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Ribavirin BioPartners is a brand name for Ribavirin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Ribavirin BioPartners is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults, children 3 years of age and older and adolescents and must only be used as part of a combination regimen with interferon alfa-2b. Ribavirin monotherapy must not be used. There is no safety or efficacy…
Verbatim from this product's EMA label. Tap a section to expand.
Treatment should be initiated, and monitored, by a physician experienced in the management of chronic hepatitis C. Medicinal product no longer authorised 3 Please refer also to the interferon alfa-2b Summary of Product Characteristics (SPC) for prescribing information particular to that product.
Dose to be administered The dose of Ribavirin BioPartners is based on patient body weight. Ribavirin BioPartners tablets are to be administered orally each day in two divided doses (morning and evening) with food.
Adult patients:
The dose of Ribavirin BioPartners is based on patient body weight (Table 1). Ribavirin BioPartners must be used in combination with interferon alfa-2b (3 million international units [MIU] three times a week). The choice of combination regimen is based on the characteristics of the patient.
1). Table 1 Ribavirin BioPartners dose based on body weight Patient weight (kg) Daily Ribavirin BioPartners dose Number of 200 mg film-coated tablets < 65 800 mg 4 a 65 - 80 1,000 mg 5 b 81 - 105 1,200 mg 6 c > 105 1,400 mg 7 d a: 2 morning, 2 evening b: 2 morning, 3 evening c: 3 morning, 3 evening d: 3 morning, 4 evening Ribavirin BioPartners film-coated tablets in combination with interferon alfa-2b: Based on the results of clinical trials, it is recommended that patients be treated for at least six months.
During those clinical trials in which patients were treated for one year, patients who failed to show a virological response after six months of treatment (HCV-RNA below lower limit of detection) were unlikely to become sustained virological responders (HCV-RNA below lower limit of detection six months after withdrawal of treatment).
, age > 40 years, male gender, bridging fibrosis). , a total of one year) in patients who exhibit negative HCV-RNA after six months of treatment. , age > 40 years, male gender, bridging fibrosis).
Children 3 years of age and older and adolescents:
Note: For patients who weigh < 47 kg, or are unable to swallow tablets, ribavirin oral solution is available and should be used if appropriate. Dosing for children and adolescent patients is determined by body weight for Ribavirin BioPartners and by body surface area for interferon alfa-2b.
Adult patients:
The safety of ribavirin is evaluated from data from four clinical trials in patients with no previous exposure to interferon (interferon-naïve patients): two trials studied ribavirin in combination with interferon alfa-2b, two trials studied ribavirin in combination with peginterferon alfa-2b.
Patients who are treated with interferon alfa-2b and ribavirin after previous relapse from interferon therapy or who are treated for a shorter period are likely to have an improved safety profile than that described below. The adverse reactions listed in Table 4 are based on experience from clinical trials in adult naïve patients treated for 1 year and post-marketing use.
A certain number of adverse reactions, generally attributed to interferon therapy but that have been reported in the context of hepatitis C therapy (in combination with ribavirin) are also listed for reference in Table 4. Also, refer to peginterferon alfa-2b and interferon alfa-2b SPCs for adverse reactions that may be attributable to interferons monotherapy.
