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Gadopiclenol

FDA Drug Information • Also known as: Elucirem, Vueway

Brand Names
Elucirem, Vueway
Route
INTRAVENOUS
Dosage Form
INJECTION
Product Type
HUMAN PRESCRIPTION DRUG

⚠ Boxed Warning (Black Box)

WARNING: RISK ASSOCIATED WITH INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS Risk Associated with Intrathecal Use Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. Vueway is not approved for intrathecal use [see Warnings and Precautions ( 5.1 )] . Nephrogenic Systemic Fibrosis GBCAs increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of Vueway in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs. The risk for NSF appears highest among patients with: Chronic, severe kidney disease (GFR < 30 mL/min/1.73 m 2 ), or Acute kidney injury. Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (e.g. age > 60 years, hypertension, diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing. 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 from the body prior to any re-administration [see Warnings and Precautions ( 5.2 )] . WARNING: RISK ASSOCIATED WITH INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS See full prescribing information for complete boxed warning Intrathecal administration of gadolinium based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. Vueway is not approved for intrathecal use. ( 5.1 ) GBCAs increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of Vueway in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. The risk for NSF appears highest among patients with: Chronic, severe kidney disease (GFR <30 mL/min/1.73 m 2 ), or Acute kidney injury. Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (for example, age >60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing. ( 5.2 )

Description

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

What Is Gadopiclenol Used For?

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 )

Dosage and Administration

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...

Side Effects (Adverse Reactions)

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.

Contraindications

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

Pregnancy and Breastfeeding

8.1 Pregnancy Risk Summary There are no available data on Vueway use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. GBCAs cross the human placenta and result in fetal exposure and gadolinium retention. The available human data on GBCA exposure during pregnancy and adverse fetal outcomes are limited and inconclusive (see Data ) . In animal reproduction studies, there were no adverse developmental effects observed in rats or rabbits with intravenous administration of Vueway during organogenesis (see Data ) . Because of the potential risks of gadolinium to the fetus, use Vueway only if imaging is essential during pregnancy and cannot be delayed. The estimated background risk of major birth defects and miscarriage for the indicated population(s) are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20% respectively. Data Human Data Contrast enhancement is visualized in the placenta and fetal tissues after maternal GBCA administration. Cohort studies and case reports on exposure to GBCAs during pregnancy have not reported a clear association between GBCAs and adverse effects in the exposed neonates. However, a retrospective cohort study comparing pregnant women who had a GBCA MRI to pregnant women who did not have an MRI reported a higher occurrence of stillbirths and neonatal deaths in the group receiving GBCA MRI. Limitations of this study include a lack of comparison with non-contrast MRI and lack of information about the maternal indication for MRI. Overall, these data preclude a reliable evaluation of the potential risk of adverse fetal outcomes with the use of GBCAs in pregnancy. Animal Data Gadolinium Retention: GBCAs administered to pregnant non-human primates (0.1...

Overdosage

10 OVERDOSAGE Among subjects who received a single 0.3 mmol/kg intravenous dose of gadopiclenol (6 times the recommended dose of Vueway), headache and nausea were the most frequently reported adverse reactions. Gadopiclenol can be removed from the body by hemodialysis [see Clinical Pharmacology ( 12.3 )] .

How Supplied

16 HOW SUPPLIED/STORAGE AND HANDLING HOW SUPPLIED Vueway is a clear, colorless to yellow aqueous solution supplied in the following presentations: Strength Sale Unit NDC Single-Dose Vial (glass) 1.5 mmol/3 mL (0.5 mmol/mL) Carton of 1 0270-7020-37 Carton of 10 0270-7020-38 3.75 mmol/7.5 mL (0.5 mmol/mL) Carton of 1 0270-7025-39 Carton of 10 0270-7025-40 5 mmol/10 mL (0.5 mmol/mL) Carton of 1 0270-7030-41 Carton of 10 0270-7030-42 7.5 mmol/15 mL (0.5 mmol/mL) Carton of 1 0270-7035-43 Carton of 10 0270-7035-44 Single-Dose Prefilled Syringe (plastic) 3.75 mmol/7.5 mL (0.5 mmol/mL) Carton of 1 0270-7040-43 Carton of 10 0270-7040-44 5 mmol/10 mL (0.5 mmol/mL) Carton of 1 0270-7045-45 Carton of 10 0270-7045-46 7.5 mmol/15 mL (0.5 mmol/mL) Carton of 1 0270-7050-47 Carton of 10 0270-7050-48 Pharmacy Bulk Package (glass) 15 mmol/30 mL (0.5 mmol/mL) Carton of 1 0270-7015-45 Carton of 25 0270-7015-46 25 mmol/50 mL (0.5 mmol/mL) Carton of 1 0270-7015-47 Carton of 25 0270-7015-48 50 mmol/100 mL (0.5 mmol/mL) Carton of 1 0270-7015-63 Carton of 6 0270-7015-64 Carton of 12 0270-7015-65 Storage and Handling Store at 25°C (77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP, Controlled Room Temperature]. Do not freeze Pre-filled syringes.

About This Information

This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.

What are side effects?

Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.

What are drug interactions?

Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.