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

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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):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

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

• Oral

• Intravenous

Monitoring

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

• Description

IV Compatibility

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

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

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

Structure

File:Bicisate dihydrochloride01.png

This image is provided by the National Library of Medicine.

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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