Bicisate dihydrochloride

Bicisate dihydrochloride
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

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Overview

Bicisate dihydrochloride is a diagnostic agent that is FDA approved for the diagnosis of stroke in patients in whom stroke has already been diagnosed. Common adverse reactions include headache, dizziness, seizure, anxiety, malaise, parosmia, hallucinations, rash, nausea, syncope, cardiac failure, hypertension, angina,apnea and cyanosis..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

• Neurolite single photon emission computerized tomography (SPECT) is indicated as an adjunct to conventional CT or MRI imaging in the localization of stroke in patients in whom stroke has already been diagnosed.

• Neurolite is not indicated for assessment of functional viability of brain tissue. Also, Neurolite is not indicated for distinguishing between stroke and other brain lesions.

Dosing

• The recommended dose range for intravenous administration for a 70 kg patient is 370-1110 MBq (10-30mCi). Dose adjustments for age, weight, gender or renal or hepatic impairment have not been studied.

• The dose for the patient should be measured by a suitable radioactivity calibration system immediately before administration to the patient. Radiochemical purity should be checked before administration to the patient.

• Neurolite, like other parenteral drug products, should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Preparations containing particulate matter or discoloration should not be administered. They should be disposed of in a safe manner, in compliance with all applicable regulations.

• Prior to reconstitution, vial A and vial B are stored at 15-25°C. Protect vial A from light.

• Store at controlled room temperature after preparation.

• Aseptic techniques and effective shielding should be employed in withdrawing doses for administration to patients. Waterproof gloves and effective shielding should be worn when handling the product.

RADIATION DOSIMETRY

• The radiation doses to organs and tissues of an average patient (70 kg) for Technetium Tc99m Bicisate injected intravenously for 370 MBq (10 mCi) are shown in Table 4 and for 1110 MBq (30 mCi) are shown in Table 5.

This image is provided by the National Library of Medicine.

This image is provided by the National Library of Medicine.

Radiation dosimetry calculations performed by Radiation Internal Dose Information Center, Oak Ridge Institute for Science and Education, PO Box 117, Oak Ridge, TN 37831-0117 (865) 576-3448.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Bicisate dihydrochloride in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Bicisate dihydrochloride in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Bicisate dihydrochloride in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Bicisate dihydrochloride in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Bicisate dihydrochloride in pediatric patients.

Contraindications

• None known

Warnings

• None known

Adverse Reactions

Clinical Trials Experience

• In clinical trials, Neurolite has been administered to 1063 subjects (255 normals, 808 patients). Of these, 566 (53%) were men and 494 (47%) were women. The mean age was 58 years (range 17 to 92 years). In the 808 patients, who had experienced neurologic events, there were 11 (1.4%) deaths, none of which were clearly attributed to Neurolite.

• A total of 60 subjects experienced adverse reactions; the adverse reaction rates were comparable in the <65 year, and the >65 year age groups.

• The following adverse effects were observed in ≤ 1% of the subjects: headache, dizziness, seizure, agitation/anxiety, malaise/somnolence, parosmia, hallucinations, rash, nausea, syncope, cardiac failure, hypertension, angina, and apnea/cyanosis.

• In clinical trials of 197 patients, there were inconsistent changes in the serum calcium and phosphate levels. The cause of the changes has not been identified and their frequency and magnitude have not been clearly characterized. None of the changes required medical intervention.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Bicisate dihydrochloride in the drug label.

Drug Interactions

There is limited information regarding Bicisate dihydrochloride Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Bicisate dihydrochloride in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Bicisate dihydrochloride in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Bicisate dihydrochloride during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Bicisate dihydrochloride with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Bicisate dihydrochloride with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Bicisate dihydrochloride with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Bicisate dihydrochloride with respect to specific gender populations.

