ELUCIREM gadopiclenol 485.1 mg/mL Injection, 1 syringe

1 INDICATIONS AND USAGE ELUCIREM is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: the central nervous system (brain, spine, and associated tissues), the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system). ELUCIREM is a gadolinium-based contrast agent indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: the central nervous system (brain, spine, and associated tissues), the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).

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2 DOSAGE AND ADMINISTRATION The recommended dose for adult and pediatric patients, including term neonates, is 0.05 mmol/kg actual body weight (equivalent to 0.1 mL/kg) administered intravenously at approximately 2 mL/sec. ( 2.1 )

2.1Recommended Dosage The recommended dose of ELUCIREM for adult and pediatric patients, including term neonates, is 0.05 mmol/kg actual body weight (equivalent to 0.1 mL/kg) administered intravenously at approximately 2 mL/sec.

2.2Administration and Imaging Instructions Administer ELUCIREM as an intravenous bolus injection, manually or by compatible power injector, at approximately 2 mL/sec followed by a flush of 0.9% sodium chloride injection. For pediatric patients, adjust the flow rate and flush volume based on age. Use aseptic technique for all handling and administration of ELUCIREM.

Visually inspect ELUCIREM for particulate matter and discoloration prior to administration. Do not use the solution if any particulate matter is present or the solution is discolored. Do not mix with other medications because of the potential for chemical incompatibility.

Prime intravenous line before use. Contrast MRI can begin immediately following the injection of ELUCIREM.

2.3Directions for Use of Single-Dose Vial and Pre-filled Syringe Vial Pierce the rubber stopper only once. Aseptically draw up ELUCIREM into a disposable syringe and use immediately. If solidification occurs in the vial due to cold exposure, bring the vial of ELUCIREM to room temperature before use and inspect to ensure that the solution is clear and colorless to yellow without any particulate matter or discoloration.

Discard any unused portion. Pre-filled syringe Remove the tip cap of the syringe, screw the plunger rod and use immediately. All luer connections should be gently hand tightened without over tightening, to ensure secure connections and to prevent damage to the device.

Pre-filled syringes must not be frozen. Frozen pre-filled syringes of ELUCIREM should be discarded. Discard any unused portion.

2.4Directions for Use of Pharmacy Bulk Package ELUCIREM Pharmacy Bulk Package (PBP) is not for direct infusion. Perform the transfer of ELUCIREM from the PBP in an aseptic work area, such as laminar flow hood, using aseptic technique and suitable transfer device for filling empty sterile syringes. Penetrate the closure only one time.

Once the container closure is punctured, do not remove the PBP from the aseptic work area. Use each individual dose of ELUCIREM promptly following withdrawal from the PBP. Use the contents of the PBP within 24 hours at room temperature after puncture.

If solidification occurs in the PBP due to cold exposure, bring the PBP of ELUCIREM to room temperature before use and inspect to ensure that the solution is clear and colorless to yellow without any particulate matter or discoloration.

2.5Directions for Use of Imaging Bulk Package ELUCIREM Imaging Bulk Package (IBP) is not for direct infusion. The IBP is for use only with an automated contrast injection system, contrast management system, or contrast media transfer set approved or cleared for use with this contrast agent in this IBP. This allows for the administration of multiple single doses of ELUCIREM to multiple patients.

See drug and device labeling for information on devices indicated for use with this IBP and techniques to help assure safe use. The ELUCIREM IBP is to be used only in a room designated for performing radiological procedures that involve administration of a contrast agent. Utilize aseptic technique for penetrating the container closure of the IBP and transferring ELUCIREM.

Penetrate the container closure only one time with a suitable sterile component of the automated contrast injection system, contrast management system, or contrast media transfer set (e.g., transfer spike) approved or cleared for use with this IBP. During the entire period of use, ensure that the contents of the ELUCIREM IBP container remain in continuous contact with…

3 DOSAGE FORMS AND STRENGTHS Injection: 0.5 mmol/mL of gadopiclenol as a clear, colorless to yellow aqueous solution available as: Strength Packaging 1.5 mmol/3 mL (0.5 mmol/mL) 3.75 mmol/7.5 mL (0.5 mmol/mL) 5 mmol/10 mL (0.5 mmol/mL) 7.5 mmol/15 mL (0.5 mmol/mL) Single-dose vials (glass) 3.75 mmol/7.5 mL (0.5 mmol/mL) 5 mmol/10 mL (0.5 mmol/mL) 7.5 mmol/15 mL (0.5 mmol/mL) Single-dose prefilled syringes (plastic) 15 mmol/30 mL (0.5 mmol/mL) 25 mmol/50 mL (0.5 mmol/mL) 50 mmol/100 mL (0.5 mmol/mL) Pharmacy bulk package (glass) 15 mmol/30 mL (0.5 mmol/mL) 25 mmol/50 mL (0.5 mmol/mL) 50 mmol/100 mL (0.5 mmol/mL) Imaging Bulk Package (glass) Injection: 0.5 mmol/mL of gadopiclenol in single-dose vials, single-dose prefilled syringes, pharmacy bulk packages, and imaging bulk packages ( 3 )

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Nephrogenic Systemic Fibrosis Inform the patient that ELUCIREM may increase the risk for NSF among patients with impaired elimination of the drugs and that NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs. Instruct the patients to contact their physician if they develop signs or symptoms of NSF following ELUCIREM administration, such as burning, itching, swelling, scaling, hardening and tightening of the skin; red or dark patches on the skin; stiffness in joints with trouble moving, bending or straightening the arms, hands, legs or feet; pain in the hip bones or ribs; or muscle weakness [see Warnings and Precautions ( 5.2 )] .

