Optimark
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Questions & Answers
Side Effects & Adverse Reactions
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Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
Optimark is indicated for use with magnetic resonance imaging (MRI) in patients with abnormal blood-brain barrier or abnormal vascularity of the brain, spine and associated tissues.
Optimark is indicated for use with MRI to provide contrast enhancement and facilitate visualization of lesions with abnormal vascularity in the liver of patients who are highly suspect for liver structural abnormalities on computed tomography.
Optimark is indicated for use with magnetic resonance imaging (MRI) in patients with abnormal blood-brain barrier or abnormal vascularity of the brain, spine and associated tissues.
1.2 MRI of LiverOptimark is indicated for use with MRI to provide contrast enhancement and facilitate visualization of lesions with abnormal vascularity in the liver of patients who are highly suspect for liver structural abnormalities on computed tomography.
History
There is currently no drug history available for this drug.
Other Information
Optimark (gadoversetamide) injection is a nonionic gadolinium chelate of diethylenetriamine pentaacetic acid bismethoxyethylamide (gadoversetamide), for intravenous injection.
Optimark injection is provided as a sterile, preservative-free, nonpyrogenic, clear, and colorless to pale yellow, aqueous solution of gadoversetamide. Each mL of Optimark contains 330.9 mg of gadoversetamide (0.5 millimole), 28.4 mg of calcium versetamide sodium (0.05 millimole), 0.7 mg calcium chloride dihydrate (0.005 millimole), and water for injection. Sodium hydroxide and/or hydrochloric acid may have been added for pH adjustment.
Gadoversetamide is designated chemically as [8, 11-bis(carboxymethyl)-14-[2-[(2-methoxyethyl)amino]-2-oxoethyl]-6-oxo-2-oxa-5,8,11,14-tetraazahexadecan-16-oato(3-)] gadolinium with a formula weight of 661.77 g/mol and empirical formula of C20H34N5O10Gd. The structural formula of gadoversetamide in aqueous solution is:
Optimark has a pH of 5.5 to 7.5. Pertinent physiochemical data are provided below (Table 4).
| Table 4 Physiochemical Properties of Optimark |
|
| Osmolality (mOsmol/kg water) @ 37°C |
1110 |
| Viscosity (cP) @ 20°C |
3.1 |
| @ 37°C |
2.0 |
| Density (g/mL) @ 25°C |
1.160 |
Optimark has an osmolality of approximately 3.9 times that of plasma (285 mOsm/kg water) and is hypertonic under conditions of use.
Sources
Optimark Manufacturers
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Mallinckrodt Inc.
![Optimark (Gadoversetamide) Injection, Solution [Mallinckrodt Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Optimark | Mallinckrodt Inc.
2.1 Dosing Guidelines Administer Optimark as a bolus peripheral intravenous injection at a dose of 0.2 mL/kg (0.1 mmol/kg) and at a rate of 1 to 2 mL/sec delivered by manual or by power injection (see Table 1). Use sterile technique to withdraw and administer Optimark. Follow injection with a 5 mL normal saline flush to ensure complete administration of the contrast. Discard unused portions of the drug.Table 1 Dosage Chart for Optimark Injection
Body Weight
Kilograms (kg)0.1 mmol/kg
Volume (mL)40
8
50
10
60
12
70
14
80
16
90
18
100
20
110
22
120
24
130
26
140
28
150
30
2.2 Drug Handling Visually inspect Optimark for particulate matter and discoloration prior to administration. Do not use the solution if it is discolored or particulate matter is present. Do not mix Optimark with other medications or parenteral nutrition and do not administer Optimark in the same intravenous line as other medications because of the potential for chemical incompatibility. 2.3 Imaging Complete the imaging procedure within 1 hour of the injection of Optimark. Paramagnetic contrast agents may impair the visualization of lesions seen on non-contrast MRI. Interpret Optimark MR images with companion non-contrast MR images [see Clinical Pharmacology (12.2)]. 2.1 Dosing Guidelines Administer Optimark as a bolus peripheral intravenous injection at a dose of 0.2 mL/kg (0.1 mmol/kg) and at a rate of 1 to 2 mL/sec delivered by manual or by power injection (see Table 1). Use sterile technique to withdraw and administer Optimark. Follow injection with a 5 mL normal saline flush to ensure complete administration of the contrast. Discard unused portions of the drug.Table 1 Dosage Chart for Optimark Injection
Body Weight
Kilograms (kg)0.1 mmol/kg
Volume (mL)40
8
50
10
60
12
70
14
80
16
90
18
100
20
110
22
120
24
130
26
140
28
150
30
2.2 Drug Handling Visually inspect Optimark for particulate matter and discoloration prior to administration. Do not use the solution if it is discolored or particulate matter is present. Do not mix Optimark with other medications or parenteral nutrition and do not administer Optimark in the same intravenous line as other medications because of the potential for chemical incompatibility. 2.3 Imaging Complete the imaging procedure within 1 hour of the injection of Optimark. Paramagnetic contrast agents may impair the visualization of lesions seen on non-contrast MRI. Interpret Optimark MR images with companion non-contrast MR images [see Clinical Pharmacology (12.2)]. -
Mallinckrodt Inc.