Race

There is no FDA guidance on the use of Bicisate dihydrochloride with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Bicisate dihydrochloride in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Bicisate dihydrochloride in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Bicisate dihydrochloride in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Bicisate dihydrochloride in patients who are immunocompromised.

Administration and Monitoring

Administration

INSTRUCTIONS FOR PREPARATION OF TECHNETIUM TC99M BICISATE

• Preparation of the Technetium Tc99m Bicisate from the NEUROLITE®, Kit for the Preparation of Technetium Tc99m Bicisate Injection, is done by the following aseptic procedure:

Prior to adding the Sodium Pertechnetate Tc99m Injection to vial B (the liquid vial), write the estimated activity, date, and time of preparation in the space provided on the vial label. Then tear off a radiation symbol and attach it to the neck of the vial.

• Waterproof gloves should be worn during the preparation procedure. Remove the plastic disc from both vials and swab the top of each vial closure with alcohol to disinfect the surface.

• Place vial B in a suitable radiation shield appropriately labeled with date, time of preparation, volume and activity.

• With a sterile shielded syringe, aseptically add 3.70 GBq (100 mCi) sterile, non-pyrogenic, oxidant-free Sodium Pertechnetate Tc99m Injection, in approximately 2.0 mL, to vial B. Without withdrawing the needle, remove an equal volume of air to maintain pressure within the vial.

• With a sterile syringe, rapidly inject 3.0 mL of Sodium Chloride Injection (0.9%) into vial A (the lyophilized vial) to dissolve the contents. Without withdrawing the needle, remove an equal volume of air to maintain pressure within the vial. Shake the contents of the vial for a few seconds.

• With another sterile syringe, immediately (within 30 seconds) withdraw 1.0 mL of vial A and inject it into vial B. Discard vial A immediately.

• Swirl the contents of the vial B for a few seconds, and allow this mixture to stand for thirty (30) minutes at room temperature.

• Examine the vial contents for particulates and discoloration prior to patient administration. If particulate matter and/or discoloration are seen, DO NOT USE.

Assay the reaction vial using a suitable radioactivity calibration system. Record the Technetium Tc99m concentration, total volume, assay time and date, expiration time and lot number on the vial shield label and affix the label to the shield. Store the reaction vial containing the Technetium Tc99m Bicisate at controlled room temperature until use; at such time the product should be aseptically withdrawn. The vial contains no preservative.

• Note: Adherence to the above product reconstitution instructions is recommended.

• Product should be used within 6 hours of preparation.

Monitoring

There is limited information regarding Monitoring of Bicisate dihydrochloride in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Bicisate dihydrochloride in the drug label.

Overdosage

• There is limited information regarding Chronic Overdose of Bicisate dihydrochloride in the drug label.

Pharmacology

There is limited information regarding Bicisate dihydrochloride Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Bicisate dihydrochloride Mechanism of Action in the drug label.

Structure

There is limited information regarding Bicisate dihydrochloride Structure in the drug label.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Bicisate dihydrochloride in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Bicisate dihydrochloride in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Bicisate dihydrochloride in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Bicisate dihydrochloride in the drug label.

How Supplied

• Lantheus Medical Imaging, Inc. Neurolite® Kit for the Preparation of Technetium Tc99m Bicisate for Injection, is supplied in kits of two (2) vials of A and two (2) vials of B (NDC # 11994-006-02); and five (5) vials of A and five (5) vials of B (NDC 11994-006-05). Included in each kit are one (1) package insert and twelve (12) radiation labels.

Storage

• Prior to reconstitution, vial A and vial B are stored 15-25°C. Protect vial A from light.

• Store at controlled room temperature after preparation.

• Use within 6 hours of preparation.

Images

Drug Images

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Package and Label Display Panel

This image is provided by the National Library of Medicine.

This image is provided by the National Library of Medicine.

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Bicisate dihydrochloride in the drug label.

Precautions with Alcohol

• Alcohol-Bicisate dihydrochloride interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• NEUROLITE®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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