Gadolinium Retention Advise patients that gadolinium is retained for months or years in brain, bone, skin, and other organs following ELUCIREM administration even in patients with normal renal function. The clinical consequences of retention are unknown. Retention depends on multiple factors and is greater following administration of linear GBCAs than following administration of macrocyclic GBCAs [see Warnings and Precautions ( 5.4 )] .

Injection Site Reactions Inform the patient that ELUCIREM may cause reactions along the venous injection site, such as mild and transient burning or pain or feeling of warmth or coldness at the injection site [see Warnings and Precautions ( 5.6 )] . Pregnancy Advise pregnant women of the potential risk of fetal exposure to ELUCIREM [see Use in Specific Populations ( 8.1 )] . Vials and pre-filled syringes manufactured by Liebel-Flarsheim Company LLC, 8800 Durant Road, Raleigh, North Carolina (NC) 27616-3104, USA Vials manufactured by BIPSO GmbH 78224 Singen, Germany Distributed by Guerbet LLC 214 Carnegie Center, Suite 300, Princeton, NJ 08540, USA logo

MEDICATION GUIDE ELUCIREM TM (ah LOOS er em) (gadopiclenol) injection, for intravenous use What is the most important information I should know about ELUCIREM? GBCAs like ELUCIREM may cause serious side effects including death, coma, encephalopathy, and seizures when it is given intrathecally (injection given into the spinal canal). It is not known if ELUCIREM is safe and effective with intrathecal use.

ELUCIREM is not approved for this use. ELUCIREM contains a metal called gadolinium. Small amounts of gadolinium can stay in your body including the brain, bones, skin and other parts of your body for a long time (several months to years).

It is not known how gadolinium may affect you, but so far, studies have not found harmful effects in patients with normal kidneys. Rarely patients have reported pains, tiredness, and skin, muscle or bone ailments for a long time, but these symptoms have not been directly linked to gadolinium. There are different GBCAs that can be used for your MRI exam.

The amount of gadolinium that stays in the body is different for different gadolinium medicines. Gadolinium stays in the body more after gadodiamide than after gadoxetate disodium or gadobenate dimeglumine. Gadolinium stays in the body the least after, gadoterate meglumine, gadobutrol, gadoteridol, and gadopiclenol.

People who get many doses of gadolinium medicines, women who are pregnant and young children may be at increased risk from gadolinium staying in the body. Some people with kidney problems who get gadolinium medicines can develop a condition with severe thickening of the skin, muscles and other organs in the body (nephrogenic systemic fibrosis). Your healthcare provider should screen you to see how well your kidneys are working before you receive ELUCIREM.

What is ELUCIREM? ELUCIREM is a prescription medicine called a gadolinium-based contrast agent (GBCA). ELUCIREM, like other GBCAs, is injected into your vein and used with a magnetic resonance imaging (MRI) scanner.

An MRI exam with a GBCA, including ELUCIREM, helps your healthcare provider to see problems better than an MRI exam without a GBCA. Your healthcare provider has reviewed your medical records and has determined that you would benefit from using a GBCA with your MRI exam. Do not receive ELUCIREM if you have had a severe allergic reaction to ELUCIREM.

Before receiving ELUCIREM, tell your healthcare provider about all your medical conditions, including if you: have had any MRI procedures in the past where you received a GBCA. Your healthcare provider may ask you for more information including the dates of these MRI procedures. are pregnant or plan to become pregnant. It is not known if ELUCIREM can harm your unborn baby.

Talk to your healthcare provider about the possible risks to an unborn baby if a GBCA such as ELUCIREM is received during pregnancy. have kidney problems, diabetes, or high blood pressure. have had an allergic reaction to dyes (contrast agents) including GBCAs. What are possible side effects of ELUCIREM? See “What is the most important information I should know about ELUCIREM?” Allergic reactions.

ELUCIREM can cause allergic reactions that can sometimes be serious. Your healthcare provider will monitor you closely for symptoms of an allergic reaction. The most common side effects of ELUCIREM include: injection site pain, headache, nausea, injection site coldness, injection site warmth, dizziness, and localized swelling.

These are not all the possible side effects of ELUCIREM. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective uses of ELUCIREM. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your healthcare provider for information about ELUCIREM that is written for health professionals.

What are the ingredients in ELUCIREM? Active ingredient: gadopiclenol Inactive ingredients: tetraxetan; trom…