ProHance gadoteridol 279.3 mg/mL Injection, Solution
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.23 mg / 1 mL
UNII RPH56VWA1A
A calcium-based compound used as a source of supplemental calcium in formulations. It acts as a filler and helps ensure consistent tablet or capsule weight and composition.
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1.21 mg / 1 mL
UNII 023C2WHX2V
Tromethamine is a chemical buffer that helps maintain the proper acidity level in liquid medicines. It neutralizes acids and stabilizes the solution so the medication remains effective and safe throughout its shelf life.
2 inactive ingredients listed in the exact product block matched to this NDC.
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| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| ProHance 279.3 mg/mLthis 00270-1111-45 | Bracco | 5 syringes | — | — | FDA listed | — |
| Gadoteridol 279.3 mg/mL 70436-0121-31 | Slate | 5 vials | — | AP | FDA listed | — |
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The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00270-1111-01 | 5 VIAL, SINGLE-DOSE in 1 BOX (0270-1111-01) / 10 mL in 1 VIAL, SINGLE-DOSE | 1992-11-16 | Active |
| 00270-1111-02 | 5 VIAL, SINGLE-DOSE in 1 BOX (0270-1111-02) / 15 mL in 1 VIAL, SINGLE-DOSE | 1992-11-16 | Active |
| 00270-1111-03 | 5 VIAL, SINGLE-DOSE in 1 BOX (0270-1111-03) / 20 mL in 1 VIAL, SINGLE-DOSE | 1992-11-16 | Active |
| 00270-1111-04 | 5 VIAL, SINGLE-DOSE in 1 BOX (0270-1111-04) / 5 mL in 1 VIAL, SINGLE-DOSE | 1992-11-16 | Active |
| 00270-1111-16 | 5 SYRINGE, GLASS in 1 BOX (0270-1111-16) / 10 mL in 1 SYRINGE, GLASS | 1992-11-16 | Active |
| 00270-1111-45 You're viewing this | 5 SYRINGE, GLASS in 1 BOX (0270-1111-45) / 17 mL in 1 SYRINGE, GLASS | 1992-11-16 | Active |
| 00270-1111-70 | 5 VIAL, PHARMACY BULK PACKAGE in 1 BOX (0270-1111-70) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE | 2003-10-09 | Active |
| 00270-1111-85 | 5 VIAL, PHARMACY BULK PACKAGE in 1 BOX (0270-1111-85) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE | 2022-02-01 | Active |
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
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. ProHance 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 ProHance 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 systemic fibrosis affecting the skin, muscle and internal organs. The risk for NSF appears highest among patients with: chronic, severe kidney disease (GFR less than 30 mL/min/1.73m 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 greater than 60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing. For patients at highest risk for NSF, do not exceed the recommended ProHance dose and allow a sufficient period of time for elimination of the drug from the body prior to 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.
ProHance 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 ProHance 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 systemic fibrosis affecting the skin, muscle and internal organs. The risk for NSF appears highest among patients with: chronic, severe kidney disease (GFR less than 30 mL/min/1.73m 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 greater than 60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing ( 5.2 ).
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE ProHance is a gadolinium-based contrast agent indicated for magnetic resonance imaging (MRI) to visualize: lesions with disrupted blood brain barrier and/or abnormal vascularity in the brain (intracranial lesions), spine and associated tissues in adults and pediatric patients, including term neonates ( 1.1 ) lesions in the head and neck in adults ( 1.2 )
1.1MRI of the Central Nervous System (CNS) ProHance is indicated for magnetic resonance imaging (MRI) in adults and pediatric patients including term neonates to visualize lesions with disrupted blood brain barrier and/or abnormal vascularity in the brain (intracranial lesions), spine and associated tissues.
