Version November 2024
Serious hypersensitivity reactions, including anaphylaxis, can occur during or following administration of pegulicianine. Anaphylaxis occurred in 4/726 (0.6%) of patients in clinical studies. Signs and symptoms associated with other hypersensitivity reactions included pruritus, urticaria, hypotension, lip swelling, erythema, anxiety, chest pain, cyanosis, dizziness, dyspnea, headache, hypoesthesia, hyperventilation, maculopapular rash, nausea, paresthesia, visual changes, and vomiting. Before pegulicianine administration, assess all patients for any history of hypersensitivity reaction to contrast media or products containing polyethylene glycol (PEG). Always have emergency resuscitation drugs, equipment, and trained personnel promptly available. Monitor all patients for hypersensitivity reactions. If a hypersensitivity reaction is suspected, immediately discontinue the injection and initiate appropriate therapy. Pegulicianine is contraindicated in patients with a history of hypersensitivity reactions to pegulicianine.
Optical imaging: IV: 1 mg/kg (actual body weight) as a single dose 2 to 6 hours prior to imaging.
Mild kidney impairment: No dosage adjustment needed.
Moderate to severe kidney impairment: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Hypersensitivity reaction: Discontinue treatment and initiate appropriate therapy.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.
>10%: Genitourinary: Urine discoloration (85%)
1% to 10%: Hypersensitivity: Hypersensitivity reaction (1%; including anaphylaxis [<1%])
<1%:
Gastrointestinal: Nausea, vomiting
Respiratory: Dyspnea
Miscellaneous: Fever
Hypersensitivity (eg, anaphylaxis) to pegulicianine or any component of the formulation.
Concerns related to adverse effects:
• Anaphylaxis/Hypersensitivity reactions: Hypersensitivity reactions (including anaphylaxis) have occurred during or after administration; other reactions include anxiety, chest pain, cyanosis, dizziness, dyspnea, erythema, headache, hyperventilation, hypoesthesia, hypotension, lip swelling, maculopapular rash, nausea, paresthesia, pruritus, urticaria, visual changes, and vomiting. Assess patients for prior hypersensitivity reactions to contrast media agents or products containing polyethylene glycol; increased risk of serious reactions may occur. Equipment for resuscitation and trained personnel should be readily available.
Other warnings/precautions:
• Dyes: Blue dyes used for sentinel lymph node mapping procedures may interfere with pegulicianine imaging; avoid administration of dyes used for sentinel lymph node mapping procedures prior to imaging.
• Imaging interpretation risk: Interpretation errors may occur during intraoperative fluorescence imaging with pegulicianine to detect breast cancer, including false negatives and false positives. Nonfluorescing tissue in the lumpectomy cavity does not rule out the presence of residual cancer. Fluorescence may be seen in normal tissue.
Lumisight: FDA approved April 2024; anticipated availability is currently unknown.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Intravenous, as acetate:
Lumisight: 39 mg (1 ea)
No
IV: For IV administration with the Lumicell Direct Visualization System or other approved fluorescence imaging device specific to pegulicianine use only; refer to device labeling for proper training and use. Flush IV line with 10 to 20 mL of NS prior to and after administration. Administer over 3 minutes 2 to 6 hours prior to imaging.
Optical imaging agent: As an adjunct for the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery in adults with breast cancer.
Pegulicianine may be confused with pafolacianine, pegunigalsidase alfa, penicillAMINE.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Isosulfan Blue: May diminish the diagnostic effect of Pegulicianine. Risk X: Avoid combination
Methylene Blue: May diminish the diagnostic effect of Pegulicianine. Risk X: Avoid combination
Animal reproduction studies have not been conducted.
It is not known if pegulicianine is present in breast milk.
According to the manufacturer, the decision to breastfeed should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
Signs and symptoms of hypersensitivity reactions; vital signs.
Pegulicianine is an optical imaging agent that is optically inactive when intact and produces a fluorescent signal after the peptide chain is cleaved by cathepsins and matrix metalloproteases enzymes; these enzyme levels are higher in and around tumor and tumor-associated cells than normal cells.
Metabolism: Cleaved by cathepsins and matrix metalloprotease enzymes to active metabolites (fragment 2 and fragment 3); minimal hepatic metabolism in vitro.
Excretion: Unknown; however blue/green urine discoloration suggests renal excretion.
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