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| Product NDC Code | 81052-138 | ||||
|---|---|---|---|---|---|
| Drug Name | Cytalux |
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| Type | Brand | ||||
| Pharm Class | Fluorescence Contrast Activity [MoA], Optical Imaging Agent [EPC] |
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| Active Ingredients |
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| Route | INTRAVENOUS | ||||
| Dosage Form | INJECTION | ||||
| Application Number | NDA214907 | ||||
| Labeler Name | On Target Laboratories, Inc. | ||||
| Packages |
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Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.6 ADVERSE REACTIONS The following clinically significant adverse reaction is described elsewhere in the labeling: • Infusion-Related Reactions [ see Warnings and Precautions ( 5.1 ) ] Most common adverse reactions (incidence ≥1%; ovarian and lung combined) included nausea, vomiting, abdominal pain, flushing, other infusion-related reactions, hypersensitivity, elevation in blood pressure, dyspepsia, and chest discomfort. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact On Target Laboratories at 1-844-434-9333 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of CYTALUX was evaluated in four open label clinical studies, two studies (N = 44 and N = 150) in patients with ovarian cancer and two studies (N = 100 and N = 112) in patients with known or suspected cancer in the lung. A total of 406 patients received 0.025 mg/kg of CYTALUX via intravenous administration. The demographic characteristics of the study population were 82% female (66% female in lung studies), mean age 64 years (range 26 to 89 years), 85% White, 6% Black or African American, 5% Asian, and 4% other race, 5% Hispanic or Latino, 92% Not Hispanic or Latino, and 3% unreported ethnicity. Adverse reactions that occurred in > 1% of patients are presented in Table 1. Table 1. Adverse Reactions from Clinical Studies Reported in ≥ 1% of CYTALUX Treated Patients with Ovarian Cancer or Known or Suspected Cancer in the Lung Adverse Reaction CYTALUX 0.025 mg/kg (N = 406) % Nausea 13 Vomiting 5 Abdominal pain 2 Flushing 2 Other infusion-related reactions 2 Hypersensitivity 2 Elevation in blood pressure 1 Dyspepsia 1 Chest discomfort 1 Adverse reactions occurred during the administration of CYTALUX in 17% of patients. Overall, the safety profile observed in patients treated with CYTALUX 0.025 mg/kg was similar between patients with ovarian cancer and patients with known or suspected cancer in the lung.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of CYTALUX was evaluated in four open label clinical studies, two studies (N = 44 and N = 150) in patients with ovarian cancer and two studies (N = 100 and N = 112) in patients with known or suspected cancer in the lung. A total of 406 patients received 0.025 mg/kg of CYTALUX via intravenous administration. The demographic characteristics of the study population were 82% female (66% female in lung studies), mean age 64 years (range 26 to 89 years), 85% White, 6% Black or African American, 5% Asian, and 4% other race, 5% Hispanic or Latino, 92% Not Hispanic or Latino, and 3% unreported ethnicity. Adverse reactions that occurred in > 1% of patients are presented in Table 1. Table 1. Adverse Reactions from Clinical Studies Reported in ≥ 1% of CYTALUX Treated Patients with Ovarian Cancer or Known or Suspected Cancer in the Lung Adverse Reaction CYTALUX 0.025 mg/kg (N = 406) % Nausea 13 Vomiting 5 Abdominal pain 2 Flushing 2 Other infusion-related reactions 2 Hypersensitivity 2 Elevation in blood pressure 1 Dyspepsia 1 Chest discomfort 1 Adverse reactions occurred during the administration of CYTALUX in 17% of patients. Overall, the safety profile observed in patients treated with CYTALUX 0.025 mg/kg was similar between patients with ovarian cancer and patients with known or suspected cancer in the lung.
| Adverse Reaction | |
| Nausea | |
| Vomiting | 5 |
| Abdominal pain | 2 |
| Flushing | |
| Other infusion-related reactions | 2 |
| Hypersensitivity | 2 |
| Elevation in blood pressure | 1 |
| Dyspepsia | 1 |
| Chest discomfort | 1 |
| Adverse Reaction | |
| Nausea | |
| Vomiting | 5 |
| Abdominal pain | 2 |
| Flushing | |
| Other infusion-related reactions | 2 |
| Hypersensitivity | 2 |
| Elevation in blood pressure | 1 |
| Dyspepsia | 1 |
| Chest discomfort | 1 |
Cytalux Drug Interactions
Information about and practical guidance on preventing clinically significant drug/drug and drug/food interactions that may occur in people taking the drug.7 DRUG 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.