1.2MRI of Extracranial/Extraspinal Head and Neck ProHance is indicated for MRI in adults to visualize lesions in the head and neck.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Recommended dose in adult and pediatric patients is 0.2 mL/kg (0.1 mmol/kg) body weight administered as rapid intravenous infusion or bolus ( 2.1 ) Follow injection with a saline flush of at least 5 mL normal saline ( 2.1 )
2.1Recommended Dose The recommended dose for adult and pediatric patients, including term neonates, is 0.2 mL/kg (0.1 mmol/kg) administered as a rapid intravenous infusion (10 mL/min to 60 mL/min) or bolus (greater than 60 mL/min). Table 1 provides weight-adjusted recommended dose volumes. Table 1: Recommended Volume of ProHance Injection by Body Weight Body Weight (kg) Volume to be Administered (mL) 2.5 0.5 5 1 10 2 20 4 30 6 40 8 50 10 60 12 70 14 80 16 90 18 100 20 110 22 120 24 130 26 140 28 150 30 MRI of the CNS in Adults : A supplementary dose of 0.4 mL/kg (0.2 mmol/kg) may be given up to 30 minutes after the first dose in adult patients with normal renal function suspected of having poorly visualized CNS lesions, in the presence of negative or equivocal scans The safety and efficacy of supplementary dosing have not been established in pediatric patients
2.2Administration Visually inspect ProHance for particulate matter and discoloration prior to use Do not administer the solution if it is discolored or particulate matter is present Concurrent medications or parenteral nutrition should not be physically mixed with contrast agents and should not be administered in the same intravenous line because of the potential for chemical incompatibility Inject at least a 5 mL normal saline flush immediately after ProHance injection to ensure complete administration Imaging procedures should be completed within 1 hour ProHance vials are intended only for single-dose administration.
Administer immediately after opening and discard any unused product
2.3Directions for Use Vials Draw ProHance into the syringe immediately before use. Do not pierce the rubber stopper more than once. Discard any unused vial contents.
ProHance single dose syringe* Screw the threaded tip of the plunger rod clockwise into the cartridge plunger and push forward a few millimeters to break any friction between the cartridge plunger and syringe barrel Holding syringe erect, unscrew the plastic tip cap from the tip of the syringe and attach either a sterile, disposable needle or tubing with a compatible Luer lock using a push-twist action (slip tip) Hold the syringe erect and push plunger forward until all of the air is evacuated and fluid either appears at the tip of the needle or the tubing is filled Following the usual aspiration procedure, complete the injection Inject at least a 5 mL normal saline flush immediately after ProHance injection to ensure complete administration Properly dispose of the syringe and any other materials used *The syringe assembly is a HYPAK SCF® single dose syringe supplied by Becton Dickinson
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS ProHance is supplied as a sterile, non-pyrogenic, and colorless to slightly yellow solution available in single-dose vials or prefilled syringes. Each mL contains 279.3 mg (0.5 mmol/mL) of gadoteridol for injection. Injection: contains 279.3 mg/mL (0.5 mmol/mL) of gadoteridol supplied in single dose vials or pre-filled syringes ( 2.3 , 3 , 16 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS ProHance is contraindicated in patients with known allergic or hypersensitivity reactions to ProHance [see Warnings and Precautions ( 5.3 )]. Allergic or hypersensitivity reactions to ProHance ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Hypersensitivity: anaphylactic/anaphylactoid reactions with cardiovascular, respiratory and cutaneous manifestations, ranging from mild to severe reactions including shock can occur. Monitor patients closely for need of emergency cardiorespiratory support ( 5.3 ). Gadolinium is retained for months or years in brain, bone, and other organs. ( 5.4 )
5.1Risk Associated with Intrathecal Use Intrathecal administration of GBCAs can cause serious adverse reactions including death, coma, encephalopathy, and seizures. The safety and effectiveness of ProHance have not been established with intrathecal use. ProHance is not approved for intrathecal use [see Dosage and Administration ( 2.1 )] .
5.2Nephrogenic Systemic Fibrosis GCBAs increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of ProHance 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 less than 30 mL/min/1.73m 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/1.73m 2 ) and little, if any, for patients with chronic, mild kidney disease (GFR 60-89 mL/min/1.73m 2 ). NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs. Report any diagnosis of NSF following ProHance administration to Bracco Diagnostics (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 (for example, age greater than 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 ProHance 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. The usefulness of hemodialysis in the prevention of NSF is unknown. [see Clinical Pharmacology ( 12 )] .
5.3Hypersensitivity Reactions Anaphylactic and anaphylactoid reactions have been reported, involving cardiovascular, respiratory, and/or cutaneous manifestations. Some patients experienced circulatory collapse and died. In most cases, initial symptoms occurred within minutes of ProHance administration and resolved with prompt emergency treatment.
