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IntronA is a brand name for Interferon Alfa-2b. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 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…
Verbatim from this product's EMA label. Tap a section to expand.
Treatment must be initiated by a physician experienced in the management of the disease. Not all dose forms and strengths are appropriate for some indications. Appropriate dose form and strength must be selected. If adverse events develop during the course of treatment with IntronA for any indication, modify the dose or discontinue therapy temporarily until the adverse events abate.
If persistent or recurrent intolerance develops following adequate dose adjustment, or disease progresses, discontinue treatment with IntronA. At the discretion of the physician, the patient may self-administer the dose for maintenance dose regimens administered subcutaneously.
Chronic hepatitis B The recommended dose is in the range 5 to 10 million IU administered subcutaneously three times a week (every other day) for a period of 4 to 6 months. The administered dose should be reduced by 50 % in case of occurrence of haematological disorders (white blood cells < 1,500/mm3, granulocytes < 1,000/mm3, thrombocytes < 100,000/mm3).
Treatment should be discontinued in case of severe leukopaenia (< 1,200/mm3), severe neutropaenia (< 750/mm3) or severe thrombocytopaenia (< 70,000/mm3). Medicinal Product no longer authorised 4 Chronic hepatitis C Adults IntronA is administered subcutaneously at a dose of 3 million IU three times a week (every other day) to adult patients, whether administered as monotherapy or in combination with ribavirin.
Children 3 years of age or older and adolescents IntronA 3 MIU/m2 is administered subcutaneously 3 times a week (every other day) in combination with ribavirin capsules or oral solution administered orally in two divided doses daily with food (morning and evening).
(See ribavirin capsules SPC for dose of ribavirin capsules and dose modification guidelines for combination therapy. ) Relapse patients (adults) IntronA is given in combination with ribavirin. Based on the results of clinical trials, in which data are available for 6 months of treatment, it is recommended that patients be treated with IntronA in combination with ribavirin for 6 months.
Naïve patients (adults) The efficacy of IntronA is enhanced when given in combination with ribavirin. IntronA should be given alone mainly in case of intolerance or contraindication to ribavirin. - IntronA in combination with ribavirin Based on the results of clinical trials, in which data are available for 12 months of treatment, it is recommended that patients be treated with IntronA in combination with ribavirin for at least 6 months.
See ribavirin SPC for ribavirin-related undesirable effects if IntronA is to be administered in combination with ribavirin in patients with chronic hepatitis C. In clinical trials conducted in a broad range of indications and at a wide range of doses (from 6 MIU/m2/week in hairy cell leukaemia up to 100 MIU/m2/week in melanoma), the most commonly reported undesirable effects were pyrexia, fatigue, headache and myalgia.
Pyrexia and fatigue were often reversible within 72 hours of interruption or cessation of treatment. Adults In clinical trials conducted in the hepatitis C population, patients were treated with IntronA alone or in combination with ribavirin for one year.
All patients in these trials received 3 MIU of IntronA three times a week. In Table 1 the frequency of patients reporting (treatment related) undesirable effects is presented from clinical trials in naïve patients treated for one year.
Severity was generally mild to moderate. The adverse reactions listed in Table 1 are based on experience from clinical trials and post-marketing. Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rarely (≥1/10,000 to <1/1,000); very rarely (<1/10,000); not known.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Table 1 Adverse reactions reported during clinical trials or following the marketing use of IntronA alone or in combination with ribavirin System Organ Class Adverse Reactions Infections and infestations Very common: Common: Uncommon: Rarely: Not known: Pharyngitis*, infection viral* Bronchitis, sinusitis, herpes simplex (resistance), rhinitis Bacterial infection Pneumonia§, sepsis Hepatitis B reactivation in HCV/HBV co-infected patients Blood and lymphatic system disorders Very common: Common: Very rarely: Not known: Leukopaenia Thrombocytopaenia, lymphadenopathy, lymphopenia Aplastic anaemia Pure red cell aplasia, idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura Immune system disorders§ Very rarely: Not known: Sarcoidosis, exacerbation of sarcoidosis Systemic lupus erythematosus, vasculitis, rheumatoid arthritis (new or aggravated), Vogt-Koyanagi-Harada syndrome, acute hypersensitivity reactions including urticaria, angioedema, bronchoconstriction, anaphylaxis§ Endocrine disorders Common: Very rarely: Hypothyroidism§, hyperthyroidism§ Diabetes, aggravated diabetesMedicinal Product no longer authorised 13 Metabolism and nutrition disorders Very common: Common: Very rarely: Anorexia Hypocalcaemia, dehydration, hyperuricemia, thirst Hyperglycaemia, hypertriglyceridaemia§, increased appetite Psychiatric disorders§ Very common: Common: Rarely: Very rarely: Not known: Depression, insomnia, anxiety, emotional lability*, agitation, nervousness Confusion, sleep disorder, libido decreased Suicide ideation Suicide, suicide