In magnetic resonance imaging, visualization of normal and pathologic tissue depends in part on variations in the radiofrequency signal intensity. These variations occur due to: changes in proton density; alteration of the spin-lattice or longitudinal relaxation time (T1 ); and variation of the spin-spin or transverse relaxation time (T2 ). OMNISCAN is a paramagnetic agent with unpaired electron spins which generate a local magnetic field. As water protons move through this local magnetic field, the changes in magnetic field experienced by the protons reorient them with the main magnetic field more quickly than in the absence of a paramagnetic agent.
By increasing the relaxation rate, OMNISCAN decreases both the T1 and T2 relaxation times in tissues where it is distributed. At clinical doses, the effect is primarily on the T1 relaxation time, and produces an increase in signal intensity. Disruption of the blood-brain barrier or abnormal vascularity allows accumulation of OMNISCAN in lesions such as neoplasms, abscesses, and subacute infarcts. The pharmacokinetic parameters of OMNISCAN in various lesions are not known.
The pharmacokinetics of intravenously administered gadodiamide in normal subjects conforms to an open, two-compartment model with mean distribution and elimination half-lives (reported as mean ± SD) of 3.7 ± 2.7 minutes and 77.8 ± 16 minutes, respectively. Gadodiamide is eliminated primarily in the urine with 95.4 ± 5.5% (mean ± SD) of the administered dose eliminated by 24 hours. The renal and plasma clearance rates of gadodiamide are nearly identical (1.7 and 1.8 mL/min/kg, respectively), and are similar to that of substances excreted primarily by glomerular filtration. The volume of distribution of gadodiamide (200 ± 61 mL/kg) is equivalent to that of extracellular water. Gadodiamide does not bind to human serum proteins in vitro. Following GBCA administration, gadolinium is present for months or years in brain, bone, skin, and other organs [ see Warnings and Precautions (5.4)]. Pharmacokinetic and pharmacodynamic studies have not been systematically conducted to determine the optimal dose and imaging time in patients with abnormal renal function or renal failure, in the elderly, or in pediatric patients with immature renal function.
Long term animal studies have not been performed to evaluate the carcinogenic potential of gadodiamide. The results of the following genotoxicity assays were negative: in vitro bacterial reverse mutation assay, in vitro Chinese Hamster Ovary (CHO)/Hypoxanthine Guanine Phosphoribosyl Transferase (HGPT) forward mutation assay, in vitro CHO chromosome aberration assay, and the in vivo mouse micronucleus assay at intravenous doses of 27 mmol/kg (approximately 7 times the maximum human dose based on a body surface area comparison). Impairment of male or female fertility was not observed in rats after intravenous administration three times per week at the maximum dose tested of 1.0 mmol/kg (approximately 0.5 times the maximum human dose based on a body surface area comparison).
OMNISCAN (0.1 mmol/kg) contrast enhancement in CNS MRI was evident in a study of 439 adults. In a study of sequential dosing, 57 adults received OMNISCAN 0.1 mmol/kg followed by 0.2 mmol/kg within 20 minutes (for cumulative dose of 0.3 mmol/kg). The MRIs were compared blindly. In 54/56 (96%) patients, OMNISCAN contrast enhancement was evident with both the 0.1 mmol/kg and cumulative 0.3 mmol/kg OMNISCAN doses relative to non-contrast MRI.
In comparison to the non-contrast MRI, increased numbers of brain and spine lesions were noted in 42% of patients who received OMNISCAN at any dose. In comparisons of 0.1 mmol/kg versus 0.3 mmol/kg, the results were comparable in 25/56 (45%); in 1/56 (2%) OMNISCAN 0.1 mmol/kg dose provided more diagnostic value and in 30/56 (54%) the cumulative OMNISCAN 0.3 mmol/kg dose provided more diagnostic value.
The usefulness of a single 0.3 mmol/kg bolus in comparison to the cumulative 0.3 mmol/kg (0.1 mmol/kg followed by 0.2 mmol/kg) has not been established.
OMNISCAN as a single 0.1 mmol/kg dose was evaluated in 97 pediatric patients with a mean age of 8.9 (2-18) years referred for CNS MRI. Postcontrast MRI provided added diagnostic information, diagnostic confidence, and new patient management information in 76%, 67%, and 52%, respectively, of pediatrics.