Prior to ProHance administration, ensure the availability of trained personnel and medications to treat hypersensitivity reactions. Consider the risk for hypersensitivity reactions, especially in patients with a history of hypersensitivity reactions or a history of asthma or other allergic disorders. If such a reaction occurs, stop ProHance and immediately begin appropriate therapy.
Observe patients for signs and symptoms of a hypersensitivity reaction during and for up to 2 hours after ProHance administration.
5.4Gadolinium Retention Gadolinium is retained for months or years in several organs. The highest concentrations (nanomoles per gram of tissue) have been identif…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the prescribing information: Nephrogenic systemic fibrosis [see Boxed Warning and Warnings and Precautions ( 5.2 )] Hypersensitivity reactions [see Contraindications ( 4 ) and Warnings and Precautions ( 5.3 )] The most commonly reported adverse reactions are nausea and taste perversion with an incidence ≥ 0.9% ( 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
6.1Clinical 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 practice. The adverse events described in this section were observed in clinical trials involving 3174 subjects (including 2896 adults and 278 pediatric subjects ages 0 to 17 years) exposed to ProHance. Approximately 48% of the subjects were men and ethnic distribution was 78% Caucasian, 6% Black, 3% Hispanic, 6% Asian, and 2% other.
In 5% of the subjects, race was not reported. Average age was 47 years (range from 1 day to 91 years) and the exposure ranged from 0.03 to 0.3 mmol/kg. Overall, approximately 5.8% of subjects reported one or more adverse reactions during a follow-up period that ranged from 24 hours to 7 days after ProHance administration.
Table 2 lists adverse reactions that occurred in ≥ 0.4% subjects who received ProHance. Table 2: More frequent adverse reactions in clinical trials Reaction Rate (%) N = 3174 Nausea 1.4% Dysgeusia 0.9% Headache 0.7% Dizziness 0.4% Urticaria 0.4% The following additional adverse events occurred in fewer than 0.4% of the subjects: General disorders and administration site conditions: Asthenia; chest discomfort, facial edema, feeling hot, injection site coldness, injection site erythema, injection site pain, injection site warmth, pain, pyrexia Cardiac: Angina pectoris, palpitations, atrio-ventricular block first degree Ear and labyrinth disorders: Ear discomfort, tinnitus Eye disorders: Eye pruritis, lacrimation increased Gastrointestinal disorders: Abdominal discomfort, abdominal pain, diarrhea, dry mouth, gingival pain, oral pruritis, swollen tongue, vomiting Infections and infestations: Gingivitis, rhinitis Investigations: Alanine aminotransferase increased, aspartate aminotransferase increased, blood chloride increased, blood pressure immeasurable, blood urea decreased, hemoglobin decreased, heart rate increased Metabolism and nutrition disorders: Decreased appetite, hypoglycemia Musculoskeletal and connective tissue disorders: Back pain, musculoskeletal stiffness Nervous system disorders: Formication, hypoesthesia, hypokinesia, lethargy, loss of consciousness, migraine, paresthesia, presyncope, seizure, syncope, taste disorder Psychiatric disorders: Anxiety, mental status changes Respiratory, thoracic and mediastinal disorders: Cough, dry throat, dyspnea, nasal discomfort, throat irritation Skin and subcutaneous tissue disorders: Hyperhidrosis, pruritis, rash, rash morbilliform Vascular disorders: Flushing, hypotension, peripheral coldness, vascular rupture, vasodilatation, vasospasm
6.2Postmarketing Experience The following adverse reactions have been identified during post approval use of ProHance or other GBCAs that were not observed in the clinical trials. 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. * Cases of acute renal failure have been reported in patients with pre-existing severe renal impairment. The following adverse drug reactions have also been reported: General Disorders and Administration Site Conditions: Adverse events with variable onset and duration have been repo…
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pregnancy: Use only if imaging is essential during pregnancy and cannot be delayed. ( 8.1 )
8.1Pregnancy Risk Summary GBCAs cross the placenta and result in fetal exposure and gadolinium retention. The human data on the association between GBCAs and adverse fetal outcomes are limited and inconclusive (see Data). Because of the potential risks of gadolinium to the fetus, use ProHance only if imaging is essential during pregnancy and cannot be delayed.
In animal reproduction studies in rats, gadoteridol doubled the incidence of post-implantation loss at up to 16 times the recommended human dose (RHD). There were no adverse developmental effects observed in rabbits with intravenous administration of gadoteridol during organogenesis at doses up to 19 times the recommended human dose of 0.1 mmol/kg (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is 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 is 15 to 20%, respectively. Data Human Data Contrast agent 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.