attempts, aggressive behaviour (sometimes directed against others), psychosis including hallucinations Homicidal ideation, mental status change§, mania, bipolar disorders Nervous system disorders§ Very common: Common: Uncommon: Very rarely: Not known: Dizziness, headache, concentration impaired, mouth dry Tremor, paresthesia, hypoesthesia, migraine, flushing, somnolence, taste perversion Peripheral neuropathy Cerebrovascular haemorrhage, cerebrovascular ischaemia, seizure, impaired consciousness, encephalopathy Mononeuropathies, coma§ Eye disorders Very common: Common: Rarely: Not known: Vision blurred Conjunctivitis, vision abnormal, lacrimal gland disorder, eye pain Retinal haemorrhages§, retinopathies (including macular oedema), retinal artery or vein obstruction§, optic neuritis, papilloedema, loss of visual acuity or visual field, cotton- wool spots§ Serous retinal detachment Ear and labyrinth Common: Very rarely: Vertigo, tinnitus Hearing loss, hearing disorder Cardiac disorders Common: Uncommon: Rarely: Very rarely: Not known: Palpitation, tachycardia Pericarditis Cardiomyopathy Myocardial infarction, cardiac ischaemia Congestive heart failure, pericardial effusion, arrhythmia Vascular disorders Common: Very rarely: Hypertension Peripheral ischaemia, hypotension§ Respiratory, thoracic and mediastinal disorders Very common: Common: Very rarely: Not known: Dyspnoea*, coughing* Epistaxis, respiratory disorder, nasal congestion, rhinorrhea, cough nonproductive Pulmonary infiltrates§, pneumonitis§ Pulmonary fibrosis, pulmonary arterial hypertension#Medicinal Product no longer authorised 14 Gastrointestinal disorders Very common: Common: Very rarely: Not known: Nausea/vomiting, abdominal pain, diarrhoea, stomatitis, dyspepsia Stomatitis ulcerative, right upper quadrant pain, glossitis, gingivitis, constipation, loose stools Pancreatitis, ischaemic colitis, ulcerative colitis, gingival bleeding Periodontal disorder NOS, dental disorder NOS, tongue pigmentation § Hepatobiliary disorders Common: Very rarely: Hepatomegaly Hepatotoxicity, (including fatality) Skin and subcutaneous tissue disorders Very common: Common: Very rarely: Alopecia, pruritus*, skin dry*, rash*, sweating increased Psoriasis (new or aggravated)§, rash maculopapular, rash erythematous, eczema, erythema, skin disorder Stevens Johnson syndrome, toxic epidermal necrolysis, erythema multiforme Musculoskeletal and connective tissue disorders Very common: Common: Very rarely: Myalgia, arthralgia, musculoskeletal pain Arthritis Rhabdomyolysis, myositis, leg cramps, back pain Renal and urinary disorders Common: Very rarely: Micturition frequency Renal failure, renal insufficiency, nephrotic syndrome Reproductive system and breast disorders Common: Amenorrhea, breast pain, dysmenorrhea, menorrhagia, menstrual disorder, vaginal disorder General disorders and administration site conditions Very common: Common: Very rarely: Injection site inflammation, injection site reaction*, fatigue, rigors, […]
Psychiatric and central nervous system (CNS) Severe CNS effects, particularly depression, suicidal ideation and attempted suicide have been observed in some patients during IntronA therapy, and even after treatment discontinuation mainly during the 6-month follow-up period.
4 % vs 1 %) during treatment and during the 6-month follow-up after treatment. , depression, emotional lability, and somnolence). Other CNS effects including aggressive behaviour (sometimes directed against others such as homicidal ideation), bipolar disorders, mania, confusion and alterations of mental status have been observed with alpha interferons.
Patients should be closely monitored for any signs or symptoms of psychiatric disorders. If such symptoms appear, the potential seriousness of these undesirable effects must be borne in mind by the prescribing physician and the need for adequate therapeutic management should be considered.
If psychiatric symptoms persist or worsen, or suicidal or homicidal ideation is identified, it is recommended that treatment with IntronA be discontinued, and the patient followed, with psychiatric intervention as appropriate.
Patients with existence of, or history of severe psychiatric conditions:
If treatment with interferon alfa-2b is judged necessary in adult patients with existence or history of severe psychiatric conditions, this should only be initiated after having ensured appropriate individualised diagnostic and therapeutic management of the psychiatric condition.
3).
Patients with substance use/abuse:
HCV infected patients having a co-occurring substance use disorder (alcohol, cannabis, etc) are at an increased risk of developing psychiatric disorders or exacerbation of already existing psychiatric disorders when treated with alpha interferon.
1. , uncontrolled congestive heart failure, recent myocardial infarction, severe arrhythmic disorders. - Severe renal or hepatic dysfunction; including that caused by metastases. 4). - Chronic hepatitis with decompensated cirrhosis of the liver.
- Chronic hepatitis in patients who are being or have been treated recently with immunosuppressive agents excluding short term corticosteroid withdrawal. - Autoimmune hepatitis; or history of autoimmune disease; immunosuppressed transplant recipients.
- Pre-existing thyroid disease unless it can be controlled with conventional treatment. - Combination of IntronA with telbivudine. Children and adolescents - Existence of, or history of severe psychiatric condition, particularly severe depression, suicidal ideation or suicide attempt.
