Is Pafolacianine approved by the FDA?

Pafolacianine received FDA approval on November 29, 2021. This approval has provided surgeons with a novel tool to enhance the visualization of ovarian cancer lesions, thereby improving surgical outcomes.

Uses

Pafolacianine is specifically used to aid in the detection of ovarian cancer lesions during surgery. It is given to patients in a hospital setting, typically 1 to 9 hours before the surgical procedure. The medicine is administered slowly over a period of at least 60 minutes through an intravenous needle.

Precautions

Before using pafolacianine, several precautions should be considered:

• Allergies: Patients should inform their doctor about any known allergies to medications, foods, dyes, preservatives, or animals.
• Pregnancy and Breastfeeding: Pafolacianine can harm an unborn baby. Women of childbearing age may need a pregnancy test before starting treatment. There is no adequate data on its safety during breastfeeding.
• Interactions: Patients should avoid taking folate, folic acid, or folate-containing supplements 48 hours before receiving pafolacianine. Certain medications and lifestyle factors (such as alcohol or tobacco use) can also interact with pafolacianine.

Administration and Dosage

Pafolacianine is given as an intravenous injection by a healthcare professional. The drug is administered slowly, and patients are often given additional medications, such as allergy or anti-nausea medicine, to prevent potential side effects.

Side Effects

Like all medications, pafolacianine can cause side effects. Some of the more common and serious side effects include:

• Common: Nausea and vomiting.
• Less Common: Acid or sour stomach, back pain, chest discomfort or tightness, chills, fast heartbeat, feeling of warmth, fever, headache, heartburn, hives, itching, rash, hoarseness, indigestion, joint pain, stiffness or swelling, redness of the face, neck, arms, and sometimes upper chest, stomach pain or discomfort, swelling of the eyelids, face, lips, hands, or feet, trouble breathing, and weakness.

Conclusion

Pafolacianine (Cytalux) is an FDA-approved medication that aids in the detection and removal of ovarian cancer lesions during surgery. Approved on November 29, 2021, it represents a significant advancement in the surgical treatment of ovarian cancer. Patients receiving this medication should be aware of potential side effects and necessary precautions to ensure the best possible outcome during their surgical procedures.

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