Tofacitinib Solution
Product Images NDC 71656-071

Product Visual Gallery

This gallery contains 20 technical images submitted to the FDA as part of the official labeling for Tofacitinib (NDC 71656-071). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Saptalis Pharmaceuticals, Llc., 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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Structure (Structure)

Chemical structure diagram of Tofacitinib citrate, showing the molecular arrangement of Tofacitinib along with its citrate molecule as part of the compound.*

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Fig-1 (Figure 1)

A forest plot chart showing the pharmacokinetic (PK) ratios and 90% confidence intervals (CI) of Tofacitinib solution 1 mg/mL across various intrinsic factors such as weight, age, sex, race, and levels of renal and hepatic impairment. The chart compares area under the curve (AUC) and maximum concentration (Cmax) ratios relative to a reference, illustrating variability in drug exposure.*

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Fig-2 (Figure 2)

A chart showing the pharmacokinetic (PK) ratios and 90% confidence intervals for area under the curve (AUC) and maximum concentration (Cmax) of various coadministered drugs relative to reference values. The drugs include Methotrexate, CYP3A substrate Midazolam, oral contraceptives Levonorgestrel and Ethinyl Estradiol, and OCT & MATE substrate Metformin. The x-axis displays the ratio relative to reference from 0 to 2, with data points and error bars illustrating variability.*

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Fig-3 (Figure 3)

A scatter plot showing pharmacokinetic ratios and 90% confidence intervals for coadministered drugs with Tofacitinib. The x-axis represents the ratio relative to reference, ranging from 0 to 2.5. The y-axis lists drugs including CYP3A inhibitor Ketoconazole, CYP3A & CYP2C19 inhibitor Fluconazole, CYP inducer Rifampin, Methotrexate, Tacrolimus, and Cyclosporine, with two measures (AUC and Cmax) depicted for each.*

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Fig-5 (Figure 5)

A line graph showing response rate (%) over a 3-month visit period for two groups: Tofacitinib 5 mg BID and Placebo. The X-axis represents visit months (0, 0.5, 1, 2, 3) and the Y-axis shows response rate percentage with error bars indicating standard error (SE). The Tofacitinib group shows a higher response rate throughout compared to Placebo.*

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Fig-7 (Figure 7)

A line graph comparing the occurrence of disease flares (%) over time from Week 18 to Week 44 for Tofacitinib 5 mg BID versus placebo. The vertical axis shows the percentage occurrence with standard error bars, and the horizontal axis displays the weeks. Two lines represent groups: one for Tofacitinib (lower curve) and one for placebo (higher curve), showing lower disease flare percentages in the Tofacitinib group, with a noted p-value of 0.0007 at Week 44.*

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11 (Instrustions For Use 1)

An instructional illustration showing components of an oral dosing system for Tofacitinib solution. The diagram labels a bottle with a press-in bottle adapter featuring ribs, and an oral dosing syringe consisting of a barrel and plunger, demonstrating assembly and dosing parts.*

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111 (Step 1)

An instructional illustration demonstrating Step 1 for Tofacitinib oral solution, which involves removing the bottle from the carton. The image shows hands opening the carton flaps and lifting the bottle upward out of the carton.*

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222 (Step 2)

An instructional illustration labeled Step 2 showing how to open a medication bottle. It features two hands: one holding the bottle and the other pressing down on the cap while twisting it to open.*

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333 (Step 3)

Instructional illustration showing Step 3 for use of a liquid medication bottle: inserting a press-in bottle adapter. The left part depicts a hand holding a small black adapter above an open bottle, and the right part shows hands pressing the adapter into the bottle opening.*

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444 (Step 4)

Instructional illustration showing Step 4: removing air from an oral dosing syringe. The image depicts a hand holding the syringe and pressing to expel air before dosing.*

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555 (Step 5)

An instructional illustration showing Step 5 for using Tofacitinib oral solution. It depicts a hand holding a small bottle of the solution while inserting an oral dosing syringe into the bottle cap, indicated by a downward arrow. This image guides proper syringe insertion into the bottle.*

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666 (Step 6)

Illustration showing Step 6 of medication administration for Tofacitinib oral solution, depicting a hand withdrawing a dose from a bottle using a syringe. The image demonstrates how to draw the medication into the syringe for dosing.*

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777 (Step 7)

An instructional illustration showing a hand holding a medication bottle from which an oral dosing syringe is being removed, indicating the step to remove the syringe after dosing.*

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888 (Step 8)

An instructional illustration showing a hand holding a syringe filled with liquid. A magnified inset highlights the syringe's dose marking, emphasizing the importance of checking the dose before administration. The step is labeled 'Step 8. Check the dose.'*

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999 (Step 9)

An instructional illustration showing a person taking a dose of tofacitinib oral solution using a dosing syringe. The syringe is positioned in the person's mouth, indicating the method of oral administration.*

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1010 (Step 10)

Instructional illustration labeled Step 10 showing three steps: pressing down on a bottle cap to close it, placing the closed bottle into a carton, and folding the carton flaps to close the carton.*

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1111 (Step 11)

Instructional illustration labeled Step 11, showing how to clean an oral dosing syringe by drawing water into the syringe and then expelling the water to rinse it under running water.*

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Container (Container Label)

Tofacitinib Oral Solution 1 mg/mL in a 240 mL bottle, labeled for oral use and distributed by Saptalis Pharmaceuticals, LLC. The label includes instructions to dispense the Medication Guide to patients, storage conditions, and a barcode. The product NDC is 71656-071-08.*

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Ifc (Ifc)

Packaging label for Tofacitinib Oral Solution 1 mg/mL, an oral liquid dosage form. The label includes the proprietary name Tofacitinib, strength, and instructions to dispense the Medication Guide to each patient. It indicates a 240 mL bottle size and states the product is Rx only. The labeler is Saptalis Pharmaceuticals, LLC. Additional product details include storage instructions and contents such as an oral dosing syringe, press-in bottle adapter, and Medication Guide.*

* 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.