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); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Table 4 Adverse reactions reported during clinical trials or following the marketing use of Ribavirin with pegylated interferon alfa-2b or interferon alfa-2b System Organ Class Adverse Reactions Infections and infestations Very common: Viral infection, pharyngitisMedicinal product no longer authorised 12 Common: Bacterial infection (including sepsis), fungal infection, influenza, respiratory tract infection, bronchitis, herpes simplex, sinusitis, otitis media, rhinitis, urinary tract infection Uncommon: Injection site infection, lower respiratory tract infection Rare: Pneumonia* Neoplasms benign, malignant and unspecified (including cysts and polyps) Common: Neoplasm unspecified Blood and lymphatic system disorders Very common: Anaemia, neutropenia Common: Haemolitic anaemia, leukopenia, thrombocytopenia, lymphadenopathy, lymphopenia Very rare: Aplastic anaemia* Not known: Pure red cell aplasia, idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura Immune system disorders Uncommon: Drug hypersensitivity Rare: Sarcoidosis*, rheumatoid arthritis (new or aggravated) Not known: Vogt-Koyanagi-Harada syndrome, systemic lupus erythematosus, vasculitis, acute hypersensitivity reactions including urticaria, angioedema, bronchoconstriction, anaphylaxis Endocrine disorders Common: Hypothyroidism, hyperthyroidism Metabolism and nutrition disorders Very common: Anorexia Common: Hyperglycaemia, hyperuricaemia, hypocalcaemia, dehydration, increased appetite Uncommon: Diabetes mellitus, hypertriglyceridemia* Psychiatric disorders Very common: Depression, anxiety, emotional lability, insomnia Common: Suicidal ideation, psychosis, aggressive behaviour, confusion, agitation, anger, mood altered, abnormal behaviour, nervousness, sleep disorder, decreased libido apathy, abnormal dreams, crying Uncommon: Suicide attempts, panic attack, hallucination Rare: Bipolar disorder* Very rare: Suicide* Not known: Homicidal ideation*, mania*, mental status change Nervous system disorders Very common: Headache, dizziness, dry mouth, concentration impaired Common: Amnesia, memory impairment, syncope, migraine, ataxia, paraesthaesia, dysphonia, taste loss, hypoaesthesia, hyperaesthesia, hypertonia, somnolence, disturbance in attention, tremor, dysgeusia Uncommon: Neuropathy, peripheral neuropathy Rare: Seizure (convulsion)* Very rare: Cerebrovascular haemorrhage*, cerebrovascular ischaemia*, encephalopathy*, polyneuropathy* Not known: Facial palsy, mononeuropathies Eye disorders Common: Visual disturbance, blurred vision, conjunctivitis, eye irritation, eye pain, abnormal vision, lacrimal gland disorder, dry eye Rare: Retinal haemorrhages*, retinopathies (including macularMedicinal product no longer authorised 13 oedema)*, retinal artery occlusion*, retinal vein occlusion*, optic neuritis*, papilloedema*, loss of visual acuity or visual field*, retinal exudates Ear and labyrinth disorders Common: Vertigo, hearing impaired/loss, tinnitus, ear pain Cardiac disorders Common: Palpitation, tachycardia Uncommon: Myocardial infarction Rare: Cardiomyopathy, arrhythmia* Very rare: Cardiac ischaemia* Not known: Pericardial effusion*, pericarditis* Vascular disorders Common: Hypotension, hypertension, flushing Rare: Vasculitis Very rare: Peripheral ischaemia* Respiratory, thoracic and mediastinal disorders Very common: Dyspnoea, coughing Common: Epistaxis, respiratory disorder, respiratory tract congestion, sinus congestion, nasal congestion, rhinorrhea, increased upper airway secretion, pharyngolaryngeal pain, nonproductive cough Very rare: Pulmonary infiltrates*, pneumonitis*, interstitial pneumonitis* Gastro-intestinal disorders Very common: Diarrhoea, vomiting, nausea, abdominal pain Common: Ulcerative stomatitis, stomatitis, mouth ulceration, colitis, upper right quadrant pain, dyspepsia, gastroesophoageal reflux*, glossitis, cheilitis, abdominal distension, gingival bleeding, gingivitis, loose stools, tooth disorder, constipation, flatulence Uncommon: Pancreatitis, oral pain Rare: Ischaemic colitis Very rare: Ulcerative colitis* Not Known: Periodontal disorder, dental disorder Hepatobiliary disorders Common: Hepatomegaly, jaundice, hyperbilirubinemia* Very rare: Hepatotoxicity (including fatalities)* Skin and subcutaneous tissue disorders Very common: Alopecia, pruritus, skin dry, rash Common: Psoriasis, aggravated psoriasis, eczema, photosensitivity reaction, maculopapular rash, erythematous rash, night sweats, hyperhidrosis, dermatitis, acne, furuncule, erythema, urticaria, skin disorder, bruise, sweating increased, […]
Psychiatric and Central Nervous System (CNS):
Severe CNS effects, particularly depression, suicidal ideation and attempted suicide have been observed in some patients during ribavirin combination therapy with peginterferon alfa-2b or interferon alfa-2b, and even after treatment discontinuation mainly during the 6-month follow-up period.