Animal Data Gadolinium Retention GBCAs administered to pregnant non-human primates (0.1 mmol/kg on gestational days 85 and 135) result in measurable gadolinium concentration in the offspring in bone, brain, skin, liver, kidney, and spleen for at least 7 months. GBCAs administered to pregnant mice (2 mmol/kg daily on gestational days 16 through 19) result in measurable gadolinium concentrations in the pups in bone, brain, kidney, liver, blood, muscle, and spleen at one-month postnatal age. Reproductive Toxicology Gadoteridol was administered in intravenous doses of 0, 0.375, 1.5, 6.0, and 10 mmol/kg/day [0.6, 2.4, 9.7, and 16 times the recommended human dose (RHD) based on body surface area (BSA)] to female rats from gestational day (GD)6 until GD17.
Gadoteridol at 10 mmol/kg/day for 12 days during gestation doubled the incidence of post-implantation loss. When rats were administered 6.0 or 10.0 mmol/kg/day for 12 days, an increase in spontaneous locomotor activity was observed in the offspring. Pregnant rabbits were administered gadoteridol in intravenous doses of 0, 0.4, 1.5, and 6 mmol/kg/day (1.3, 4.8, and 19.4 times the RHD based on BSA) from GD6 to GD18.
Gadoteridol increased the incidence of spontaneous abortion and early delivery in rabbits administered 6 mmol/kg/day for 13 days during gestation.
8.2Lactation Risk Summary There are no data on the presence of gadoteridol in human milk, the effects on the breastfed infant, or the effects on milk production. However, published lactation data on other GBCAs indicate that 0.01 to 0.04% of the maternal gadolinium dose is present in breast milk and there is limited GBCA gastrointestinal absorption in the breast-fed infant. Gadoteridol is present in rat milk (see Data).
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ProHance and any potential adverse effects on the breastfed infant from ProHance or from the underlying maternal condition. Data ProHance excretion in the milk of lactating rats was evaluated at 30 minutes, 6 and 24 hours after intravenous administration of…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary GBCAs cross the placenta and result in fetal exposure and gadolinium retention. The human data on the association between GBCAs and adverse fetal outcomes are limited and inconclusive (see Data). Because of the potential risks of gadolinium to the fetus, use ProHance only if imaging is essential during pregnancy and cannot be delayed.
In animal reproduction studies in rats, gadoteridol doubled the incidence of post-implantation loss at up to 16 times the recommended human dose (RHD). There were no adverse developmental effects observed in rabbits with intravenous administration of gadoteridol during organogenesis at doses up to 19 times the recommended human dose of 0.1 mmol/kg (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is 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 is 15 to 20%, respectively. Data Human Data Contrast agent 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.
Animal Data Gadolinium Retention GBCAs administered to pregnant non-human primates (0.1 mmol/kg on gestational days 85 and 135) result in measurable gadolinium concentration in the offspring in bone, brain, skin, liver, kidney, and spleen for at least 7 months. GBCAs administered to pregnant mice (2 mmol/kg daily on gestational days 16 through 19) result in measurable gadolinium concentrations in the pups in bone, brain, kidney, liver, blood, muscle, and spleen at one-month postnatal age. Reproductive Toxicology Gadoteridol was administered in intravenous doses of 0, 0.375, 1.5, 6.0, and 10 mmol/kg/day [0.6, 2.4, 9.7, and 16 times the recommended human dose (RHD) based on body surface area (BSA)] to female rats from gestational day (GD)6 until GD17.
Gadoteridol at 10 mmol/kg/day for 12 days during gestation doubled the incidence of post-implantation loss. When rats were administered 6.0 or 10.0 mmol/kg/day for 12 days, an increase in spontaneous locomotor activity was observed in the offspring. Pregnant rabbits were administered gadoteridol in intravenous doses of 0, 0.4, 1.5, and 6 mmol/kg/day (1.3, 4.8, and 19.4 times the RHD based on BSA) from GD6 to GD18.
