Cligavyx Injection
Product Images NDC 83831-159

Product Visual Gallery

This gallery contains 19 technical images submitted to the FDA as part of the official labeling for Cligavyx (NDC 83831-159). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Avyxa Pharma, 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.

FDA Label Image

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An instructional illustration showing how to use a syringe to remove a cap. The diagram labels parts of a medication vial cap: A is the outer cap, B is the inner seal, and C is the locking ring. A hand is shown gripping and twisting the syringe component in a counterclockwise motion to access the vial.*

FDA Label Image

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An instructional diagram showing assembly steps for the CLIGAVYX injection device. It depicts a hand removing a cap from a syringe and labels three parts of the injection assembly: A, the upper gray cap; B, a middle connector; and C, the lower transparent base.*

FDA Label Image

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An instructional illustration showing two gloved hands drawing medication from a vial into a syringe, demonstrating proper preparation technique for an injection.*

FDA Label Image

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Instructional illustration showing a syringe with a needle attached, including a close-up of the needle tip. The image likely relates to the preparation or administration of the CLIGAVYX injection (fulvestrant 250 mg/5mL) by intramuscular route.*

FDA Label Image

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An instructional illustration depicting a gloved hand holding a syringe, with an arrow indicating a twisting or turning motion at the syringe's top, likely showing how to prepare or adjust the syringe for injection.*

FDA Label Image

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Chemical structure of fulvestrant, the active ingredient in CLIGAVYX injection 250 mg/5 mL by Avyxa Pharma, LLC. The structure shows a steroid backbone with hydroxyl groups and a side chain containing sulfonyl and trifluoromethyl groups.*

FDA Label Image

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A Kaplan-Meier survival curve chart displaying progression-free survival over time in months for patients treated with fulvestrant 250 mg and 500 mg. The y-axis shows the proportion of patients progression-free, ranging from 0 to 1, and the x-axis represents time up to 45 months. The chart includes a table below indicating the number of patients at risk at various time points for each dose group.*

FDA Label Image

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A survival curve chart depicting the proportion of patients alive over time in months for fulvestrant at two doses: 250 mg and 500 mg. The x-axis represents time from 0 to 80 months, and the y-axis shows the proportion of patients alive from 0.0 to 1.0. The chart includes two lines indicating survival trends for each dose with a table below listing the number of patients at risk at various monthly intervals.*

FDA Label Image

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A survival probability Kaplan-Meier curve graph showing time from randomization (in months) on the x-axis and probability of progression-free survival (PFS) on the y-axis. The graph compares two treatments: Fulvestrant 500 mg and Anastrozole 1 mg, with patient numbers at risk indicated below the x-axis at specific time points.*

FDA Label Image

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A Kaplan-Meier survival curve chart showing progression-free survival probability (%) over time in months. It compares two groups: one treated with Fulvestrant plus palbociclib and the other with Fulvestrant plus placebo. A table below the graph indicates the number of patients at risk at various time points for each group.*

FDA Label Image

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A Kaplan-Meier survival curve chart comparing overall survival probability (%) over time in months for two groups: one receiving fulvestrant plus palbociclib and the other fulvestrant plus placebo. The chart includes a legend and patient numbers at risk below the x-axis at specified time points.*

FDA Label Image

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A Kaplan-Meier survival curve showing progression-free survival probability (%) over time (months) for two treatment groups: Fulvestrant plus Abemaciclib (N=446) and Fulvestrant plus Placebo (N=223). The graph includes censored observations and a table of patients at risk at various time points.*

FDA Label Image

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A survival probability chart displaying the percentage of patients surviving over time in months. The graph compares two groups: those treated with fulvestrant plus abemaciclib, and those treated with fulvestrant plus placebo, including censored observations for both groups.*

FDA Label Image

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A Kaplan-Meier survival curve chart comparing event-free probability over time (in months) between two patient groups: those treated with Fulvestrant plus Ribociclib and those treated with Fulvestrant plus Placebo. The chart includes censorship points and a table of patients at risk at different time intervals up to 24 months.*

FDA Label Image

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A Kaplan-Meier survival curve chart showing event-free probability over time (months) for two groups: Fulvestrant+Ribociclib (N=484) and Fulvestrant+Placebo (N=242). The chart includes censoring times indicated by symbols, and a table below lists the number of patients still at risk at various time points up to 48 months.*

FDA Label Image

Cligavyx (fulvestrant) Injection -container Label (826737bb 198c 49c2 A9dc 9bacd848550f 16)

CLIGAVYX (fulvestrant) Injection 250 mg/5 mL (50 mg/mL) label showing a prefilled syringe for intramuscular use. The label includes storage instructions to refrigerate and protect from light. Manufactured for Avyxa Pharma, LLC, with lot and expiration date fields and barcode present.*

FDA Label Image

Cligavyx (fulvestrant) Injection -carton Label (826737bb 198c 49c2 A9dc 9bacd848550f 17)

Label for CLIGAVYX (fulvestrant) Injection 250 mg/5 mL (50 mg/mL) by Avyxa Pharma, LLC. The carton contains two single-dose prefilled syringes for intramuscular use totaling 500 mg. Storage instructions specify refrigeration at 2°C to 8°C (36°F to 46°F) and protection from light. The label includes usage instructions, warnings, and manufacturer information.*

FDA Label Image

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FDA Label Image

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* 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.