Combination therapy with ribavirin Also see ribavirin SPC if IntronA is to be administered in combination with ribavirin in patients with chronic hepatitis C.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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, a total of 12 months) in patients who exhibit negative HCV-RNA at month 6, and with viral genotype 1 (as determined in a pre-treatment sample) and high pre-treatment viral load. Other negative prognostic factors (age > 40 years, male gender, bridging fibrosis) should be taken into account in order to extend therapy to 12 months.
During clinical trials, patients who failed to show a virologic response after 6 months of treatment (HCV-RNA below lower limit of detection) did not become sustained virologic responders (HCV- RNA below lower limit of detection six months after withdrawal of treatment).
- IntronA alone The optimal duration of therapy with IntronA alone is not yet fully established, but a therapy of between 12 and 18 months is advised. It is recommended that patients be treated with IntronA alone for at least 3 to 4 months, at which point HCV-RNA status should be determined.
Treatment should be continued in patients who exhibit negative HCV-RNA. Naïve patients (children and adolescents) The efficacy and safety of IntronA in combination with ribavirin has been studied in children and adolescents who have not been previously treated for chronic hepatitis C.
Duration of treatment for children and adolescents Genotype 1:
The recommended duration of treatment is one year. Patients who fail to achieve virological response at 12 weeks are highly unlikely to become sustained virological responders (negative predictive value 96 %).
Medicinal Product no longer authorised 5 Genotype 2/3:
The recommended duration of treatment is 24 weeks. Hairy cell leukaemia The recommended dose is 2 million IU/m2 administered subcutaneously three times a week (every other day) for both splenectomised and non-splenectomised patients.
For most patients with hairy cell leukaemia, normalisation of one or more haematological variables occurs within one to two months of IntronA treatment. Improvement in all three haematological variables (granulocyte count, platelet count and haemoglobin level) may require six months or more.
This regimen must be maintained unless the disease progresses rapidly or severe intolerance is manifested. Chronic myelogenous leukaemia The recommended dose of IntronA is 4 to 5 million IU/m2 administered daily subcutaneously. Some patients have been shown to benefit from IntronA 5 million IU/m2 administered daily subcutaneously in association with cytarabine (Ara-C) 20 mg/m2 administered daily subcutaneously for 10 days per month (up to a maximum daily dose of 40 mg).
When the white blood cell count is controlled, administer the maximum tolerated dose of IntronA (4 to 5 million IU/m2 daily) to maintain haematological remission. IntronA treatment must be discontinued after 8 to 12 weeks of treatment if at least a partial haematological remission or a clinically meaningful cytoreduction has not been achieved.
Multiple myeloma […]
If treatment with alpha interferon is judged necessary in these patients, the presence of psychiatric co-morbidities and the potential for other substance use should be carefully assessed and adequately managed before initiating therapy.
If necessary, an inter-disciplinary approach including a mental health care provider or addiction specialist should be considered to evaluate, treat and follow the patient. Patients should be closely monitored during therapy and even after treatmentMedicinal Product no longer authorised 7 discontinuation.
Early intervention for re-emergence or development of psychiatric disorders and substance use is recommended. 1). The longer term data available in children treated with the combination therapy with standard interferon/ribavirin are also indicative of substantial growth retardation (> 15 percentile decrease in height percentile as compared to baseline) in 21 % of children (n=20) despite being off treatment for more than 5 years.
Final adult height was available for 14 of those children and demonstrated that 12 continued to show height deficits > 15 percentiles, 10 to 12 years after the end of treatment. 1). - It is important to consider that the combination therapy induced a growth inhibition that resulted in reduced final adult height in some patients.
- This risk should be weighed against the disease characteristics of the child, such as evidence of disease progression (notably fibrosis), co-morbidities that may negatively influence the disease progression (such as HIV co-infection), as well as prognostic factors of response, (HCV genotype and viral load).
Whenever possible the child should be treated after the pubertal growth spurt, in order to reduce the risk of growth inhibition. There are no data on long term effects on sexual maturation. , urticaria, angioedema, bronchoconstriction, anaphylaxis) to interferon alfa-2b have been observed rarely during IntronA therapy.
If such a reaction develops, discontinue the medicine and institute appropriate medical therapy. Transient rashes do not necessitate interruption of treatment. Adverse experiences including prolongation of coagulation markers and liver abnormalities Moderate to severe adverse experiences may require modification of the patient's dose regimen, or in some cases, termination of IntronA therapy.
IntronA increases the risk of liver decompensation and death in patients with cirrhosis. Discontinue treatment with IntronA in patients with chronic hepatitis who develop prolongation of coagulation markers which might indicate liver decomposition.
Any patient developing liver function abnormalities during treatment with IntronA must be monitored closely and treatment discontinued if signs and symptoms progress. Liver enzymes and hepatic function should be closely monitored in cirrhotic patients.
Hypotension Hypotension may occur during IntronA therapy or up to two days post-therapy and may require supportive treatment. Need for adequate hydration Adequate hydration must be maintained in patients undergoing IntronA therapy since hypotension related to fluid depletion has been seen in some patients.
Fluid replacement may be necessary. Pyrexia While […]