Yorvipath Injection, Solution
Product Images NDC 73362-101

Product Visual Gallery

This gallery contains 57 technical images submitted to the FDA as part of the official labeling for Yorvipath (NDC 73362-101). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Ascendis Pharma, Endocrinology, 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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Figure 1 (Yorvipath 01)

This text provides guidance on adjusting calcium supplements, active vitamin D, and YORVIPATH dosages based on specific scenarios. It suggests increasing calcium and vitamin D towards prior doses if YORVIPATH dose has been altered. If the answer is YES, calcium and vitamin D doses should remain the same while increasing YORVIPATH dose by 3 meg.*

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Figure 1 (Yorvipath 02)

This text appears to be discussing a medication called YORVIPATH and advises on dosage adjustments such as continuing the same dose, taking calcium supplements, and increasing YORVIPATH. It mentions decreasing or discontinuing calcium supplements while increasing YORVIPATH by a specific amount. It also refers to active vitamin D and provides different options for adjusting the dosage based on the individual's situation.*

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Figure 1 (Yorvipath 03)

This text appears to be discussing guidelines for taking vitamin D and calcium supplements. It mentions potential actions to take based on the status of the supplements. These actions could include decreasing, discontinuing or continuing the supplements at existing doses. The instructions seem to be provided based on whether the individual is still taking active vitamin D or calcium supplements. These guidelines may help in managing the intake of these supplements effectively.*

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Figure 2 (Yorvipath 04)

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Figure 3 (Yorvipath 05)

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Figure 4 (Yorvipath 06)

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Image (Yorvipath 07)

This is a set of instructions for using Yorvipath (palopegteriparatide) injection, specifically highlighting details on how to administer the specified dosage of 168 mcg/0.56 ml prefilled pen. The instructions are intended for subcutaneous use and provide guidance for 6, 9, or 12 microgram doses only.*

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Image (Yorvipath 08)

This text provides contact information for the Ascendis Pharma Helpline, including a toll-free telephone number: 1-844-442-7236. It also includes the address for Ascendis Pharma Bone Diseases A/S in Denmark. If in need of assistance, individuals can reach out to their healthcare provider or nurse for advice.*

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Image (Yorvipath 09)

This information provides troubleshooting tips for using a pen for injecting medicine. It includes instructions on testing the pen flow, changing the needle if necessary, completing the injection correctly, reasons for holding the pen in the skin for 5 seconds, and what to do if you cannot dial the required dose. Additionally, it explains that if the dose is larger than the remaining medicine in the pen, a new pen should be used to administer the full dose. Remember that each box contains an extra needle for use.*

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Image (Yorvipath 10)

This is a set of instructions for storing and handling a pen medication called YORVIPATH. The text advises refrigerating the pen before first use, storing it at room temperature after first use, avoiding extreme temperatures, not freezing the pen, keeping it away from heat sources, and out of reach of children. It also includes a tip to take out a new pen from the refrigerator 20 minutes before use to allow the medicine to come to room temperature before injecting.*

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Image (Yorvipath 11)

This text provides guidance on how to care for your pen properly. It emphasizes handling the pen with care, keeping it dry, cleaning it with a soft cloth, avoiding dropping or hitting it on hard surfaces, not applying extra force, and not attempting to repair a damaged pen on your own. In case of damage, it is advised to contact the Ascendis Pharma Helpline for assistance.*

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Image (Yorvipath 12)

This text provides important information on how to use the YORVIPATH Pen for hypoparathyroidism treatment. It includes instructions on how to correctly inject the medication into the belly or thigh, the dosage options, frequency of use, and safety precautions such as storing the pen out of reach of children. It also emphasizes the importance of receiving training from a healthcare provider or nurse before using the pen to ensure proper treatment administration.*

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Image (Yorvipath 13)

This text provides essential instructions for the proper use and care of a pen for injections. It emphasizes the importance of using the pen and needles only as directed by a healthcare provider, avoiding sharing needles to prevent infection, checking expiration dates, visually inspecting the pen for damage, using a new needle for each injection, injecting into specific areas of the body, keeping the pen capped when not in use, removing the needle after each use, and discarding the pen after 14 days. Following these instructions is crucial for ensuring the correct dosage and effectiveness of the medicine while avoiding potential risks and complications.*

