Brand Name
Cytalux
Generic Name
Pafolacianine
View Brand Information FDA approval date: November 29, 2021
Classification: Optical Imaging Agent
Form: Injection
What is Cytalux (Pafolacianine)?
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.
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Brand Information
Cytalux (Pafolacianine injection)
1INDICATIONS 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.
2DOSAGE FORMS AND STRENGTHS
Injection: 3.2 mg/1.6 mL (2 mg/mL) pafolacianine (equivalent to 3.4 mg/1.6 mL pafolacianine sodium)
3CONTRAINDICATIONS
None.
4ADVERSE REACTIONS
The following clinically significant adverse reaction is described elsewhere in the labeling:
4.1Clinical 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
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 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.
5DRUG INTERACTIONS
Use of folate, folic acid, or folate-containing supplements may reduce binding of pafolacianine to
6DESCRIPTION
CYTALUX contains pafolacianine, an optical imaging agent, as a tetrasodium salt referred to as
CYTALUX (pafolacianine) injection is a sterile, non-pyrogenic, dark bluish green, clear aqueous
7HOW 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.
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 vials in their original cartons to protect from light.
Store vials in their original cartons to protect from light.
CYTALUX may be stored according to the table below. If CYTALUX vial is not used within the maximum single period at either room temperature or under refrigerated conditions the vial may be refrozen up to three time.
Do not use the product past the expiration date
8PATIENT 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 ( ].
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 ( ].
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 ( ].
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 ( ].
9Vial Carton
NDC 81052-138-10
cytalux
3.2 mg / 1.6 mL (2 mg/mL)
10 x 1.6 mL Single-Dose Vials. Discard Unused Portion
Store vials in original carton to protect from light. Store frozen at
may be stored refrigerated at 2° to 8°C (36° to 46°F) up to 30 days
or at room temperature at 20° to 25°C (68° to 77°F) up to 24 hours.
Rx only
ON TARGET LABORATORIES
10Single Vial Carton Label
NDC 81052-138-01
cytalux
3.2 mg / 1.6 mL
For Intravenous Infusion After Dilution
Store vials in original carton to
Rx only
ON TARGET LABORATORIES
11Vial Label
NDC 81052-138-00
Sterile
cytalux
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
19086
LOT:
