Gadopiclenol

Q: Is Gadopiclenol available over the counter?

Gadopiclenol is a prescription medication. You will need a valid prescription from a licensed healthcare provider.

Prescription

Nomes comerciais: Vueway

Forma Farmacêutica

Injection

Via de Administração

INTRAVENOUS

Fabricante

Bracco Diagnostics Inc.

About This Medication

11 DESCRIPTION Vueway is a gadolinium-based contrast agent, which contains gadopiclenol, a paramagnetic macrocyclic non-ionic complex of gadolinium. The chemical name for gadopiclenol is rac- [(2R,2'Ξ,2''Ξ)-2,2',2''-(3,6,9-triaza-κ 3 N 3 ,N 6 ,N 9 -1(2,6)-pyridina-κN 1 -cyclodecaphane-3,6,9-triyl)tris(5-{[(2Ξ)-2,3-dihydroxypropyl]amino}-5-oxopentanoato-κ 3 O 1 ,O 1 ',O 1 '')(3−)]gadolinium with a molecular weight of 970.11 g/mol and a molecular formula of C 35 H 54 GdN 7 O 15 . Vueway is a sterile, nonpyrogenic, clear, colorless to yellow aqueous solution for intravenous use. Each mL contains 485.1 mg of gadopiclenol (equivalent to 0.5 mmol of gadopiclenol and 78.6 mg of gadolinium) and the following inactive ingredients: 0.404 mg tetraxetan, 1.211 mg trometamol, hydrochloric acid and/or sodium hydroxide (for pH adjustment, if needed), and water for injection. The main physicochemical properties of Vueway are provided in Table 2. Table 2: Physicochemical properties of Vueway Parameter Value Density at 20°C 1.211 g/cm 3 Mean viscosity at 20°C 12.6 mPa.s Mean viscosity at 37°C 7.6 mPa.s Osmolality at 37°C 850 mOsm/kg water pH 7.0 – 7.8 Gadopiclenol Structure

Princípios Ativos

Ingrediente	Concentração
Gadopiclenol	-

Indicações e Uso

1 INDICATIONS AND USAGE Vueway® 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). Vueway is a gadolinium-based contrast agent 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). ( 1 )

Como funciona

12.1 Mechanism of Action Gadopiclenol is a paramagnetic molecule (macrocyclic non-ionic complex of gadolinium) that develops a magnetic moment when placed in a magnetic field. The magnetic moment alters the relaxation rates of water protons in its vicinity in the body, leading to an increase in signal intensity (brightness) of tissues.

Posologia e Administração

2 DOSAGE AND ADMINISTRATION The recommended dose 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 ) 2.1 Recommended Dosage The recommended dose of Vueway 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 Vueway. Visually inspect Vueway 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 Vueway 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 Vueway. Contrast MRI can begin immediately following the injection of Vueway. 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 Vueway into a disposable syringe and use immediately. If solidification occurs in the vial because of exposure to the cold, bring the vial of Vueway 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 Vueway 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 Vueway 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 Vueway 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 Vueway to room temperature before use and inspect that the solution is clear, colorless to yellow without any particulate matter and discoloration.

Side Effects Overview

6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed elsewhere in labeling: Nephrogenic Systemic Fibrosis [see Warnings and Precautions ( 5.2 )] Hypersensitivity Reactions [see Contraindications ( 4 ) and Warnings and Precautions ( 5.3 )] Most common adverse reactions (incidence >0.2%) in patients who received Vueway are injection site pain, headache, nausea, injection site warmth and coldness, dizziness, and localized swelling. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS contact Bracco Diagnostics Inc. at 1-800-257-5181 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety of Vueway was evaluated in 1,047 patients who received Vueway at doses ranging from 0.025 mmol/kg (one half the recommended dose) to 0.3 mmol/kg (six times the recommended dose). A total of 708 patients received the recommended dose of 0.05 mmol/kg. Among patients who received the recommended dose, the average age was 51 years (range 2 years to 88 years) and 56% were female. The ethnic distribution was 79% White, 10% Asian, 7% American Indian or Alaska native, 2% Black, and 2% patients of other or unspecified ethnic groups. Overall, approximately 4.7% of subjects receiving the labeled dose reported one or more adverse reactions. Table 1 lists adverse reactions that occurred in > 0.2% of patients who received 0.05 mmol/kg Vueway. Table 1. Adverse Reactions Reported in > 0.2% of Patients Receiving Vueway in Clinical Trials Adverse Reaction Vueway 0.05 mmol/kg (n=708) (%) Injection site pain 0.7 Headache 0.7 Nausea 0.4 Injection site warmth 0.4 Injection site coldness 0.3 Dizziness 0.3 Localized swelling 0.3 Adverse reactions that occurred with a frequency ≤ 0.2% in patients who received 0.05 mmol/kg Vueway included: maculopapular rash, vomiting, worsened renal impairment, feeling hot, pyrexia, oral paresthesia, dysgeusia, diarrhea, pruritus, allergic dermatitis, erythema, injection site paresthesia, Cystatin C increase, and blood creatinine increase. Adverse Reactions in Pediatric Patients One study with a single dose of Vueway (0.05 mmol/kg) was conducted in 80 pediatric patients aged 2 years to 17 years, including 60 patients who underwent a central nervous system (CNS) MRI and 20 patients who underwent a body MRI. One adverse reaction (maculopapular rash of moderate severity) in one patient (1.3%) was reported in the CNS cohort. 6.2 Postmarketing Experience The following additional adverse reactions have been identified during postmarketing use of Vueway or other GBCAs. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Gastrointestinal Disorders: Acute pancreatitis with onset within 48 hours after GBCA administration. Respiratory, Thoracic and Mediastinal Disorders: Acute respiratory distress syndrome, pulmonary edema.

