Peginterferon alfa-2b

Peginterferon alfa-2b is a covalent conjugate of recombinant alfa interferon with monomethoxy polyethylene glycol (PEG). The molecular weight of the PEG portion of the molecule is 12,000 Daltons. Interferon alfa-2b is a water-soluble protein with a molecular weight of 19,271 Daltons produced by recombinant DNA techniques. It is obtained from the bacterial fermentation of a strain of Escherichia coli bearing a genetically engineered plasmid containing an interferon gene from human leukocytes. The biological activity of PEG-Intron is derived from its interferon alfa-2b moiety. Interferons exert their cellular activities by binding to specific membrane receptors on the cell surface and initiate a complex sequence of intracellular events. These include the induction of certain enzymes, suppression of cell proliferation, immunomodulating activities such as enhancement of the phagocytic activity of macrophages and augmentation of the specific cytotoxicity of lymphocytes for target cells, and inhibition of virus replication in virus-infected cells.


Adult Dose
Dose: 1 to 1 mcg/kg/week
Single Dose: 1 (1)
Frequency: As recommended.
Route: Sc
Instructions: Dose reduction or discontinuation is required in case of depression, haemtological and renal side effects. For patients with a history of stable cardiac disease receiving Pegnterferon alfa 2b in combination with ribavirin, dose should be reduced by half and the ribavirin dose by 200mg/day if a 2g/dL decrease in hemoglobin is observed during any 4 week period. Both Peginterferon alpha 2b and ribavirin should be permanently discontinued if patients have hemoglobin levels
Neonatal
Paedriatic
Dose: 60 to 0 mcg/m2/week
Single Dose: 30 (30)
Frequency: As recommended.
Route: Sc
Instructions: This is the dose when given in combination with ribavirin
Characteristics
It belongs to Antiviral Agents pharmacological group on the basis of mechanism of action. The Molecular Weight of peginterferon alfa-2b is 31.00.
Contraindications
peginterferon alfa-2b is contraindicated in conditions like Autoimmune hepatitis,Hypersensitivity to the drug.
Effects
peginterferon alfa-2b produces potentially life-threatening effects which include Infection. which are responsible for the discontinuation of peginterferon alfa-2b therapy.The symptomatic adverse reactions produced by peginterferon alfa-2b are more or less tolerable and if they become severe, they can be treated symptomatically, these include Headache, Fatigue, Nausea, Vomiting, Fever, Myalgia, Anxiety, Asthenia, Neutropenia, Rigors, Injection site reactions.
Indications
peginterferon alfa-2b is primarily indicated in conditions like Chronic hepatitis C.
Interactions
No data regarding the interactions of peginterferon alfa-2b was found.
Interfrence
Risks
Drug should not be given to Pregnant Mothers, Cardiac / Hypertensive Patients, and Neonates.If prescribing authority justifies the benefits of the drug against the possible damages he/she should reevaluate them and consult the reference material and previous studies.
Storage
Injection Use within 24 hours if refrigerated.
Warnings
Safety and efficacy in pediatrics less than 3 years old have not been established. Neuropsychiatric, cardiac, pulmonary, GI, and systemic (flu-like) adverse reactions may be more severe in geriatric patients. Safety and efficacy have not been estacblished in HIV or HBV co-infected and organ transplant patients. It is contraindicated in patients with creatinine clearance less than 50 mL/min. It is also contraindicated in pregnant women and patients with Hemoglobinopathies when taken in combination with ribavirin. Birth defects and fetal death with ribavirin: Patients must have a negative pregnancy test prior to therapy, use at least 2 forms of contraception, and undergo monthly pregnancy tests. Patients exhibiting the following conditions should be closely monitored and may require dose reduction or discontinuation of therapy: Hemolytic anemia with ribavirin. Neuropsychiatric events. History of significant or unstable cardiac isease. Hypothyroidism, hyperthyroidism, hyperglycemia, diabetes mellitus that cannot be effectively treated by medication. New or worsening ophthalmologic disorders. Ischemic and hemorrhagic cerebrovascular events. Severe decreases in neutrophil or platelet counts. History of autoimmune disorders. Pancreatitis and ulcerative or hemorrhagic/ischemic colitis and pancreatitis. Pulmonary infiltrates or pulmonary function impairment. Child-Pugh score greater than 6 (class B and C). Increased creatinine levels in patients with renal insufficiency. Serious, acute hypersensitivity reactions and cutaneous eruptions. Dental/periodontal disorders reported with combination therapy. Hypertriglyceridemia may result in pancreatitis (e.g., triglycerides greater than 1000 mg/dL). Weight loss and growth inhibition reported with combination therapy in pediatric patients. Peripheral neuropathy when used in combination with telbivudine.
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