67630-00-6 Tert-butoxycarbonyl-4-NO2-phenylalanine-ethyl ester

Nidanib, it's a chemical. Chemical name 1 h - indole - 6 - carboxylic acid, 2, 3 - dihydro - 3 - [[[4 - (methyl [(4 - methyl - 1 - piperazine) acetyl] amino] phenyl] amino] benzene heartland of methyl] - 2 - oxygen -, methyl ester, (z) -. Clinically, this product is used to treat idiopathic pulmonary fibrosis (IPF).
Nidanib has studied 1,529 patients with idiopathic pulmonary fibrosis (IPF) in multiple clinical trials. The safety data presented are based on a comparison of 1061 patients given nidanib 150 mg twice daily and placebo in two 52-week phase 3, randomized, double-blind, placebo-controlled studies (INPULSIS-1 and INPULSIS-2). The most common adverse events associated with the use of nidanib included diarrhea, nausea and vomiting, abdominal pain, loss of appetite, weight loss, and elevated liver enzymes. Please refer to [Precautions] for the management of the corresponding adverse reactions. The Systematic Organ Classification (SOC) of MedDRA provides a summary of adverse reactions and frequency classification.
Nidanib is a substrate for P-gp (see Pharmacokinetics). In a specific study of drug interactions, combined administration of ketoconazole, a powerful P-gp inhibitor, increased exposure to nidanib to 1.61 times by area under the curve (AUC) and 1.83 times by peak concentration (Cmax).
In a drug interaction study with the powerful P-gp inducer rifampicin, exposure to nidanib decreased to 50.3%, as measured by area under the curve (AUC), when combined with rifampicin compared with Nidanib alone. By peak concentration (Cmax), it decreased to 60.3%.
When administered in combination with this product, powerful P-gp inhibitors (e.g., ketoconazole or erythromycin) can increase exposure to nidanib. In these cases, the patient's tolerance to nidanib should be closely monitored. Management of adverse reactions may require discontinuation, dosing reduction, or discontinuation of treatment with this product (see [Usage and dosage]).
P-gp potent inducers (e.g., rifampicin, carbamazepine, phenytoin and St. John's wort) can reduce exposure to nidanib. Alternative combinations with no or minimal P-gp induction should be considered.