ELUCIREM

ELUCIREM- gadopiclenol injection
Guerbet LLC

1 INDICATIONS AND USAGE

ELUCIREM^TM is indicated in adult and pediatric patients aged 2 years and older 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).

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

The recommended dose of ELUCIREM for adult and pediatric patients aged 2 years and older is 0.05 mmol/kg actual body weight (equivalent to 0.1 mL/kg) administered intravenously at approximately 2 mL/sec.

2.2 Administration and Imaging Instructions

• 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.
• Administer ELUCIREM as an intravenous bolus injection, manually or by compatible power injector. The recommended injection rate is approximately 2 mL/second.
• Flush the intravenous line with 0.9% Sodium Chloride Injection, USP after the administration of ELUCIREM.
• Contrast MRI can begin immediately following the injection of ELUCIREM.

2.3 Directions for Use of Single-Dose Vial and Pre-filled Syringe

Vial

• Do not pierce the rubber stopper more than once.
• Aseptically draw up ELUCIREM into a disposable syringe and use immediately.
• If solidification occurs in the vial because of exposure to the cold, bring the vial of ELUCIREM to room temperature before use and inspect that the solution is clear, colorless to yellow without any particulate matter and 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.

2.4 Directions for Use of Pharmacy Bulk Package

• Do not use the Pharmacy Bulk Package for direct infusion.
• Perform the transfer of ELUCIREM from the Pharmacy Bulk Package in an aseptic work area, such as laminar flow hood, using aseptic technique and suitable transfer device for filling empty syringes.
• Penetrate the closure only one time. Once the container closure is punctured, do not remove the Pharmacy Bulk Package from the aseptic work area.
• The Pharmacy Bulk Package is used with an appropriate transfer device for filling empty sterile syringes. Use each individual dose of ELUCIREM promptly following withdrawal from the Pharmacy Bulk Package.
• Use the contents of the Pharmacy Bulk Package within 24 hours at room temperature after initial puncture.
• If solidification occurs in the vial because of exposure to the cold, bring the vial of ELUCIREM to room temperature before use and inspect that the solution is clear, colorless to yellow without any particulate matter and discoloration.

3 DOSAGE FORMS AND STRENGTHS

Injection: ELUCIREM is a clear, colorless to yellow aqueous solution at a concentration of 0.5 mmol/mL of gadopiclenol 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)

4 CONTRAINDICATIONS

ELUCIREM is contraindicated in patients with history of hypersensitivity reactions to ELUCIREM.

5 WARNINGS AND PRECAUTIONS

5.1 Nephrogenic Systemic Fibrosis

Gadolinium-based contrast agents (GBCAs) increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of GBCAs among these patients unless the diagnostic information is essential and not available with non-contrast MRI or other modalities. The GBCA-associated NSF risk appears highest for patients with chronic, severe kidney disease (GFR <30 mL/min/1.73 m²) as well as patients with acute kidney injury. The risk appears lower for patients with chronic, moderate kidney disease (GFR 30-59 mL/min/1.73 m²) and little, if any, for patients with chronic, mild kidney disease (GFR 60-89 mL/min/1.73 m²). NSF may result in fatal or debilitating fibrosis affecting the skin, muscle, and internal organs. Report any diagnosis of NSF following ELUCIREM administration to Guerbet LLC (1-877-729-6679) or FDA (1-800-FDA-1088 or www.fda.gov/medwatch).

Screen patients for acute kidney injury and other conditions that may reduce renal function. Features of acute kidney injury consist of rapid (over hours to days) and usually reversible decrease in kidney function, commonly in the setting of surgery, severe infection, injury or drug-induced kidney toxicity. Serum creatinine levels and estimated GFR may not reliably assess renal function in the setting of acute kidney injury. For patients at risk for chronically reduced renal function (e.g., age >60 years, diabetes mellitus or chronic hypertension), estimate the GFR through laboratory testing.

Among the factors that may increase the risk for NSF are repeated or higher than recommended doses of a GBCA and the degree of renal impairment at the time of exposure. Record the specific GBCA and the dose administered to a patient. For patients at highest risk for NSF, do not exceed the recommended ELUCIREM dose and allow a sufficient period of time for elimination of the drug prior to re-administration. For patients receiving hemodialysis, physicians may consider the prompt initiation of hemodialysis following the administration of a GBCA in order to enhance the contrast agent’s elimination [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]. The usefulness of hemodialysis in the prevention of NSF is unknown.

5.2 Hypersensitivity Reactions

With GBCAs, serious hypersensitivity reactions have occurred. In most cases, initial symptoms occurred within minutes of GBCA administration and resolved with prompt emergency treatment.

• Before ELUCIREM administration, assess all patients for any history of a reaction to contrast media, bronchial asthma and/or allergic disorders. These patients may have an increased risk for a hypersensitivity reaction to ELUCIREM.
• ELUCIREM is contraindicated in patients with history of hypersensitivity reactions to ELUCIREM [see Contraindications (4)].
• Administer ELUCIREM only in situations where trained personnel and therapies are promptly available for the treatment of hypersensitivity reactions, including personnel trained in resuscitation.
• During and following ELUCIREM administration, observe patients for signs and symptoms of hypersensitivity reactions.