Pafolacianine

Pafolacianine is an optical imaging agent indicated as an adjunct for intraoperative identification of malignant lesions in adult patients with ovarian cancer  and malignant and non-malignant pulmonary lesions in adult patients with known or suspected cancer in the lung.

• Pafolacianine is available under the following different brand names: Cytalux

Common side effects of Pafolacianine include:

• nausea
• vomiting
• abdominal pain
• flushing
• indigestion
• chest discomfort
• itching
• hypersensitivity

Serious side effects of Pafolacianine include:

• hives
• difficulty breathing
• swelling of the face, lips, tongue, or throat
• vomiting
• abdominal pain
• flushing (warmth, redness)
• chest pain or pressure
• bloating or feeling of fullness
• itching

Rare side effects of Pafolacianine include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injectable solution

• 2 mg/mL (3.2mg/1.6mL single-dose vial); equivalent to 3.4 mg/1.6 mL pafolacianine sodium

Ovarian cancer imaging

Adult dosage

• 0.025 mg/kg IV for 1 dose; administer 1-9 hours before surgery

Lung lesion imaging

Adult dosage

• 0.025 mg/kg IV for 1 dose; administer 1-24 hours before surgery

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Pafolacianine has severe interactions with no other drugs.
• Pafolacianine has serious interactions with the following drugs:
  • folic acid
• iron/folic acid/vitamin/mineral
• Pafolacianine has moderate interactions with no other drugs.
• Pafolacianine has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Pafolacianine?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Pafolacianine?”

Cautions

• Infusion-related reactions including nausea, vomiting, abdominal pain, flushing, dyspepsia, hypersensitivity, elevated blood pressure, and chest discomfort were reported; reactions typically occurred within 15 minutes of starting the infusion
• Errors may occur during intraoperative fluorescence imaging to detect ovarian cancer and lesions in the lung, including false negatives and false positives; nonfluorescent tissue in the surgical field does not rule out the presence of ovarian or lung cancer; fluorescence may be seen in normal tissues (including the bowel, kidneys, lymph nodes, and lungs) as well as in inflamed tissues
• Based on its mechanism of action, pafolacianine may cause fetal harm when administered to pregnant women
• Use only D5W to dilute the drug; using an incorrect diluent to prepare infusion solution can cause aggregation of Pafolacianine; aggregation may induce infusion reactions, such as nausea, vomiting, abdominal pain, or rash
• Drug interactions overview
  • Folate, folic acid, or folate-containing supplements
  • Avoid use within 48 hours before administration
  • Use of folate, folic acid, or folate-containing supplements may reduce the binding of Pafolacianine to folate receptors overexpressed on ovarian cancer cells and could reduce the detection of malignant lesions

Pregnancy and Lactation

• Based on its mechanism of action, pafolacianine may cause fetal harm when administered to pregnant women
• No human data are available to evaluate the drug-associated risks for major birth defects, miscarriage, or other adverse maternal-fetal outcomes
• Verify the pregnancy status of women of reproductive potential before administration
• Lactation
  • No data available on the presence of pafolacianine in either human or animal milk, its effects on breastfed infants, or milk production