Contraindications
Hypersensitivity. History of severe cardiac disease (e.g. recent MI, uncontrolled CHF, severe arrhythmic disorders), epilepsy and/or compromised CNS function, autoimmune hepatitis or history of autoimmune disease, immunosuppressed transplant recipients, rapidly progressive visceral disease, pre-existing thyroid disease (unless it can be controlled with conventional treatment); current or history of severe psychiatric condition (e.g. severe depression, suicidal ideation or suicide attempt) particularly in children and adolescents. Severe renal or hepatic impairment (including decompensated liver disease or that caused by metastases).
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Special Precautions
Patient with current or history of severe psychiatric conditions (adults), previous or current arrhythmic disorders, debilitating medical conditions (e.g. history of pulmonary disease, diabetes mellitus prone to ketoacidosis), coagulation disorders (e.g. thrombophlebitis, pulmonary embolism), pre-existing myelosuppression, thyroid disease or eye disorders; psoriasis or sarcoidosis, predisposition to autoimmune disorders, HCV/HIV co-infection, HCV/HBV co-infection, substance use disorder (alcohol, cannabis). Children. Pregnancy and lactation. Patient Counselling Maintain adequate hydration. This drug may cause fatigue, somnolence, or confusion, if affected, do not drive or operate machinery. Monitoring Parameters Perform standard haematological tests and blood chemistries (e.g. CBC with differential, platelet count, electrolytes, liver enzymes, lipid levels, serum protein, serum bilirubin and serum creatinine), eye examination prior to and periodically during treatment; liver biopsy to establish the diagnosis of chronic hepatitis. Monitor for weight changes and signs of depression or suicidal ideation.
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Adverse Reactions
Significant: Hypotension, prolongation of coagulation markers, liver abnormalities, pyrexia, flu-like symptoms, obtundation and coma (including cases of encephalopathy), hypertriglyceridaemia, exacerbation of pre-existing psoriatic or sarcoidosis, increased rate of kidney graft or liver graft rejection, development of auto-antibodies and autoimmune disorders, dental and periodontal disorders, bone marrow suppression (e.g. neutropenia, thrombocytopenia, anaemia), haemorrhagic and ischaemic cerebrovascular events, hypothyroidism or hyperthyroidism, nausea and vomiting, hepatitis B virus reactivation; weight loss and growth inhibition in children. Rarely, acute serious hypersensitivity reactions (e.g. urticaria, angioedema, bronchoconstriction, anaphylaxis), retinal haemorrhage, cotton wool spots, serous retinal detachment, retinal artery or vein obstruction. Very rarely, seizures (at high doses).
Blood and lymphatic system disorders: Leucopenia, lymphadenopathy, lymphopenia.
Cardiac disorders: Palpitations, tachycardia.
Ear and labyrinth disorders: Tinnitus, vertigo.
Eye disorders: Blurred vision, conjunctivitis, abnormal vision, lacrimal gland disorder,
eye pain.
Gastrointestinal disorders: Abdominal pain, diarrhoea, dyspepsia, stomatitis, right upper quadrant pain, glossitis, gingivitis, constipation, loose stools.
General disorders and administration site conditions: Fatigue, rigors, asthenia, chest pain, malaise, inj site reactions (e.g. inflammation, pain).
Hepatobiliary disorders: Hepatomegaly.
Infections and infestations: Viral infection.
Investigations: Decreased weight.
Metabolism and nutrition disorders: Anorexia, dehydration, hypocalcaemia, hyperuricaemia, thirst.
Musculoskeletal and connective tissue disorders: Arthralgia, myalgia, musculoskeletal pain, arthritis.
Nervous system disorders: Dizziness, headache, impaired concentration, dry mouth, tremors, paraesthesia, hypoaesthesia, migraine, flushing, somnolence, taste perversion.
Psychiatric disorders: Depression, insomnia, agitation, anxiety, emotional lability, nervousness, irritability, confusion, sleep disorder.
Renal and urinary disorders: Micturition frequency.
Reproductive system and breast disorders: Amenorrhoea, breast pain, dysmenorrhoea, menorrhagia, menstrual or vaginal disorder, decreased libido.
Respiratory, thoracic and mediastinal disorders: Bronchitis, pharyngitis, sinusitis, rhinitis dyspnoea, cough, epistaxis, respiratory disorder, nasal congestion, rhinorrhoea.
Skin and subcutaneous tissue disorders: Alopecia, pruritus, rash (including erythematous or maculopapular rash), dry skin, increased sweating, eczema, skin disorder, Stevens-Johnson syndrome, toxic epidermal necrolysis.
Vascular disorders: Hypertension.
Potentially Fatal: Pulmonary infiltrates, pneumonitis, pneumonia; aggravate neuropsychiatric (e.g. depression, suicidal ideation and attempted suicide), autoimmune (e.g. thrombocytopenia, vasculitis, Raynaud's phenomenon, rheumatoid arthritis, lupus erythematosus, rhabdomyolysis), ischaemic, infectious disorders; hepatoxicity. |
ROUTE(S) : Intralesional: X
when used in combination w/ ribavirin
ROUTE(S) : IM / IV / Parenteral / SC: X
when used in combination w/ ribavirin.
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Drug Interactions
May increased risk of peripheral neuropathy of telbivudine. Increased toxicity with other chemotherapeutic agents (e.g. cytarabine, cyclophosphamide, doxorubicin, teniposide). Concomitant use with hydroxyurea may increase the frequency and severity of cutaneous vasculitis. Increased myelosuppressive effects with other potentially myelosuppressive agents (e.g. zidovudine). Increases serum concentrations of theophylline.
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CIMS Class
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ATC Classification
L03AB05 - interferon alfa-2b ; Belongs to the class of interferons. Used as immunostimulants.
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