Cytalux 3.2 mg/1.6mL
Pafolacianine injection · INJECTION · On Target Laboratories, Inc.
Cytalux (pafolacianine injection) is a prescription medication given by injection into a vein that helps surgeons visualize certain types of ovarian cancer during surgery. It works by binding to cancer cells so they fluoresce under special imaging equipment during the procedure.
Key Facts
- Brand Name
- Cytalux
- Generic Name
- Pafolacianine injection
- NDC Code (Product)
81052-138- Manufacturer
- On Target Laboratories, Inc.
- Strength
- 3.2 mg/1.6mL
- Dosage Form
- INJECTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA214907
- Marketing Start
- 11/29/2021
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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 )
Dosage & Administration
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 W…
Contraindications
4 CONTRAINDICATIONS None. None. (4)
Drug Interactions
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.
Adverse Reactions
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 …
Frequently Asked Questions
What is Cytalux used for?
Cytalux (pafolacianine injection) is a prescription medication given by injection into a vein that helps surgeons visualize certain types of ovarian cancer during surgery. It works by binding to cancer cells so they fluoresce under special imaging equipment during the procedure.
Is Cytalux a controlled substance?
Cytalux is not classified as a controlled substance by the DEA.
What is the generic name for Cytalux?
The generic name for Cytalux is Pafolacianine injection. There are no other listed brand versions of Pafolacianine injection.
What is the NDC code for Cytalux 3.2 mg/1.6mL?
The NDC (National Drug Code) for Cytalux 3.2 mg/1.6mL is 81052-138, listed by On Target Laboratories, Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)