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Image (Yorvipath 14)

This is a set of compatible pen needles for use with YORVIPATH pre-filled pens. Each box contains 15 disposable Clickfine AutoProtect Needles. The text also provides guidance on correct disposal of used needles and pens, emphasizing the need for proper sharps disposal containers and following community guidelines for safe disposal. For more information on safe disposal practices and specific regulations in your state, you can visit the FDA's website.*

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Image (Yorvipath 15)

This text appears to be a parts overview for a medical device. The parts mentioned include a dose selector, pen cap, inspection pen, dose window, and single-use components. The text also indicates that there is no medicine inside the needle. Additionally, it suggests that other items may be needed, such as alcohol wipes.*

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Image (Yorvipath 16)

This text provides step-by-step instructions on how to prepare a pen and needle for use. It includes details such as washing hands before using the pen, ensuring the needle is not expired, and how to attach the needle securely to the pen. Additionally, it emphasizes the importance of cleanliness and handling the needle cover properly.*

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Image (Yorvipath 17)

This is a set of instructions for using a new pen for injecting medicine. It involves steps like setting the dose selector, making sure there are no air bubbles in the pen, pressing the push button to administer medicine, and checking for drops coming out of the needle. The text emphasizes the correct handling and usage of the pen for medicine administration.*

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Image (Yorvipath 18)

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Image (Yorvipath 19)

This text provides instructions for preparing an injection and selecting the correct dose. It advises on choosing different injection sites each time, avoiding areas that are red, swollen, or sore. It also mentions the importance of washing hands and cleaning the injection site with an alcohol wipe. The text emphasizes following the prescribed dose by a healthcare provider and demonstrates how to set the dosage accordingly.*

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Image (Yorvipath 20)

This text appears to provide instructions for using an injection device. It includes steps for preparing and administering a dose of medication using a pen-like device. The instructions involve inserting the needle, pushing the pen towards the skin, pressing a button, and ensuring the correct dose is administered. Additionally, it mentions symbols and figures to reference during the process.*

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Image (Yorvipath 21)

This text provides steps for safely disposing of a used needle. Step 13 instructs to unscrew and safely throw away the needle in accordance with regulations. Step 14 guides on how to attach a new needle tip to the pen for injection. Following these steps is crucial for safe medical practices.*

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Image (Yorvipath 22)

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Image (Yorvipath 23)

This is an instruction manual for using Yorvipath® (palopegteriparatide) injection for subcutaneous use. It provides details on how to properly administer the YORVIPATH prefilled pen which contains 294 mcg/0.98 mL (300 mcg/ml) for doses of 15, 18, or 21 megs.*

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Image (Yorvipath 24)

This text provides additional information on how to contact Ascendis Pharma for assistance. You can reach out to your health care provider, nurse, or contact the Ascendis Pharma Helpline at 1-844-442-7236. The helpline is based in Denmark and is associated with Ascendis Pharma Bone Diseases A/S located at Tuborg Boulevard 12, DK-2900 Hellerup.*

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Image (Yorvipath 25)

This is a troubleshooting guide for using a pen injector for administering medicine. It provides information on testing pen flow, troubleshooting issues with flow, completing the injection correctly, holding the pen in the skin, dosing requirements, and handling the needle cover. The guide offers step-by-step instructions to ensure the proper functioning of the pen injector for accurate medicine delivery.*

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Image (Yorvipath 26)

This text provides guidance on storing and handling medication pens, emphasizing refrigeration after first use and keeping the pen away from extreme temperatures. It also mentions not freezing the pen and storing it away from heat sources. Additionally, it suggests taking a new pen out of the refrigerator 20 minutes before use to allow the medicine to reach room temperature before injecting. Overall, this is a set of instructions to maintain the effectiveness of the medication pen and ensure safe use.*

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Image (Yorvipath 27)

This is a set of instructions on how to care for your pen properly. It advises handling the pen carefully, keeping it dry, cleaning it with a moist cloth, avoiding dropping or knocking the pen against hard surfaces, not applying extra force, testing the pen flow if dropped, and contacting Ascendis Pharma Helpline if the pen is damaged and needs repair.*

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Image (Yorvipath 28)

