients 18 years of age or older with malignant melanoma who are free of disease but at high risk for systemic recurrence, within 56 days of surgery.

Chronic myelogenous leukaemia
Treatment of adult patients with Chronic Myelogenous Leukaemia.

Hairy cell leukaemia
Treatment of patients 18 years of age or older with hairy cell leukaemia.
AIDS-related Kaposi's sarcoma
Treatment of selected patients 18 years of age or older with AIDS-Related Kaposi's Sarcoma. Studies have demonstrated a greater likelihood of response to INTRON A therapy in patients who are without systemic symptoms, who have limited lymphadenopathy and who have a relatively intact immune system.
Lesion measurements and blood counts should be performed prior to initiation of therapy and should be monitored periodically during treatment to determine whether response to treatment or disease stabilization has occurred.
When disease stabilization or a response to treatment occurs, treatment should continue until there is no further evidence of tumour or until discontinuation is required by evidence of a severe opportunistic infection or adverse effect (see section 4.2). For patients with progressive, asymptomatic Kaposi’s Sarcoma who have a CD4 count 250/mm3 , AIDS patients with CD4 counts <250/mm3 or those with a history of opportunistic infections or constitutional symptoms, are unlikely to respond to INTRON A therapy and therefore should not be treated (see section 4.4).
Chronic hepatitis C
Treatment of chronic hepatitis C known for at least 6 months in patients 18 years of age or older with compensated liver disease who have a history of blood or blood product exposure and/or are HCV antibody positive by the ELISA method (anti-HCV) and one of two RIBA (Radioimmunoblotting) or HCV-RNA in PCR tests. Studies in these patients demonstrated that INTRON A therapy can produce clinically meaningful effects on this disease, manifested by normalization of serum alanine aminotransferase (ALT) and reduction in liver necrosis and degeneration.
A liver biopsy should be performed to establish the diagnosis of chronic hepatitis and show an inflammatory process at least in the portal tracks. Patients should be tested for the presence of antibody to HCV.
Chronic hepatitis B
Treatment of chronic hepatitis B in patients 18 years of age or older with compensated liver disease and HBV replication. Patients must be serum HBsAg positive for at least 6 months and have HBV replication (serum HbeAg positive or HBV-DNA in the serum) with elevated serum ALT.
Current clinical experience in patients who remain on interferon alfa-2b for 4 to 6 months indicates that therapy can produce clearance of serum HBV-DNA and improvement in liver histology. In patients with loss of HBsAg and HBV-DNA, a significant reduction in morbidity and mortality has been observed.
Prior to initiation of INTRON A therapy, it is recommended that a liver biopsy be performed to establish the presence of chronic hepatitis and show inflammatory activity at least in the portal tracks, and the extent of liver damage. The physician should establish that the patient has compensated liver disease.
The authorization to use the product for these Hepatitis B and C indications is subject to prior approval of the treatment by a committee which shall be appointed in each hospital and medical institution.
The names of the members of the committee shall be communicated to the Pharmaceutical Administration of the Ministry of Health.
In patients who fail to respond after three to four months of treatment, discontinuation of interferon alfa-2b therapy should be considered.
Treatment of metastatic or recurrent renal cell carcinoma
Non-Hodgkin's lymphoma
Adjuvant treatment of high tumour burden follicular lymphoma (stage III or IV) in combination with appropriate chemotherapy, such as a CHOP-like regimen.
High tumour burden is defined as having at least one of the following: bulky tumour mass (>7 cm), involvement of three or more nodal sites (each >3 cm), systemic symptoms (weight loss >10%, fever >38ºC for more than 8 days, or nocturnal sweats), splenomegaly beyond the umbilicus, major organ obstruction or compression syndrome, orbital or epidural involvement, serous effusion, or leukaemia.