Source: FDA, National Drug Code (US) Revision Year: 2020
FLUORESCITE Injection 10% is contraindicated in patients with known hypersensitivity to fluorescein sodium or any other ingredients in this product. Rare cases of death due to anaphylaxis have been reported. [see Warnings and Precautions (5.1) and Adverse Reactions (6)].
Fluorescein sodium can induce serious intolerance reactions. These reactions of intolerance are always unpredictable but they are more frequent in patients who have previously experienced an adverse reaction after fluorescein injection (symptoms other than nausea and vomiting) or in patients with history of allergy such as food or drug induced urticaria, asthma, eczema, allergic rhinitis.
Detailed questioning of each patient is recommended before the angiography to evaluate any prior history of allergy.
Caution is to be exercised in patients with a history of allergy or bronchial asthma. An emergency tray should be available in the event of possible reaction to FLUORESCITE Injection 10%.
If a potential allergy is suspected, an intradermal skin test may be performed prior to intravenous administration, i.e., 0.05 mL injected intradermally to be evaluated 30 to 60 minutes following injection. Given the sensitivity and specificity of skin testing, a negative skin test is not proof that a patient is not allergic to fluorescein.
Care must be taken to avoid extravasation during injection as the high pH of fluorescein solution can result in severe local tissue damage. The following complications resulting from extravasation of fluorescein have been noted to occur: severe pain in the arm for several hours, sloughing of the skin, superficial phlebitis, subcutaneous granuloma, and toxic neuritis along the median curve in the antecubital area. When significant extravasation occurs, the injection should be discontinued and conservative measures to treat damaged tissue and to relieve pain should be implemented. [see Administration (2.3) and Adverse Reactions(6)].
Nausea and/or vomiting and gastrointestinal distress occur commonly within the first few minutes following injection. These reactions usually subside within 10 minutes.
Skin and Urine Discoloration: The most common reaction is temporary yellowish discoloration of the skin and urine. Urine may attain a bright yellow color. Discoloration of the skin usually fades in 6 to 12 hours and usually fades in urine in 24 to 36 hours.
Gastrointestinal Reactions: Nausea, vomiting, and gastrointestinal distress are common adverse events. A strong taste may develop after injection.
Hypersensitivity Reactions: Symptoms and signs of hypersensitivity have occurred. Generalized hives and itching, bronchospasm and anaphylaxis have been reported. Rare cases of death have been reported [see Contraindications (4.1) and Warnings and Precautions (5.1)].
Cardiopulmonary Reactions: Cardiac arrest, basilar artery ischemia, severe shock and death may occur rarely.
Neurologic Reactions: Headache may occur. Convulsions and syncope may rarely occur following injection.
Thrombophlebitis: Thrombophlebitis at the injection site has been reported. Extravasation of the solution at the injection site causes intense pain at the site and a dull aching pain in the injected arm [see Administration (2.3) and Warnings and Precautions (5.2)].
Adequate animal reproduction studies have not been conducted with fluorescein sodium. It is also not known whether fluorescein sodium can cause fetal harm when administered to a pregnant woman. Fluorescein sodium should be given to a pregnant woman only if clearly needed.
Fluorescein sodium injection has been demonstrated to be excreted in human milk for up to 4 days. Following fluorescein angiography, breast-feeding should therefore be discontinued for at least 4 days and the milk should be pumped off and discarded during this period.
Pediatric patients have been included in clinical studies. No overall differences in safety or effectiveness have been observed between pediatric and adult patients.
No overall differences in safety or effectiveness have been observed between elderly and other adult patients.
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