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Pafolacianine binds to folate receptor (FR)-expressing cells with ~1 nM affinity, internalizes via receptor-mediated endocytosis, and accumulates intracellularly. Pafolacianine absorbs light in the near-infrared (NIR) region within a range of 760 nm to 785 nm with peak absorption of 776 nm and emits fluorescence within a range of 790 nm to 815 nm with a peak emission of 796 nm. CYTALUX is a fluorescent drug that targets FR, which are overexpressed in ovarian cancer. The mechanism of CYTALUX detection of lung lesions is not well understood. The density of FR in malignant lesions in the lung is generally similar to that of normal lung tissue. 12.2 Pharmacodynamics Tumor to background ratios of fluorescence intensity changed with different mass doses studied in patients with ovarian cancer. High tumor to background ratio was observed with 0.025 mg/kg dose. CYTALUX exposure-response relationships and the time course of pharmacodynamic responses are unknown. 12.3 Pharmacokinetics The mean C max of pafolacianine was 59.1 ± 5.94 ng/mL and AUC inf was 63.6 ± 12.6 ng.hr/mL. Distribution The mean volume of distribution (V z ) is 17.1 ± 5.99 L, indicating distribution into tissues. Plasma protein binding of pafolacianine is 93.7%. No notable partitioning into red blood cells has been observed. Elimination The elimination half-life of pafolacianine is 0.44 ± 0.23 hours and mean plasma clearance is 28.6 ± 4.97 L/hr. Metabolism Pafolacianine sodium is not metabolized by cytochrome P450 (CYP) enzymes. Excretion Following a single IV infusion of radiolabeled pafolacianine sodium, approximately 35% of the dose was recovered in urine (19.1%) and in feces (15.8%) after approximately 3-5 weeks. Specific Populations No clinically significant differences in pharmacokinetics of pafolacianine were identified based on age 18 to 89 years, weight 41.6 to 133.6 kg, mild to moderate renal impairment (CLcr 30 to 89 mL/min), mild to moderate hepatic impairment (total bilirubin < 3 ULN and AST > ULN). The effect of severe renal impairment (CLcr < 30 mL/min) and severe hepatic impairment (total bilirubin > 3 ULN and any AST value) on the pharmacokinetics of pafolacianine have not been studied. Drug Interaction Studies No clinical studies evaluating the drug interaction potential of pafolacianine have been conducted. In Vitro Studies CYP Enzymes: Pafolacianine is not an inhibitor of CYPs 1A2, 2B6, 2C8, 2C9, 2C19 2D6, 3A4/5. UDP-glucuronosyltransferase (UGT) Enzymes: Pafolacianine is not an inhibitor of UGT1A1. Transporter Systems: Pafolacianine is a substrate for OATP1B1, OATP1B3, and OAT1. Pafolacianine is not an inhibitor of OATP1B1, OATP1B3, OAT1, OAT3, OCT2, MATE1, MATE2-K, P-gp, or BCRP
12.1 Mechanism of Action Pafolacianine binds to folate receptor (FR)-expressing cells with ~1 nM affinity, internalizes via receptor-mediated endocytosis, and accumulates intracellularly. Pafolacianine absorbs light in the near-infrared (NIR) region within a range of 760 nm to 785 nm with peak absorption of 776 nm and emits fluorescence within a range of 790 nm to 815 nm with a peak emission of 796 nm. CYTALUX is a fluorescent drug that targets FR, which are overexpressed in ovarian cancer. The mechanism of CYTALUX detection of lung lesions is not well understood. The density of FR in malignant lesions in the lung is generally similar to that of normal lung tissue.
12.2 Pharmacodynamics Tumor to background ratios of fluorescence intensity changed with different mass doses studied in patients with ovarian cancer. High tumor to background ratio was observed with 0.025 mg/kg dose. CYTALUX exposure-response relationships and the time course of pharmacodynamic responses are unknown.
12.3 Pharmacokinetics The mean C max of pafolacianine was 59.1 ± 5.94 ng/mL and AUC inf was 63.6 ± 12.6 ng.hr/mL. Distribution The mean volume of distribution (V z ) is 17.1 ± 5.99 L, indicating distribution into tissues. Plasma protein binding of pafolacianine is 93.7%. No notable partitioning into red blood cells has been observed. Elimination The elimination half-life of pafolacianine is 0.44 ± 0.23 hours and mean plasma clearance is 28.6 ± 4.97 L/hr. Metabolism Pafolacianine sodium is not metabolized by cytochrome P450 (CYP) enzymes. Excretion Following a single IV infusion of radiolabeled pafolacianine sodium, approximately 35% of the dose was recovered in urine (19.1%) and in feces (15.8%) after approximately 3-5 weeks. Specific Populations No clinically significant differences in pharmacokinetics of pafolacianine were identified based on age 18 to 89 years, weight 41.6 to 133.6 kg, mild to moderate renal impairment (CLcr 30 to 89 mL/min), mild to moderate hepatic impairment (total bilirubin < 3 ULN and AST > ULN). The effect of severe renal impairment (CLcr < 30 mL/min) and severe hepatic impairment (total bilirubin > 3 ULN and any AST value) on the pharmacokinetics of pafolacianine have not been studied. Drug Interaction Studies No clinical studies evaluating the drug interaction potential of pafolacianine have been conducted. In Vitro Studies CYP Enzymes: Pafolacianine is not an inhibitor of CYPs 1A2, 2B6, 2C8, 2C9, 2C19 2D6, 3A4/5. UDP-glucuronosyltransferase (UGT) Enzymes: Pafolacianine is not an inhibitor of UGT1A1. Transporter Systems: Pafolacianine is a substrate for OATP1B1, OATP1B3, and OAT1. Pafolacianine is not an inhibitor of OATP1B1, OATP1B3, OAT1, OAT3, OCT2, MATE1, MATE2-K, P-gp, or BCRP