4 % versus 1 %) during treatment and during the 6-month follow-up after treatment. g. depression, emotional lability, and somnolence). Other CNS effects including aggressive behaviour (sometimes directed against others such as homicidal ideation), bipolar disorder, 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 ideation is identified, it is recommended that treatment with Ribavirin and peginterferon alfa-2b or interferon alfa-2b be discontinued, and the patient followed, with psychiatric intervention as appropriate.
Patients with existence of or history of severe psychiatric conditions:
If treatment with Ribavirin in combination with peginterferon alfa-2b or 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:
3). Ribavirin BioPartners must not be initiated until a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy. - Lactation. 4). - Patients with severe, debilitating medical conditions. - Patients with chronic renal failure, patients with creatinine clearance < 50 ml/minute and/or on haemodialysis.
- Severe hepatic impairment (Child-Pugh Classification B or C) or decompensated cirrhosis of the liver. , thalassemia, sickle-cell anaemia). - Initiation of peginterferon alfa-2b is contraindicated in HCV/HIV patients with cirrhosis and a Child-Pugh score ≥6.
Children and adolescents: - Existence of, or history of severe psychiatric condition, particularly severe depression, suicidal ideation, or suicide attempt. Because of co-administration with peginterferon alfa-2b or interferon alfa-2b: - Autoimmune hepatitis; or history of autoimmune disease.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Dose to be administered for the combination therapy with interferon alfa-2b:Medicinal product no longer authorised 4 In clinical studies performed in this population ribavirin and interferon alfa-2b were used in doses of 15 mg/kg/day and 3 million international units (MIU)/m2 three times a week respectively (Table 2).
a1 morning, 2 evening b2 morning, 2 evening Duration of treatment in children and adolescents Genotype 2 or 3: The recommended duration of treatment is 24 weeks. Dose modification for all patients If severe adverse reactions or laboratory abnormalities develop during therapy with ribavirin and interferon alfa-2b, modify the dosages of each product if appropriate, until the adverse reactions abate.
Guidelines were developed in clinical trials for dose modification (see Dosage modification guidelines, Table 3). As adherence might be of importance for outcome of therapy, the dose should be kept as close as possible to the recommended standard dose.
The potential negative impact of ribavirin dose reduction on efficacy results could not be ruled out. 0 mg/dl Creatinine - - Discontinue Ribavirin Table 2 Ribavirin BioPartners dose based on body weight when used in combination with interferon alfa-2b in children and adolescents Patient weight (kg) Daily Ribavirin BioPartners dose Number of 200 mg tablets 47 - 49 600 mg 3 tablets a 50 - 65 800 mg 4 tablets b > 65 Refer to adult dosing table (Table 1)Medicinal product no longer authorised 5 Clearance BioPartners if CrCl < 50 ml/minute Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) - - 2 x baseline and > 10 x ULN* or 2 x baseline and > 10 x ULN* * Upper limit of normal ** Refer to the SPC for interferon alfa-2b for dose modification and discontinuation.
Note 1:
In adult patients, 1st dose reduction of Ribavirin BioPartners is by 200 mg/day (except in patients receiving the 1,400 mg, dose reduction should be by 400 mg/day). If needed, 2nd dose reduction of Ribavirin BioPartners is by an additional 200 mg/day.
Patients whose dose of Ribavirin […]
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.
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 initiatingMedicinal product no longer authorised 7 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 treatment 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 despite being off treatment for more than 5 years.
1). – It is important to consider that the combination therapy induced a growth inhibition, the reversibility of which is uncertain. – 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. Based on results of clinical trials, the use of ribavirin as monotherapy is not effective and Ribavirin must not be used alone.
The safety and efficacy of this combination have been established only using ribavirin together with peginterferon alfa-2b or interferon alfa-2b solution for injection. e. patients with genotype 2 and 3), treatment may be possible without histological confirmation.
Current treatment guidelines should be consulted as to whether a liver biopsy is needed prior to commencing treatment.
Haemolysis:
A decrease in haemoglobin levels to < 10 g/dl was observed in up to 14 % of adult patients and 7 % of children and adolescents treated with ribavirin in combination with peginterferon alfa-2b or interferon alfa-2b in clinical trials.
Although ribavirin has no direct cardiovascular effects, anaemia associated with ribavirin may result in deterioration of cardiac function, or exacerbation of the symptoms of coronary disease, or both. 3). 2).
Cardiovascular:
Adult patients with a history of congestive heart failure, myocardial infarction and/or previous or current […]