Gadoteridol increased the incidence of spontaneous abortion and early delivery in rabbits administered 6 mmol/kg/day for 13 days during gestation.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of ProHance have been established for use with MRI to visualize lesions with abnormal blood brain barrier or abnormal vascularity of the brain, spine, and associated tissues in pediatric patients from birth, including term neonates, to 17 years of age. Pediatric use is based on evidence of effectiveness in adults and in 103 pediatric patients 2 years of age and older, in addition to experience in 125 pediatric patients birth to less than 2 years of age that supported extrapolation from adult data [see Clinical Studies ( 14 )] .
Adverse reactions in pediatric patients were similar to those reported in adults [see Adverse Reactions ( 6.1 )] . The safety and efficacy of > 0.1 mmol/kg, and sequential and/or repeat procedures have not been studied in pediatric patients [see Indications and Usage ( 1 ) and Dosage and Administration ( 2 )] . No case of NSF associated with ProHance or any other GBCA has been identified in pediatric patients ages 6 years and younger.
Pharmacokinetic studies suggest that weight normalized clearance of ProHance is similar in pediatric patients and adults, including pediatric patients age younger than 2 years. Normal estimated GFR (eGFR) is around 30 mL/min/1.73m 2 at birth and increases to mature levels around 1 year of age, reflecting growth in both glomerular function and relative body surface area. Clinical studies in pediatric patients younger than 1 year of age have been conducted in patients with the following minimum eGRF; 59.37 mL/min/1.73m 2 (age just after birth to < 30 days), 118.84 mL/min/1.73m 2 (age 30 days to < 6 months), 140.44 mL/min/1.73m 2 (age 6 to 12 months).
🧓 Geriatric Use ▾
8.5Geriatric Use Of the total number of 2673 adult subjects in clinical studies of ProHance, 22% were 65 and over. No overall differences in safety were observed between these elderly subjects and the younger subjects. ProHance is known to be substantially excreted by the kidneys, and the risk of toxic reactions from ProHance may be greater in patients with impaired renal function.
Because elderly patients are more likely to have decreased renal function, it may be useful to monitor renal function.
🆘 Overdosage ▾
10 OVERDOSAGE Clinical consequences of overdose with ProHance have not been reported. The safety of ProHance has been tested in clinical studies using doses up to 0.3 mmol/kg and no clinical consequences related to increasing dose have been observed to date. ProHance can be removed by hemodialysis [see Use in Specific Populations ( 8.6 ) and Clinical Pharmacology ( 12.3 )] .
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Gadoteridol is a paramagnetic agent and, as such, develops a magnetic moment when placed in a magnetic field. The relatively large magnetic moment produced by the paramagnetic agent results in a relatively large local magnetic field, which can enhance the relaxation rates of water protons in the vicinity of the paramagnetic agent. In MRI, visualization of normal and pathologic brain tissue depends, in part, on variations in the radiofrequency signal intensity that occur with: 1) differences in proton density; 2) differences of the spin-lattice or longitudinal relaxation times (T1); and 3) differences in the spin-spin or transverse relaxation time (T2).
When placed in a magnetic field, gadoteridol decreases T1 relaxation times in the target tissues. At recommended doses, the effect is observed with greatest sensitivity in the T1-weighted sequences.
12.2Pharmacodynamics Gadoteridol affects proton relaxation times and consequently the MR signal. Signal intensity is affected by the dose and relaxivity of the gadoteridol molecule. Consistently, for all gadolinium based contrast agents, the relaxivity of gadoteridol decreases with the increase of the magnetic field strength used in clinical MRI (0.2 – 3.0T).
Disruption of the blood-brain barrier or abnormal vascularity allows accumulation of gadoteridol in lesions such as neoplasms, abscesses, and subacute infarcts. The pharmacokinetics of gadoteridol in various lesions is not known.
12.3Pharmacokinetics The pharmacokinetics of intravenously administered gadoteridol in normal subjects conforms to a two-compartment open model. Distribution After intravenous administration, gadoteridol is rapidly distributed in the extracellular space. The plasma distribution volume (mean ± SD) for the non-renally impaired adults was 0.205 ± 0.025 L/kg.
It is unknown if protein binding of gadoteridol occurs in vivo . Following GBCA administration, gadolinium is present for months or years in brain, bone, skin, and other organs [see Warnings and Precautions ( 5.4 )] . Metabolism It is unknown if biotransformation or decomposition of gadoteridol occur in vivo.
Elimination Gadoteridol is eliminated unchanged via the kidneys. The elimination half-life (mean ± SD) is about 1.57 ± 0.08 hours. Within 24 hours post-injection, 94.4 ± 4.8% of the dose is excreted in the urine.
