Opsumit Tablet, Film Coated
Product Images NDC 66215-501

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Opsumit (NDC 66215-501). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

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

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Chemical Structure (Opsumit 01)

Chemical structure of macitentan, the active ingredient in OPSUMIT 10 mg film-coated tablets. The structure shows the molecular framework with sulfonamide, brominated aromatic rings, and ether linkages.*

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Figure 1 (Opsumit 02)

A chart showing the effects of interacting drugs on macitentan and its active metabolite, with point estimates and 90% confidence intervals. It compares changes in pharmacokinetic parameters relative to macitentan alone for sildenafil, cyclosporine-A, ketoconazole, and rifampin. Recommendations for dose adjustment or avoidance accompany each drug listed.*

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Figure 2 (Opsumit 03)

A Kaplan-Meier survival curve comparing the percentage of patients event-free over time for OPSUMIT 10 mg versus placebo. The x-axis represents months from treatment start (0 to 36 months), and the y-axis shows the percentage of patients event-free (0% to 100%). The OPSUMIT 10 mg group (solid line) shows higher event-free survival compared to placebo (dashed line). A risk table below the graph displays the number of patients at risk at various time points for both groups.*

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Figure 3 (Opsumit 04)

A forest plot showing hazard ratios and 95% confidence intervals for various subgroup analyses of treatment effect comparing OPSUMIT (macitentan) to placebo. Subgroups include age, sex, race, PAH etiology, baseline PAH therapy, WHO functional class, geographical region, and baseline walk test distance. The plot visually represents whether OPSUMIT or placebo is favored across these subgroups.*

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Figure 4 (Opsumit 05)

A Kaplan-Meier survival curve comparing the percentage of patients event-free over time between OPSUMIT 10 mg and placebo groups over 36 months. The solid line represents OPSUMIT 10 mg with higher event-free survival, and the dashed line represents placebo. Number of patients at risk is shown below the graph at specific time points.*

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Figure (Opsumit 06)

A Drug Facts style panel titled "Acceptable birth control options" detailing four options. Each option lists various contraceptive methods such as intrauterine devices, hormonal contraceptives (oral, patch, ring, injection), barrier methods like diaphragms and cervical caps with spermicide, male condoms, sterilization procedures including tubal and vasectomy. The panel emphasizes combining methods in some options.*

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Principal Display Panel (10 mg Tablet Bottle Carton)

Packaging label for Opsumit (macitentan) tablets, 10 mg film-coated oral tablets by Actelion Pharmaceuticals US, Inc., a Janssen Pharmaceutical Company. The label indicates a 30-count package with instructions to dispense the accompanying Medication Guide. Storage instructions specify temperature ranges with a note for controlled room temperature. The label includes barcodes and tamper-evident areas.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.