Imcivree Solution
Product Images NDC 72829-010

Product Visual Gallery

This gallery contains 23 technical images submitted to the FDA as part of the official labeling for Imcivree (NDC 72829-010). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Rhythm Pharmaceuticals, 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-structures (Imcivree 01)

Chemical structure diagram of setmelanotide, the active ingredient in Imcivree. The diagram shows the molecule with amino acid residues, peptide bonds, and functional groups, along with a note indicating association with acetic acid (CH3COOH) where X equals 2 to 4.*

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Figure 2 (Imcivree 02)

Two line graphs showing percent change in body weight over multiple visits, with a highlighted placebo-withdrawal period. The left graph is titled Study 1 (POMC or PCSK1), the right graph is Study 2 (LEPR). Both display a general downward trend in body weight change from baseline (BL) to final visit (FV), with a brief increase during the placebo-withdrawal period around visit 7-8.*

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Figure A (Imcivree 03)

A data table titled Figure A displays dosing information for Imcivree (setmelanotide) 10 mg/mL solution multiple-dose vial. It lists prescribed doses in mg and mL along with the corresponding number of doses per vial, ranging from 0.5 mg (0.05 mL) with 20 doses to 3 mg (0.3 mL) with 3 doses per vial.*

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Figure B (Imcivree 04)

An instructional diagram labeled Figure B showing supplies needed for injection: a vial with a plastic cap and rubber stopper, two alcohol wipes, a 1 mL syringe with a 28- or 29-gauge needle detailing its parts (plunger, barrel, needle, black rubber stopper, protective needle cap), a gauze pad, and a sharps container.*

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Figure C (Imcivree 05)

An instructional illustration labeled Figure C showing a vial with a close-up inset highlighting the bottom area of the vial, possibly to show a detail or feature of the vial appearance or contents. The vial appears to be intended for injectable solution.*

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Figure D (Imcivree 06)

An instructional diagram labeled "Figure D" showing a hand with arrows indicating a rolling or massaging motion using the thumb over the back of the other hand. The image appears to demonstrate a manual technique, possibly related to application or preparation of a subcutaneous solution.*

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Figure E (Imcivree 07)

An instructional illustration showing a close-up of hands opening or removing the cap from a small vial, likely part of a medication preparation or administration process.*

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Figure F (Imcivree 08)

An instructional illustration labeled Figure F showing a vial with a flip-off cap and a square alcohol prep pad positioned with an arrow indicating the action of wiping or cleaning the vial's rubber stopper prior to use.*

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Figure G (Imcivree 09)

An instructional illustration showing syringes filled with different volumes of solution corresponding to doses of 0.5 mg, 1 mg, 1.5 mg, 2 mg, and 3 mg. Each syringe has a magnified view highlighting the measurement markings for precise dosing.*

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Figure H (Imcivree 10)

Illustration labeled Figure H showing a syringe with measurement markings. The diagram includes arrows indicating the direction of plunger movement, likely demonstrating how to use or prepare the syringe for injection.*

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Figure I (Imcivree 11)

An instructional illustration labeled Figure I showing a hand drawing liquid from a vial into a syringe. The image is part of usage instructions for a subcutaneous solution product.*

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Figure J (Imcivree 12)

An instructional diagram titled Figure J showing hands preparing a subcutaneous injection using a syringe and vial. The illustration emphasizes drawing solution from the vial into the syringe, with a close-up inset highlighting the vial's stopper.*

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Figure K (Imcivree 13)

An illustration labeled Figure K showing two syringes with different sized air bubbles. One syringe has small air bubbles and the other has large air bubbles, highlighting the difference in bubble size within the syringes.*

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Figure L (Imcivree 14)

An instructional illustration labeled Figure L depicts a hand using a syringe to withdraw solution from a vial. The image shows one hand holding the vial steady and the other hand pulling the syringe plunger to draw liquid from the vial, indicating a subcutaneous injection preparation step.*

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Figure M (Imcivree 15)

An illustration labeled Figure M showing a center reference scale with a labeled length of 2 inches, seemingly part of a calibration or sizing guide within a larger instructional diagram.*

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Figure N (Imcivree 16)

An illustration labeled 'Figure N' showing the back of the upper legs and buttocks of a seated person, highlighting two shaded areas on the outer upper thighs indicative of possible injection sites for a subcutaneous solution.*

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Figure O (Imcivree 17)

Illustration labeled Figure O showing the upper arm of a person with a shaded rectangular area on the outer side, indicating a site for subcutaneous injection.*

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Figure P (Imcivree 18)

An instructional illustration labeled "Figure P" depicting a hand pinching a fold of skin, likely demonstrating a technique for subcutaneous injection administration.*

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Figure Q (Imcivree 19)

An instructional illustration titled 'Figure Q,' showing a hand holding a syringe at a 90-degree angle as part of a subcutaneous injection technique.*

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Figure R (Imcivree 20)

Instructional illustration labeled Figure R shows a person administering a subcutaneous injection, demonstrating the proper technique for injecting the solution, likely of Imcivree (setmelanotide) 10 mg/mL, into the abdominal area.*

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Figure S (Imcivree 21)

An instructional illustration labeled 'Figure S' showing a hand using a dosing device or applicator to insert or handle an object into a container with an open lid.*

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Carton Label (Imcivree 22)

Imcivree 10 mg/mL (setmelanotide) injection packaging label for subcutaneous use, distributed by Rhythm Pharmaceuticals, Inc. The label states it is a 1 mL multiple-dose vial for single-patient use. It includes storage instructions to protect from light, avoid freezing, and refrigerate unopened vials at 2°C to 8°C. The label lists inactive ingredients like MPEG-2000-DSPE and mannitol, and notes the vial should be discarded 30 days after first opening or if stored above 30°C. Recommended dosage and administration refer to prescribing information.*

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Vial Label (Imcivree 23)

Label for Imcivree (setmelanotide) injection, 10 mg/mL solution for subcutaneous use. The label includes the NDC 72829-010-01 and shows it is manufactured by Rhythm Pharmaceuticals, Inc, Boston, MA. It also has spaces for lot number and expiration date.*

* 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.