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.4 CONTRAINDICATIONS None. None. (4)
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.11 DESCRIPTION CYTALUX contains pafolacianine, an optical imaging agent, as a tetrasodium salt referred to as pafolacianine sodium. Chemically, pafolacianine sodium is (S)-2-(4-(((2-amino-4-oxo-3,4- dihydropteridin-6-yl)methyl)amino)benzamido)-3-(4-(((E)-2-((E)-2-(3,3-dimethyl-5-sulfonato-1-(4- sulfonatobutyl)-3H-indol-1-ium-2-yl)vinyl)-6-((E)-2-(3,3-dimethyl-5-sulfonato-1-(4- sulfonatobutyl)indolin-2-ylidene)ethylidene)cyclohex-1-en-1-yl)oxy)phenyl)propanoate hydrate tetrasodium. Pafolacianine sodium has a molecular formula of C 61 H 63 N 9 Na 4 O 17 S 4 , a molecular mass of 1414.42 g/mol and has the following structure: CYTALUX (pafolacianine) injection is a sterile, non-pyrogenic, dark bluish green, clear aqueous solution for intravenous use. Each vial contains 3.2 mg (2 mg/mL) pafolacianine (equivalent to 3.4 mg pafolacianine sodium),14.4 mg sodium chloride, 0.23 mg potassium phosphate monobasic, 1.27 mg sodium phosphate dibasic heptahydrate in 1.6 mL volume. The pH is adjusted with sodium hydroxide and/or hydrochloric acid and is between 7.1 to 7.8. 214907s000lbl.jpg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.2 DOSAGE AND ADMINISTRATION For recommended testing, evaluations, and premedications, see Full Prescribing Information. ( 2.1 ) Recommended intravenous dosage of CYTALUX is: Adult Patients with Ovarian Cancer: 0.025 mg/kg over 60 minutes, 1 hour to 9 hours prior to surgery Adult Patients with Known or Suspected Cancer in the Lung: 0.025 mg/kg over 60 minutes, 1 hour to 24 hours prior to surgery. ( 2.2 ) For preparation, management of infusion-related reactions, and imaging information see Full Prescribing Information. CYTALUX should only be used by trained surgeons using FDA cleared imaging systems. ( 2.3 , 2.4 , 2.5 ) 2.1 Recommended Testing, Evaluations and Premedications Prior to Administration of CYTALUX Obtain a pregnancy test in females of reproductive potential and verify the absence of pregnancy prior to administration of CYTALUX [ see Warnings and Precautions (5.3) and Use in Specific Populations ( 8.1 , 8.3 ) ]. Discontinue folate, folic acid, or folate containing supplements 48 hours before administration of CYTALUX [ see Drug Interactions (7) ]. Consider administering antihistamines and/or anti-nausea medication for prophylaxis against infusion related reactions [ see Warnings and Precautions (5.1) ]. 2.2 Recommended Dosage and Administration Adult Patients with Ovarian Cancer The recommended dose of CYTALUX is a single intravenous infusion of 0.025 mg/kg diluted in 250 mL of 5% Dextrose Injection, administered over 60 minutes using a dedicated infusion line, 1 hour to 9 hours prior to surgery. Adult Patients with Known or Suspected Cancer in the Lung The recommended dose of CYTALUX is a single intravenous infusion of 0.025 mg/kg diluted in 250 mL of 5% Dextrose Injection, administered over 60 minutes using a dedicated infusion line, 1 hour to 24 hours prior to surgery. 2.3 Preparation and Storage Instructions Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. 1. Use aseptic technique for the preparation of CYTALUX infusion solution. 2. Only use 5% Dextrose Injection for dilution. Do not use other diluents due to incompatibility [see Warnings and Precautions (5.4) ]. 3. Thaw frozen CYTALUX vial in original carton at controlled room temperature between 20° to 25°C (68° to 77°F) for at least 90 minutes. 4. Hand shake or vortex the thawed CYTALUX vial for 60 seconds. 5. Withdraw the calculated volume of CYTALUX for a dose of 0.025 mg/kg. Discard any unused portion in the vial. 6. Add into a 250 mL of 5% Dextrose Injection, USP bag. 7. Gently swirl the bag by hand for 1 minute to mix the solution. 8. Visually inspect the infusion bag. The solution should be light blue/green to clear in color and should not contain any visible particulate matter. 9. Protect the infusion bag from light using a light-blocking cover during infusion and storage. 10. If not immediately used, store the diluted CYTALUX infusion solution in a refrigerator at 2°C to 8°C (36°F to 46°F) for not more than 24 hours. Once the bag is removed from refrigeration, infusion must be completed within 3 hours. 2.4 Management of Infusion-Related Reactions If the patient develops an infusion reaction during administration, interrupt the infusion and treat with antihistamines and/or anti-nausea medication as necessary, based on clinical decision. Complete the infusion within 3 hours of the start of the initial administration [ see Warnings and Precautions (5.1) ]. 2.5 Imaging Clinical data demonstrate that near infrared (NIR) imaging devices that excite at 760 nm to 785 nm and detect emission at 790 nm to 815 nm are suitable for use with CYTALUX. CYTALUX is to be used with an NIR imaging system cleared by the FDA for specific use with pafolacianine. CYTALUX should only be used by surgeons who have completed a training program on the use of NIR imaging systems for fluorescence imaging during surgery. Training is provided by the device manufacturer.
