Pegulicianine Dosage

Applies to the following strengths: 10 mg/mL

Usual Adult Dose for:

Body Imaging

Additional dosage information:

Renal Dose Adjustments
Liver Dose Adjustments
Precautions
Dialysis
Other Comments

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.