Gadopiclenol Dosage

Applies to the following strengths: 485.1 mg/mL

Usual Adult Dose for Magnetic Resonance Imaging

Usual dose: 0.05 mmol/kg actual body weight (equivalent to 0.1 mL/kg) administered intravenously at approximately 2 mL/sec.

Use: To detect and visualize lesions with abnormal vascularity in adult and pediatric patients aged 2 years and older for use in:

The central nervous system (brain, spine, and associated tissues)
The body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system)

Usual Pediatric Dose for Magnetic Resonance Imaging

Usual dose: 0.05 mmol/kg actual body weight (equivalent to 0.1 mL/kg) administered intravenously at approximately 2 mL/sec

Use: To detect and visualize lesions with abnormal vascularity in adult and pediatric patients aged 2 years and older for use in:

The central nervous system (brain, spine, and associated tissues)
The body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system)

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

Data not available

Dose Adjustments

Data not available

Precautions

US BOXED WARNING:
NEPHROGENIC SYSTEMIC FIBROSIS (NSF):

Patients with impaired elimination of Gadolinium-based contrast agents (GBCAs) are at an increased risk of developing NSF. Therefore, the use of GBCAs should be avoided in such patients, unless essential for diagnosis and cannot be substituted with non-contrast MRI or other modalities. NSF can lead to fatal or debilitating fibrosis, affecting the skin, muscles, and internal organs.

Patients with chronic, severe kidney disease (GFR less than 30 mL/min/1.73 m2) or acute kidney injury are at the highest risk of developing NSF. Hence, patients should be screened for acute kidney injury and other conditions that may impair renal function. For patients at risk of chronic reduction in renal function (e.g., age more than 60 years, hypertension, diabetes), GFR estimation through laboratory testing should be performed.
In patients at the highest risk of developing NSF, the recommended dose of this drug should not be exceeded, and sufficient time should be allowed for drug elimination from the body before any re-administration.

CONTRAINDICATIONS: History of hypersensitivity reactions to this drug

Safety and efficacy have not been established in patients younger than 2 years.

Consult WARNINGS section for additional precautions.

Dialysis

Hemodialysis: In patients with eGFR less than 15 mL/min, decrease in blood concentration was 95 to 98% at the end of first hemodialysis session and 100% after the third session.

Other Comments

Administration advice:

Use aseptic technique whenever handling and administering this drug.
Before administering, check visually for any particulate matter or discoloration. If you notice any, do not use the solution.
Do not mix this drug with other medications due to the risk of chemical incompatibility.
Make sure to prime the intravenous line before using this drug.
Administer this drug as an intravenous bolus injection, either manually or using a compatible power injector. The recommended injection rate is around 2 mL per second.
After administering this drug, flush the intravenous line with 0.9% Sodium Chloride Injection, USP.
Begin a contrast MRI immediately after injecting this drug.

Storage requirements:

Store at 25C (77F); excursions permitted from 15C to 30C (59F to 86F).
Do not freeze pre-filled syringes.

Reconstitution/preparation techniques:
Directions for Use:

Single dose vial:
Only puncture the rubber stopper of the vial once.
Using a disposable syringe and aseptic technique, draw up the solution from the vial and use it immediately.
If the drug solidifies due to cold exposure, let the vial reach room temperature and inspect the solution for clarity, color (clear or yellow), and absence of particulate matter or discoloration before use.
Dispose of any unused solution.
Pre-filled syringe:
Remove the tip cap from the pre-filled syringe, screw the plunger rod, and use the syringe immediately.
When connecting the syringe to other devices using luer connections, gently hand-tighten them without over-tightening to ensure secure connections and prevent damage to the device.
Never freeze pre-filled syringes. If they have been frozen, discard them.
Dispose of any unused solution.

Patient advice:

Patients should be advised to read FDA-approved patient labeling.
Patients should contact their physician if they experience signs or symptoms of NSF, such as skin burning, itching, swelling, scaling, hardening, and tightening, as well as joint stiffness, pain in hip bones or ribs, muscle weakness, and red or dark patches on the skin after receiving this drug.
Patients should be informed that administration of this drug may result in gadolinium retention for an extended period, ranging from months to years, in various organs such as the brain, bone, and skin. This retention occurs even in individuals with normal renal function, and the potential clinical implications of such retention remain uncertain. Retention levels depend on several factors, and linear gadolinium-based contrast agents (GBCAs) have a higher likelihood of causing retention than macrocyclic GBCAs. It is advisable to educate patients about these risks before administering this drug.
Patients should be informed about potential of this drug to cause injection site reactions along the venous injection site, such as mild and transient burning or pain or feeling of warmth or coldness at the injection site.
Pregnant women should be apprised of the potential risk of fetal exposure to this drug.