2.1 Recommended Testing, Evaluations and Premedications Prior to Administration of CYTALUX Obtain a pregnancy test in females of reproductive potential and verify the absence of pregnancy prior to administration of CYTALUX [ see Warnings and Precautions (5.3) and Use in Specific Populations ( 8.1 , 8.3 ) ]. Discontinue folate, folic acid, or folate containing supplements 48 hours before administration of CYTALUX [ see Drug Interactions (7) ]. Consider administering antihistamines and/or anti-nausea medication for prophylaxis against infusion related reactions [ see Warnings and Precautions (5.1) ].
2.2 Recommended Dosage and Administration Adult Patients with Ovarian Cancer The recommended dose of CYTALUX is a single intravenous infusion of 0.025 mg/kg diluted in 250 mL of 5% Dextrose Injection, administered over 60 minutes using a dedicated infusion line, 1 hour to 9 hours prior to surgery. Adult Patients with Known or Suspected Cancer in the Lung The recommended dose of CYTALUX is a single intravenous infusion of 0.025 mg/kg diluted in 250 mL of 5% Dextrose Injection, administered over 60 minutes using a dedicated infusion line, 1 hour to 24 hours prior to surgery.
2.3 Preparation and Storage Instructions Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. 1. Use aseptic technique for the preparation of CYTALUX infusion solution. 2. Only use 5% Dextrose Injection for dilution. Do not use other diluents due to incompatibility [see Warnings and Precautions (5.4) ]. 3. Thaw frozen CYTALUX vial in original carton at controlled room temperature between 20° to 25°C (68° to 77°F) for at least 90 minutes. 4. Hand shake or vortex the thawed CYTALUX vial for 60 seconds. 5. Withdraw the calculated volume of CYTALUX for a dose of 0.025 mg/kg. Discard any unused portion in the vial. 6. Add into a 250 mL of 5% Dextrose Injection, USP bag. 7. Gently swirl the bag by hand for 1 minute to mix the solution. 8. Visually inspect the infusion bag. The solution should be light blue/green to clear in color and should not contain any visible particulate matter. 9. Protect the infusion bag from light using a light-blocking cover during infusion and storage. 10. If not immediately used, store the diluted CYTALUX infusion solution in a refrigerator at 2°C to 8°C (36°F to 46°F) for not more than 24 hours. Once the bag is removed from refrigeration, infusion must be completed within 3 hours.
2.4 Management of Infusion-Related Reactions If the patient develops an infusion reaction during administration, interrupt the infusion and treat with antihistamines and/or anti-nausea medication as necessary, based on clinical decision. Complete the infusion within 3 hours of the start of the initial administration [ see Warnings and Precautions (5.1) ].
2.5 Imaging Clinical data demonstrate that near infrared (NIR) imaging devices that excite at 760 nm to 785 nm and detect emission at 790 nm to 815 nm are suitable for use with CYTALUX. CYTALUX is to be used with an NIR imaging system cleared by the FDA for specific use with pafolacianine. CYTALUX should only be used by surgeons who have completed a training program on the use of NIR imaging systems for fluorescence imaging during surgery. Training is provided by the device manufacturer.
Dosage forms and strengths
Information about all available dosage forms and strengths for the drug product to which the labeling applies. This field may contain descriptions of product appearance.3 DOSAGE FORMS AND STRENGTHS Injection: 3.2 mg/1.6 mL (2 mg/mL) pafolacianine (equivalent to 3.4 mg/1.6 mL pafolacianine sodium) supplied as a dark bluish green, clear aqueous solution in a single-dose vial. Injection: 3.2 mg/1.6 mL (2 mg/mL) of pafolacianine in a single-dose vial. (3)
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.1. INDICATIONS AND USAGE CYTALUX is indicated as an adjunct for intraoperative identification of: Malignant lesions in adult patients with ovarian cancer. Malignant and non-malignant pulmonary lesions in adult patients with known or suspected cancer in the lung. CYTALUX is an optical imaging agent indicated as an adjunct for intraoperative identification of: Malignant lesions in adult patients with ovarian cancer. Malignant and non-malignant pulmonary lesions in adult patients with known or suspected cancer in the lung. ( 1 )
Spl product data elements
Usually a list of ingredients in a drug product.Cytalux Pafolacianine injection WATER SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE SODIUM CHLORIDE HYDROCHLORIC ACID PAFOLACIANINE SODIUM PAFOLACIANINE POTASSIUM PHOSPHATE, MONOBASIC SODIUM HYDROXIDE Dark Bluish
Nonclinical toxicology
Information about toxicology in non-human subjects.13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis No carcinogenicity studies of pafolacianine have been conducted. Mutagenesis No genotoxic hazards were identified when pafolacianine was evaluated in a standard testing battery consisting of a bacterial reverse mutation assay, an in vitro micronucleus study conducted in Chinese Hamster Ovary (CHO) cells, and a rat bone marrow micronucleus study. Impairment of Fertility Reproductive and developmental toxicity (fertility and embryonic development, pre- and postnatal development) studies in animals have not been performed to evaluate the effects of pafolacianine on fertility.