Optimark | Mallinckrodt Inc.
2.1 Directions for Proper use of Pharmacy Bulk Package
NOT FOR DIRECT INFUSIONThe 50 mL Pharmacy Bulk Package is used as a multiple dose container with an appropriate transfer device to fill empty sterile syringes. Use the following procedure when transferring Optimark from the pharmacy bulk package to individual syringes:
Use of this product is restricted to a suitable work area, such as a laminar flow hood, utilizing aseptic technique. Prior to entering the vial, remove the seal and cleanse the rubber closure with a suitable antiseptic agent. Once the pharmacy bulk package is punctured, do not remove from the aseptic work area during the entire period of use. Penetrate the container closure only one time, utilizing a suitable transfer device or dispensing set that allows measured dispensing of the contents. Withdrawal of container contents should be accomplished without delay. A maximum time of 24 hours from initial closure entry is permitted to complete fluid transfer operations. Discard any unused Optimark 24 hours after the initial puncture of the bulk package. 2.2 Dosing Guidelines Administer Optimark as a bolus peripheral intravenous injection at a dose of 0.2 mL/kg (0.1 mmol/kg) and at a rate of 1 to 2 mL/sec delivered by manual or by power injection (see Table 1). Follow injection with a 5 mL normal saline flush to ensure complete administration of the contrast. Discard unused portions of the drug.Table 1 Dosage Chart for Optimark Injection
Body Weight
Kilograms (kg)0.1 mmol/kg
Volume (mL)40
8
50
10
60
12
70
14
80
16
90
18
100
20
110
22
120
24
130
26
140
28
150
30
2.3 Drug Handling Visually inspect Optimark for particulate matter and discoloration prior to administration. Do not use the solution if it is discolored or particulate matter is present. Do not mix Optimark with other medications or parenteral nutrition and do not administer Optimark in the same intravenous line as other medications because of the potential for chemical incompatibility. 2.4 Imaging Complete the imaging procedure within 1 hour of the injection of Optimark. Paramagnetic contrast agents may impair the visualization of lesions seen on non-contrast MRI. Interpret Optimark MR images with companion non-contrast MR images [see Clinical Pharmacology (12.2)]. -
Mallinckrodt Inc.
Optimark | Mallinckrodt Inc.
2.1 Dosing Guidelines Administer Optimark as a bolus peripheral intravenous injection at a dose of 0.2 mL/kg (0.1 mmol/kg) and at a rate of 1 to 2 mL/sec delivered by manual or by power injection (see Table 1). Use sterile technique to withdraw and administer Optimark. Follow injection with a 5 mL normal saline flush to ensure complete administration of the contrast. Discard unused portions of the drug.Table 1 Dosage Chart for Optimark Injection
Body Weight
Kilograms (kg)0.1 mmol/kg
Volume (mL)40
8
50
10
60
12
70
14
80
16
90
18
100
20
110
22
120
24
130
26
140
28
150
30
2.2 Drug Handling Visually inspect Optimark for particulate matter and discoloration prior to administration. Do not use the solution if it is discolored or particulate matter is present. Do not mix Optimark with other medications or parenteral nutrition and do not administer Optimark in the same intravenous line as other medications because of the potential for chemical incompatibility. 2.3 Imaging Complete the imaging procedure within 1 hour of the injection of Optimark. Paramagnetic contrast agents may impair the visualization of lesions seen on non-contrast MRI. Interpret Optimark MR images with companion non-contrast MR images [see Clinical Pharmacology (12.2)]. 2.1 Dosing Guidelines Administer Optimark as a bolus peripheral intravenous injection at a dose of 0.2 mL/kg (0.1 mmol/kg) and at a rate of 1 to 2 mL/sec delivered by manual or by power injection (see Table 1). Use sterile technique to withdraw and administer Optimark. Follow injection with a 5 mL normal saline flush to ensure complete administration of the contrast. Discard unused portions of the drug.Table 1 Dosage Chart for Optimark Injection
Body Weight
Kilograms (kg)0.1 mmol/kg
Volume (mL)40
8
50
10
60
12
70
14
80
16
90
18
100
20
110
22
120
24
130
26
140
28
150
30
2.2 Drug Handling Visually inspect Optimark for particulate matter and discoloration prior to administration. Do not use the solution if it is discolored or particulate matter is present. Do not mix Optimark with other medications or parenteral nutrition and do not administer Optimark in the same intravenous line as other medications because of the potential for chemical incompatibility. 2.3 Imaging Complete the imaging procedure within 1 hour of the injection of Optimark. Paramagnetic contrast agents may impair the visualization of lesions seen on non-contrast MRI. Interpret Optimark MR images with companion non-contrast MR images [see Clinical Pharmacology (12.2)].
![Optimark (Gadoversetamide) Injection, Solution [Mallinckrodt Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=eeba2959-9b95-4bd1-87af-00ed8c3976e8&name=optimark-pharmacy-bulk-package-2.jpg)
![Optimark (Gadoversetamide) Injection, Solution [Mallinckrodt Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=7e96c780-e9c2-472e-9de2-3a297bfc062b&name=optimark-in-plastic-container-2.jpg)
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