Advertências e Precauções

5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Serious hypersensitivity reactions have occurred with GBCAs. Monitor patients closely for need of emergency cardiorespiratory support. ( 5.3 ) Gadolinium Retention: Gadolinium is retained for months or years in brain, bone, and other organs. ( 5.4 ) 5.1 Risk Associated with Intrathecal Use Intrathecal administration of GBCAs can cause serious adverse reactions including death, coma, encephalopathy, and seizures. The safety and effectiveness of Vueway have not been established with intrathecal use. Vueway is not approved for intrathecal use [see Dosage and Administration ( 2.1 )] . 5.2 Nephrogenic Systemic Fibrosis GBCAs increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of Vueway 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 m 2 ) 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 m 2 ) and little, if any, for patients with chronic, mild kidney disease (GFR 60-89 mL/min/1.73 m 2 ). NSF may result in fatal or debilitating fibrosis affecting the skin, muscle, and internal organs. Report any diagnosis of NSF following Vueway administration to Bracco Diagnostics Inc. (1-800-257-5181) 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 Vueway 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. 5.3 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 Vueway 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 Vueway. Vueway is contraindicated in patients with history of hypersensitivity reactions to Vueway [see Contraindications ( 4 )] . Administer Vueway 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 Vueway administration, observe patients for signs and symptoms of hypersensitivity reactions. 5.4 Gadolinium Retention Gadolinium is retained for months or years in several organs. The highest concentrations (nanomoles per gram of tissue) have been identified in the bone, followed by other organs (e.g. brain, skin, kidney, liver, and spleen). The duration of retention also varies by tissue and is longest in bone. Linear GBCAs cause more retention than macrocyclic GBCAs. At equivalent doses, gadolinium retention varies among the linear agents with gadodiamide causing greater retention than other linear agents such as gadoxetate disodium and gadobenate dimeglumine. Retention is lowest and similar among the macrocyclic GBCAs such as gadoterate meglumine, gadobutrol, gadoteridol, and gadopiclenol. Consequences of gadolinium retention in the brain have not been established. Pathologic and clinical consequences of GBCA administration and retention in skin and other organs have been established in patients with impaired renal function [see Warnings and Precautions ( 5.2 )] . There are rare reports of pathologic skin changes in patients with normal renal function. Adverse events involving multiple organ systems have been reported in patients with normal renal function without an established causal link to gadolinium. While clinical consequences of gadolinium retention have not been established in patients with normal renal function, certain patients might be at higher risk. These include patients requiring multiple lifetime doses, pregnant and pediatric patients, and patients with inflammatory conditions. Consider the retention characteristics of the agent when choosing a GBCA for these patients. Minimize repetitive GBCA imaging studies, particularly closely spaced studies, when possible. 5.5 Acute Kidney Injury In patients with chronically reduced renal function, acute kidney injury requiring dialysis has occurred with the use of GBCAs. The risk of acute kidney injury may increase with increasing dose of the contrast agent. Do not exceed the recommended dose. 5.6 Extravasation and Injection Site Reactions Injection site reactions such as injection site pain have been reported in the clinical studies with Vueway [see Adverse Reactions ( 6.1 )] . Extravasation during Vueway administration may result in tissue irritation [see Nonclinical Toxicology ( 13.2 )] . Ensure catheter and venous patency before the injection of Vueway. 5.7 Interference with Visualization of Lesions Visible with Non-Contrast MRI As with any GBCA, Vueway may impair the visualization of lesions seen on non-contrast MRI. Therefore, caution should be exercised when Gadopiclenol MRI scans are interpreted without a companion non-contrast MRI scan.

