Sirolimus Solution
Product Images NDC 16571-806

Product Visual Gallery

This gallery contains 30 technical images submitted to the FDA as part of the official labeling for Sirolimus (NDC 16571-806). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Rising Pharma Holdings, 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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Table-1.jpg (Table 1)

Table presenting adverse reactions occurring at a frequency of 20% or higher among Sirolimus oral solution treatment groups (2 mg/day and 5 mg/day) compared to placebo in a study of prophylaxis of organ rejection following renal transplantation. The table lists specific adverse reactions and their percentage occurrence in each group.*

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Table-10.jpg (Table 10)

A data table titled 'Graft and Patient Survival (%) for Study 1 (12 and 24 Months) and Study 2 (12 and 36 Months)' comparing graft and patient survival rates across different treatment groups including Sirolimus Oral Solution at 2 mg/day and 5 mg/day, Azathioprine, and Placebo. The table presents survival percentages at various time points (12, 24, and 36 months) for Study 1 and Study 2 cohorts.*

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Table-11.jpg (Table 11)

A data table titled 'Percentage of Efficacy Failure by Race at 6 Months' showing efficacy failure rates in two studies for Black and Non-Black groups. Columns compare Sirolimus Oral Solution at 2 mg/day and 5 mg/day, Azathioprine 2-3 mg/kg/day, and Placebo. The table presents percentages and sample sizes for each category.*

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Table-12.jpg (Table 12)

Data table presenting overall calculated glomerular filtration rates (mean ± SEM, cc/min) for Sirolimus oral solution at 2 mg/day and 5 mg/day, Azathioprine (2-3 mg/kg/day), and placebo across two studies at different time points (months 12, 24, and 36). Sample sizes (n) are included for each group.*

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Table-13.jpg (Table 13)

A data table titled 'Graft and Patient Survival (%): Study 3' comparing survival percentages between 'Sirolimus with Cyclosporine Therapy' and 'Sirolimus Following Cyclosporine Withdrawal' across months 12, 24, and 36 for graft and patient survival, with numerical survival rates listed for each time point and treatment group.*

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Table-14.jpg (Table 14)

A data table presenting values for two groups: 'Sirolimus with Cyclosporine Therapy' and 'Sirolimus Following Cyclosporine Withdrawal,' each with 215 subjects. It lists numerical data across periods including pre-randomization, post-randomization through 12 months, post-randomization from 12 to 36 months, post-randomization through 36 months, and total at 36 months.*

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Table-15.jpg (Table 15)

Data table titled 'Calculated Glomerular Filtration Rates (mL/min) by Nankivell Equation at 12, 24, and 36 Months Post-Transplant: Study 3' comparing Sirolimus with Cyclosporine Therapy and Sirolimus Following Cyclosporine Withdrawal. It presents mean filtration rates with standard error of the mean (SEM) and sample sizes at months 12, 24, and 36 post-transplant for both treatment groups.*

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Table-16.jpg (Table 16)

A data table showing efficacy failure, graft loss or death, and calculated glomerular function rates in mL/min by Nankivell equation at 12 months post-transplant for a group receiving sirolimus with cyclosporine and corticosteroids (n=224). Parameters include efficacy failure (23.2%), graft loss or death (9.8%), and renal function mean ± SEM (52.6 ± 1.6, n=222).*

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Table-17.jpg (Table 17)

A table presenting renal function data in stable renal transplant patients with baseline GFR greater than 40 mL/min, comparing sirolimus conversion (N=496) and CNI continuation (N=245) groups. It shows GFR values at 1 and 2 years with respective numerical results and 95% confidence intervals for the differences, from the Sirolimus Conversion Study (Study 5).*

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Table-18.jpg (Table 18)

A data table titled 'Table 18' presenting mean and median values for urinary protein to creatinine ratio (mg/mg) between two treatment groups, Sirolimus Conversion and CNI Continuation. The table lists values at Baseline, 1 year, and 2 years of the study period, including the number of subjects (N), mean ± standard deviation (SD), median values, and p-values comparing groups in the baseline stratum with calculated GFR >40 mL/min.*

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Table-2.jpg (Table 2)

A data table titled 'Incidence (%) of Malignancies in Study 1 (24 Months) and Study 2 (36 Months) Post-Transplant' showing percentages of various malignancies observed in different treatment groups: Sirolimus Oral Solution at 2 mg/day and 5 mg/day, Azathioprine at 2 to 3 mg/kg/day, and a placebo group. The table details incidence rates of lymphoma/lymphoproliferative disease, types of skin carcinoma (squamous cell, basal cell, melanoma, miscellaneous), total skin carcinoma, and other malignancies across two studies for each group with respective sample sizes.*

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Table-3.jpg (Table 3)

A data table titled 'Incidence (%) of Malignancies in Study 3 (Cyclosporine Withdrawal Study) at 36 Months Post-Transplant,' comparing malignancy rates among three groups: Nonrandomized, Sirolimus with Cyclosporine Therapy, and Sirolimus Following Cyclosporine Withdrawal. The table lists lymphoma/lymphoproliferative disease, various skin carcinomas, total malignancy incidence, and other malignancies as categories with corresponding percentages in each group.*

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Table-4.jpg (Table 4)