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis No carcinogenicity studies of pafolacianine have been conducted. Mutagenesis No genotoxic hazards were identified when pafolacianine was evaluated in a standard testing battery consisting of a bacterial reverse mutation assay, an in vitro micronucleus study conducted in Chinese Hamster Ovary (CHO) cells, and a rat bone marrow micronucleus study. Impairment of Fertility Reproductive and developmental toxicity (fertility and embryonic development, pre- and postnatal development) studies in animals have not been performed to evaluate the effects of pafolacianine on fertility.
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PACKAGING - PRINCIPAL DISPLAY PANEL 10 Vial Carton NDC 81052-138-10 cytalux™ (pafolacianine) injection 3.2 mg / 1.6 mL (2 mg/mL) 10 x 1.6 mL Single-Dose Vials. Discard Unused Portion For Intravenous Infusion After Dilution Store in freezer at -25° to -15°C ( -13° to 5°F) Store in original carton to protect from light. Rx only ON TARGET LABORATORIES Contains: 3.2 mg pafolacianine (equivalent to 3.4 mg pafolacianine sodium) 14.4 mg sodium chloride, USP 0.23 mg potassium phosphate monobasic 1.27 mg potassium phosphate dibasic heptahydrate Thaw at room temperature, 20° to 25°C (68° to 77°F), for at least 90 minutes in the carton prior to preparation. Must dilute with 5% dextrose injection, USP only before use. Store diluted solution in dark in refrigerator and use within 24 hrs. of preparation. Recommended Dosage: See Prescribing Information Manufactured for: On Target Laboratories West Lafayette, IN 47906 For more information, visit www.CYTALUX.com or call 1.844.434.9333. 10 Vial Carton Label Single Vial Carton Label NDC 81052-138-10 cytalux™ (pafolacianine) injection 3.2 mg / 1.6 mL (2 mg/mL) For Intravenous Infusion After Dilution 1 Single-Dose Vial Discard Unused Portion Store in freezer at -25° to -15°C (-13° to 5°F) Store in original carton to protect from light. Rx only ON TARGET LABORATORIES Contains: 3.2 mg pafolacianine (equivalent to 3.4 mg pafolacianine sodium) 14.4 mg sodium chloride, USP 0.23 mg potassium phosphate monobasic 1.27 mg potassium phosphate dibasic heptahydrate Thaw at room temperature, 20° to 25°C (68° to 77°F), for at least 90 minutes in the carton prior to preparation. Must dilute with 5% dextrose injection, USP only before use. Store diluted solution in dark in refrigerator and use within 24 hrs. of preparation. Recommended Dosage: See Prescribing Information Manufactured for: On Target Laboratories West Lafayette, IN 47906 For more information, visit www.CYTALUX.com or call 1.844.434.9333. Single Vial Carton Vial Label NDC 81052-138-10 Sterile cytalux™ (pafolacianine) injection 3.2 mg / 1.6 mL (2 mg/mL) For Intravenous Infusion After Dilution Discard Unused Portion Single-Dose Vial Rx only ON TARGET LABORATORIES 14372 LOT: EXP: YYYY/MM Vial Label
10 Vial Carton NDC 81052-138-10 cytalux™ (pafolacianine) injection 3.2 mg / 1.6 mL (2 mg/mL) 10 x 1.6 mL Single-Dose Vials. Discard Unused Portion For Intravenous Infusion After Dilution Store in freezer at -25° to -15°C ( -13° to 5°F) Store in original carton to protect from light. Rx only ON TARGET LABORATORIES Contains: 3.2 mg pafolacianine (equivalent to 3.4 mg pafolacianine sodium) 14.4 mg sodium chloride, USP 0.23 mg potassium phosphate monobasic 1.27 mg potassium phosphate dibasic heptahydrate Thaw at room temperature, 20° to 25°C (68° to 77°F), for at least 90 minutes in the carton prior to preparation. Must dilute with 5% dextrose injection, USP only before use. Store diluted solution in dark in refrigerator and use within 24 hrs. of preparation. Recommended Dosage: See Prescribing Information Manufactured for: On Target Laboratories West Lafayette, IN 47906 For more information, visit www.CYTALUX.com or call 1.844.434.9333. 10 Vial Carton Label
Single Vial Carton Label NDC 81052-138-10 cytalux™ (pafolacianine) injection 3.2 mg / 1.6 mL (2 mg/mL) For Intravenous Infusion After Dilution 1 Single-Dose Vial Discard Unused Portion Store in freezer at -25° to -15°C (-13° to 5°F) Store in original carton to protect from light. Rx only ON TARGET LABORATORIES Contains: 3.2 mg pafolacianine (equivalent to 3.4 mg pafolacianine sodium) 14.4 mg sodium chloride, USP 0.23 mg potassium phosphate monobasic 1.27 mg potassium phosphate dibasic heptahydrate Thaw at room temperature, 20° to 25°C (68° to 77°F), for at least 90 minutes in the carton prior to preparation. Must dilute with 5% dextrose injection, USP only before use. Store diluted solution in dark in refrigerator and use within 24 hrs. of preparation. Recommended Dosage: See Prescribing Information Manufactured for: On Target Laboratories West Lafayette, IN 47906 For more information, visit www.CYTALUX.com or call 1.844.434.9333. Single Vial Carton
Vial Label NDC 81052-138-10 Sterile cytalux™ (pafolacianine) injection 3.2 mg / 1.6 mL (2 mg/mL) For Intravenous Infusion After Dilution Discard Unused Portion Single-Dose Vial Rx only ON TARGET LABORATORIES 14372 LOT: EXP: YYYY/MM Vial Label
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.RECENT MAJOR CHANGES Indications and Usage ( 1 ) 12/2022 Dosage and Administration, Recommended Dosage and Administration ( 2.2 ) 12/2022 Dosage and Administration, Imaging ( 2.5 ) 12/2022 Warnings and Precautions, Infusion-Related Reactions ( 5.1 ) 12/2022 Warnings and Precautions, Risk of Misinterpretation ( 5.2 ) 12/2022
