IntronA

RSS

interferon alfa-2b

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for IntronA. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for IntronA.

This EPAR was last updated on 13/11/2019

Authorisation details

Product details
Name
IntronA
Agency product number
EMEA/H/C/000281
Active substance
interferon alfa-2b
International non-proprietary name (INN) or common name
interferon alfa-2b
Therapeutic area (MeSH)
  • Carcinoid Tumor
  • Leukemia, Hairy Cell
  • Lymphoma, Follicular
  • Hepatitis B, Chronic
  • Hepatitis C, Chronic
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Melanoma
  • Multiple Myeloma
Anatomical therapeutic chemical (ATC) code
L03AB05
Publication details
Marketing-authorisation holder
Merck Sharp & Dohme B.V.
Revision
32
Date of issue of marketing authorisation valid throughout the European Union
09/03/2000
Contact address

Waarderweg 39
2031 BN Haarlem
The Netherlands

Product information

22/10/2019 IntronA - EMEA/H/C/000281 - IB/0120

Contents

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Immunostimulants

Therapeutic indication

Chronic hepatitis B

Treatment of adult patients with chronic hepatitis B associated with evidence of hepatitis-B viral replication (presence of DNA of hepatitis-B virus (HBV-DNA) and hepatitis-B antigen (HBeAg), elevated alanine aminotransferase (ALT) and histologically proven active liver inflammation and / or fibrosis.

Chronic hepatitis C

Before initiating treatment with IntronA, consideration should be given to the results from clinical trials comparing IntronA with pegylated interferon.

Adult patients

IntronA is indicated for the treatment of adult patients with chronic hepatitis C who have elevated transaminases without liver decompensation and who are positive for hepatitis-C virus-RNA (HCV-RNA).

The best way to use IntronA in this indication is in combination with ribavirin.

Children three years of age and older and adolescents

IntronA is indicated, in a combination regimen with ribavirin, for the treatment of children three years of age and older and adolescents, who have chronic hepatitis C, not previously treated, without liver decompensation, and who are positive for HCV-RNA. When deciding not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition that resulted in reduced final adult height in some patients.

The decision to treat should be made on a case-by-case basis.

Hairy-cell leukaemia

Treatment of patients with hairy cell leukaemia.

Chronic myelogenous leukaemia

Monotherapy

Treatment of adult patients with Philadelphia-chromosome- or bcr/abl-translocation-positive chronic myelogenous leukaemia.

Clinical experience indicates that a haematological and cytogenetic major / minor response is obtainable in the majority of patients treated. A major cytogenetic response is defined by < 34 % Ph+ leukaemic cells in the bone marrow, whereas a minor response is ≥ 34 %, but < 90 % Ph+ cells in the marrow.

Combination therapy

The combination of interferon alfa-2b and cytarabine (Ara-C) administered during the first 12 months of treatment has been demonstrated to significantly increase the rate of major cytogenetic responses and to significantly prolong the overall survival at three years when compared to interferon alfa-2b monotherapy.

Multiple myeloma

As maintenance therapy in patients who have achieved objective remission (more than 50% reduction in myeloma protein) following initial induction chemotherapy.

Current clinical experience indicates that maintenance therapy with interferon alfa-2b prolongs the plateau phase; however, effects on overall survival have not been conclusively demonstrated.

Follicular lymphoma

Treatment of high-tumour-burden follicular lymphoma as adjunct to appropriate combination induction 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 %, pyrexia > 38°C for more than eight days, or nocturnal sweats), splenomegaly beyond the umbilicus, major organ obstruction or compression syndrome, orbital or epidural involvement, serous effusion, or leukaemia.

Carcinoid tumour

Treatment of carcinoid tumours with lymph node or liver metastases and with 'carcinoid syndrome'.

Malignant melanoma

As adjuvant therapy in patients who are free of disease after surgery but are at high risk of systemic recurrence, e.g. patients with primary or recurrent (clinical or pathological) lymph-node.

Assessment history

How useful was this page?

Add your rating
Average
2 ratings
1 rating