Molecule
Pafolacianine is an optical imaging agent indicated as an adjunct for intraoperative identification of malignant lesions in adult patients with ovarian cancer. It is available as injection for intravenous use. MedsAcross supplies Pafolacianine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
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.
Source: US FDA prescribing information
Pafolacianine binds to alpha and beta folate receptors (FR) on cells, is internalized via receptor-mediated endocytosis, and accumulates intracellularly. Pafolacianine enhances lesion visualization through the differential level of expression and accessibility of folate receptors within lesions relative to normal tissue. 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 peak emission of 796 nm.
Source: US FDA prescribing information
For recommended testing, evaluations, and premedications, see Full Prescribing Information. 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. 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.
Source: US FDA prescribing information
None. None.
Source: US FDA prescribing information
Infusion-Related Reactions: Interrupt the infusion and treat as necessary with antihistamines and/or nausea medications. 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. Embryo-Fetal Toxicity: CYTALUX may cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus. Risk of Pafolacianine Aggregation and Infusion Reactions: Use only 5% Dextrose Injection for dilution. Do not use other diluents.
Source: US FDA prescribing information
The following clinically significant adverse reaction is described elsewhere in the labeling: • Infusion-Related Reactions 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.
Source: US FDA prescribing information
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. Folate Supplements: Avoid folate, folic acid, or folate-containing supplements within 48 hours before administration of CYTALUX.
Source: US FDA prescribing information
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. Storage Condition Condition Temperature Range Maximum Single Period Permissible Freeze-Thaw Cycles Frozen -25°C to -15°C (-13°F to 5°F) Until Expiration Date Not applicable Refrigeration 2°C to 8°C (36°F to 46°F) Up to 30 days Three Room Temperature 20°C to 25°C (68°F to 77°F) Up to 24 hours Three Do not use the product past the expiration date Store vials in their original cartons to protect from light. CYTALUX may be stored according to the table below.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Pafolacianine, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Cytalux 3.2 mg/1.6 mL injectionIntravenous Cold chain | On Target Laboratories | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 29 November 2021 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Yes, on request. MedsAcross lists 1 presentations of Pafolacianine and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Pafolacianine, including Cytalux.
Yes. The US FDA first approved Pafolacianine on 29 November 2021, according to Drugs@FDA.
At least one listed presentation of Pafolacianine must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.