The renal and plasma clearance rates (1.41 ± 0.33 mL/ min/kg and 1.50 ± 0.35 mL/ min/kg, respectively) of gadoteridol are essentially identical, indicating no alteration in elimination kinetics on passage through the kidneys and that the drug is essentially cleared through the kidney. The volume of distribution (204 ± 58 mL/kg) is equal to that of extracellular water, and clearance is similar to that of substances which are subject to glomerular filtration. Specific Populations Gender Gender has no clinically relevant effect on the pharmacokinetics of gadoteridol.
Geriatric There were 7 elderly subjects receiving 0.1 (n = 3) and 0.3 mmol/kg (n = 4) dose of ProHance. The clearance was slightly lower in elderly subjects as compared to non-elderly subjects [see Use in Specific Populations ( 8.5 )] . Pediatric A population pharmacokinetic analysis incorporated data from 79 subjects, 45 males and 34 females.
Among 79 subjects, 41 were healthy subjects including 28 pediatric subjects between 5 years and 15 years of age. The pediatric subjects received a single intravenous dose of 0.1 mmol/kg of ProHance. From population PK model, the mean C max was 0.66 ± 0.21 mmol/L in pediatric subjects 2 years to 6 years of age, 0.58 ± 0.06 mmol/L in pediatric subjects 6 years to 12 years of age, and 0.68 ± 0.12 mmol/L in adolescent subjects older than 12 years.
The mean AUC 0-∞ was 0.74 ± 0.20 mmol/L⋅h in pediatric subjects 2 years to 6 years of age, 0.74 ± 0.09 mmol/L⋅h in pediatric subjects 6 years to 12 years of age, and 0.98 ± 0.09 mmol/L⋅h in adolescent subjects older than 12 years of age. The mean di…
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied ProHance is supplied as a sterile, nonpyrogenic, and colorless to slightly yellow solution containing 279.3 mg/mL (0.5 mmol/mL) of gadoteridol in single-dose rubber stoppered vials or prefilled syringes; ProHance is available in boxes of: Five 5 mL fills in single dose 15 mL vials (NDC 0270-1111-04) Five 10 mL fills in single dose 30 mL vials (NDC 0270-1111-01) Five 15 mL fills in single dose 30 mL vials (NDC 0270-1111-02) Five 20 mL fills in single dose 30 mL vials (NDC 0270-1111-03) Storage and Handling Store at 25°C (77° F).
Excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Protect from light. DO NOT FREEZE.
Should freezing occur in the vial, ProHance should be brought to room temperature before use. If allowed to stand at room temperature for a minimum of 60 minutes, ProHance should return to a clear, colorless to slightly yellow solution. Before use, examine the product to assure that all solids are redissolved and that the container and closure have not been damaged.
Should solids persist, discard vial.
📋 Description ▾
11 DESCRIPTION ProHance, a gadolinium-based paramagnetic MRI contrast agent, is a colorless to slightly yellow aqueous, sterile, nonpyrogenic injectable solution. Each mL contains 279.3 mg (0.5 mmol/mL) gadoteridol, 0.23 mg calteridol calcium, 1.21 mg tromethamine and water for injection; pH adjusted with hydrochloric acid and/or sodium hydroxide. ProHance contains no antimicrobial preservative.
Gadoteridol is the gadolinium complex of 10-(2-hydroxy-propyl)-1,4,7,10- tetraazacyclododecane-1,4,7-triacetic acid with a molecular weight of 558.7, an empirical formula of C 17 H 29 N 4 O 7 Gd and has the following structural formula: ProHance has a pH of 6.5 to 8.0. Pertinent physiochemical parameters are provided below: Osmolality 630 mOsmol/kg water at 37 °C Viscosity 1.3 cP at 37 °C Density 1.137 g/mL at 25 °C ProHance has an osmolality that is 2.2 times that of plasma (285 mOsmol/kg water) and is hypertonic under conditions of use.