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.17 PATIENT COUNSELING INFORMATION Embryo-Fetal Toxicity Advise females of reproductive potential of the potential risk to a fetus and to contact their healthcare provider with a known or suspected pregnancy [ see Warnings and Precautions ( 5.3 ) and Use In Specific Populations ( 8.1 ) ]. Folate Supplements Usage Inform patients that folic acid may reduce the detection of cancer tissue with CYTALUX. Advise the patient to stop taking folate, folic acid, or folate-containing supplements 48 hours before administration of CYTALUX [ see Dosage and Administration ( 2.1 ) and Drug Interactions ( 7 ) ]. Manufactured by: Grand River Aseptic Manufacturing 140 Front Ave SW Grand Rapids, MI 49506 Distributed by: Patheon Logistics 100 Berkeley Dr. Swedesboro, NJ 08085 Packaged by: Fisher Clinical Services Inc. 7554 Schantz Rd. Allentown, PA 18100-9032
Clinical studies
This field may contain references to clinical studies in place of detailed discussion in other sections of the labeling.14 CLINICAL STUDIES 14.1 Patients with Known or Suspected Ovarian Cancer The safety and efficacy of CYTALUX were evaluated in a randomized, multicenter, open-label study (NCT03180307). The study enrolled 178 women with a diagnosis or high clinical suspicion of ovarian cancer scheduled to undergo primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery. One hundred and fifty women received CYTALUX (dosed at 0.025 mg/kg at least 1 hour before initiation of fluorescence imaging). Among them, 134 women underwent both normal light and CYTALUX evaluation (Intent-to-Image Set). The demographic characteristics were mean age 60 (range 33 to 81) years, 85% White, 4% Asian, 5% Black or African American, 3% American Indian or Alaska native, 3% other races, 11% Hispanic or Latino, and 2% unreported ethnicity. Table 2 shows the proportion of patients with at least one evaluable ovarian cancer lesion confirmed by central histopathology that was detected with CYTALUX but not with normal light or palpation and not otherwise identified for resection prior to surgery. The detection performance met the pre-specified success threshold. Table 2: Detection Proportion with CYTALUX but Not with Normal Light or Palpation in the Intent-To-Image Set N=134 patients Patients with at least one confirmed ovarian cancer evaluable lesion Number (n) 36 Proportion (%) 95% CI 0.269 (26.9%) (0.196*, 0.352) *The pre-specified lower bound of the 95% confidence interval (CI) was 0.10. In 20.2% (95% CI: 13.7%, 28.0%) of patients, all lesions detected by CYTALUX alone were negative by central histopathology (false positive). 14.2 Patients with Known or Suspected Cancer in the Lung The safety and efficacy of CYTALUX were evaluated in a randomized, multicenter, open-label study (NCT04241315). The study enrolled 140 patients scheduled to undergo thoracoscopic or open segmental or subsegmental resection for primary lung lesions that were either confirmed or suspected to be cancer. One hundred and twelve patients received CYTALUX (dosed at 0.025 mg/kg between 1 and 24 hours before initiation of fluorescence imaging). Among them, 100 patients underwent both normal light and CYTALUX evaluation (Intent-to-Image Set). The demographic characteristics were 61% female, mean age 66 (range 26 to 83) years, 88% White, 8% Black or African American, 2% Asian, 2% other races, 99% Not Hispanic or Latino, and 1% unreported ethnicity. Histopathology of the primary lung lesions in these 100 patients showed primary lung cancer in 65%, metastasis to the lung in 21%, benign lung lesions in 11%, and other/unknown cancer in 3%. Among the primary lung cancers, 86% were adenocarcinoma, 8% were squamous cell carcinoma, 3% were adeno-squamous carcinoma, and 3% were atypical carcinoid. Table 3 shows the proportion of patients in whom at least one of the following clinically significant events (CSE) occurred with CYTALUX but not with normal light or palpation: localization of the primary lung lesion, whether benign or malignant (CSE A), and detection of one or more synchronous malignant lung lesions (CSE B). Synchronous lesions were not identified prior to surgery. The combined CSE A and CSE B detection performance met the pre-specified success threshold. Table 3: Proportion of Clinically Significant Events Occurring with CYTALUX but Not with Normal Light or Palpation in the Intent-To-Image Set N=100 patients Primary Lung Lesion (CSE A) Synchronous Malignant Lung Lesion (CSE B) Patients with CSE A and/or CSE B Number (n) 19* 8 24** Proportion (%) 95% CI 0.19 (19%) (0.118, 0.281) 0.08 (8%) (0.035, 0.152) 0.24 (24%) (0.160***, 0.336) * Including two subjects with benign primary lesions. ** Three patients had both primary lesion localization and synchronous malignant lesion detection, resulting in 27 events in 24 unique patients. *** The pre-specified lower bound of the 95% confidence interval (CI) was 0.10. CYTALUX did not identify the primary lung lesion in 23% (95% CI:15%, 32%) of patients. Among the 20 patients who had synchronous lesions detected only by CYTALUX, 12 patients had only benign synchronous lesions. The depth of primary lung lesions detected by CYTALUX ranged from 0 to 38 mm from the lung surface (mean depth 6 mm).
