What is IntronA?
IntronA is a medicine that contains the active substance interferon alfa-2b. It is available as a powder and solvent for solution for injection or infusion, as a ready-to-use solution and as a pen for multidose injection.All of these formulations contain between 1 and 50 million IU (international units) per milliliter.
What is IntronA used for?
IntronA is indicated in the treatment of:
• chronic (long-lasting) hepatitis B (a "liver infection caused by the hepatitis B virus") in adult patients;
• chronic (long-lasting) hepatitis C (liver infection caused by the hepatitis C virus). In adults IntronA can be used alone (alone), but the optimal use of IntronA in this indication is in combination to ribavirin (an antiviral drug);
in children it is used in combination with ribavirin;
• hairy cell leukemia (cancer of white blood cells);
• chronic myeloid leukemia (CML, another form of white blood cell cancer) in adults. IntronA can be given in combination with cytarabine (an anticancer medicine) for the first 12 months;
• multiple myeloma (a tumor of the spinal cord). IntronA is used to maintain anticancer effects in patients who have responded to previous treatment with anticancer drugs;
• follicular lymphoma (cancer of the lymphatic tissue). IntronA is given as an adjunct therapy to anticancer treatments;
• carcinoid tumor (a tumor that affects the endocrine system responsible for producing hormones);
• malignant melanoma (a type of skin cancer which attacks cells called melanocytes). IntronA is used after surgery in patients whose melanoma may come back.
The medicine can only be obtained with a prescription.
How is IntronA used?
IntronA treatment should be started by a doctor who has experience in the treatment of the condition for which the medicine was prescribed. IntronA is usually given three times a week (every other day), but the injection may be more frequent in some diseases (CML and melanoma). The medicine is usually given subcutaneously (under the skin); in patients with melanoma it can be given by intravenous infusion (drip into a vein). The dose and duration of treatment depend on the disease being treated and the patient's response; dosages range from 2 to 20 million IU per square meter of body surface area. more information, see the package leaflet.
IntronA must be stored in the refrigerator (2 ° C-8 ° C).
How does IntronA work?
The active substance in IntronA, interferon alfa-2b, belongs to the group of 'interferons'.
Interferons are natural substances produced by the body to help it cope with attacks such as viral infections.
The mechanism of action of alpha interferons in tumors and viral diseases is not yet fully known, but it is believed that they act as immunomodulators (substances that modify the body's immune, ie defense, responses). Alpha interferons can also stop the proliferation of viruses.
The interferon alfa-2b contained in IntronA is produced by a method known as the "recombinant DNA technique": that is, it is obtained by a bacterium in which a gene (DNA) has been inserted which makes it capable of producing interferon. The replacement interferon alfa-2b acts like naturally produced interferon alfa.
How has IntronA been studied?
Since interferon alfa-2b has previously been used to treat a number of diseases in the European Union (EU), the company that makes IntronA has provided data from the scientific literature and studies on its use with cytarabine in the CML (745 patients) and its use in children with chronic hepatitis B. The company also presented information from a number of studies in which IntronA was used alone or with ribavirin in the treatment of chronic hepatitis C. These studies involved a total of 2,552 treatment-naïve (i.e. never treated before) patients. ) and a total of 345 patients in the disease relapsed (came back) after previous treatment with interferon. The use of IntronA in combination with ribavirin was finally studied in 118 treatment-naïve children and adolescents with hepatitis C. aged between 3 and 16 years.
The main measures of efficacy were response rates in hepatitis studies and survival time in cancer studies.
What benefit has IntronA shown during the studies?
Studies have shown that IntronA is effective in the diseases for which it is indicated. In CML, the number of surviving patients treated with IntronA in combination with cytarabine after 3 years was greater than the number of patients treated with IntronA alone. IntronA has also been shown to produce benefits in children with chronic hepatitis B. IntronA, in combination or not with ribavirin, was effective in treating hepatitis C in adult patients, whether they were treatment naïve or relapsed. Finally, IntronA has been shown to be effective in children in combination with ribavirin: it has been observed a response to treatment at the follow-up visit 6 months after one year of therapy in 46% of children.
What is the risk associated with IntronA?
Side effects with IntronA (typically seen in more than 1 in 10 patients) are viral infections, pharyngitis (sore throat), anorexia (loss of appetite), depression, insomnia, anxiety, emotional lability (mood changes) , headache, decreased concentration, dizziness, cough, dyspnoea (difficulty in breathing), nausea, diarrhea, abdominal pain, alopecia (hair loss), itching, dry skin, rash, myalgia (muscle pain), arthralgia (joint pain), musculoskeletal pain (pain in muscles and bones), injection site reactions including inflammation, fatigue, tremors, fever, flu-like symptoms, asthenia (weakness), irritability and weight loss. See the package leaflet for the full list of side effects reported with IntronA.
IntronA must not be used in people who may be hypersensitive (allergic) to interferon alfa-2b or any other ingredients of the medicine. IntronA must not be given to:
- patients with severe heart disease;
- patients with severe kidney or liver dysfunction, including that caused by cancer;
- patients with epilepsy or other central nervous system problems;
- Patients with thyroid disease, if not controlled;
- patients with associated hepatitis with liver cirrhosis or patients recently treated with immunosuppressive drugs;
- Patients with immune system disorders or who have undergone organ transplantation and are taking immunosuppressive drugs;
- children and adolescents with a history of severe mental illness, particularly severe depression, suicidal thoughts or suicide attempts.
For the complete list of restrictions on use, see the package leaflet.
Why has IntronA been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that IntronA's benefits are greater than its risks for the treatment of chronic hepatitis B and C, hairy cell leukemia, CML, multiple myeloma, follicular lymphoma, carcinoid cancer and malignant melanoma. The Committee therefore recommended the granting of a marketing authorization for the product.
More information about IntronA
On 9 March 2000, the European Commission granted SP Europe a "Marketing Authorization" for IntronA, valid throughout the European Union. The "Marketing Authorization" was renewed on 9 March 2005.
For the full version of IntronA's EPAR, click here.
Last update of this summary: 06-2007.
The information on Introna - interferon alfa-2b published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