Prohance Structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Medication Guide Advise the patient to read the FDA-approved patient labeling ( Medication Guide ) found at www.prohancemedicationguide.com . Nephrogenic Systemic Fibrosis Instruct patients to inform their physician if they: have a history of kidney disease have recently received a GBCA GBCAs increase the risk for NSF in patients with impaired elimination of the drugs. To counsel patients at risk for NSF: describe the clinical manifestations of NSF describe procedures to screen for the detection of renal impairment Instruct patients to contact their physician if they develop signs or symptoms of NSF following ProHance administration, such as burning, itching, swelling, scaling, hardening and tightening of the skin; red or dark patches on the skin; stiffness in joints with trouble moving, bending or straightening the arms, hands, legs or feet; pain in the hip bones or ribs; or muscle weakness.
General Precautions Pregnancy: Advise a pregnant woman of the potential risk of fetal exposure to ProHance [see Use in Specific Populations ( 8.1 )] Gadolinium retention: Advise patients that gadolinium is retained for months or years in brain, bone, skin, and other organs in patients with normal renal function. The clinical consequences of retention are unknown. Retention depends on multiple factors and is greater following administration of linear GBCAs than following administration of macrocyclic GBCAs [see Warnings and Precautions ( 5.4 )] .
Manufactured for: Bracco Diagnostics Inc. Princeton, NJ 08540 By BIPSO GmbH 78224 Singen (Germany) March 2025 CL101A-06
💬 Medication Guide ▾
This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: 03/2025 MEDICATION GUIDE PROHANCE ® (prō-ˈhan(t)s) (Gadoteridol injection) for intravenous use What is the most important information I should know about PROHANCE? GBCAs like PROHANCE may cause serious side effects including death, coma, encephalopathy, and seizures when it is given intrathecally (injection given into the spinal canal).
It is not known if PROHANCE is safe and effective with intrathecal use. PROHANCE is not approved for this use. PROHANCE contains a metal called gadolinium.
Small amounts of gadolinium can stay in your body including the brain, bones, skin and other parts of your body for a long time (several months to years). It is not known how gadolinium may affect you, but so far, studies have not found harmful effects in patients with normal kidneys. Rarely, patients have reported pains, tiredness, and skin, muscle or bone ailments for a long time, but these symptoms have not been directly linked to gadolinium.
There are different GBCAs that can be used for your MRI exam. The amount of gadolinium that stays in the body is different for different gadolinium medicines. Gadolinium stays in the body more after Omniscan or Optimark than after Eovist, Magnevist, or MultiHance.
Gadolinium stays in the body the least after Dotarem, Gadavist, or ProHance. People who get many doses of gadolinium medicines, women who are pregnant and young children may be at increased risk from gadolinium staying in the body. Some people with kidney problems who get gadolinium medicines can develop a condition with severe thickening of the skin, muscles and other organs in the body (nephrogenic systemic fibrosis).
Your healthcare provider should screen you to see how well your kidneys are working before you receive PROHANCE. What is PROHANCE? PROHANCE is a prescription medicine called a gadolinium-based contrast agent (GBCA).
PROHANCE, like other GBCAs, is used with a magnetic resonance imaging (MRI) scanner. An MRI exam with a GBCA, including PROHANCE, helps your doctor to see problems better than an MRI exam without a GBCA. Your doctor has reviewed your medical records and has determined that you would benefit from using a GBCA with your MRI exam.
Do not receive PROHANCE if you have had a severe allergic reaction to PROHANCE. Before receiving PROHANCE, tell your healthcare provider about all your medical conditions, including if you : have had any MRI procedures in the past where you received a GBCA. Your healthcare provider may ask you for more information including the dates of these MRI procedures. are pregnant or plan to become pregnant.
It is not known if PROHANCE can harm your unborn baby. Talk to your healthcare provider about the possible risks to an unborn baby if a GBCA such as PROHANCE is received during pregnancy have kidney problems, diabetes, or high blood pressure have had an allergic reaction to dyes (contrast agents) including GBCAs What are the possible side effects of PROHANCE? See “What is the most important information I should know about PROHANCE?” Allergic reactions.
PROHANCE can cause allergic reactions that can sometimes be serious. Your healthcare provider will monitor you closely for symptoms of an allergic reaction. The most common side effects of PROHANCE include: nausea, distortion of the sense of taste, and headache.
These are not all the possible side effects of PROHANCE. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of PROHANCE. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your healthcare provider for information about PROHANCE that is written for health professionals.
What are the ingredients in PROHANCE? Active ingredient: gadoteridol Inactive ingredients: calteridol calcium, tromethamine Manufactured by: BIPSO GmbH-78224 Singen (Germ…