IgANEF
Description
IgANEF Tablet is a new treatment in IgA nephropathy. IgANEF tablet is a corticosteroid indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥ 1.5 g/g.
IgA nephropathy, also known as Berger’s disease, is a kidney disease that occurs when an antibody called immunoglobulin A (IgA) builds up in kidneys. This results in local inflammation that, over time, can hamper kidneys’ ability to filter waste from blood.
IgA nephropathy usually progresses slowly over years, but the course of the disease varies from person to person. Some people leak blood in their urine without developing problems, some eventually achieve complete remission and others develop end-stage kidney failure.
Each tablet of IgANEF contains enteric coated controlled release Budesonide 3mg & 9mg.
As per the disease condition, the Doctor will decide the dose and duration of the treatment.
As per the disease condition, the Doctor will decide the dose and duration of the treatment.
Most common adverse reactions ( ≥5%) are hypertension, peripheral edema, muscle spasms, acne, dermatitis, weight increase, dyspnea, face edema, dyspepsia, fatigue, hirsutism.
Drug Interaction
Potent CYP3A4 Inhibitors (e.g. ketoconazole, grapefruit juice): Can increase systemic budesonide concentrations: avoid concomitant use.
Use in Specific Population
Lactation: Routine monitoring of linear growth in infants is recommended with chronic use of budesonide in the nursing mother.
Contraindication
IgANEF is contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of IgANEF. Serious hypersensitivity reactions, including anaphylaxis have occurred with other budesonide formulations.
Clinical Pharmacology
Mechanism of Action Budesonide is a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism. Mucosal B-cells present in the ileum, including the Peyer’s patches, express glucocorticoid receptors and are responsible for the production of galactose-deficient IgA1 antibodies (Gd-Ag1) causing IgA nephropathy. Through their anti-inflammatory and immunosuppressive effects at the glucocorticoid receptor, corticosteroids can modulate B-cell numbers and activity.
Interaction
It is unsafe to consume alcohol with IgANEF Tablet CR
