Besremi

Besremi Uses, Dosage, Side Effects, Food Interaction and all others data.

Besremi 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 Besremi. Besremi 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 Besremi 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 Besremi 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 Besremi for the treatment of Hepatitis C . Besremi 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 .

Besremi 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, Besremi 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.

Besremi
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	Besremi
Generic	Peginterferon alfa-2b
Peginterferon alfa-2b Other Names	Peginterferon alfa-2b
Type	Injection
Weight	31000.0 Da
Groups	Approved
Therapeutic Class
Manufacturer	AOP Orphan Pharmaceuticals AG
Available Country	United Kingdom
Last Updated:	September 19, 2023 at 7:00 am

Uses

Besremi 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.

Besremi 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.

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

How Besremi works

Besremi 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. Besremi may also acitvate the nuclear factor κB pathway.

Toxicity

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

Food Interaction

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

Elimination Route

Besremi 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 Besremi increases with trough concentrations at week 48 3-fold higher than those at week 4.