14.1 Patients with Known or Suspected Ovarian Cancer The safety and efficacy of CYTALUX were evaluated in a randomized, multicenter, open-label study (NCT03180307). The study enrolled 178 women with a diagnosis or high clinical suspicion of ovarian cancer scheduled to undergo primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery. One hundred and fifty women received CYTALUX (dosed at 0.025 mg/kg at least 1 hour before initiation of fluorescence imaging). Among them, 134 women underwent both normal light and CYTALUX evaluation (Intent-to-Image Set). The demographic characteristics were mean age 60 (range 33 to 81) years, 85% White, 4% Asian, 5% Black or African American, 3% American Indian or Alaska native, 3% other races, 11% Hispanic or Latino, and 2% unreported ethnicity. Table 2 shows the proportion of patients with at least one evaluable ovarian cancer lesion confirmed by central histopathology that was detected with CYTALUX but not with normal light or palpation and not otherwise identified for resection prior to surgery. The detection performance met the pre-specified success threshold. Table 2: Detection Proportion with CYTALUX but Not with Normal Light or Palpation in the Intent-To-Image Set N=134 patients Patients with at least one confirmed ovarian cancer evaluable lesion Number (n) 36 Proportion (%) 95% CI 0.269 (26.9%) (0.196*, 0.352) *The pre-specified lower bound of the 95% confidence interval (CI) was 0.10. In 20.2% (95% CI: 13.7%, 28.0%) of patients, all lesions detected by CYTALUX alone were negative by central histopathology (false positive).
14.2 Patients with Known or Suspected Cancer in the Lung The safety and efficacy of CYTALUX were evaluated in a randomized, multicenter, open-label study (NCT04241315). The study enrolled 140 patients scheduled to undergo thoracoscopic or open segmental or subsegmental resection for primary lung lesions that were either confirmed or suspected to be cancer. One hundred and twelve patients received CYTALUX (dosed at 0.025 mg/kg between 1 and 24 hours before initiation of fluorescence imaging). Among them, 100 patients underwent both normal light and CYTALUX evaluation (Intent-to-Image Set). The demographic characteristics were 61% female, mean age 66 (range 26 to 83) years, 88% White, 8% Black or African American, 2% Asian, 2% other races, 99% Not Hispanic or Latino, and 1% unreported ethnicity. Histopathology of the primary lung lesions in these 100 patients showed primary lung cancer in 65%, metastasis to the lung in 21%, benign lung lesions in 11%, and other/unknown cancer in 3%. Among the primary lung cancers, 86% were adenocarcinoma, 8% were squamous cell carcinoma, 3% were adeno-squamous carcinoma, and 3% were atypical carcinoid. Table 3 shows the proportion of patients in whom at least one of the following clinically significant events (CSE) occurred with CYTALUX but not with normal light or palpation: localization of the primary lung lesion, whether benign or malignant (CSE A), and detection of one or more synchronous malignant lung lesions (CSE B). Synchronous lesions were not identified prior to surgery. The combined CSE A and CSE B detection performance met the pre-specified success threshold. Table 3: Proportion of Clinically Significant Events Occurring with CYTALUX but Not with Normal Light or Palpation in the Intent-To-Image Set N=100 patients Primary Lung Lesion (CSE A) Synchronous Malignant Lung Lesion (CSE B) Patients with CSE A and/or CSE B Number (n) 19* 8 24** Proportion (%) 95% CI 0.19 (19%) (0.118, 0.281) 0.08 (8%) (0.035, 0.152) 0.24 (24%) (0.160***, 0.336) * Including two subjects with benign primary lesions. ** Three patients had both primary lesion localization and synchronous malignant lesion detection, resulting in 27 events in 24 unique patients. *** The pre-specified lower bound of the 95% confidence interval (CI) was 0.10. CYTALUX did not identify the primary lung lesion in 23% (95% CI:15%, 32%) of patients. Among the 20 patients who had synchronous lesions detected only by CYTALUX, 12 patients had only benign synchronous lesions. The depth of primary lung lesions detected by CYTALUX ranged from 0 to 38 mm from the lung surface (mean depth 6 mm).