This text provides important information on using the YORVIPATH Pen for the daily treatment of hypoparathyroidism. It includes instructions on injecting the medication, ensuring correct dosages, and seeking help if needed. Users are advised on proper storage and disposal of the pre-filled disposable pen. It emphasizes the necessity of receiving training from a healthcare provider before use and contacting them or the manufacturer's helpline for assistance if needed.*

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Image (Yorvipath 29)

This is a set of instructions for the proper use and care of a pen and needle for injections. The guidelines include checking expiration dates, visual inspection of the pen, using a new needle for each injection, injecting into specific areas as directed, storing the pen with the cap on, removing the needle after each use, and disposing of the pen after 14 days. Not following these instructions could affect the efficacy of the medicine. Additional warnings include avoiding bending or breaking the needle, and seeking immediate medical help if a broken needle remains stuck in the body.*

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Image (Yorvipath 30)

This text provides information on the use and disposal of compatible pen needles for the YORVIPATH prefilled pen. It outlines the need for correct disposal of used needles in FDA-cleared sharps disposal containers and offers guidance on selecting appropriate containers for safe disposal. It also emphasizes not disposing of YORVIPATH in household trash and highlights the importance of following community guidelines for proper disposal of sharps containers when full. For more detailed information on safe sharps disposal, individuals are directed to visit the FDA's website provided.*

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Image (Yorvipath 31)

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Image (Yorvipath 32)

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Image (Yorvipath 33)

This text appears to be instructions for testing the flow of a new pen for medicine administration. It includes steps such as testing the pen flow, making bubbles go to the top of the pen, pressing the push button to release medicine drops, and checking if the drops are visible. There are also notes about correcting the selection, ensuring the dosage selector rotates correctly, and changing the needle if drops are not seen.*

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Image (Yorvipath 34)

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Image (Yorvipath 35)

This text provides instructions on how to properly prepare for and administer injections, including selecting the correct dose as prescribed by a healthcare provider. It emphasizes the importance of avoiding certain regions of the body for injections and being careful not to press the button while selecting the dose. Additionally, it suggests discarding the pen after use and using a new one for each dose.*

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Image (Yorvipath 36)

This text appears to provide instructions for using a specific type of pen or device. It mentions placing the pen in a particular position, ensuring the correct dosage window is selected, and describes how the device automatically locks around the neck of the pen. Additionally, there may be figures or illustrations accompanying the instructions for further clarity.*

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Image (Yorvipath 37)

This text provides instructions such as throwing away used needles, clicking the pen cap firmly, and protecting the pen between uses. It also mentions protecting the pen to prevent damage and covers basic pen usage guidelines.*

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Image (Yorvipath 38)

This document provides guidelines for discarding a used pen after 14 days of use. It emphasizes the importance of adhering to regulations and ensuring the effectiveness of medication delivery.*

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Image (Yorvipath 39)

This is an Instruction Manual for Yorvipath (palopegteriparatide) injection, designed for subcutaneous use. The manual provides details on administering Yorvipath using the 420 mcg/1.4mL prefilled pen for 24, 27 or 30 mcg doses only.*

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Image (Yorvipath 40)

This text provides additional information for individuals seeking help regarding health-related concerns. It includes contact details for the Ascendis Pharma Helpline, a toll-free telephone number (1-844-442-7236), and the company's address located in Denmark. If further clarification is needed, individuals are encouraged to reach out to their healthcare provider or nurse for advice.*

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Image (Yorvipath 41)

This is a troubleshooting guide for using a pen for injections. It provides information on testing the pen flow, what to do if drops do not appear, how to know when the injection is completed, why one should hold the pen in the skin for a few seconds, and what to do if the pen does not allow the desired dose to be set. Additionally, it advises on how to handle situations where the red lock covers the needle before starting the injection.*

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Image (Yorvipath 42)

This text provides instructions for storing your pen, particularly focusing on temperature conditions to maintain its efficacy. It recommends refrigerating the pen between 2°C to 8°C before first use and then storing it at room temperature below 30°C for up to 14 days. It cautions against leaving the pen in places that are too hot or too cold, emphasizing not to freeze the pen. Additionally, it suggests keeping the pen away from heat sources and out of reach of children. A useful tip included is to take a new pen out of the refrigerator 20 minutes before first use to allow the medicine to reach room temperature for injection.*

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Image (Yorvipath 43)

