Pegulicianine Dosage
Applies to the following strengths: 10 mg/mL
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Body Imaging
Initial dose: 1 mg/kg IV over 3 minutes
Comments:
- Inject this drug 2 hours to 6 hours prior to imaging.
Use: Imaging agent indicated for fluorescence imaging in patients with breast cancer as an adjunct for the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery.
Renal Dose Adjustments
Data not available
Liver Dose Adjustments
Data not available
Precautions
US BOXED WARNINGS:
- Patients have reported pruritus, urticaria, hypotension, lip swelling, erythema, anxiety, chest pain, cyanosis, dizziness, dyspnea, headache, hypoesthesia, hyperventilation, maculopapular rash, nausea, paresthesia, visual changes, and vomiting. Assess for history of hypersensitivity to contrast media or products with polyethylene glycol. Always have available emergency resuscitation drugs, equipment, and trained personnel. Monitor for hypersensitivity through symptom reporting, direct observation, and vital sign measurements. Discontinue injection and initiate appropriate therapy in the case of a suspected hypersensitivity reaction.
CONTRAINDICATIONS:
- Hypersensitivity to the active component or any of the ingredients
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice:
- Flush IV line with 10 mL to 20 mL of 0.9% sodium chloride before and after administering.
Storage requirements:
- Store in freezer at -25C to -15C (-13F to 5F).
- Protect from light.
Reconstitution/preparation techniques:
- Allow the vials to acclimate to room temperature.
- Aseptic technique should be used.
- Only 0.45% sodium chloride injection, USP should be used for reconstitution.
- Reconstitute with 4 mL.
- Visually inspect for particulate matter. Discard if necessary.
- After reconstitution, may be stored at room temperature for 4 hours and refrigerated at 2C to 8C (35F to 46F) for 24 hours prior to use.
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