OMNISCAN was evaluated in a controlled trial of 276 patients referred for body MRI. These patients had a mean age of 57 (9-88) years. Patients received 0.1 mmol/kg OMNISCAN for imaging the thorax (noncardiac), abdomen, and pelvic organs, or a dose of 0.05 mmol/kg for imaging the kidney. Pre- and post-OMNISCAN images were evaluated blindly for the degree of diagnostic value rated on a scale of “remarkably improved, improved, no change, worse, and cannot be determined.” The postcontrast results showed “remarkably improved” or “improved” diagnostic value in 90% of the thorax, liver, and pelvis patients, and in 95% of the kidney patients.
In a dose ranging study 258 patients referred for body MRI received OMNISCAN 0.025, 0.05, 0.1 mmol/kg. The lowest effective dose of OMNISCAN for the kidney was 0.05 mmol/kg.
OMNISCAN (gadodiamide) Injection is a sterile, clear, colorless to slightly yellow, aqueous solution containing 287 mg/mL of gadodiamide in rubber stoppered vials and polypropylene syringes. OMNSICAN is supplied in the following sizes:
5 mL fill in 10 mL vial, box of 10 (NDC 0407-0690-05)
10 mL vial, box of 10 (NDC 0407-0690-10)
15 mL fill in 20 mL vial, box of 10 (NDC 0407-0690-15)
20 mL vial, box of 10 (NDC 0407-0690-20)
10 mL fill in 20 mL prefilled syringe, box of 10 (NDC 0407-0690-12)
15 mL fill in 20 mL prefilled syringe, box of 10 (NDC 0407-0690-17)
20 mL prefilled syringe, box of 10 (NDC 0407-0690-22)
Prefill Plus™ needle-free system
OMNISCAN 15 mL, box of 10 (NDC 0407-0691-62)
Contains: OMNISCAN 15 mL fill in 20 mL Single Dose Prefilled Syringe and 5 mL 0.9% Sodium Chloride Injection, USP I.V. Flush Syringe
Prefill Plus™ needle-free system
OMNISCAN 20 mL, box of 10 (NDC 0407-0691-63)
Contains: OMNISCAN 20 mL fill in 20 mL Single Dose Prefilled Syringe and 5 mL 0.9% Sodium Chloride Injection, USP I.V. Flush Syringe
Protect OMNISCAN from strong daylight and direct exposure to sunlight. Do not freeze. Freezing can cause small cracks in the vials, which would compromise the sterility of the product. Do not use if the product is inadvertently frozen.
Store OMNISCAN at controlled room temperature 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP].
Advise the patient to read the FDA-approved patient labeling (Medication Guide)
Patients receiving OMNISCAN should be instructed to inform their physician if they:
- are pregnant or breast feeding, or
- have a history of renal and/or liver disease, convulsions, asthma or allergic respiratory disorders, or recent administration of gadolinium-based contrast.
GBCAs increase the risk for NSF among 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 the patients to contact their physician if they develop signs or symptoms of NSF following OMNISCAN 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 deep in the hip bones or ribs; or muscle weakness.
- 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)].
Distributed by GE Healthcare Inc. Marlborough, MA 01752 U.S.A.
Manufactured by GE Healthcare Ireland Limited, Cork, Ireland
Product of Norwegian Origin.
OMNISCAN is a trademark of General Electric Company or one of its subsidiaries.
GE and the GE Monogram are trademarks of General Electric Company.
© 2018 General Electric Company – All rights reserved. ONC-2Z-CORK
|MEDICATION GUIDE OMNISCAN™ (OMNI-scan) (gadodiamide) Injection for intravenous use|
| What is OMNISCAN? |
| What is the most important information I should know about OMNISCAN? |
|Do not receive OMNISCAN if you have had a severe allergic reaction to OMNISCAN.|
| Before receiving OMNISCAN, tell your healthcare provider about all your medical conditions, including if you: |
|What are the possible side effects of OMNISCAN? |
|General information about the safe and effective use of OMNISCAN. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your healthcare provider for information about OMNISCAN that is written for health professionals.|
|What are the ingredients in OMNISCAN? Active ingredient: gadodiamideInactive ingredients: caldiamide sodium, hydrochloric acid, sodium hydroxide Manufactured by: GE Healthcare AS Oslo, Norway or GE Healthcare Ireland or GE Healthcare (Shanghai) Co., Ltd OMNISCAN is a trademark of General Electric Company or one of its subsidiaries. GE and the GE Monogram are trademarks of General Electric Company. For more information, go to www.GEHealthcare.com or call 1-800-654-0118.|
|This Medication Guide has been approved by the U.S. Food and Drug Administration||04/2018|
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