Pegasys Proclick Autoinjector
Pegasys Proclick Autoinjector Uses, Dosage, Side Effects, Food Interaction and all others data.
Pegasys Proclick Autoinjector is a form of recombinant interferon used as part of combination therapy to treat chronic Hepatitis C, an infectious liver disease caused by infection with Hepatitis C Virus (HCV). HCV is a single-stranded RNA virus that is categorized into nine distinct genotypes, with genotype 1 being the most common in the United States, and affecting 72% of all chronic HCV patients . Treatment options for chronic Hepatitis C have advanced significantly since 2011, with the development of Direct Acting Antivirals (DAAs) resulting in less use of Pegasys Proclick Autoinjector. Pegasys Proclick Autoinjector is derived from the alfa-2a moeity of recombinant human interferon and acts by binding to human type 1 interferon receptors. Activation and dimerization of this receptor induces the body's innate antiviral response by activating the janus kinase/signal transducer and activator of transcription (JAK/STAT) pathway. Use of Pegasys Proclick Autoinjector is associated with a wide range of severe adverse effects including the aggravation and development of endocrine and autoimmune disorders, retinopathies, cardiovascular and neuropsychiatric complications, and increased risk of hepatic decompensation in patients with cirrhosis. The use of Pegasys Proclick Autoinjector has largely declined since newer interferon-free antiviral therapies have been developed.
In a joint recommendation published in 2016, the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) no longer recommend Pegasys Proclick Autoinjector for the treatment of Hepatitis C . Pegasys Proclick Autoinjector was used alongside Ribavirin with the intent to cure, or achieve a sustained virologic response (SVR), after 48 weeks of therapy. SVR and eradication of HCV infection is associated with significant long-term health benefits including reduced liver-related damage, improved quality of life, reduced incidence of Hepatocellular Carcinoma, and reduced all-cause mortality .
Pegasys Proclick Autoinjector is available as a fixed dose injector (tradename Pegasys) used for the treatment of chronic Hepatitis C. Approved in 2002 by the FDA, Pegasys is indicated for the treatment of HCV with Ribavirin or other antiviral drugs . When combined together, Pegasys Proclick Autoinjector and Ribavirin have been shown to achieve a SVR between 36% for genotype 1 and 59% for genotypes 2-6 after 48 weeks of treatment.
Trade Name | Pegasys Proclick Autoinjector |
Generic | Peginterferon alfa-2a |
Peginterferon alfa-2a Other Names | Peginterferon alfa-2a, Pegylated Interfeaon alfa-2A, Pegylated interferon alfa-2a, Pegylated interferon alpha-2a, Pegylated-interferon alfa 2a |
Weight | 180mcg/0.5ml, 180mcg/ml |
Type | Subcutaneous solution |
Weight | 60000.0 Da |
Groups | Approved, Investigational |
Therapeutic Class | |
Manufacturer | |
Available Country | United States |
Last Updated: | September 19, 2023 at 7:00 am |
Uses
Pegasys Proclick Autoinjector is a modified form of recombinant human interferon used to stimulate the innate antiviral response in the treatment of hepatitis B and C viruses.
Pegasys Proclick Autoinjector is indicated for the treatment of HCV in combination with other antiviral drugs in patients over 5 years of age with compensated liver disease . May be used as a monotherapy in patients with contraindications to or significant intolerance to other anti-viral therapies.
Pegasys Proclick Autoinjector is also indicated as a monotherapy for adult patients with HBeAg positive and HBeAg negative chronic hepatitis B infection who have compensated liver disease and evidence of viral replication and liver inflammation .
Pegasys Proclick Autoinjector is also used to associated treatment for these conditions: Hepatitis B Chronic Infection, Compensated liver disease
How Pegasys Proclick Autoinjector works
Pegasys Proclick Autoinjector is derived from recombinant human interferon's alfa-2a moeity . It binds to and activates human type 1 interferon receptors causing them to dimerize. This activates the JAK/STAT pathway. Activation of the JAK/STAT pathway increases expression of multiple genes in multiple tissues involved in the innate antiviral response.
Toxicity
Pegasys Proclick Autoinjector may manifest neuropsychiatric complications include suicide, suicidal ideation, homicidal ideation, depression, relapse of drug addiction, and drug overdose . Hypertension, supraventricular arrhythmias, chest pain, and myocardial infarction have been observed in patients using Pegasys Proclick Autoinjector. Pegasys Proclick Autoinjector may produce myelosuppression as well as the development or aggravation of autoimmune disorders including myositis, hepatitis, thrombotic thrombocytopenic purpura, idiopathic thrombocytopenic purpura, psoriasis, rheumatoid arthritis, interstitial nephritis, thyroiditis, and systemic lupus erythematosus. Pegasys Proclick Autoinjector causes or aggravates hypothyroidism and hyperthyroidism. Hyperglycemia, hypoglycemia, and diabetes mellitus have been observed to develop in patients treated with Pegasys Proclick Autoinjector. Pegasys Proclick Autoinjector may decrease or produce loss of vision, retinopathy including macular edema, retinal artery or vein thrombosis, retinal hemorrhages and cotton wool spots, optic neuritis, papilledema and serous retinal detachment. Peginterferon mayy be related to increased ischemic and hemorrhagic cerebrovascular events. Patients with cirrhosis on Pegasys Proclick Autoinjector are at risk of hepatic decompensation. Dyspnea, pulmonary infiltrates, pneumonia, bronchiolitis obliterans, interstitial pneumonitis, pulmonary hypertension and sarcoidosis may be induced or aggravated by Pegasys Proclick Autoinjector. Serious and severe infections (bacterial, viral, or fungal) have been reported during treatment with Pegasys Proclick Autoinjector. Ulcerative and hemorrhagic/ischemic colitis have been observed within 12 weeks of starting Pegasys Proclick Autoinjector treatment. Pancreatitis and peripheral nephropathy have also been reported. Pegasys Proclick Autoinjector is associated with growth inhibition in pediatric patients. Use of Pegasys Proclick Autoinjector while pregant may result in delopmental abnormalities or death of the fetus.
Food Interaction
- Drink plenty of fluids.
Elimination Route
Pegasys Proclick Autoinjector reaches peak plasma concentration 72-96 hours after subcutaneous administration . Trough concentrations at week 48 are approximately 2 fold higher than week 1. The peak to trough ratio at week 48 is 2.
Half Life
The mean terminal half-life of peginterferon alfa-2a is 164 in a range of 84-353 hours .
Clearance
The mean systemic clearance of peginterferon alfa-2a is 94 milliliters per hour .
Innovators Monograph
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