| N=134 patients | |
| Number (n) | 36 |
| N=100 patients | Primary Lung Lesion (CSE A) | Synchronous Malignant Lung Lesion (CSE B) | Patients with CSE A and/or CSE B |
| Number (n) | 19* | 8 | 24** |
| N=134 patients | |
| Number (n) | 36 |
| N=100 patients | Primary Lung Lesion (CSE A) | Synchronous Malignant Lung Lesion (CSE B) | Patients with CSE A and/or CSE B |
| Number (n) | 19* | 8 | 24** |
Use in specific populations
Information about use of the drug by patients in specific populations, including pregnant women and nursing mothers, pediatric patients, and geriatric patients.8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary Based on its mechanism of action, pafolacianine may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )] . There are no available human data to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. No adverse developmental effects were observed in rats and rabbits with intravenous administration of pafolacianine during organogenesis (embryofetal development) at doses up to 158-fold (rat) and 570-fold (rabbit) the recommended human dose of 0.025 mg/kg based on AUC, otherwise 9.6 and 38.4-fold based on human equivalent dose (HED) ( see Data ). The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In the definitive embryo-fetal development (EFD) studies, pafolacianine was intravenously administered during the period of organogenesis as follows: 0.015, 0.15, and 1.5 mg/kg/day from gestational day (GD) 6 to GD17 in rats (HEDs of 0.002, 0.024 and 0.242 mg/kg/day), and 0.3, 1, and 3 mg/kg/day from GD7 to GD20 in rabbits (HEDs of 0.097, 0.323 and 0.968 mg/kg/day). No significant drug-related maternal toxicity and embryo-fetal development toxicity were observed. NOAELs were 1.5 mg/kg/day in rats and 3 mg/kg/day in rabbits. Estimated systemic exposures were 158 times (rat) and 570 times (rabbit) the human exposure at a human dose of 0.025 mg/kg based on plasma AUC comparison. 8.2 Lactation Risk Summary There are no data on the presence of pafolacianine in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for CYTALUX and any potential adverse effects on the breastfed infant from CYTALUX or from the underlying maternal condition. 8.3 Females and Males of Reproductive Potential CYTALUX may cause fetal harm if administered to a pregnant woman [see Warnings And Precautions ( 5.3 ) and Use in Specific Populations ( 8.1 )] . Pregnancy Testing Obtain a pregnancy test in females of reproductive potential and verify the absence of pregnancy prior to administration of CYTALUX [see Dosage and Administration ( 2.1 )] . 8.4 Pediatric Use Safety and effectiveness of CYTALUX in pediatric patients have not been established. 8.5 Geriatric Use Of the total number of patients in clinical studies of CYTALUX, 221 patients (54%) were 65 years of age and older: 153 (38%) were 65 to 74 years of age, 66 (16%) were 75 to 84 years of age, and 2 (0.5%) were 85 years of age and older. No overall differences in safety, effectiveness, or pharmacokinetics were observed between patients 65 years of age and older and younger adult patients.
8.1 Pregnancy Risk Summary Based on its mechanism of action, pafolacianine may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )] . There are no available human data to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. No adverse developmental effects were observed in rats and rabbits with intravenous administration of pafolacianine during organogenesis (embryofetal development) at doses up to 158-fold (rat) and 570-fold (rabbit) the recommended human dose of 0.025 mg/kg based on AUC, otherwise 9.6 and 38.4-fold based on human equivalent dose (HED) ( see Data ). The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In the definitive embryo-fetal development (EFD) studies, pafolacianine was intravenously administered during the period of organogenesis as follows: 0.015, 0.15, and 1.5 mg/kg/day from gestational day (GD) 6 to GD17 in rats (HEDs of 0.002, 0.024 and 0.242 mg/kg/day), and 0.3, 1, and 3 mg/kg/day from GD7 to GD20 in rabbits (HEDs of 0.097, 0.323 and 0.968 mg/kg/day). No significant drug-related maternal toxicity and embryo-fetal development toxicity were observed. NOAELs were 1.5 mg/kg/day in rats and 3 mg/kg/day in rabbits. Estimated systemic exposures were 158 times (rat) and 570 times (rabbit) the human exposure at a human dose of 0.025 mg/kg based on plasma AUC comparison.
8.2 Lactation Risk Summary There are no data on the presence of pafolacianine in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for CYTALUX and any potential adverse effects on the breastfed infant from CYTALUX or from the underlying maternal condition.
8.3 Females and Males of Reproductive Potential CYTALUX may cause fetal harm if administered to a pregnant woman [see Warnings And Precautions ( 5.3 ) and Use in Specific Populations ( 8.1 )] . Pregnancy Testing Obtain a pregnancy test in females of reproductive potential and verify the absence of pregnancy prior to administration of CYTALUX [see Dosage and Administration ( 2.1 )] .
8.4 Pediatric Use Safety and effectiveness of CYTALUX in pediatric patients have not been established.
8.5 Geriatric Use Of the total number of patients in clinical studies of CYTALUX, 221 patients (54%) were 65 years of age and older: 153 (38%) were 65 to 74 years of age, 66 (16%) were 75 to 84 years of age, and 2 (0.5%) were 85 years of age and older. No overall differences in safety, effectiveness, or pharmacokinetics were observed between patients 65 years of age and older and younger adult patients.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied CYTALUX (pafolacianine) injection, 3.2 mg /1.6 mL (2 mg/mL), is a dark bluish green, clear aqueous solution packaged in a sealed amber glass single-dose vial. It is supplied in a carton containing 10 vials (NDC 81052-138-10), individually packaged. Storage and Handling Store frozen between -25° to -15°C (-13° to 5°F). Store in original carton to protect from light.
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