Cytalux

— THERAPEUTIC CATEGORIES —
  • Imaging agents
PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Cytalux Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Pafolacianine 3.2mg/1.6mL (2mg/mL); soln for IV infusion after dilution.

    Pharmacological Class

    Optical imaging agent.

    How Supplied

    Single-dose vials—10

    Manufacturer

    On Target Laboratories

    Generic Availability

    NO

    Mechanism of Action

    Pafolacianine is a fluorescent drug that targets folate receptor (FR). Pafolacianine binds to FR-expressing cancer cells with ~1nM affinity, internalizes via receptor mediated endocytosis, and concentrates in FR-positive cancer tissues.

    Cytalux Indications

    Indications

    As an adjunct for intraoperative identification of: malignant lesions in adults with ovarian cancer; or malignant and non-malignant pulmonary lesions in adults with known or suspected lung cancer.

    Cytalux Dosage and Administration

    Adult

    See full labeling. Give as a single IV infusion of 0.025mg/kg diluted in 250mL of 5% Dextrose Injection, over 60mins (using dedicated infusion line), at 1–9hrs (ovarian cancer) or 1–24hrs (known or suspected lung cancer) prior to surgery. To be used with a near infrared (NIR) imaging system cleared by the FDA for specific use with pafolacianine.

    Children

    Not established.

    Cytalux Contraindications

    Not Applicable

    Cytalux Boxed Warnings

    Not Applicable

    Cytalux Warnings/Precautions

    Warnings/Precautions

    Should only be used by trained surgeons. Infusion-related reactions. Treat or prophylaxis with antihistamines and/or anti-nausea medication may be used. Interrupt if infusion-related reactions develop; resume after resolved. Risk of misinterpretation (including false [–] and [+]). False (+) fluorescence may be seen in areas of the bowel, kidneys, lymph nodes, and inflamed tissue. Risk of pafolacianine aggregation and infusion reactions; use only 5% Dextrose Injection for dilution. Embryo-fetal toxicity. Pregnancy: exclude status prior to initiation. Nursing mothers.

    Cytalux Pharmacokinetics

    Metabolism

    93.7% plasma protein bound.

    Elimination

    Renal (19.1%), fecal (15.8%). Half-life: 0.44 ± 0.23 hours.

    Cytalux Interactions

    Interactions

    Avoid concomitant folate, folic acid, or folate-containing supplements within 48hrs prior to Cytalux administration.

    Cytalux Adverse Reactions

    Adverse Reactions

    Nausea, vomiting, abdominal pain, flushing, other infusion-related reactions, hypersensitivity, elevation in blood pressure, dyspepsia, chest discomfort.

    Cytalux Clinical Trials

    See Literature

    Cytalux Note

    Not Applicable

    Cytalux Patient Counseling

    See Literature

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