A data table comparing pharmacokinetic parameters of Sirolimus solution and tablets after multiple daily doses. Variables include maximum concentration (Cmax), time to maximum concentration (tmax), area under the curve (AUC), minimum concentration (Cmin), and clearance (CL/F) with associated values and standard deviations.*

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Table-5.jpg (Table 5)

A data table presenting sirolimus whole blood trough concentrations observed in renal transplant patients enrolled in Phase 3 studies. It shows mean values and 10th to 90th percentile ranges of sirolimus concentrations (ng/mL) during Year 1 and Year 3 across various patient populations categorized by risk and treatment regimens, including combinations with CsA or sirolimus alone.*

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Table-6.jpg (Table 6)

A data table displaying sirolimus pharmacokinetic parameters including Cmax, tmax, Cmin, AUC, and clearance rates in pediatric renal transplant patients aged 6-11 and 12-18 years. It compares values such as body weight, drug concentration, and clearance metrics for these two age groups.*

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Table-7.jpg (Table 7)

A data table showing sirolimus pharmacokinetic parameters including sample size (n), time to maximum concentration (tmax), half-life (t1/2), and clearance normalized by weight (CL/F/WT) for pediatric patients aged 5-11 and 12-18 years undergoing hemodialysis or peritoneal dialysis after a single dose.*

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Table-8.jpg (Table 8)

Data table titled 'Incidence (%) of Efficacy Failure at 6 and 24 Months for Study 1' comparing three treatment groups: Sirolimus Oral Solution at 2 mg/day, Sirolimus Oral Solution at 5 mg/day, and Azathioprine 2-3 mg/kg/day. The table details percentages of overall efficacy failure and components including biopsy-proven acute rejection, graft loss, death, and loss to follow-up at 6 and 24 months.*

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Table-9.jpg (Table 9)

A data table titled 'Incidence (%) of Efficacy Failure at 6 and 36 Months for Study 2' comparing Sirolimus Oral Solution at 2 mg/day and 5 mg/day doses versus placebo. It presents percent values for overall efficacy failure and components including biopsy-proven acute rejection, graft loss, death, and lost to follow-up at both 6 months and 36 months.*

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Sirolimus-figure.jpg (Sirolimus Figure)

A line graph showing changes in FEV1 (liters) over 24 months comparing Sirolimus oral solution 1 mg/mL to placebo during treatment and observation phases. The graph plots mean FEV1 values with error bars for each group with subject numbers indicated below the x-axis at several time points.*

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Sirolimus1.jpg (Sirolimus1)

An instructional diagram showing components of an oral solution medication kit. It includes a small bottle (a), a dropper or syringe (b), and two long, flexible tubes with attached loops or hooks (c and d), likely used for administration or measurement purposes.*

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Sirolimus2.jpg (Sirolimus2)

An instructional illustration showing a hand grasping a bottle cap and turning it, demonstrating how to open the bottle of Sirolimus oral solution.*

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Sirolimus3.jpg (Sirolimus3)

An instructional illustration showing a hand holding the cap of a small bottle with a dropper or tube inside. A downward arrow next to the hand indicates a pressing or pushing motion onto the bottle.*

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Sirolimus4.jpg (Sirolimus4)

Illustration showing how to use a dropper to measure and dispense liquid medication. The image depicts a hand drawing liquid into a dropper and then inserting the dropper into a medication bottle.*

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Sirolimus5.jpg (Sirolimus5)

An instructional illustration showing a person using a syringe to draw liquid from a small bottle labeled for Sirolimus oral solution. The image includes a magnified view indicating proper alignment or measurement on the syringe, emphasizing correct technique for dosing.*

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Sirolimus6.jpg (Sirolimus6)

An instructional illustration showing a hand holding an oral solution syringe and another hand removing or placing a cap on the syringe tip, demonstrating the proper handling of the dosing device for Sirolimus oral solution.*

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Sirolimus7.jpg (Sirolimus7)

An instructional line drawing showing a hand holding a vial or container being inserted into a box or packaging tray designed to hold it securely in place.*

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Sirolimus8.jpg (Sirolimus8)

An instructional diagram showing a syringe positioned above a cup filled with liquid, with an arrow indicating the syringe drawing liquid from the cup. The image likely demonstrates the preparation or administration step for an oral solution medication.*

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Sirolimusinnercarton.jpg (Sirolimusinnercarton)

The packaging label for Sirolimus Oral Solution 1 mg/mL by Rising Pharma Holdings, Inc. It includes directions to dispense the enclosed Medication Guide and notes that it is for oral use only. The label states the product strength as 1 mg/mL and the bottle size as 60 mL with Rx only designation. Storage instructions specify refrigeration at 2° to 8°C (36° to 46°F) and protection from light.*

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Sirolimusoutercarton.jpg (Sirolimusoutercarton)

Sirolimus Oral Solution 1 mg/mL packaging label for a 60 mL patient kit by Rising Pharma Holdings, Inc. The label includes contents, usage instructions, and storage information. Ingredients mentioned include sirolimus with ethanol, propylene glycol, phosphatidylcholine, and polysorbate 80. The label features step-by-step instructions for use and storage guidelines.*

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Sirolimusstruct.jpg (Sirolimusstruct)

Chemical structure of Sirolimus, showing its complex macrolide lactone ring with multiple hydroxyl, methyl, and ester functional groups.*

* 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.