Drug

INTRON A®

interferon alfa-2b

intron A 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.

Treatment with IntronA should be started by a doctor who has experience in the management of the disease it is being used for. IntronA is generally given three times per week but the injection can be given more frequently in CML and melanoma. It is generally given by injection under the skin, but in melanoma it can also be given by infusion. The dose and duration of treatment depend on the disease being treated and the response of the patient, with doses ranging from 2 to 20 million IU per square metre of body surface area (calculated using the patient’s height and weight). Patients can inject themselves once they have been trained appropriately. For more information, see the package leaflet.

The active substance in IntronA, interferon alfa-2b, belongs to the group ‘interferons’. Interferons are natural substances produced by the body to help it fight against attacks such as infections caused by viruses. The exact way that they work in cancer and viral diseases is not fully understood, but it is thought that they act as immunomodulators (substances that modify how the immune system works).

They may also block the multiplication of viruses.

Interferon alfa-2b has been available in the European Union (EU) for the treatment of various diseases for a number of years. The interferon alfa-2b in IntronA is produced by a method known as ‘recombinant DNA technology’: it is made by a bacterium that has received a gene (DNA), which makes it able to produce interferon alfa-2b. The replacement interferon alfa-2b acts in same way as naturally produced interferon alpha.

The studies showed that IntronA is effective in the diseases for which it can be used. In CML, more patients who received IntronA with cytarabine were still alive after three years than patients who only received IntronA. IntronA was also shown to be effective in treating hepatitis C in adults when it was used with or without ribavirin, and in younger patients when used with ribavirin.

The Committee for Medicinal Products for Human Use (CHMP) decided that IntronA’s benefits are greater than its risks and recommended that it be given marketing authorisation.

The European Commission granted a marketing authorisation valid throughout the EU for IntronA on 9 March 2000. The marketing authorisation is valid for an unlimited period.

For more information about treatment with IntronA, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

What are the risks associated with Intron A?

In adults, the most common side effects with IntronA used with or without ribavirin (seen in more than 1 patient in 10) are pharyngitis (sore throat), viral infection, leucopenia (low white-blood-cell counts), loss of appetite, depression, insomnia (difficulty sleeping), anxiety, emotional lability (mood swings), agitation, nervousness, dizziness, headache, impaired concentration, dry mouth, blurred vision, dyspnoea (difficulty breathing), coughing, nausea (feeling sick) or vomiting, abdominal pain (stomach ache), diarrhoea, stomatitis (inflammation of the lining of the mouth), dyspepsia (heartburn), alopecia (hair loss), pruritus (itching), dry skin, rash, increased sweating, myalgia (muscle pain), arthralgia (joint pain), musculoskeletal pain (pain in the muscles and bones), reactions at the site of the injection including inflammation, fatigue (tiredness), rigors (shaking chills), pyrexia (fever), flu-like symptoms, asthenia (weakness), irritability, chest pain, malaise (feeling unwell) and weight loss. In children and adolescents receiving IntronA in combination with ribavirin, side effects were similar to adults, although anaemia (low red blood cell counts), neutropenia (low levels of neutrophils, a type of white blood cell), hypothyroidism (underactive thyroid gland) and reduced growth were also seen in more than 1 patient in 10.

IntronA should not be used in people who may be hypersensitive (allergic) to interferon alfa-2b or any of the other ingredients. IntronA must not be used in patients with severe kidney or liver disease, epilepsy or other central-nervous-system problems, or thyroid disease that is not controlled. It must not be used in patients who have had severe heart disease or certain immune-system disorders, in patients who are taking medicines that suppress the immune system, in hepatitis patients who have liver cirrhosis (scarring) that is causing symptoms or who have recently received medicines that affect the immune system, or in children or adolescents with a history of severe mental illness, particularly severe depression, thoughts about committing suicide or suicide attempts. 

Because IntronA is linked to side effects such as depression, patients must be closely monitored during treatment. IntronA in combination with ribavirin is also linked to weight loss and reduced growth in children and adolescents. Doctors should take this risk into account when deciding whether to treat a patient before adulthood.

Owner of copyright and other intellectual property rights to European Medicines Agency

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