INTERACTIONS Use of folate, folic acid, or folate-containing supplements may reduce binding of pafolacianine to folate receptors and could reduce the detection of lesions with CYTALUX. Avoid administration of folate, folic acid, or folate-containing supplements within 48 hours before administration of CYTALUX [see Dosage and Administration (2.1) and Clinical Pharmacology (12.1) ].
Folate
Supplements: Avoid folate, folic acid, or folate-containing supplements within 48 hours before administration of CYTALUX. (7)
See
17 for PATIENT COUNSELING INFORMATION.
AND PRECAUTIONS Infusion-Related Reactions: Interrupt the infusion and treat as necessary with antihistamines and/or nausea medications. ( 5.1 ) Risk of misinterpretation: Non-fluorescing tissue in the surgical field does not rule out the presence of tumor. Fluorescence may be seen in non-cancerous tissues. ( 5.2 ) Embryo-Fetal Toxicity: CYTALUX may cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus. ( 5.3 , 8.1 , 8.3 ) Risk of Pafolacianine Aggregation and Infusion Reactions: Use only 5% Dextrose Injection for dilution. Do not use other diluents. ( 5.4 )
5.1 Infusion-Related Reactions Adverse reactions including nausea, vomiting, abdominal pain, flushing, hypersensitivity, elevation in blood pressure, dyspepsia, and chest discomfort were reported in patients receiving CYTALUX in clinical studies. A total of 17% of patients experienced reactions during the administration of CYTALUX <span class="opacity-50 text-xs">[see Adverse Reactions ( 6.1 )]</span> . Reactions typically occurred within 15 minutes of the start of infusion. CYTALUX infusion interruption or discontinuation due to adverse reactions occurred in 11% of all patients. Treatment with antihistamines and/or anti-nausea medication may be used. If an adverse reaction occurs during administration, the infusion can be interrupted and resumed after treatment of the reaction <span class="opacity-50 text-xs">[see Dosage and Administration ( 2.1 , 2.4 )]</span> .
5.2 Risk of Misinterpretation Errors may occur with the use of CYTALUX during intraoperative fluorescence imaging to detect ovarian cancer and lesions in the lung, including false negatives and false positives. Non-fluorescing tissue in the surgical field does not rule out the presence of ovarian cancer or lesions in the lung <span class="opacity-50 text-xs">[see Clinical Studies ( 14 )]</span> . Fluorescence may be seen in normal tissues including bowel, kidneys, lymph nodes, and lungs as well as in inflamed tissues.
5.3 Embryo-Fetal Toxicity Based on its mechanism of action, CYTALUX may cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential of the potential risk to a fetus. Verify pregnancy status of females of reproductive potential prior to initiating CYTALUX treatment. [ see Use in Specific Populations ( 8.1 , 8.3 ), Clinical Pharmacology ( 12.1 ) ].
5.4 Risk of Pafolacianine Aggregation and Infusion Reactions Use of the incorrect diluent to prepare the CYTALUX infusion solution can cause the aggregation of pafolacianine; aggregation may induce infusion reactions, such as nausea, vomiting, abdominal pain or rash. Use only 5% Dextrose Injection to prepare the CYTALUX infusion solution. Do not use other diluents. <span class="opacity-50 text-xs">[see Dosage and Administration ( 2.3 )]</span>.
5.1 Infusion-Related Reactions Adverse reactions including nausea, vomiting, abdominal pain, flushing, hypersensitivity, elevation in blood pressure, dyspepsia, and chest discomfort were reported in patients receiving CYTALUX in clinical studies. A total of 17% of patients experienced reactions during the administration of CYTALUX <span class="opacity-50 text-xs">[see Adverse Reactions ( 6.1 )]</span> . Reactions typically occurred within 15 minutes of the start of infusion. CYTALUX infusion interruption or discontinuation due to adverse reactions occurred in 11% of all patients. Treatment with antihistamines and/or anti-nausea medication may be used. If an adverse reaction occurs during administration, the infusion can be interrupted and resumed after treatment of the reaction <span class="opacity-50 text-xs">[see Dosage and Administration ( 2.1 , 2.4 )]</span> .
5.2 Risk of Misinterpretation Errors may occur with the use of CYTALUX during intraoperative fluorescence imaging to detect ovarian cancer and lesions in the lung, including false negatives and false positives. Non-fluorescing tissue in the surgical field does not rule out the presence of ovarian cancer or lesions in the lung <span class="opacity-50 text-xs">[see Clinical Studies ( 14 )]</span> . Fluorescence may be seen in normal tissues including bowel, kidneys, lymph nodes, and lungs as well as in inflamed tissues.
5.3 Embryo-Fetal Toxicity Based on its mechanism of action, CYTALUX may cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential of the potential risk to a fetus. Verify pregnancy status of females of reproductive potential prior to initiating CYTALUX treatment. [ see Use in Specific Populations ( 8.1 , 8.3 ), Clinical Pharmacology ( 12.1 ) ].
5.4 Risk of Pafolacianine Aggregation and Infusion Reactions Use of the incorrect diluent to prepare the CYTALUX infusion solution can cause the aggregation of pafolacianine; aggregation may induce infusion reactions, such as nausea, vomiting, abdominal pain or rash. Use only 5% Dextrose Injection to prepare the CYTALUX infusion solution. Do not use other diluents. <span class="opacity-50 text-xs">[see Dosage and Administration ( 2.3 )]</span>.