The text provides care instructions for maintaining your pen. It emphasizes handling the pen with care, storing it properly, using a moist cloth for cleaning, avoiding dropping or knocking it against hard surfaces. Additionally, it advises against applying excessive force to the pen and warns against attempting to repair a damaged pen oneself. Instead, it suggests reaching out to Ascendis Pharma Helpine for assistance. The text focuses on preventing damage to ensure the pen works properly.*

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Image (Yorvipath 44)

This text is providing important information about using the YORVIPATH Pen for injections under the skin for the treatment of hypoparathyroidism. It emphasizes following the instructions carefully, ensuring proper training before use, administering the correct dose, and seeking help if needed. The pen delivers doses of 24, 27, or 30 mcg and is pre-filled for 14 days of use, with a once-daily dosage. It is recommended to inject into the belly or thigh. Additionally, it cautions against using the pen without proper assistance if visually impaired or lacking concentration, and storing the pen safely away from children or unauthorized users.*

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Image (Yorvipath 45)

This text provides essential instructions for using a medical pen for injections. It emphasizes the importance of proper handling, storage, and disposal of the pen and needles to prevent infection and ensure the effectiveness of the medication. Users are advised on checking expiration dates, inspecting the pen for damage, using a new needle for each injection, injecting in specific areas as directed, and discarding the pen after 14 days. Additionally, precautions like avoiding bending or breaking the needle are highlighted to prevent potential health risks.*

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Image (Yorvipath 46)

This text provides information about compatible pen needles for YORVIPATH prefilled pens, along with instructions for correct disposal of used needles in a sharps container. It emphasizes the importance of proper disposal to ensure safety and prevent hazards. The text also highlights the features of an FDA-approved sharps disposal container, including durability, puncture resistance, leak resistance, and proper labeling for hazardous waste. Additionally, it mentions the necessity of following community guidelines for disposing of sharps containers and directs readers to the FDA website for more information on safe sharps disposal practices.*

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Image (Yorvipath 47)

Parts Overview: This text appears to be a list of items related to medical dosages and supplies. It mentions topics like "Parts Overview," "Oral Doses," "Need," and items that are required with medication administration such as alcohol wipes. Information regarding medicine dosage and consumables such as alcohol wipes are provided.*

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Image (Yorvipath 48)

This text provides instructions for preparing a pen and needle for use with YORVIATH medication. It outlines steps such as checking the pen before use, removing the pen cap and checking the medicine inside, attaching the needle to the pen securely, and removing the needle cover. Important reminders are given regarding the single-use nature of the needle and the need to avoid contaminating the needle to prevent issues with its use.*

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Image (Yorvipath 49)

Description: The text appears to be instructions on how to use a new pen for testing pen flow. It includes steps such as turning the dose selector clockwise, making sure the drop is visible in the dose window, and pressing the push button to release drops of medicine from the needle. The text emphasizes the importance of checking for drops and adjusting if necessary. It also provides guidance on inspecting the pen and changing the needle. Instructions seem detailed and precise.*

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Image (Yorvipath 50)

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Image (Yorvipath 51)

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Image (Yorvipath 52)

This document provides step-by-step instructions on how to use a pen device for a certain procedure. It includes guidance on how to hold the pen, push buttons, and rotate selectors. It also mentions specific actions to perform, such as pushing the pen straight forward and pressing buttons for a certain number of seconds. Following these instructions will help in effectively and accurately using the pen device.*

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Image (Yorvipath 53)

Not available.*

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Image (Yorvipath 54)

This text discusses the importance of throwing away used pens after 14 days of use, especially when handling medication. It emphasizes the need to consistently dispose of pens and needles to ensure proper hygiene and prevent contamination.*

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Principal Display Panel (168 mcg/0.56 mL Pen Carton)

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Principal Display Panel (294 mcg/0.98 mL Pen Carton)

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Principal Display Panel (420 mcg/1.4 mL Pen Carton)

This text contains information about Yorvipathe (palopegteriparatide) for injection in prefilled pens of various doses. It includes instructions for subcutaneous use, storage, and disposal. The medication is indicated for single patient use only. The text also mentions the importance of following enclosed instructions for use, refrigeration, room temperature storage after first use, and disposing of the pen after 14 days of use. Additionally, it includes a GTIN code, lot number, expiration date, and a description of the package contents.*

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