PegIntron/Pen

PegIntron/Pen Uses, Dosage, Side Effects, Food Interaction and all others data.

PegIntron/Pen 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 PegIntron/Pen. PegIntron/Pen is derived from the alfa-2b 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 PegIntron/Pen 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 PegIntron/Pen 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 PegIntron/Pen for the treatment of Hepatitis C . PegIntron/Pen was used alongside Ribavirin(https://go.drugbank.com/drugs/DB00811) 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 .

PegIntron/Pen is available as a variable dose injectable product (tradename Pegintron) used for the treatment of chronic Hepatitis C. Approved in 2001 by the FDA, Pegintron is indicated for the treatment of HCV with Ribavirin or other antiviral drugs . When combined together, PegIntron/Pen and Ribavirin have been shown to achieve a SVR between 41% for genotype 1 and 75% for genotypes 2-6 after 48 weeks of treatment.

PegIntron/Pen
Uses
Dosage
Side Effect
Precautions
Interactions
Uses during Pregnancy
Uses during Breastfeeding
Accute Overdose
Food Interaction
Half Life
Volume of Distribution
Clearance
Interaction With other Medicine
Contradiction
Storage

Trade Name	PegIntron/Pen
Generic	Peginterferon alfa-2b
Peginterferon alfa-2b Other Names	Peginterferon alfa-2b
Type
Weight	31000.0 Da
Groups	Approved
Therapeutic Class
Manufacturer
Available Country	Switzerland
Last Updated:	September 19, 2023 at 7:00 am

Uses

PegIntron/Pen is a purified form of human interferon used to stimulate the innate antiviral response in the treatment of hepatitis B and C, genital warts, and some cancers.

PegIntron/Pen is indicated for the treatment of HCV in combination with Ribavirin and a NS3/4A protease inhibitor for genotype 1 or without a NS3/4A protease inhibitor for genotypes 2-6 . May be used as a monotherapy in patients with contraindications to or significant intolerance to other anti-viral therapies.

PegIntron/Pen is also used to associated treatment for these conditions: Chronic Hepatitis C Virus (HCV) Infection, Melanomas

How PegIntron/Pen works

PegIntron/Pen is derived from recombinant human interferon's alfa-2b 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. PegIntron/Pen may also acitvate the nuclear factor κB pathway.

Toxicity

PegIntron/Pen 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 PegIntron/Pen. PegIntron/Pen 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. PegIntron/Pen causes or aggravates hypothyroidism and hyperthyroidism. Hyperglycemia, hypoglycemia, and diabetes mellitus have been observed to develop in patients treated with PegIntron/Pen. PegIntron/Pen 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 PegIntron/Pen are at risk of hepatic decompensation. Dyspnea, pulmonary infiltrates, pneumonia, bronchiolitis obliterans, interstitial pneumonitis, pulmonary hypertension and sarcoidosis may be induced or aggravated by PegIntron/Pen. Serious and severe infections (bacterial, viral, or fungal) have been reported during treatment with PegIntron/Pen. Ulcerative and hemorrhagic/ischemic colitis have been observed within 12 weeks of starting PegIntron/Pen treatment. Pancreatitis and peripheral nephropathy have also been reported. PegIntron/Pen is associated with growth inhibition in pediatric patients. Use of PegIntron/Pen while pregant may result in delopmental abnormalities or death of the fetus.

Food Interaction

Limit caffeine intake. PegIntron/Pen can increase the serum levels of caffeine by inhibiting its metabolism through the CYP1A2 pathway.

Elimination Route

PegIntron/Pen reaches peak plasma concentration 15-44 hours after subcutaneous administration . The mean absorption half-life is 4.6 hours. After multiple doses the bioavailability of PegIntron/Pen increases with trough concentrations at week 48 3-fold higher than those at week 4.