Contraindicações

4 CONTRAINDICATIONS Vueway is contraindicated in patients with history of hypersensitivity reactions to Vueway. History of hypersensitivity reactions to Vueway ( 4 )

Farmacocinética

12.3 Pharmacokinetics The C max and AUC inf of gadopiclenol increased proportionally over a dosage range from 0.025 mmol/kg to 0.3 mmol/kg (0.5 times to 6 times the recommended dosage). At the recommended dose, the mean (CV%) C max and AUC inf were 525 (13%) µg/mL and 569 (18%) µg·h/mL, respectively. Distribution After intravenous administration of Vueway, gadopiclenol is distributed in the extracellular fluids. The mean (CV%) volume of distribution of gadopiclenol at steady state is 13 (13%) L. Protein binding of gadopiclenol is ≤ 1.8% at clinically relevant concentrations. Following GBCA administration, gadolinium is present for months or years in brain, bone, skin, and other organs [see Warnings and Precautions ( 5.4 )] . It is unknown whether the recommended dose of Vueway results in similar or different levels of gadolinium retention relative to those of other approved macrocyclic GBCAs at their recommended doses. Elimination The mean (CV%) elimination half-life (t 1/2 ) of gadopiclenol is 1.5 (14%) hour. The mean (CV%) total body clearance (CL) and renal clearance (CLr) of gadopiclenol are 100 (9.5%) mL/min and 81 (35%) mL/min, respectively. Metabolism Gadopiclenol is not metabolized. Excretion Gadopiclenol is mainly eliminated through the kidneys by glomerular filtration. Approximately 98% of the dose was recovered in urine within 48 hours after administration. Specific Populations No clinically significant differences in the pharmacokinetics of gadopiclenol were observed based on sex. Pediatric Patients The pharmacokinetics of gadopiclenol for pediatric patients (2 to 17 years of age) were within range to those of adults (> 18 years of age) [see Dosage and Administration ( 2.1 )] . The pharmacokinetic parameters (median [range]) of gadopiclenol in pediatric patients are presented in Table 4. Table 4. Pharmacokinetic Parameters (Median [Range]) a According to Age Classes a At the recommended dosage 2-6 years 7–11 years 12–17 years >18 years CL (L/h/kg) 0.12 [0.05; 0.28] 0.10 [0.04; 0.24] 0.08 [0.04; 0.20] 0.08 [0.05; 0.14] t 1/2 (h) 1.29 [0.69; 3.38] 1.48 [0.83; 3.20] 1.77 [1.00; 3.57] 1.82 [0.93; 3.68] AUC inf (µg•h/mL) 403 [169; 964] 478 [183; 1077] 582 [267; 12901] 590 [353; 937] C20 (µg/mL) 236 [136; 387] 260 [151; 401] 286 [155; 441] 296 [166; 485] Patients with Renal Impairment The pharmacokinetic parameters (mean (%CV)) of gadopiclenol in patients with renal impairment are presented in Table 5. Table 5. Effect of Renal Impairment on the Pharmacokinetics of Gadopiclenol a,b a Following administration of a single gadopiclenol 0.1 mmol/kg dose (2 times the recommended dosage). b eGFR: estimate of GFR based on an estimation equation and expressed in mL/min. To convert mL/min/1.73 m 2 to mL/min, multiply by the individual’s BSA and divide by 1.73. Normal (eGFR ≥ 90 mL/min) Mild (eGFR 60 to < 90 mL/min) Moderate (eGFR 30 to < 60 mL/min) Severe (eGFR 15 to < 30 mL/min) AUC inf (µg•h/mL) 1113 (24%) 1711 (31%) 2759 (28%) 9671 (18%) CL r (mL/min) 96 (10%) 76 (23%) 44 (25%) 14 (26%) t 1/2 (h) 1.9 3.3 3.8 11.7 In patients with mild or moderate renal impairment, more than 90% of the administered Vueway was recovered in urine within 48 hours. In patients with severely impaired renal function about 84% of the administered Vueway was recovered in urine within 5 days. In patients with eGFR < 15 mL/min, hemodialysis effectively removed gadopiclenol from plasma as the percentage of decrease in blood concentrations was 95 to 98% at the end of the first hemodialysis session and 100% after the third hemodialysis session [see Warnings and Precautions ( 5.2 ), Use in Specific Populations ( 8.6 )] .

Frequently Asked Questions

1 INDICATIONS AND USAGE Vueway® 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). Vueway is a gadolinium-based contrast agent indicated in adult and pediatric patients aged 2 years and older for use with magnetic resonance imaging (MRI) to detect and …

2 DOSAGE AND ADMINISTRATION The recommended dose 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 ) 2.1 Recommended Dosage The recommended dose of Vueway 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 …

5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Serious hypersensitivity reactions have occurred with GBCAs. Monitor patients closely for need of emergency cardiorespiratory support. ( 5.3 ) Gadolinium Retention: Gadolinium is retained for months or years in brain, bone, and other organs. ( 5.4 ) 5.1 Risk Associated with Intrathecal Use Intrathecal administration of GBCAs can cause serious adverse reactions including death, coma, encephalopathy, and seizures. The safety and effectiveness of Vueway have not been established with intrathecal use. Vueway is not …

4 CONTRAINDICATIONS Vueway is contraindicated in patients with history of hypersensitivity reactions to Vueway. History of hypersensitivity reactions to Vueway ( 4 )

Gadopiclenol is a prescription medication. You will need a valid prescription from a licensed healthcare provider.

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References & Data Sources

• DailyMed — Gadopiclenol drug label (National Library of Medicine)
• openFDA — Gadopiclenol label data (U.S. Food & Drug Administration)
• NDC Directory — Gadopiclenol (FDA National Drug Code)

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Fontes de dados: DailyMed (NLM), openFDA, MFDS