Macitentan Tablet, Film Coated
Product Images NDC 46708-373

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Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Macitentan (NDC 46708-373). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Alembic Pharmaceuticals Limited, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

30 Tablets (Macitentan 10mg)

FDA Label Image

Figure 1 (Macitentan Fig1)

Figure 1 (Macitentan Fig1)
This text appears to be a comparison of drug interactions involving macitentan, its active metabolite, and other drugs such as sildenafil, ketoconazole, and rifampin. The text discusses parameters such as AUCtau, Cmax, and CI, presenting point estimates and 90% confidence intervals for these interactions. The analysis also includes changes relative to the effects of macitentan alone.*
FDA Label Image

Figure 2 (Macitentan Figur2)

Figure 2 (Macitentan Figur2)
This text appears to be a comparison between Macitentan 10mg and Placebo in a study, indicating hazard ratio, confidence intervals, logrank p-value, and the number at risk over different months from treatment start. Macitentan 10mg had a hazard ratio of 0.547 with a confidence interval between 0.392 and 0.762. The logrank p-value was found to be less than 0.0001, suggesting a significant difference between the two groups in the study. The table also provides the number at risk for both Macitentan 10mg and Placebo at different time points.*
FDA Label Image

Figure 3 (Macitentan Figur3)

Figure 3 (Macitentan Figur3)
This is a detailed summary of the subgroup analysis results from the SERAPHIN Study, which evaluated the effect of treatment on different characteristics such as age, sex, race, PAH etiology, WHO functional class, and geographic region. The hazard ratios and confidence intervals for different subgroups are presented, providing valuable insights into how these factors may impact the treatment response. Additionally, there are specific notes about the number of patients in each group and special circumstances in the study.*
FDA Label Image

Figure 4 (Macitentan Figur4)

Figure 4 (Macitentan Figur4)
This is a study that evaluated the event-free survival of patients given Macitentan 10 mg compared to a placebo. The Kaplan-Meier analysis showed that the patients on Macitentan had a hazard ratio of 0.5 with a 97.5% confidence interval of (0.335, 0.747) and a statistically significant p-value of <0.0001. The graph shows the event-free survival percentages over time for both groups, indicating potential benefits of Macitentan treatment.*
FDA Label Image

Macitentan Structure (Macitentan Structure)

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.