ELUCIREM
Generic: GADOPICLENOL
Basic Information
Manufacturer
Guerbet LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
ca582f31-1042-487f-82e4-533f1b541902
Indications & Usage
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).
( 1 )
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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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%) are injection site pain, headache, nausea, injection site warmth and coldness, dizziness, localized swelling, and erythema.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS contact GUERBET LLC at 1-877-729-6679 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 ELUCIREM was evaluated in 1,083 patients who received ELUCIREM 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 744 patients (including 116 pediatric patients) received the recommended dose of 0.05 mmol/kg.
Among patients who received the recommended dose, the average age was 49 years (range from less than one month to 88 years) and 55% were female.
The race distribution was 80% White, 10% Asian, 6% American Indian or Alaska native, 2% Black, and 2% patients of other or unspecified race groups.
Overall, approximately 4.6% 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 ELUCIREM.
Table 1.
Adverse Reactions Reported in > 0.2% of Patients Receiving ELUCIREM in Clinical Trials Adverse Reaction ELUCIREM 0.05 mmol/kg (n=744) (%) 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 Erythema 0.3 Adverse reactions that occurred with a frequency ≤ 0.2% in patients who received 0.05 mmol/kg ELUCIREM included: maculopapular rash, vomiting, worsened renal impairment, feeling hot, pyrexia, oral paresthesia, dysgeusia, diarrhea, pruritus, allergic dermatitis, injection site paresthesia, Cystatin C increase, and blood creatinine increase.
Adverse Reactions in Pediatric Patients The overall safety profile observed in pediatric patients was similar to the safety profile of adult patients [see Use in Specific Populations ( 8.4 )] .
6.2 Postmarketing Experience The following additional adverse reactions have been identified during postmarketing use of ELUCIREM 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.
General Disorders and Administration Site Conditions: Fatigue, asthenia, pain syndromes, and heterogeneous clusters of symptoms in the neurological, cutaneous, and musculoskeletal systems with variable onset and duration after GBCA administration [see Warnings and Precautions ( 5.4 )] .
Respiratory, Thoracic and Mediastinal Disorders: Acute respiratory distress syndrome, pulmonary edema.
Skin Disorders: Gadolinium-associated plaques
6.2 Postmarketing Experience The following additional adverse reactions have been identified during postmarketing use of ELUCIREM 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.
General Disorders and Administration Site Conditions: Fatigue, asthenia, pain syndromes, and heterogeneous clusters of symptoms in the neurological, cutaneous, and musculoskeletal systems with variable onset and duration after GBCA administration [see Warnings and Precautions ( 5.4 )] .
Respiratory, Thoracic and Mediastinal Disorders: Acute respiratory distress syndrome, pulmonary edema.
Skin Disorders: Gadolinium-associated plaques
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS contact GUERBET LLC at 1-877-729-6679 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 ELUCIREM was evaluated in 1,083 patients who received ELUCIREM 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 744 patients (including 116 pediatric patients) received the recommended dose of 0.05 mmol/kg.
Among patients who received the recommended dose, the average age was 49 years (range from less than one month to 88 years) and 55% were female.
The race distribution was 80% White, 10% Asian, 6% American Indian or Alaska native, 2% Black, and 2% patients of other or unspecified race groups.
Overall, approximately 4.6% 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 ELUCIREM.
Table 1.
Adverse Reactions Reported in > 0.2% of Patients Receiving ELUCIREM in Clinical Trials Adverse Reaction ELUCIREM 0.05 mmol/kg (n=744) (%) 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 Erythema 0.3 Adverse reactions that occurred with a frequency ≤ 0.2% in patients who received 0.05 mmol/kg ELUCIREM included: maculopapular rash, vomiting, worsened renal impairment, feeling hot, pyrexia, oral paresthesia, dysgeusia, diarrhea, pruritus, allergic dermatitis, injection site paresthesia, Cystatin C increase, and blood creatinine increase.
Adverse Reactions in Pediatric Patients The overall safety profile observed in pediatric patients was similar to the safety profile of adult patients [see Use in Specific Populations ( 8.4 )] .
6.2 Postmarketing Experience The following additional adverse reactions have been identified during postmarketing use of ELUCIREM 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.
General Disorders and Administration Site Conditions: Fatigue, asthenia, pain syndromes, and heterogeneous clusters of symptoms in the neurological, cutaneous, and musculoskeletal systems with variable onset and duration after GBCA administration [see Warnings and Precautions ( 5.4 )] .
Respiratory, Thoracic and Mediastinal Disorders: Acute respiratory distress syndrome, pulmonary edema.
Skin Disorders: Gadolinium-associated plaques
6.2 Postmarketing Experience The following additional adverse reactions have been identified during postmarketing use of ELUCIREM 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.
General Disorders and Administration Site Conditions: Fatigue, asthenia, pain syndromes, and heterogeneous clusters of symptoms in the neurological, cutaneous, and musculoskeletal systems with variable onset and duration after GBCA administration [see Warnings and Precautions ( 5.4 )] .
Respiratory, Thoracic and Mediastinal Disorders: Acute respiratory distress syndrome, pulmonary edema.
Skin Disorders: Gadolinium-associated plaques